Abbott Alinity c, L-Gammaglutamyl-3-carboxy-4-nitroanilid-Substrate

Serum: Serum separator

Plasma: Lithium heparin, Sodium heparin

20-25℃: 7 days                  

2-8℃: 7 days        

-20℃: 3 months

Abbott IFu

24 Hours

U/L

Male: < 55

Female: < 38

Blood sample on or after 10 weeks of gestation

GeneSafe is a single gene NIPT that screens for a broad range of genetic disorders, including both inherited conditions and those caused by de novo mutations. By analysing cfDNA from a maternal blood sample, GeneSafe offers a more comprehensive risk assessment compared to traditional NIPT, covering conditions often missed in routine testing and allowing for early detection. Available in 3 panels: Inherited, De Novo, and Complete, GeneSafe is indicated for couples with advanced parental age, abnormal ultrasound findings, or those wishing to avoid invasive diagnostic procedures.

GeneSafe Inherited screens for common autosomal recessive genetic disorders, including cystic fibrosis, thalassemia-beta, sickle cell anaemia, and autosomal recessive deafness (types 1A and 1B).

GeneSafe De Novo detects 44 severe genetic disorders caused by de novo mutations in 25 genes. These mutations, which are associated with advanced paternal age, include skeletal dysplasia, congenital heart defects and neurodevelopmental disorders such as autism and intellectual disability.

GeneSafe Complete combines the Inherited and De Novo panels, providing a comprehensive genetic screen for couples seeking a thorough risk assessment during pregnancy.

12 Days

Next Generation Sequenccing

3ml Blood or buccal swab

Genescreen is an advanced carrier screening test using NGS for full-exon analysis of genes associated with autosomal recessive and X-linked monogenic disorders. It detects pathogenic variants in asymptomatic individuals, providing an accurate reproductive risk assessment for severe genetic conditions.

With high sensitivity, GeneScreen detects both common and rare pathogenic variants, ensuring a comprehensive assessment of carrier status. Customisable panels for partner or donor-recipient matching can be expanded based on family history or clinical needs.

GeneScreen is indicated for individuals or couples with a genetic disease history, consanguinity, or those undergoing ART, gamete donation, or pregnancy.

• Matching - 18 days
• Extension - 23 days
• Customisation - 33 days

Abbott Alinity c, Particle-enhanced turbidimetric inhibition immunoassay (PETINIA)

Serum:

Serum tubes (with or without gel barrier)

Plasma: Acceptable anticoagulants are:

Lithium heparin (with or without gel barrier)

Sodium heparin

K2-EDTA

K3-EDTA

2-8℃: 7 days      

<-10℃: 14 days

Abbott IFU

24 hours

mg/L

Trough (Less Severe Infection): <1

Trough (Severe Infection): <2 - 4

Peak (Less Severe Infection): 5 - 8

Peak (Severe Infection): 8 - 10

Toxic Levels: >10 - 12

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CALCULATION based on Abbott Alinity methodologies for Total Protein and Albumin.

Serum: Serum tubes (with or without gel barrier)

Plasma: Acceptable anticoagulants are:

Sodium heparin

Potassium EDTA

Sodium citrate

Abbott:

20-25°C: 7 days

2-8°C: 7 days

-20°C: 3 months

Abbott IFU

‍

24 hours

g/L

Abbott:

Adults: 21 - 36

Abbott Alinity c, Enzymatic (Hexokinase/ G-6-PDH)

Plasma: Acceptable anticoagulants are:

Sodium Fluoride

Potassium Oxalate

Sodium Fluoride/K2 EDTA

20-25℃: 2 days                    

2-8℃: 7 days        

-20℃: 3 months

WHO criteria for the diagnosis of diabetes mellitus.

Glucose levels can indicate insulin resistance and dysglycaemia, which may impair ovulatory function, endometrial receptivity and fertility outcomes. This is especially relevant with PCOS, where hyperinsulinemia contributes to anovulation, and in cases of recurrent implantation failure

24 Hours

mmol/L

Fasting glucose: ≤ 6.00

Molecular Biology – Real-time PCR

Whole blood EDTA

Temperature: + 4ºC

Miscellaneous: Non fasting

Whole blood at room temperature: 7 days.

Long term storage (>10 days) of blood samples intended for nucleic acid isolation should be in EDTA tubes at 4 °C.

DNA extracts: 3 Months at -20˚C

Primary EDTA tube: 3 Months at 4˚C

HLA-B27 is a class I surface antigen strongly associated with seronegative spondyloarthropathies, such as ankylosing spondylitis. Ankylosing spondylitis is a type of arthritis characterised by long-term inflammation of the joints of the spine. 90% of patients diagnosed with Ankylosing spondylitis (AS) test positive for HLA-B27, thus genotyping is suitable for the differential diagnosis of AS. However, only 1-2% of those who test positive for HLA-B27 develop AS. Therefore, the test is not indicated as a screening test.

HLA-B27 has a frequency of approximately 8% in the general Caucasian population.

Preparation of patient: There is no physical preparation for the HLA-B27 test.

Precautions: None.

5 working days from sample receipt

HLA-B27 Positive

HLA-B27 Negative

Invalid

Chemiluminescent microparticle immunoassay (CMIA)

Chemiluminescent microparticle immunoassay (CMIA)

Serum (Gold and red cap);

Plasma (green and lavender cap)

Temperature: + 4ºC

Miscellaneous: Non fasting

Serum (Gold and red cap);

Plasma (green and lavender cap)

Temperature: + 4ºC

Miscellaneous: Non fasting

≤ 3 days at 15-30 ºC

≤ 14 days at 2-8ºC

Separated: ≥ 14 days at -20ºC or colder

≤ 3 days at 15-30 ºC

≤ 14 days at 2-8ºC

Separated: ≥ 14 days at -20ºC or colder

Source: Abbott IFU

Source: Abbott IFU

HTLV-I and HTLV-II are closely related human type C retroviruses. HTLV-I has been etiologically associated with neoplastic conditions and a variety of demyelinating neurologic disorders including adult T-cell leukaemia, tropical spastic paraparesis and/or HTLV-I associated myelopathy and more recently HTLV-I associated polymyositis, arthritis, and infective dermatitis.

Detection of antibodies against HTLV-I and HTLV-II serves to aid in the diagnosis of HTLV infection and to protect the safety of blood supply.

Preparation of Patient: There is no special physical preparation for the HTLV-I/II test.

5 working days

5 working days

Specimens with S/CO values < 1.00 are considered Non-reactive (NR).

Specimens with S/CO values >= 1.00 are considered Reactive (R).

This is a screening test and reactive samples will be referred to NVRL for confirmatory testing.

A negative (non-reactive) test result does not exclude the possibility of exposure to human T-cell lymphotropic virus types I and II.

Levels of total antibodies to these viruses may be undetectable in early infection.

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Molecular Biology - Real time PCR

Whole blood EDTA

Temperature: + 2-8ºC

Miscellaneous: Non fasting

Whole blood at room temperature: 3 days.

Long term storage (>3 days) of blood samples intended for nucleic acid isolation should be in EDTA tubes at 2-8 °C.

DNA extracts: 3 Months at -20˚C.

Primary EDTA tube: 3 Months at 4˚C

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Haemochromatosis is an inherited condition leading to excessive iron absorption from food and is more common in Ireland than anywhere else in the world. One in 83 Irish people carry two copies of the HFE gene (i.e. a faulty gene from each parent) and are predisposed to develop iron overload. One in five carry one copy of the gene and are said to be carriers.

Early diagnosis and treatment are crucial to prevent serious complications.

What to look out for in patients:

• Chronic unexplained fatigue, weakness and abdominal pain
• Asymptomatic patients with incidental elevated LFT, ferritin or hepatomegaly
• Family members of HH patients - in the case of brothers and sisters (siblings) there is a 1 in 4 chance of being affected
• Liver disease of unknown cause, suspected alcoholic liver disease
• Early onset arthralgia (joint pain), atypical arthropathy
• Early onset male impotency, early menopause and loss of libido in women
• Early onset arrhythmias and cardiomyopathy
• Unexplained increasing skin pigmentation
• When women enter menopause and stop menstruating, it may emerge
• Diabetes, especially where there might be a family history of genetic haemochromatosis

Why get tested?

Excess iron is a free radical, with deposits building up in organs, mainly in the liver, and the pancreas, heart, anterior pituitary and joints.

Treatment

Regular venesections or phlebotomy is still the most effective treatment for haemochromatosis. (In some case, chelation therapy may be recommended for cases where patients cannot tolerate venesection treatment).

Dietary modifications: Avoid iron supplements, multivitamins that contain iron and Vitamin C supplements. Avoid raw or undercooked shellfish. Limit alcohol consumption.

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Price:

Email: sales@ctie.eurofinseu.com

‍

7 working days from sample receipt.

Homozygous for C282Y and H63D mutations.

Heterozygous for C282Y and H63D mutations.

C282Y and H63D mutations not present.

TOSOH - High Performance Liquid Chromatography (HPLC)

Whole Blood Acceptable anticoagulants are:

Potassium EDTA

20-25°C: 1 day

2-8°C: 14 days

Irish College of General Practitioners "A Practical Guide to Integrated Type II Diabetes Care 2016"

24 Hours

mmol/mol

Adult: 20 - 42

Chemiluminescent microparticle immunoassay (CMIA)

Chemiluminescent microparticle immunoassay (CMIA)

Serum (Gold and red cap);

Plasma (green and lavender cap)

Temperature: + 4ºC.

Miscellaneous: Non fasting

Serum (Gold and red cap);

Plasma (green and lavender cap)

Temperature: + 4ºC.

Miscellaneous: Non fasting

Whole blood:

Up to 24 hours at RT or ≤ 6 days at 2-8ºC

Separated: ≥ 6 days at -20ºC or colder.

Avoid more than 3 freeze/thaw cycles

Whole blood:

Up to 24 hours at RT or ≤ 6 days at 2-8ºC

Separated: ≥ 6 days at -20ºC or colder.

Avoid more than 3 freeze/thaw cycles

Source: Abbott IFU

Source: Abbott IFU

This is a polypeptide component of the Hepatitis B virus particle external envelope. Its presence in the blood indicates infection by the virus; it is the first hepatitis B immunological marker and is present in blood days or weeks before symptoms appear. It may persist in persons who are chronic carriers of hepatitis B.

Preparation of Patient: There is no special physical preparation for this test.

1 working day

1 working day

Specimens with S/CO values < 1.00 are considered nonreactive (NR). Specimens with S/CO values >=1.00 are considered reactive (R).

This is a screening test and reactive samples will be referred to NVRL for confirmatory testing.

Hep B surface antigen alone is not useful during the "window period" of acute hepatitis B infection (i.e. after the disappearance of Hep B surface antigen and before the appearance of Hep B surface antibody). Testing for acute hepatitis B infection should also include hepatitis B core IgM antibody.

Chemiluminescent microparticle immunoassay (CMIA)

Chemiluminescent microparticle immunoassay (CMIA)

Serum (Gold and red cap);

Plasma (green and lavender cap)

Temperature: + 4ºC

Miscellaneous: Non fasting

Serum (Gold and red cap);

Plasma (green and lavender cap)

Temperature: + 4ºC

Miscellaneous: Non fasting

≤ 7 days at 2-8ºC

≤ 3 months at -20ºC or colder.

≤ 7 days at 2-8ºC

≤ 3 months at -20ºC or colder.

Source: Abbott IFU

Source: Abbott IFU

This test detects the presence of antibodies to the Hepatitis C virus. Preparation of Patient: There is no special physical preparation for the Hepatitis C Ab test.

1 working day

1 working day

Specimens with S/CO values < 1.00 are considered Non-reactive (NR).

Specimens with S/CO values >= 1.00 are considered Reactive (R).

This is a screening test and reactive samples will be referred to NVRL for confirmatory testing

‍

Chemiluminescent microparticle immunoassay (CMIA)

Serum (Gold and red cap); plasma (green and lavender cap)

Temperature: + 4ºC

Miscellaneous: Non fasting.

≤ 5 days at 2-8ºC

> 5 days at -20ºC or colder.

Source: Abbott IFU

ARCHITECT HCV Ag is a Chemiluminescent Microparticle Immunoassay (CMIA) using microparticles coated with monoclonal anti-HCV for the detection of HCV Ag. HCV Ag assays are used as an aid in the diagnosis of suspected Hepatitis C viral (HCV) infection and to monitor the status of infected individuals, i.e., whether the patient’s infection has resolved or the patient has become a chronic carrier of the virus. For the diagnosis of acute or chronic hepatitis, HCV Ag reactivity should be correlated with patient history and the presence of other Hepatitis C serological markers.

Preparation of Patient: There is no special physical preparation for the Hepatitis C Ag test.

‍

4 working days

Specimens with concentration values <3.00 fmol/L are considered non-reactive for HCV Ag.

Values ≥3.00 fmol/L are considered reactive for HCV Ag.

Specimens with concentration values ≥3.00 fmol/L to <10.00 fmol/L should be retested after re-centrifuging at 3,000 g for 10 minutes).

If recent contact or exposure risk suggest repeat sample after 6 weeks for Hepatitis C RNA.

Histology Processing. Diagnosis

• The specimen container(s) must be adequately labelled.
• An adequately completed test request form must accompany the specimen.

Specimen(s) are stable at room temperature once fixed in 10% neutral buffered formalin.

Small biopsies: encompass needle tissue cores (prostate, breast, etc) and small surgical tissue pieces measuring less than 5mm.

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Endoscopic biopsies: are widely used to diagnose and manage gastro- intestinal disease. They may be taken from the upper gastrointestinal tract (e.g. oesophageal and gastric biopsies) or the lower gastrointestinal tract (e.g. colonic or rectal biopsies). The average size of a GI biopsy ranges from 1-5mm.

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Non-biopsy / Other: encompasses a wide range of specimen types. Commonly encountered specimens in this category are: skin excisions, curetting’s, tonsils, gallbladders, appendices.

‍

Malignant resections: are obtained by the therapeutic surgical removal of an entire diseased area or organ. These procedures are often intended as definitive surgical treatment of a disease in which the diagnosis is already known or strongly suspected. However, pathological analysis of these specimens is critically important in confirming the previous diagnosis, staging the extent of malignant disease, establishing whether or not the entire diseased area was removed, identifying the presence of unsuspected concurrent diseases, and providing information for postoperative treatment, such as adjuvant chemotherapy in the case of cancer

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10 working days routine specimens.

15 working days dermatology specimens.

Up to 7 days for urgent specimens

Abbott Alinity i Chemiluminescent Microparticle Immunoassay (CMIA)

Serum: Serum, Serum separator Plasma: Lithium heparin, Potassium EDTA

ON ICE: 6 hours                  

2-8℃: 14 days      

-20℃: 1 year

Abbott IFU

24 Hours

µmol/L

Adult Male: 5.5 - 16.2

Adult Female: 4.4 - 13.6

The cobas® 4800 HPV Test is a qualitative in vitro test for the detection of HPV in patient specimens, The test utilises amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridisation for the detection of 14 HR HPV types in a single analysis. The test specifically identifies HPV 16 and HPV 18 while concurrently detecting the other high-risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) at clinically relevant infection levels.

Sample Type: Cervical smear in ThinPrep PreservCyt Solution.

The total volume of sample in the tube should be at least 3ml.

Specimens collected in PreservCyt Solution can be transported at 2-30°C. Specimens may be stored at 2-30°C for up to 6 months after the date of collection.

Persistent infection with human papillomavirus (HPV) is the cause of cervical cancer and its precursor cervical intraepithelial neoplasia (CIN). The presence of HPV has been implicated in greater than 99% of cervical cancers, worldwide.

HPV is a small, non-enveloped, double-stranded DNA virus, with a genome of approximately 8000 nucleotides. There are more than 118 different types of HPV, and approximately 40 different HPVs that can infect the human anogenital mucosa. However, only a subset of 13 to 18 of these types is considered high-risk for the development of cervical cancer and its precursor legions.

Although persistent infection with high-risk (HR) HPV is a necessary cause of cervical cancer and its precursor lesions, a very small percentage of infections progress to these disease states. Sexually transmitted infection with HPV is extremely common, with estimates of up to 75% of all women experiencing HPV at some point. However, > 90% of infected women will mount an effective immune response and clear the infection in 6 to 24 months without any long-term health consequences.

Nucleic acid (DNA) testing by PCR is a non-invasive method for determining the presence of a cervical HPV infection. The implementation of HPV DNA testing has increased the efficiency of cervical cancer screening programs by detecting high-risk lesions earlier in women 30 years and older with NILM cytology and by reducing the need for unnecessary colposcopy and treatment in patients 21 and older with ASC-US (abnormal) cytology.

10 working days from sample receipt for co-testing (all samples sent to Eurofins NMDL, The Netherlands for cytology following HPV testing).

HPV16 and/or HPV18 and/or Other HR HPV

• Detected
• Not Detected
• Invalid

Chemiluminescent microparticle immunoassay (CMIA)

Chemiluminescent microparticle immunoassay (CMIA)

Serum (Gold and red cap);

Plasma (green and lavender cap)

Temperature: + 4ºC

Miscellaneous: Non fasting

Serum (Gold and red cap);

Plasma (green and lavender cap)

Temperature: + 4ºC

Miscellaneous: Non fasting

Whole blood: ≥ 3 days at RT or 14 days at 2-8ºC

Separated: at -20ºC or colder.

Whole blood: ≥ 3 days at RT or 14 days at 2-8ºC

Separated: at -20ºC or colder.

Source: Abbott IFU

Source: Abbott IFU

This Combo test measures antibodies to HIV-1 and HIV-2, and the HIV p24 antigen. The test is positive if either or both of these are present, and does not distinguish between them.

Preparation of Patient: There is no special physical preparation for the HIV test.

1 working day

1 working day

Negative

Non Reactive

Please send a further sample taken at least 7 days after the current sample if HIV infection is still suspected.

Specimens with S/CO values < 1.00 are considered non-reactive.(NR).

Specimens with S/CO values >= 1.00 are considered reactive (R).

This is a screening test and reactive samples will be referred to NVRL for confirmatory testing.

Abbott Alinity c, Immuno turbidimetric

Serum: Serum tubes (with or without gel barrier)

Plasma - Acceptable anticoagulants are: Lithium heparin (with or without gel barrier)Sodium heparin EDTA

20-25℃: 7 days                

2-8℃: 7 days        

-20℃: 6 months

Abbott IFu

24 Hours

g/L

Male 12 to 60 years: 0.63 - 4.84

Female 12 to 60 years: 0.65 to 4.21

Male > 60 years: 1.01 to 6.45

Female > 60 years: 0.69 to 5.17

Abbott Alinity c, Immuno turbidimetric

Serum: Serum tubes

Plasma - Acceptable anticoagulants are: Sodium heparin, Lithium heparin, Sodium EDTA Potassium EDTA, Sodium citrate

2-8℃: 2 days

Abbott IFU

24 Hours

IU/mL

Adults: < 100 IU/mL

Abbott Alinity c, Immuno turbidimetric

Serum: Serum tubes (with or without gel barrier)

Plasma -Acceptable anticoagulants are: Lithium heparin (with or without gel barrier) Sodium heparin

20-25℃: 7 days                

2-8℃: 7 days      

-20℃: 6 months

Abbott IFU

24 Hours

g/L

Male 2 to 80 years: 5.4 - 18.22

Female 2 to 80 years: 5.52 - 16.31

Abbott Alinity c, Immuno turbidimetric

Serum: Serum tubes (with or without gel barrier)

Plasma - Acceptable anticoagulants are: Lithium heparin (with or without gel barrier)Sodium heparin EDTA

20-25℃: 7 days                

2-8℃: 7 days      

-20℃: 6 months

Abbott IFU

24 Hours

g/L

Male >12years: 0.22 - 2.40

Female >12years: 0.33 - 2.93

Automated

The specimen container(s) must be adequately labelled.

• An adequately completed test request form must accompany the specimen.

Specimen(s) are stable at room temperature once fixed in 10% neutral buffered formalin.

IHC is used in histology to detect the presence of specific protein markers that can assist with accurate tumour classification and diagnosis. IHC has evolved to complement the Haematoxylin & Eosin (H&E) and Special Stain techniques that typically show tissue morphology (structure). Where H&E and Special Stains are non-specific, IHC is directed to a specific protein marker or markers. IHC is used as a diagnostic tool to assist in the diagnosis of solid tumours and cytological specimens and has been used as a mainstream diagnostic tool for almost half a century.

The Platform used in Eurofins Pathology is the BenchMark ULTRA Advanced Staining System which is intended to automatically stain histological or cytological specimens on microscope slides with specific immunohistochemistry or in situ hybridization reagents for in vitro diagnostic use. Evolved from the BenchMark series of instruments, the BenchMark ULTRA instrument fully automates the processes of baking, deparaffinization, and staining.

+5 working days

Haematology- Immunoassay

Whole blood serum or plasma

Temperature: + 2-8ºC

Miscellaneous: N/A

3 days @ + 2-8ºC

SOP: H20, H62

Infectious mononucleosis (glandular fever) is an acute infectious disease caused by the Epstein-Barr virus and primarily affects lymphoid tissue.  It is characterized by the appearance of enlarged and often tender lymph nodes, enlarged spleen, and abnormal lymphocytes in the blood.  Patients usually, but not always, develop a transient heterophile antibody response.

The detection of heterophile antibodies of Infectious Mononucleosis by the agglutination of sheep red cells was first reported by Paul and Bunnel in 19321. Subsequent work identified the need for differential absorption of sera to remove non-infectious mononucleosis heterophile antibodies.  Fetcher and Woolfolk showed

that antigens obtained from bovine erythrocytes were more effective than those antigens obtained from either sheep or horse erythrocytes.

1Israëls MC. Infectious Mononucleosis and Monocytic Leukaemia. Br Med J. 1937 Mar 20;1(3976):601-624.3. PMID: 20780547; PMCID: PMC2088424.

Preparation of patients: There is no physical preparation for the infectious mononucleosis test.

Precautions: IgG and IgM values obtained with different manufacturers' assay methods may not be used interchangeably. The magnitude of the reported IgG or IgM level cannot be correlated to an endpoint titre.

24 hours

Positive or negative

ELISA

Serum (Gold and red cap); Plasma (lavender cap)

Temperature: + 4ºC or spun, separated and frozen at -20°C

Whole blood: unknown.

Separated: RT 7 days. Longer @ -20ºC

IDK Infliximab drug level IFU

Tumor Necrosis Factor alpha (TNFɑ) belongs to the proinflammatory cytokines which promote and sustain inflammatory reactions. It is produced by macrophages and T cells and plays a central role in both acute and chronic inflammations. Consequently, chronic inflammatory diseases like Crohn’s disease, ulcerative colitis, rheumatoid arthritis, or psoriasis are increasingly being treated with antibodies against TNFɑ, which target directly the underlying inflammatory process.

During recent years, reports of an association between anti-drug antibodies (ADAs) and adverse effects of treatments both in CD and UC have surfaced. Development of ADAs is usually considered to be associated to immunogenicity of monoclonal antibodies. The clinical efficacy of an anti-TNFɑ therapy usually correlates with the trough level of the therapeutic antibody, or the drug level just before the next application of the anti-TNFɑ antibody. Several factors influence the trough level, among them dosage and frequency of anti-TNFɑ blocker infusion, disease activity, individual pharmacokinetics and immune reaction (formation of anti-drug antibodies, ADA)

The IDKmonitor® infliximab drug level ELISA for the determination of the drug level of infliximab (eg REMICADE®) measures quantitatively free infliximab in EDTA plasma and serum. In combination with the detection of ADA against infliximab, the IDKmonitor®infliximab drug level ELISA is an opportunity for the treating physician to monitor and optimize treatment early on.

Preparation of Patient: No special preparation.

‍

10 working days

(ug/mL) A detectable anti-TNF trough level (immediately pre-dose) is associated with a higher rate of clinical and endoscopic remission

‍

ELISA

Serum (Gold and red cap); Plasma (lavender cap)

Temperature: + 4ºC or spun, separated and frozen at -20°C

Whole blood: unknown.

Separated: RT 7 days. Longer @ -20ºC

IDK total Infliximab Antibody level IFU

Tumor Necrosis Factor alpha (TNFɑ) belongs to the proinflammatory cytokines which promote and sustain inflammatory reactions. It is produced by macrophages and T cells and plays a central role in both acute and chronic inflammations. Consequently, chronic inflammatory diseases like Crohn’s disease, ulcerative colitis, rheumatoid arthritis, or psoriasis are increasingly being treated with antibodies against TNFɑ, which target directly the underlying inflammatory process.

During recent years, reports of an association between anti-drug antibodies (ADAs) and adverse effects of treatments both in CD and UC have surfaced. Development of ADAs is usually considered to be associated to immunogenicity of monoclonal antibodies. The clinical efficacy of an anti-TNFɑ therapy usually correlates with the trough level of the therapeutic antibody, or the drug level just before the next application of the anti-TNFɑ antibody. Several factors influence the trough level, among them dosage and frequency of anti-TNFɑ blocker infusion, disease activity, individual pharmacokinetics and immune reaction (formation of anti-drug antibodies, ADA). It is thought that ADA functionally neutralize the therapeutic antibodies or induce their rapid elimination. Consequences of ADA formation can be therapy failure and allergic reactions during anti-TNFɑ antibody application.

The IDKmonitor® Infliximab total ADA ELISA for the detection of total antibodies against infliximab measures free and bound antibodies against infliximab. This assay allows a reliable determination of ADA even in the presence of infliximab; therefore, it is ideal for therapy monitoring when a measurable infliximab concentration is expected, for example shortly after last infusion. In combination with the drug level determination, the IDKmonitor® Infliximab total ADA ELISA is an opportunity for the treating physician to monitor and optimize treatment early on.

Preparation of Patient: No special preparation.

10 working days

(AU/mL) - A total Infliximab Antibody concentration >/= 10 AU/mL is positive.

This assay measures TOTAL infliximab antibody concentration, and is not sensitive to the presence of drug.

Abbott Alinity i Chemiluminescent Microparticle Immunoassay (CMIA)

Serum: Serum, Serum separator

Plasma: Potassium EDTA Sodium EDTA, Sodium heparin, Sodium fluoride

-20℃: 7 days

Williams Textbook of Endocrinology 13th edition 2015

24 Hours

mIU/L

Fasting: 3.4 - 19.6

Postprandial: 3.0 - 50.0

Abbott Alinity i Chemiluminescent Microparticle Immunoassay (CMIA)

Serum: Serum (use of serum separator tubes may result in a decrease in concentration)

Plasma: Potassium EDTA, Lithium Heparin, Sodium Heparin

2-8℃: 2 days        

-20℃: 6 months

Abbott IFu

24 Hours

pg/mL

Adult: 15 - 68.3

Manual Culture

Unless otherwise stated, swabs for bacterial and fungal culture should be placed in Amies transport medium with charcoal.

Temperature: 2-8°C

‍

2 days @ 2-8 ºC

Abscesses are accumulations of pus in the tissues and any organism isolated from them may be of significance. They occur in many parts of the body as superficial infections or as deep-seated infections associated with any internal organ. Many abscesses are caused by Staphylococcus aureus alone, but others are caused by mixed infections. Anaerobes are predominant isolates in intra-abdominal abscesses and abscesses in the oral and anal areas. Members of the "Streptococcus anginosus" group and Enterobacterales are also frequently present in lesions at these sites. Post-operative wound infections arise when microorganisms contaminate surgical wounds during an operation or immediately afterwards. Colonised body sites are frequent sources of pathogens, although they may be transmitted via medical and nursing staff or via inanimate objects from other patients or elsewhere in the hospital environment.

Organisms most commonly isolated include:

• S. aureus including MRSA.
• Bacteroides species
• Clostridium species
• Enterobacterales
• Pseudomonads
• β-haemolytic streptococci
• Enterococci
• Peptostreptococcus species

Coagulase-negative staphylococci and coryneforms isolated from post-operative sites overlying implants or prostheses may indicate infection. This is particularly true in the presence of a sinus tract in direct communication with the joint. However, with the exception of S. aureus, superficial flora do not necessarily represent the flora deep inside a wound and cultures should be interpreted with care.

PLEASE NOTE: Samples and accompanying relevant patient/ isolate data maybe referred for confirmatory or further laboratory testing to Reference laboratories. Relevant Public Health departments may also be notified IF a notifiable disease is identified under the Infectious Diseases (Amendment) Regulations 2020 (S.I. No. 53/2020).

Preparation of patient: Collect specimens before antimicrobial therapy where possible.

Precautions: Samples of pus are preferred to swabs. However, pus swabs are often received (when using swabs, the deepest part of the wound should be sampled, avoiding the superficial microflora). If processing is delayed, refrigeration is preferable to storage at ambient temperature. Delays of over 48hr are undesirable.

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48h for a negative result.

72h for a positive result.

(Pus swabs 7d for a negative result 8d for a positive result. Preliminary results available on request).

*Excludes Sundays and Bank Holidays

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Manual Culture

Samples should be collected using sterile techniques to reduce the chance of contamination. The recommended volume of blood to be collected is 8-10 mL.

‍

Samples should be transported to the laboratory within 4 hours of sampling and remain at ambient temperature until delivered for testing.

‍

Blood culture is considered to be the ‘‘gold standard’’ investigation for the detection of micro-organisms in blood. The culture of micro-organisms from blood is essential for microbiological diagnosis of bacteraemia, fungaemia, infective endocarditis, and many infective conditions associated with a clinical presentation of pyrexia of unknown origin (PUO). It is also an important component of the diagnosis of prosthetic material infections (eg joints and vascular grafts) and intravascular line-associated sepsis. Blood cultures may also detect bloodstream infection in association with other infectious diseases such as pneumonia, septic arthritis and osteomyelitis.

Negative Result: 5 days (21 days if infective endocarditis is suspected by the clinician) *Excludes Sundays and bank holidays.

Positive Results: Clinicians will be informed once a blood culture has alerted as positive, with preliminary and final results communicated as soon as possible.

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Manual Culture

Sputum - Ideally, a minimum volume of 1 mL.

BAL - It is difficult to be specific on volume required; in principle, as large a volume as possible is preferred.

Temperature: 2-8°C

‍

2 days @ 2-8ºC

Recovery and recognition of organisms responsible for pneumonia depends on:

• The adequacy of the lower respiratory tract specimen.
• Avoidance of contamination by upper respiratory tract flora.
• The use of microscopic techniques and culture methods.
• Current and recent antimicrobial treatment.

Distinction between tracheobronchial colonisation and true pulmonary infection can prove difficult. The expression lower respiratory tract infection (LRTI) includes pneumonia, where there is inflammation of the lung parenchyma, and infections such as bronchiolitis that affect the small airways. Lung abscess, where the lung parenchyma is replaced by pus filled cavities, and empyema, where pus occupies the pleural space, are less common manifestations of LRTI.

‍

48h for a negative result.

72h for a positive result.

*Excludes Sundays and Bank Holidays

Manual Microscopy & Culture

See above precautions.

Temperature: Ambient Room Temperature

Specimens should be kept at ambient room temperature and transported and processed as soon as possible although, provided the samples are kept dry, the fungus will remain viable for several months.

‍

Dermatophytes are the most common cause for superficial mycoses in hair, nail and skin.

Dermatophytes can be divided into three groups: anthropophilic, zoophilic, and geophilic. Anthropophilic dermatophytes are passed from human to human and are the most common in the community. Zoophilic or animal acquired infections are usually sporadic. Infections with geophilic dermatophytes are most often acquired following a close association with soil or from an animal itself infected by soil contact. Infection is diagnosed by observing the presence of fungal hyphae in skin, hair or nail specimens. However, it is important to culture the material to determine the infecting genus and species. This is done to ensure selection of the most appropriate therapy and in order to trace its likely epidemiology.

Dermatophyte (otherwise known as ringworm) infections are usually referred to as tinea followed by the Latin name of the body area involved. The most common dermatophyte infections are tinea pedis in adults (athlete’s foot) which may also include tinea unguium (nail infection), and tinea capitis (scalp ringworm) in children.

Infection by dermatophytes is cutaneous and generally restricted to the non-living cornified layers in patients who are immunocompetent. This is because the dermatophyte group of fungi are generally unable to penetrate tissues which are not fully keratinised (i.e. deeper tissues and organs). However, reactions to such infections can range from mild to severe depending upon the host’s immune response, the virulence of the infecting species, the site of infection and environmental factors.

The dermatophyte group of fungi are classified in three genera: Epidermophyton species, Microsporum species and Trichophyton species.

Non-dermatophytes;

There are few non-dermatophyte moulds that can infect otherwise healthy skin and these include Scytalidium dimidiatum, Scytalidium hyalinum (a white variant of S. dimidiatum), Phaeoannellomyces werneckii and Piedraia hortae. Non-dermatophyte moulds, including those above, can infect nails damaged by physical trauma, disease or pre-existing infection with a dermatophyte. There are many non-dermatophyte moulds that have been implicated in nail infection, therefore isolation of a mould from a nail specimen should only be reported if certain strict criteria are met because contamination of nail samples with mould spores is common. A non-dermatophyte mould accounts for the diagnosis in less than 5% of infected nails.

Microscopy results available after 3 days.

Culture results available following 3 weeks incubation.

*Excludes Saturdays, Sundays and Bank Holidays

Manual Culture

Unless otherwise stated, swabs for bacterial and fungal culture should be placed in Amies transport medium with charcoal.

Temperature: 2-8°C

‍

2 days @ 2-8ºC

Infections of the ear can be divided into otitis externa and otitis media.

Otitis externa: In general, infection of the external auditory canal resembles infection of skin and soft tissue elsewhere. However, there are some notable differences. The canal is narrow and, as a result, foreign materials and fluid that enter can become trapped, causing irritation and maceration of the superficial tissues. Otitis externa can be subdivided into categories: acute localised; acute diffuse; chronic; and invasive (‘malignant’). However, except for invasive, they are rarely differentiated as such in clinical practice.

Otitis media: Acute otitis media is defined by the co-existence of fluid in the middle ear and signs and symptoms of acute illness. It can occur when oropharyngeal flora ascends the Eustachian tube and are not eliminated by the defence mechanisms of the middle ear. Otitis media is a common disease in children with frequent recurrence of infections. It is important to treat otitis media because possible complications include the loss of hearing. This could have adverse effects on the development of speech and behaviour in children. Symptomatic relief is suggested as the initial form of treatment with antibiotic therapy prescribed only upon reoccurrence of infection. The role of antibiotic treatment at the

first presentation of infection is a contentious issue as most infections are of viral origin. However, common bacteria causing otitis media, such as Streptococcus pneumoniae and Haemophilus influenzae can be isolated from ear swabs if the tympanic membrane has perforated. Other less common causes include S. aureus, S. pyogenes and Moraxella catarrhalis. Although uncommon in adults, the causative organisms and treatment of otitis media are the same as in children. An external ear swab is not useful in the investigation of otitis media unless there is perforation of the eardrum. Tympanocentesis, to sample middle ear effusion, is rarely justified.

PLEASE NOTE: Samples and accompanying relevant patient/ isolate data maybe referred for confirmatory or further laboratory testing to Reference laboratories. Relevant Public Health departments may also be notified IF a notifiable disease is identified under the Infectious Diseases (Amendment) Regulations 2020 (S.I. No. 53/2020).

‍

48h for a negative result.

72h for a positive result.

*Excludes Sundays and Bank Holidays

‍

Manual Culture

Unless otherwise stated, swabs for bacterial and fungal culture should be placed in Amies transport medium with charcoal.

Temperature: 2-8°C

‍

2 days @ 2-8ºC

Infections of the eye can be caused by a variety of microorganisms. Swabs from eyes may be contaminated with skin microflora, but any organism may be considered for further investigation if

clinically indicated. Exogenous organisms may be introduced to the eye via hands, fomites (eg contact lenses), traumatic injury involving a foreign body, following surgery, or simply by spread from adjacent sites.

PLEASE NOTE: Samples and accompanying relevant patient/ isolate data maybe referred for confirmatory or further laboratory testing to Reference laboratories. Relevant Public Health departments may also be notified IF a notifiable disease is identified under the Infectious Diseases (Amendment) Regulations 2020 (S.I. No. 53/2020).

‍

48h for a negative result.

72h for a positive result.

*Excludes Sundays and Bank Holidays

Manual Culture

Stool. 1-2g is sufficient for routine culture. In an appropriate sterile leak proof container.

Temperature: 2-8°C

‍

2 days @ 2-8°C

Diarrhoea may be defined as unusual frequency of bowel action (usually at least three times in a 24 hour period), passing loose, watery, unformed faeces. The consistency of the stools is more important than the frequency: frequently passed formed stools are not considered to be diarrhoea. It may be associated with symptoms such as abdominal cramps, nausea and malaise, and with vomiting, fever and consequent dehydration. Patients with visible blood and mucus in the faeces suggesting inflammation of the bowel, accompanied by symptoms such as abdominal cramps and constitutional disturbance, may be said to be suffering from dysentery.

A wide range of bacterial pathogens, viruses and parasites are capable of causing diarrhoea by a number of mechanisms. Routine screening of faecal samples includes screening for Salmonella species, Shigella species, E.coli 0157 and Campylobacter species.

Additional Screening;

Vibrio cholera can be requested if there is suspicion that the patient has ingested contaminated water or seafood or travelled to endemic areas.

Yersinia enterocolitica which causes Yersiniosis is a zoonotic infection. Y. enterocolitica can be isolated from wild and domestic animals, environmental samples and food samples.

48h for a negative result.

72h for a positive result.

*Excludes Sundays and Bank Holidays

Manual Gram Stain Microscopy & Culture

Sample type: Unless otherwise stated, swabs for bacterial and fungal culture should be placed in Amies transport medium with charcoal.

Temperature: 2-8 °C

‍

2 days @ 2-8 °C

Normal vaginal flora consists of a wide range of organisms including Lactobacillus species, streptococci, enterococci and coagulase-negative staphylococci. Anaerobes, such as Bacteroides species and anaerobic cocci, Gardnerella vaginalis, yeasts, coliforms, Ureaplasma urealyticum and Mycoplasma species may also be present as part of the normal flora, but they have also been incriminated in vaginal infections.

Common Genital Infections;

• Vaginal candidosis occurs when alterations in the vaginal environment allow yeasts (which are often present as commensal organisms in the vagina), to proliferate.
• Bacterial vaginosis (BV) is characterised by an increase in anaerobes and a decrease in Lactobacillus species.
• Lancefield group B streptococcus normally colonises the vagina in many women. In pregnancy this organism can infect the amniotic fluid which can lead to neonatal sepsis, pneumonia and meningitis. Trichomoniasis is caused by the flagellate protozoan, T. vaginalis, is almost always acquired through sexual contact. Presenting symptoms include an increased vaginal discharge, pruritus and dysuria. Swabs for Trichomonis investigation should be received into the lab as soon as possible after sampling. For the investigation of Neisseria gonorrhoeae infection, endocervical or urethral swabs are the preferred specimens.

48h for a negative result.

72h for a positive result.

*Excludes Sundays and Bank Holidays

Manual Gram Stain Microscopy & Culture

A minimum volume of 1mL should be sent in a sterile leak proof container.

Temperature: 2-8°C

2 days @ 2-8ºC

The detection of organisms in fluids that are normally sterile indicates significant infection, which can be life-threatening. Specimens may be taken primarily for culture or this may be incidental to the prime reason for obtaining the specimen.

Blood cultures may be positive with the same infecting organism, and occasionally may be positive when culture of the fluid fails to reveal the organism.

Fluids will be sterile in the absence of infection, as will "sympathetic effusions", and those of immunological or traumatic origin and those due to metabolic disease or heart failure.

Signs of infection may be difficult to detect clinically in patients whose joints are already inflamed due to rheumatological conditions. This is important because these patients are at increased risk of joint sepsis.

‍

5d for a negative result.

6d for a positive result.

Preliminary results available on request.

*Excludes Sundays and Bank Holidays except in cases of prior clinical agreement

Manual Culture

Cannulae should be collected in appropriate sterile leak proof containers.

Temperature: 2-8 °C

2 days @ 2-8°C

The use of indwelling cannulae/catheters for reliable intravascular access is an essential feature of modern health care for both monitoring and intervention. Insertion of intravascular cannulae and catheters allows continuous and painless access to the circulation for administration of fluids and electrolytes, medications, blood products and nutritional support. In addition the intravascular access can be used for blood sampling, haemodynamic monitoring, haemodialysis and haemofiltration.

Specific examples of descriptions of cannulae, defining their siting, use or design, include:

• Peripheral e.g. Venflons, Abbocaths.
• Central lines e.g. triple lumen, subclavian lines, jugular lines, femoral lines.
• Monitoring lines e.g. central venous pressure lines, Swan Ganz lines, arterial lines.
• Long term access e.g. Hickman lines, Broviac lines, Portacath.
• Miscellaneous e.g. Vascath for haemofiltration, and umbilical cannulae for exchange transfusions in neonates.
• Antimicrobial coated or impregnated CVCs: recent studies have demonstrated that antimicrobial coated or impregnated CVC can reduce the incidence of catheter colonisation and CR-BSI in appropriate situations.

Cannula tip culture gives valuable information but necessitates the removal of the cannula. This can sometimes result in the loss of venous access that can interfere seriously with the medical management of the patient, although sometimes catheter removal is necessary to gain control of a catheter-related infection, especially with certain organisms, such as Candida species.

Cannula associated swabs (e.g. swabs of catheter insertion sites) may be employed as alternative specimens. However, routine investigation of cannula associated swabs from asymptomatic patients is of dubious value.

Culture of the skin around insertion sites or of cannula connectors (hubs) is becoming increasingly used in confirming cannula site infection. This is reported as having high sensitivity and specificity but is only useful where there is clinical evidence of localised infection, as positive culture results may reflect the presence of commensals and be misleading. Careful interpretation of these culture results should be correlated with blood culture isolates.

48h for a negative result.

72h for a positive result.

*Excludes Sundays and Bank Holidays

Manual Culture

Unless otherwise stated, swabs for bacterial and fungal culture should be placed in Amies transport medium with charcoal.

Temperature: 2-8°C

‍

2 days @ 2-8 ºC

Urethral swabs, prostatic secretions can aid in the diagnosis of various male genital tract infections, including prostatitis, epididymitis, balanoposthitis and penile thrush. Causative agents can include;

• Enterobacterales
• Streptococcus
• Anaerobes
• Candida species
• Neisseria gonorrhoeae
• Pseumonads
• Staphylococci
• Anaerobes

48h for a negative result.

72h for a positive result.

*Excludes Sundays and Bank Holidays

Manual Culture

Unless otherwise stated, swabs for bacterial and fungal culture should then be placed in Amies transport medium with charcoal.

Temperature: 2-8°C

‍

2 days @ 2-8ºC

Candidosis is the most frequent type of oral infection. Infection of the buccal mucosa, tongue or oropharynx is usually due to Candida albicans. Species of yeast other than C. albicans, such as Candida krusei and Candida glabrata, can also occasionally colonise the mouth but are rarely associated with infection. However, they are becoming increasingly important, particularly in patients who are immunocompromised.

PLEASE NOTE: Samples and accompanying relevant patient/ isolate data maybe referred for confirmatory or further laboratory testing to Reference laboratories. Relevant Public Health departments may also be notified IF a notifiable disease is identified under the Infectious Diseases (Amendment) Regulations 2020 (S.I. No. 53/2020).

48h for a negative result.

72h for a positive result.

*Excludes Sundays and Bank Holidays

Manual Culture

Unless otherwise stated, swabs for bacterial and fungal culture should be placed in Amies transport medium with charcoal.

Temperature: 2-8°C

‍

2 days @ 2-8ºC

Nasal colonisation with Staphylococcus aureus increases the risk of staphylococcal infections at other sites of the body such as postoperative wounds and dialysis access sites. It is also associated with recurrent skin infections and nosocomial infections in nurseries and hospital wards. S. aureus is a major cause of morbidity and mortality in haemodialysis patients as most patients carry the organism in their anterior nares.

Eradication of nasal carriage of S. aureus may be beneficial in certain clinical conditions such as recurrent furunculosis. Systemic, in addition to topical, treatment is appropriate for nasally colonised patients who have infection elsewhere. Topical antibacterial agents such as mupirocin and chlorhexidine/neomycin are preferred to systemic formulations when a patient is identified as a carrier. Nose swabs may be used to investigate carriage of Lancefield group A streptococcus and Methicillin Resistant Staphylococcus aureus (MRSA) (Please see Investigation of specimens for screening for MRSA).

There is no clear evidence regarding the significance of isolating Haemophilus influenzae and Streptococcus pneumoniae from nose swabs as a predictor of involvement in infections such as sinusitis.

Although nose swabs are not the ideal specimen for the examination of nasal discharge, they are sometimes received. Nasal discharge may be a presentation of diphtheria. However, nose swabs are not routinely cultured for Corynebacterium diphtheriae. Nasal swabs should not be taken to investigate the presence of Bordetella pertussis. Rhinoscleroma, due to infection with Klebsiella rhinoscleromatis, is a rare form of chronic granulomatous nasal infection affecting the nasal passages and sinuses which can also include the pharynx and larynx. The disease is progressive and manifests itself by tumour-like growths with local extension. Although common in Eastern Europe, Central Africa, Latin America and South East Asia, rhinoscleroma appears to be poorly communicable. Ozaenia (ozena) is a chronic atrophic rhinitis. The condition can destroy the mucosa and is characterised by a chronic, purulent and often foul-smelling nasal discharge. Klebsiella ozaenae may have an etiological role.

48h for a negative result.

72h for a positive result.

*Excludes Sundays and Bank Holidays

Manual Culture

Unless otherwise stated, swabs for bacterial and fungal culture should be placed in Amies transport medium with charcoal.

‍

2 days @ 2-8 °C

Infections of the skin and subcutaneous tissues are caused by a wide range of organisms. Organisms isolated from a clinically infected wound may be clinically significant but this decision needs to be made in conjunction with clinical details. Examination of biopsies might be more effective for diagnosis than swabs. Commonly isolated organisms include:

• Staphylococcus aureus
• Lancefield groups A, B, C and G streptococci
• Bacteroides species
• Clostridium species
• Anaerobic cocci
• Coagulase-negative staphylococci
• Corynebacterium species
• Enterobacterales
• Pseudomonads

Organisms isolated from a clinically infected wound may be clinically significant although they must be carefully assessed for their true clinical significance.

PLEASE NOTE: Samples and accompanying relevant patient/ isolate data maybe referred for confirmatory or further laboratory testing to Reference laboratories. Relevant Public Health departments may also be notified IF a notifiable disease is identified under the Infectious Diseases (Amendment) Regulations 2020 (S.I. No. 53/2020).

‍

48h for a negative result.

72h for a positive result.

*Excludes Sundays and Bank Holidays

Manual Culture

Rectal swab is preferred but 1-2g of stool is also sufficient in an appropriate sterile leak proof container. Temperature: 2-8°C

‍

2 days @ 2–8 ºC

ESBLs are Gram Negative organisms that possess an acquired class A β-lactamases that hydrolyses and confers resistance to oxyimino- ‘2nd- and 3rd-generation’ cephalosporins, e.g. cefuroxime, cefotaxime, ceftazidime and ceftriaxone.

VREs are Enterococcus species resistant to vancomycin.

CPEs are Gram Negative organisms that possess a β-lactamase that hydrolyses carbapenems i.e. any or all of doripenem, ertapenem, imipenem and meropenem.

These resistant mechanisms can all be screened for by requesting a culture Multi-Drug Resistant (MDR) Screen. Alternatively they can also be requested individually.

If processing is delayed, refrigeration is preferable to storage at ambient temperature. Delays of over 48hr are undesirable.

‍

Negative result: 48 hours (24 hours for CPE only)

Positive results: 72-96 hours

*Excludes Sundays and Bank Holidays

Manual Culture

Unless otherwise stated, swabs for bacterial culture should be placed in Amies transport medium with charcoal.

Temperature: 2-8°C

‍

2 days @ 2-8ºC

MRSA strains are a continuing and increasing problem in many hospitals. Colonised and infected patients represent the most important reservoir of MRSA strains in hospitals. MRSA are mainly transmitted by direct person-to-person contact, usually via the hands of health care workers, and through environmental contamination. Screening for MRSA provides a means of identifying patients and staff who may be involved in transmission of the organism.

24h for a negative result.

72h for a positive result.

*Excludes Sundays and Bank Holidays

Immunochromatographic – Coris BioConcept Clostridium K-Set & Meridian ImmunoCard Toxins A&B

‍

Stool; a liquid specimen of 3 ml is sufficient for GDH and toxin detection. In an appropriate sterile leak proof container.

4 days @ 2–8 ºC

Clostridium difficile is a leading cause of nosocomial diarrhoea. The production of two toxins A (enterotoxin) and B (cytotoxin) causes the characteristic mucosal damage consisting of plaque-like lesions leading to the formation of a pseudomembrane. Not all strains of C. difficile produce toxin and therefore not all can cause illness. The spectrum of disease ranges from a self-limiting mild diarrhoea to the advanced and severe illness characteristic of pseudomembranous colitis. The most accurate diagnosis of pseudomembranous colitis is affected by endoscopic detection of colonic pseudomembranes or microabscesses in antibiotic-treated patients who are suffering from diarrhoea and who have C. difficile and its toxins in their stools.

Clostridium difficile testing algorithm:

A GDH screening test is initially performed on a stool sample requesting C. difficile. If this is negative, C. difficile infection is highly unlikely and no further testing is required. If the GDH screen is positive, C. difficile toxin testing is performed. If this toxin test is positive, C. difficile infection is highly probable and the sample is reported as positive. If the C. difficile toxin testing is negative, we recommend testing samples for confirmatory PCR testing. Clinicians will be contacted before a sample is referred for PCR testing.

‍

24 hours

*Excludes Sundays and Bank Holidays

Immunochromatographic – Meridian ImunoCard STAT HpSA

1-2g of stool in an appropriate sterile leak proof container.

Temperature: 2-8°C up to 3 days or frozen immediately at ≤-20°C where processing or transport is delayed

‍

3 days @ 2-8ºC. >3days at ≤-20°C

The detection of H. pylori stool antigen is intended to aid in the diagnosis of H. pylori infection. This can also be used to demonstrate loss of H. pylori following treatment, however it is recommended that this is done at least four weeks following completion of therapy.

H. pylori has been established as an etiologic agent in chronic gastritis and peptic ulcer disease, and has been associated with mucosa-associated lymphoid tissue lymphoma and gastric adenocarcinoma.

24 hours. 48 hours if sample received frozen.

*Excludes Sundays and Bank Holidays

Manual Culture

Unless otherwise stated, swabs for bacterial and fungal culture should be placed in Amies transport medium with charcoal.

Temperature: 2-8°C

‍

2 days @ 2-8°C

The commonest cause of bacterial pharyngitis is the Lancefield group A, Streptococcus pyogenes while Lancefield group C streptococci have also been reported as a cause of pharyngitis. Diphtheria is an acute infectious disease of the upper respiratory tract and occasionally the skin. It is caused by toxigenic strains of Corynebacterium diphtheria. Please contact the laboratory if Diphtheria is suspected.

Other causes of infection include;

• H. Influenza type B (Children <5)
• Fungal/Yeast (Immunocompromised patients/patients undergoing antimicrobial therapy)
• Arcanobacterium haemolyticum (recurrent tonsillitis)
• Fusobacterium necrophorum (recurrent/persistent sore throat, peritonsillar abscess)
• Neisseria gonorrhoeae

If any such infections are suspected please contact the laboratory.

‍

48h for a negative result.

72h for a positive result.

*Excludes Sundays and Bank Holidays

Manual Gram Stain Microscopy & Culture

Samples should be placed in a sterile leak proof container.

Temperature: 2-8°C

2 days @ 2-8ºC

A biopsy may be defined as a portion of tissue removed from the living body for further examination. With the increasing sophistication of clinical imaging and sampling devices there are few organs in the human body that cannot be biopsied. Tissue obtained at operation is particularly precious as the sampling procedure may not be repeatable. Ideally these specimens should be discussed with the laboratory prior to sampling to ensure that transport and processing are timely and appropriate tests are performed.

7d for a negative result.

8d for a positive result.

Preliminary results available on request.

*Excludes Sundays and Bank Holidays except in cases of prior clinical agreement

Automated method Sysmex UF-5000 analyser.

Manual Microscopy & Culture for specimens that cannot be processed using the automated method & for the confirmation of presence of yeast cells and examination of the morphology of casts & crystals if present.

‍

MSU, CSU or Bag urine. In an appropriate sterile leak proof container. Minimum volume: 1mL

Temperature: 2-8°C

‍

48 hours @ 2-8°C

Where there is a delay >48 hours the use of sterile urine containers with boric acid preservative may be beneficial this will increase the sample stability to 96hours.

‍

Urinary tract infection (UTI) results from the presence and multiplication of microorganisms in one or more structures of the urinary tract with associated tissue invasion. This can give rise to a wide variety of clinical syndromes. These include acute and chronic pyelonephritis (kidney and renal pelvis), cystitis (bladder), urethritis (urethra), epididymitis (epididymis) and prostatitis (prostate gland). Infection may spread to surrounding tissues (eg perinephric abscess) or to the bloodstream.

24h for a negative result.

48h for a positive result.

*Excludes Sundays and Bank Holidays

Abbott Alinity c, Ferene

Serum: Serum separator Plasma -Acceptable anticoagulants are: Lithium Heparin Sodium heparin

20-25℃: 10 hours                

2-8℃: 7 days      

-20℃: 1 year

Abbott IFu

24 Hours

µmol/L

Adult (Female): 9.0 - 30.4

Adult (Male): 11.6 – 31.3

Abbott Alinity c, Oxidation of Lactate to Pyruvate

Serum: Serum separator.

Plasma: Lithium heparin Lithium heparin separator Sodium heparin

20-25℃: 3 days                  

2-8℃: 3 days      

-20℃: 8 weeks

Abbott IFU

24 Hours

U/L

Adult: 125 - 220

Abbott Alinity c, Kinetic Colorimetric method

Serum: Serum separator.

Plasma: Lithium heparin Sodium heparin EDTA unsuitable

20-25℃: 7 days                

2-8℃: 7 days      

-20℃: 1 year

Sentinel Diagnostics IFU

24 Hours

U/L

Adult: 0-60

Abbott Alinity c, Turbidimetric/ Immunturbidimetric

Serum: Serum tubes

Plasma - Acceptable anticoagulants: Sodium EDTA, Potassium EDTA, Lithium heparin, Sodium heparin, Citrate Gel separator tubes were not tested.

20-25℃: 7 days                

2-8℃: 7 days      

-20℃: 1 year

European Atherosclerosis Society Consensus Position Paper (Lipoprotein(a) as a cardiovascular risk factor: current status. Eur Heart J (2010) doi: 10.1093/eurheartj/ehq386)

24 Hours

g/L

Adult <500 Values above 0.500 g/L are associated with an increased risk of athero- sclerosis.

Abbott Alinity c, Colorimetric Method

Serum: Serum tubes (with or without gel barrier)

Plasma Collection tubes Acceptable anticoagulants are: Sodium heparin K2-EDTA Do not use lithium heparin.

20-25℃: 7 days                

2-8℃: 7 days      

-20℃: 1 year

https://www.nice.org.uk/guida nce/cg185/resources/bipolardisorder-assessment-andmanagement35109814379461)

24 Hours

mmol/L

Immediate release formulations:

‍0.5 - 0.8 12 hours after last dose

Slow release formulations:

0.8 - 1.20 12 hours after last dose

0.5 - 0.8 immediately before next dose

Abbott Alinity i Chemiluminescent Microparticle Immunoassay (CMIA)

Serum: Serum, Serum separator

Plasma: Potassium EDTA, Sodium heparin

2-8℃: 7 days        

-20℃: longer

Abbott IFU

LH, secreted by the anterior pituitary, regulates gonadal steroidogenesis. In females, it triggers ovulation and promotes luteal progesterone synthesis. In males, LH stimulates Leydig cells for testosterone production, supporting spermatogenesis.

24 Hours

IU/L

Follicular phase: 1.8 - 11.8

Mid Cycle phase: 7.6 – 89.1

Luteal phase: 0.6 - 14.0

Post Meno pause: 5.2 – 62

Male: 0.6 - 12.1

Abbott Alinity c, Enzymatic

Serum: Serum tubes (with or without gel barrier) Use non haemolyzed specimens.

Plasma Collection tubes Acceptable anticoagulants are: Lithium heparin, Sodium heparin

20-25℃: 7 days                

2-8℃: 7 days      

-20℃: 1 year

Abbott IFu

24 Hours

mmol/L

Adult: 0.66 - 1.07

Abbott Alinity c, Enzymatic

Urine (24 hour) Collect specimens in a container with boric acid or 20 to 30 mL of 6N HCl to prevent precipitation of magnesium complexes.

OR

Spot urine

20-25℃: 7 days                

2-8℃: 7 days      

-20℃: 1 year

Abbott IFU

24 Hours

mmol/ 24hr

mmol/L

Urine (24 Hour): Adult: 3.00 – 5.00

Abbott Alinity c, Enzyme immunoassay

Urine Clean plastic or glass container

2-8℃: 5 days      

-20℃: longer

Abbott IFU

24 Hours

ng/mL

Positivity Cut-off: 300

Abbott Alinity c, Turbidimetric/ Immunturbidimetric

Urine spot/ timed/24hr: Clean, unused plastic or glass container with preservatives

20-25℃: 7 days                

2-8℃: 7 days      

-20℃: 1 year

NICE Guideline NG203, August 2021

24 Hours

mg/mmol

ACR (Albumin/ Creatinine Ratio): <3.0

Abbott Alinity i Chemiluminescent Microparticle Immunoassay (CMIA)

Serum: Serum, Serum separator

Plasma: Potassium EDTA, Lithium heparin

20-25℃: 3 days                  

2-8℃: 6 days      

-20℃: 30 days

Abbott IFU

24 Hours

pg/ml

Adults <75 years: < 125.0

Adults >75 years: < 450.0

Buccal swab

Nutrifert identifies predispositions to subfertility and obstetric pathologies by analyzing 11 genes and 23 SNV’s. It assesses genetic factors associated with obesity, gestational diabetes, coeliac disease, PCOS, endometriosis and recurrent miscarriage. Additionally, FSH receptor mutations are analyzed, providing insights to optimise ovarian stimulation in ART by identifying low or high responders, minimizing the risks of ovarian hyperstimulation or hypostimulation.

11 days

Abbott Alinity c, Enzyme immunoassay

Urine Clean plastic or glass container

2-8℃: 5 days      

-20℃: longer

Abbott IFU

24 Hours

ng/mL

Positivity Cut-off: 300

Genotech Osmometer, Freezing-point depression osmometry

Serum: Serum, Serum separator

Plasma: Potassium EDTA, Lithium heparin

OR

Urine Clean plastic or glass container

Serum/Plasma:

20-25°C: 2 days          

2-8°C: 8 days        

-20°C: 30 days

‍

Urine:

20-25°C: 5 days            

4°C: 4 days      

-20°C: 30 days

Serum/Plasma:

Clinical Chemistry 44: 1582, 1998

Urine:

Wu, A.H.B. ed: Tietz Clinical Guide to Laboratory Tests 4th Edition, Saunders 2006

24 Hours

mOsm/kg

Serum/Plasma: Adult: 280 - 298

‍

Urine: Adult: 50 - 1200

The cobas® 4800 HPV Test is a qualitative in vitro test for the detection of HPV in patient specimens, The test utilises amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridisation for the detection of 14 HR HPV types in a single analysis. The test specifically identifies HPV 16 and HPV 18 while concurrently detecting the other high-risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) at clinically relevant infection levels.

Cervical smear in ThinPrep PreservCyt Solution. The total volume of sample in the tube should be at least 3ml.

Specimens collected in PreservCyt Solution can be transported at 2-30°C. Specimens may be stored at 2-30°C for up to 6 months after the date of collection.

Persistent infection with human papillomavirus (HPV) is the cause of cervical cancer and its precursor cervical intraepithelial neoplasia (CIN). The presence of HPV has been implicated in greater than 99% of cervical cancers, worldwide.

The HSE offer a FREE cervical screening test, via a GP, to anyone with a cervix between the age of 25 and 65, once they have registered. In most cases, it takes 15 to 20 years for a HPV infection to develop into cervical cancer. The frequency of testing depends on age:  25-29 : every 3 years   30 – 65 : every 5 years

Sometimes patients can request additional tests to the 3 -5 year frequency and this will not be covered by the HSE. In these instances, doctors can order a private test from Eurofins Biomnis.

Preparation of patient: Patient should avoid using any vaginal medications, lubricants or creams in the 2 days prior to the sample being taken.

Precautions: None for patient. Media is classified as hazardous, adequate PPE for the person taking  the sample

10 working days from sample receipt for co-testing (all samples sent to Eurofins NMDL, The Netherlands for cytology following HPV testing).

HPV16 and/or HPV18 and/or Other HR HPV Detected Not Detected Invalid.

Midi Parasep Kit & Manual Microscopy

Stool/Sellotape test/Urine/ Perianal swab

Temperature: 2-8°C

5 days @ 2–8 ºC

Investigation of stool and urine samples for ova, cysts and parasites.

3-4 working Days

*Excludes Bank Holidays

3ml Blood from mother and buccal swab from alleged father

PaternitySafe is a non-invasive prenatal paternity that determines paternity from 10 weeks gestation by analysing cfDNA in the mother’s blood. Unlike traditional invasive methods, such as amniocentesis, it poses no risk to the foetus. The test compares foetal DNA with a buccal swab from the alleged father using NGS, offering over 99% accuracy.

17 Days

Abbott Alinity c, Enzyme immunoassay

Serum Serum tubes (with or without gel barrier)

Plasma Collection tubes Acceptable anticoagulants are: Lithium heparin, Sodium heparin, Potassium EDTA, Sodium citrate, Sodium fluoride/potassium oxalate

20-25℃: 7 days                

2-8℃: 7 days      

-20℃: 1 year

Abbott IFU

24 Hours

µg/mL

Adult: 10.0 - 20.0

Toxicity: > 20.0

Abbott Alinity c, Spectrophotometry, Phosphomolybdate

Serum: Serum tubes (with or without gel barrier)

Plasma: Acceptable anticoagulants:

Lithium heparin

Sodium heparin

20-25℃: 7 days            

2-8℃: 7 days      

-20℃: 1 year

Abbott IFU

24 Hours

mmol/L

Adult: 0.74 - 1.52

Abbott Alinity c, Spectrophotometry, Phosphomolybdate

Urine (24 hour) Clean plastic or glass container with preservatives.

OR

Spot Urine (random) Clean plastic or glasscontainer without preservatives

20-25℃: 7 days                

2-8℃: 7 days      

-20℃: 1 year

Abbott IFU

24 Hours

Urine (24 hour): mmol/24hr

Urine (Spot): mmol/L

Urine (24 hour): Adult: 12.9 - 42.0

Abbott Alinity c, Indirect ISE

Serum: Serum tubes (with or without gel barrier)

Plasma Collection tubes Acceptable anticoagulants are:

Lithium heparin (with or without gel barrier)

Sodium heparin (full draw)

20-25℃: 7 days                

2-8℃: 7 days      

-20℃: 1 year

Abbott IFU

24 Hours

mmol/L

Adult: 3.5 - 5.1

Abbott Alinity c, Indirect ISE

Urine (24- hour) Without preservatives

20-25℃: 7 days                

2-8℃: 7 days      

-20℃: 1 year

Abbott IFU

24 Hours

mmol/24hr

Adult: 25 - 125

Pre-eclampsia (PE) is still a leading cause of maternal and perinatal mortality and morbidity in Ireland. PE is defined as recent onset hypertension (arterial pressure ≥ 140/90 mmHg).

Assays of pre-eclampsia biomarkers can be used for:

Screening Assay (1st trimester of pregnancy):

PIGF (Placental Growth Factor) is, together with PAPP-A, a biochemical marker for pre-eclampsia. Assays are performed during the first trimester of pregnancy. It is possible to calculate the risk of early-onset (before 34 weeks of gestation) or late-onset pre-eclampsia (before 37 SA). This calculation of risk includes data about the patient (BMI, smoker/non-smoker, geographic origin, etc.) the history (number of viable pregnancies, history of pre-eclampsia, hypertension) and pregnancy underway (dating: date of ultrasound and craniocaudal length) in addition to blood pressure and Doppler of uterine arteries.

Predictive Assay (>20 weeks of amenorrhea):

The predictive test is for patients between 20 and 37 weeks of gestation, at risk of pre-eclampsia with at least one warning sign. A low sFlt-1/PlGF ratio (<38) enables predicting the absence of pre-eclampsia (and complications) at 1 week (NPV 99.3%).

Blood sample on or after 10 weeks of gestation

PrenatalSafe is a non-invasive test analysing foetal DNA to detect chromosomal abnormalities and genetic conditions. Offering 9 CE-IVD levels of investigation, it can identify aneuploidies, structural chromosomal abnormalities such as microdeletions and microduplications, and both de novo and inherited genetic conditions. With a sensitivity and specificity of over 99%, the test provides an accurate assessment with no risk to the developing foetus.

RhSafe Test

RhSafe detects the presence or deletion of the RHD gene (fetus RhD+) in RhD-negative mothers using real time PCR for exons 5 and 7.

Microdeletions

Screens for microdeletions associated with several genetic syndromes, including DiGeorge, Prader-Willi, Angelman, and Jacobsen’s syndrome.

Abbott Alinity i Chemiluminescent Microparticle Immunoassay (CMIA)

Serum: Serum, Serum separator

Plasma: Sodium heparin, Lithium heparin Potassium EDTA

2-8℃: 10 days        

-20℃: 6 months

Abbott IFU

Progesterone regulates the menstrual cycle, facilitating endometrial preparation for implantation and supporting pregnancy. In males, it is involved in steroidogenesis and spermatogenesis, contributing to reproductive function.

Ref: https://pmc.ncbi.nlm.nih.gov/articles/PMC8538505/

24 Hours

nmol/L

Follicular Phase: < 0.95

Luteal Phase: 3.8 - 51

Post Meno pausal: < 0.63

1st Trimester: 8.9 - 468

2nd Trimester: 72 - 303

3rd Trimester: 89 - 771

Male: < 0.63 nmol/L

Abbott Alinity i Chemiluminescent Microparticle Immunoassay (CMIA)

Serum: Serum, Serum separator

Plasma: Potassium EDTA, Sodium heparin, Lithium heparin

2-8℃: 7 days        

-20℃: 1 year

Abbott IFU

Prolactin is a peptide hormone secreted by the anterior pituitary that regulates lactation and reproductive function. Hyperprolactinaemia can supress GnRH secretion, disrupt gonadotropin release and impair ovulation and fertility.

Ref: https://www.ncbi.nlm.nih.gov/books/NBK279070/

24 Hours

uIU/ml

Adult Female: 109 - 557

Adult Male: 73 -407

CALCULATION based on Abbott Alinity methodology for Prolactin and PEG precipitation

Serum: Serum, Serum separator

Plasma: Potassium EDTA, Sodium heparin, Lithium heparin

2-8℃: 7 days        

-20℃: 1 year

Abbott IFU

24 Hours

mIU/L

Adult Female: 79 - 347

Adult Male: 72 - 229

Stago Compact Max, Stago Satellite Max

Sodium Citrate Plasma 3.2% 0.105M

Temperature: 12 hours Room Temperature or 2 weeks @ -20ºC

Miscellaneous: N/A

Collection: Cf. Special requirement for Coagulation test

Whole blood: 12 hours at room temperature.

If a longer delay is expected in transport to the laboratory, centrifuge at 1500g for at least 15 minutes, separate, and freeze plasma.

Can only be thawed once. (SIEMENS Kit Insert & CSLI H21- A5)

‍

‍

‍

Dacie and Lewis, Practical Haematology 12th edition, 2017

The PT test (scientific name- tissue activated induced coagulation time) has been in clinical practice for over 60 years. The first standardised one-stage PT test was devolved by Dr. Armand Quick in 1932. It has now become the basic coagulation screening test for the diagnosis of acquired and congenital deficiencies of clotting factors in the Extrinsic pathway. The assay was designed to measure a coagulation defect before the introduction of oral anticoagulants, and later adapted for monitoring their dosage. The PT reflects changes in the Extrinsic factors II, VII and X, three of the principle clotting factors depressed by Coumarin drugs, and FV, not reduced by oral anticoagulation. It can also be used to assess the protein synthesis capability of the liver in chronic or acute hepatic disorders. The test depends on the activation of Factor X in the presence of Factor VII by Tissue Factor (TF) and bypassing of the Intrinsic clotting pathway. The speed of the reaction and the responsiveness of the PT to deficiencies of clotting factors depend upon the properties and concentration of the TF as well as on the clotting factor concentrations.

Preparation of patients: Patients should be relaxed pre-venepuncture. Excessive stress and exercise will increase Factor VIII, vWF antigen and fibrinolysis. Veno-occlusion should be avoided.

Precautions: The doctor should check to see if the patient is taking any medications that may affect test results. This precaution is particularly important if the patient is taking Warfarin, because there are a number of medications that can interact with Warfarin to increase or decrease the PT time

24 Hours

PT: 11.0 – 16.0 Seconds

INR – Not applicable

Haematology – SYSMEX XN2000

Whole Blood (Lavender cap)

Temperature: + 2-8ºC

Miscellaneous: N/A

2 days @ + 2-8ºC

Haematology, G. Moore, G. Knight & A. Blann, 2nd edition, Oxford 2016. The RR was derived from the Drogheda OLOL SYSMEX XN-1000 Analyser. The RR from OLOL Drogheda Our Ladys Hospital for Sick Children Crumlin, Great Ormond Street Hospital, Dacie & Lewis Practical Haematology 10th Edition and Pediatric Haematology 3rd Edition. This is based on the correlation study between OLOL hospital and Eurofins-Biomnis during validation and compatible platforms, reagents, calibrators and controls.

The process of red blood cell production starts in the bone marrow, where cells pass through various stages of development, becoming increasingly mature. The reticulocyte is the final stage of the development of the red blood cell before full maturation. Reticulocyte is an immature red blood cell without a nucleus, having a granular or reticulated appearance when suitably stained. They are present in normal blood in very low numbers, increased numbers are maybe the product of a pathological process or could be the body’s response to pregnancy, therapy with iron B12, or folate or to blood loss. Reticulocytes are not part of the full blood count, so they need to be specifically requested.

Preparation of patients: There is no physical preparation for the test.

Precautions: Frozen, clotted, or grossly haemolysed samples cannot be analysed.

24 Hours

Abbott Alinity c, Immuno turbidimetric

Serum Serum tubes

20-25℃: 7 days              

2-8℃: 7 days      

20℃: 1 year

Abbott IFU

24 Hours

IU/mL

Negative: <30

Chemiluminescent microparticle immunoassay (CMIA)

Chemiluminescent microparticle immunoassay (CMIA)

Serum (Gold and red cap);

Plasma (green and lavender cap)

Temperature: + 4ºC

Miscellaneous: Non fasting

Serum (Gold and red cap);

Plasma (green and lavender cap)

Temperature: + 4ºC

Miscellaneous: Non fasting

Whole blood: ≤ 14 days at 2-8ºC

Separated: ≥ 14 days -20ºC or colder.

Whole blood: ≤ 14 days at 2-8ºC

Separated: ≥ 14 days -20ºC or colder.

Source: Abbott IFU

Source: Abbott IFU

Primary in utero rubella infection can lead to severe birth defects. A positive IgG with a negative IgM result indicates previous rubella infection/vaccination and implies immunity to further infection. A positive IgM result indicates current/recent infection and risk to the foetus in case of pregnancy.

Preparation of Patient: There is no special physical preparation for the rubella Ab test.

3 working days

3 working days

Rubella IgG Antibody: klU/L

• 0.0 to 4.9: Non-reactive
• 5.0 to 9.9: Equivocal
• >/= 10 : Reactive

Rubella IgM Antibody: - Index

• Index less than 1.20: nonreactive (Negative)
• Index 1.20 - 1.59: equivocal; repeat in 7 to 14 days.
• Index >/= 1.60: reactive (Positive).

Electrophoresis: Sebia Capillarys 3 Octa capillary Immunofixation: Hydrasys 2 agarose gel

Serum: Serum tubes (with or without gel barrier)

2-8℃: 10 days      

-20℃: 2 months

Source: In-house study

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10 days +2 days if Immunofixation required.

Fraction %:

Albumin Fraction: 54.1 - 64.8

Alpha - 1 Fraction: 3.1 - 5.2

Alpha - 2 Fraction: 7.3 - 11.9

Beta -1 Fraction: 5.1 - 7.8

Beta- 2 Fraction: 3.6 - 7.7

Gamma Fraction: 10.9 - 20.0

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Fraction g/L:

Albumin Fraction: 38 - 51

Alpha - 1 Fraction: 2.3 - 3.9

Alpha - 2 Fraction: 5.3 - 9.0

Beta -1 Fraction: 3.6 - 5.7

Beta- 2 Fraction: 2.6 - 5.9

Gamma Fraction: 7.7 - 15.5

Abbott Alinity i Chemiluminescent Microparticle Immunoassay (CMIA)

Serum: Serum, Serum separator

Plasma: Lithium heparin, Ammonium heparin, Sodium heparin

2-8℃: 8 days        

-20℃: 3 months

Abbott IFU

SHBG binds circulating sex hormones, primarily testosterone and estradiol, regulating their bioavailability. Abnormal SHBG levels can disrupt the balance of free testosterone and oestrogen, potentially affecting endocrine function, ovulation and fertility.

24 Hours

nmol/L

Adult Female >19 years: 20.0 - 155.0

Pregnancy: <500

Post Meno pausal: 26 - 118

Adult Male >19years: 13.0 - 71.0

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Haematology- qualitative solubility test for testing the presence of sickling haemoglobins

Tube Type: Whole blood EDTA

Temperature: + 2-8ºC

Miscellaneous: N/A

3 days @ + 2-8ºC

Sickledex kit insert, Streck – 350512-13, 05-2016.

Sickle cell disease is an inherited condition characterised by the presence of Haemoglobin S (HB-S). Hb-S exists in a homozygous state (S/S) known as Sickle Cell Anaemia or in a heterozygous state (A/S) known as Sickle Cell Trait. Homozygous individuals (S/S) commonly exhibit symptoms of severe haemolytic anaemia and/or vascular occlusions. Heterozygous individuals (A/S) are usually asymptomatic. Hb-S may be present with other haemoglobins, such as Haemoglonbin A, C or D, or with thalassemia, a condition that interferes with the synthesis of normal haemoglobin.

Under conditions of low oxygen tension, the heterozygous (A/S) form can cause erythrocytes to form the characteristic sickle-shaped tactoids. The formation of these irreversible sickled red blood cells causes the onset of the acute symptoms. Detection of both the homozygous and heterozygous condition is important so high-risk individuals can be identified, and their symptoms reduced.

SICKLEDEX® kit is a qualitative solubility test for testing the presence of sickling haemoglobins in human blood. Deoxygenated Hb-S is insoluble in the presence of a concentrated phosphate buffer solution and forms a turbid suspension that can be easily visualised. Normal Haemoglobin A and other haemoglobins remain in solution under these conditions. These different qualitative outcomes allow for the detection of sickle cell disease and its traits.

SICKLEDEX uses Saponin to lyse the red blood cells. Sodium Hydrosulfite then reduces the released haemoglobin. Reduced Hb-S is insoluble in the concentrated phosphate buffer and forms a cloudy turbid suspension. Other sickling haemoglobin subtypes may also give a positive result.

Preparation of patients: There is no physical preparation for the test.

Precautions: Frozen, clotted, or grossly haemolysed samples cannot be analysed.

24 Hours

Positive or negative

Abbott Alinity c, Indirect ISE

Serum: Serum tubes (with or without gel barrier)

Plasma Collection tubes Acceptable anticoagulants are: Lithium heparin

20-25℃: 2 weeks              

2-8℃: 2 weeks      

-20℃: 1 year

Abbott IFU

24 Hours

mmol/L

Adult: 136 - 145

Abbott Alinity c, Indirect ISE

Spot Urine (random) Without preservatives

OR

Urine (random; 24- hour)

20-25℃: 7 days                

2-8℃: 7 days      

-20℃: 1 year

Abbott IFU

24 Hours

mmol/L

mmol/24hr

Urine (Spot):

Adult Male: 40 - 220

Adult Female: 27 - 287

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Manual

The specimen container(s) must be adequatedly labelled.

• An adequately completed test request form must accompany the specimen.

Specimen(s) are stable at room temperature once fixed in 10% neutral buffered formalin.

Unlike routine H&E staining that is either progressive or regressive, special stains require different techniques that are based on simple chemical reactions such as acid-base chemistry and oxidation reduction.

After a tissue specimen has been examined with Haematoxylin and Eosin, a special stain is applied to a sample for a more in–depth evaluation and allow target substances and foreign elements to be identified.

This includes components in tissue sections, based on their: chemical, biological and pathological character for example; lipids, calcium, carbohydrates, nerve fibers and fungi to name a small few.

The advantage of special stains is that specific stains can be applied to detect the presence of tissue structures with the addition of a more detailed evaluation of a specimen, diving in deeper into the morphological profile. The stains also act as a confirmation of changes taking place to the tissue including microorganisms and/or specific tissue molecules that cannot be picked up within routine staining.

‍

+5 working days

Chemiluminescent microparticle immunoassay (CMIA)

Chemiluminescent microparticle immunoassay (CMIA)

‍

Serum (Gold and redcap);

Plasma (green and lavender cap)

Temperature: + 4ºC

Miscellaneous: Non fasting

Serum (Gold and redcap);

Plasma (green and lavender cap)

Temperature: + 4ºC

Miscellaneous: Non fasting

Serum: RT ≤ 72 hours; 2-8°C ≤ 7 days

Plasma: RT ≤ 72 hours; 2-8°C ≤ 30 days

Serum: RT ≤ 72 hours; 2-8°C ≤ 7 days

Plasma: RT ≤ 72 hours; 2-8°C ≤ 30 days

Source: Abbott IFU

Source: Abbott IFU

Syphilis is caused by infection with the bacterium TP which can be transmitted congenitally or by sexual contact. The disease can evolve into a latent phase in which syphilis is clinically unapparent. Serological tests (non-treponemal and treponemal specific), in addition to patients’ clinical history, are currently the primary methods for the diagnosis and management of syphilis.

Preparation of Patient: There is no special physical preparation for the Syphilis Ab test.

3 working days

3 working days

Specimens with S/CO values < 1.00 are considered nonreactive (negative).

Specimens with S/CO values >=1.00 are considered reactive (positive).

This is a screening test and reactive samples will be referred to NVRL for confirmatory testing

Abbott Alinity I, Manual Pre-treatment precipitation. Chemiluminescent Microparticle Immunoassay (CMIA)

Whole Blood: EDTA

2-8℃: 8 days        

-20℃: 6 months

Consensus document: therapeutic monitoring of tacrolimus (FK-206). Ther Drug Monit 995; 17(6): 606 - 14.

24 Hours

ug/L

Target 24hr trough levels: 5 - 20

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Histology Processing. Diagnosis.

*Any unstained slide cases for staining only must be accompanied by

• HLF64 Blocks and Slides Chain of Custody Log or, an approved local version
• Clear identification of case number on slide

*Any block cases for microtomy and staining only must be accompanied by

• HLF64 Blocks and Slides Chain of Custody Log or, an approved local version
• Clear identification of case number on block

*Any block cases for microtomy, staining and reporting should be accompanied by

• HLF64 Blocks and Slides Chain of Custody Log or, an approved local version, and a Test Request Form with gross description
• Previous history where available

Any slide cases for reporting only should be accompanied by the following:

• HLF16 Chain of Custody Log or an approved local version
• A copy of gross report and test request form
• Previous history where available
• Clear identification of case number on slide

Slides, and specimen tissue blocks are both stable at room temperature. They should be kept out of direct sunlight.

Slides should be securely placed and sealed in a slide mailer or slide tray.

Specimen tissue blocks should be wrapped in a piece of tissue.

Clients may submit tissue blocks for microtomy and/or staining only to Eurofins Pathology. Clients may submit unstained slides for staining only.

Clients may submit pathology material for Consultant Services. In some instances, routine histology technical work up may also be carried out in Eurofins Pathology prior to submission to a Consultant Pathologist.

As per service level agreement with client.

Abbott Alinity i Chemiluminescent Microparticle Immunoassay (CMIA)

Serum: Serum, Serum separator

Plasma: Dipotassium EDTA

20-25℃: 8 hrs            

2-8℃: 7 days      

-20℃: longer

Abbott IFU

Testosterone regulates spermatogenesis in males via Sertoli cell stimulation and maintenance of the HPG axis. In females, it contributes to follicular development and ovarian function. Dysregulated levels can impair gametogenesis, ovulatory function, and fertility outcomes in both sexes.

24 Hours

nmol/L

Male 21 - 49 years: 8.33 - 30.19

Male >50 years: 7.66 - 24.82

Abbott Alinity c, Enzyme Immunoassay

Serum: Serum tubes (with or without gel barrier)

20-25℃: 7 days                

2-8℃: 7 days      

-20℃: 1 year

Abbott IFU

24 Hours

mg/L

Adult: 8 - 20

Abbott Alinity i Chemiluminescent Microparticle Immunoassay (CMIA)

Serum: Serum, Serum separator

Plasma: Potassium EDTA Sodium heparin Lithium heparin

2-8℃: 7 days      

-20℃: 6 months

Abbott I

TSH, secreted by the anterior pituitary, stimulates T3 and T4 production and is regulated by thyrotropin-releasing hormone (TRH). Abnormal levels may indicate thyroid dysfunction, which can disrupt menstrual cycles, ovulation, and implantation, impacting fertility.

Ref: https://pmc.ncbi.nlm.nih.gov/articles/PMC10298303/

24 Hours

mIU/L

Adult: 0.35 - 4.94

Abbott Alinity. CMIA

Serum (Gold and red cap)

Temperature: + 4ºC

Serum: RT 24 hours,

2-8ºC 3 days.

30 days @ -20ºC

Abbott IFU

TRAb is a third generation assay to detect anti-TSH receptor antibody using the human thyroid-stimulating monoclonal antibody M22. The M22 antibody acridinium-labelled conjugate competes with TRAb in the specimen for the bound human TSH receptor on the microparticle. Elevations of these thyrotropin receptor antibodies demonstrated high clinical sensitivity and specificity for Graves' disease when used as an aid in the differential diagnosis and etiology of hyperthyroidism. These antibodies can be classified as stimulating, inhibitory, or neutral; and the stimulating type of antibody is not subject to the typical negative feedback of elevated thyroid hormone levels. This results in continuous stimulation of the thyroid leading to the typical thyrotoxic symptoms of Graves' hyperthyroidism.

Preparation of Patient: No special preparation.

4 working days

Negative: < 3.1 IU/L

Positive: ≥ 3.1 IU/L

Abbott Alinity i Chemiluminescent Microparticle Immunoassay (CMIA)

Serum: Serum, Serum separator

Plasma: Potassium EDTA, Lithium heparin, Lithium heparin plasma separator, Sodium heparin

2-8℃: 6 days        

-20℃: 6 days

Abbott IFU

24 hours

nmol/L

Adult: 63 - 151

Abbott Alinity i Chemiluminescent Microparticle Immunoassay (CMIA)

Serum: Serum, Serum separator

Plasma: Potassium EDTA, Lithium heparin, Sodium heparin

2-8℃: 6 days        

-20℃: 6 days

Abbott IFU

24 Hours

nmol/L

Adult: 0.54 - 2.96

CALCULATION based on Abbott Alinity methodologies for  Iron and UIBC (Latent capacity)

Serum: Serum tubes (with or without gel barrier)

Plasma Collection tubes

Acceptable anticoagulants are: Lithium heparin (with or without gel barrier) Sodium heparin

20-25℃: 7 days                  

2-8℃: 7 days      

-20℃: 1 year

Abbott IFU

24 Hours

Adult: 44.8 - 76.1

Abbott Alinity i Chemiluminescent Microparticle Immunoassay (CMIA)

Serum: Serum, Serum separator

2-8℃: 24 hrs        

-20℃: longer

NCCP Prostate Cancer GP Referral Guideline v 5 2018

24 Hours

ng/mL

Adult Male <50 years: < 2.0

Adult Male 50 - 59 years: < 3.0

Adult Male 60 - 69 years: < 4.0

Adult Male >70 years: < 5.0

Abbott Alinity c, Biuret Reaction

Serum: Serum Serum separator

Plasma Dipotassium EDTA Lithium heparin Lithium heparin separator Sodium heparin

20-25℃: 7 days                  

2-8℃: 7 days      

-20℃: 1 year

Abbott IFU

24 Hours

g/L

Adult, ambulatory: 64 - 83

Abbott Alinity c, Immuno turbidimetric

Serum: Serum tubes (with or without gel barrier)

Plasma Collection tubes Acceptable anticoagulants are: Lithium heparin (with or without gel barrier) Sodium heparin EDTA

20-25℃: 7 days                

2-8℃: 7 days      

-20℃: 1 year

Abbott IFU

24 Hours

g/L

Male 14 to 60 Years: 1.74 - 3.64

Female 14 to 60 Years: 1.80 - 3.64

Male 60 to 80 Years: 1.63 - 3.44

Female 60 to 80 Years: 1.73 - 3.60

CALCULATION based on Abbott Alinity methodologies for  Iron and UIBC (Latent capacity)

Serum: Serum tubes (with or without gel barrier)

Plasma - Acceptable anticoagulants are: Sodium heparin Potassium EDTA Sodium citrate

20-25℃: 7 days                

2-8℃: 7 days      

-20℃: 1 year

Abbott IFU

24 Hours

%

Male Adult: 20.0 - 50.0

Female Adult: 15.0 -50.0

Nal Von Minden GmbH- Point of Care dipstick

Urine Clean plastic or glass container

2-8℃: 2 days        

-20℃: longer

Nal Von Minden GmbH IFU

24 Hours

ng/ml

Positivity Cut-off: 1000