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Anti-HEV – IgM Enzyme Immunoassay (EIA)

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Accredited by the Standards Council of Canada to Laboratory no. 594 (ISO/IEC 17025)

Requisition Forms

Reference Details

Description:

Detection of IgM antibody to the Hepatitis E virus by enzyme immunoassay (EIA).

Test Category:
Serology
Pathogen:
Hepatitis E virus (HEV)
Illnesses and Diseases:
  • Hepatitis E
Specimen:

Serum or plasma sample. Minimum volume required for serum or plasma – 0.5 mL.

Collection Method:

Collect blood in serum separator tubes (SST) or EDTA tubes.

Specimen Processing, Storage and Shipping:

Store samples refrigerated or frozen until shipped for testing.  Ship frozen on wet or dry ice. 

Transportation of Dangerous Goods:

Shipping of specimens shall be done by a TDG certified individual in accordance with TDG regulations. For additional information regarding classification of specimens for the purposes of shipping, consult either Part 2 Appendix 3 of the TDG Regulations or section 3.6.2 of the IATA Dangerous Goods Regulations as applicable.

 

Patient Criteria:

Suspected Hepatitis E infection.

Accompanying Documentation:

Completed Viral Hepatitis and Bloodborne Pathogens requisition including sender name, address and telephone number.  Patient name or identifier (referring specimen lab #), date of birth, suspected exposure, test(s) requested.  Type of specimen and date collected.  If possible, include the clinical history and lab results that have already been done at local or provincial laboratories.

Comments:

N/A

Methods and Interpretation of Results:

Microplate EIA, commercially available assay (Wantai, Beijing Biological Pharmacy Enterprise Co., Ltd.), research use only (RUO).  A positive anti-HEV IgM result may be indicative of current or recent infection. A laboratory confirmed case of acute HEV infection requires a combination of anti-HEV IgG and IgM. A single anti-HEV IgM (+) result in the absence of anti-HEV IgG and HEV RNA by PCR could be false positive.  It is recommended that a follow-up specimen is collected two weeks later and submitted again for HEV testing.

Turnaround Time:

15 calendar days. Borderline samples that need to be repeated have an extended turnaround time of 21 calendar days. Urgent clinical specimens require contact with the laboratory prior to submission and have a turnaround time of 3 calendar days.

 

Contact:
Phone #: (204) 789-6512
Fax: (204) 318-2222
References:
  1. Myint KS, Endy TP, Gibbons RV, Laras K, Mammen MP Jr, Sedyaningsih ER, Seriwatana J, Glass JS, Narupiti S, Corwin AL. . Evaluation of diagnostic assays for hepatitis E virus in outbreak settings. J Clin Microbiol. 2006;44(4):1581-3.
  2. Lin CC, Wu JC, Chang TT, Chang WY, Yu ML, Tam AW, Wang SC, Huang YH, Chang FY, Lee SD. Diagnostic value of immunoglobulin G (IgG) and IgM anti-hepatitis E virus (HEV) tests based on HEV RNA in an area where hepatitis E is not endemic. J Clin Microbiol. 2000 38(11):3915-8.
  3. Dawson GJ, Chau KH, Cabal CM, Yarbough PO, Reyes GR, Mushahwar IK. Solid-phase enzyme-linked immunosorbent assay for hepatitis E virus IgG and IgM antibodies utilizing recombinant antigens and synthetic peptides. Virol Methods. 1992 Jul;38(1):175-86.
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