Molecular Detection by Real-Time RT-PCR

Molecular detection of Hepatitis E virus by commercial quantitative real-time RT-PCR.

Serum, plasma or fecal sample.  Minimum volume required for serum or plasma – 1.0 mL.

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

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

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.

Suspected Hepatitis E virus infection.   Serologically confirmed acute or chronic Hepatitis E virus infection. If sample is anti-HEV IgM negative/IgG positive, please provide justification on the requisition for molecular testing (i.e., immunosuppression, transplant, etc.).

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.

Only samples that are positive for anti-HEV IgM antibodies will be tested. Samples submitted for anti-HEV serology testing are automatically reflexed to HEV RNA testing, if positive for IgM antibodies. Anti-HEV IgM negative specimens are not automatically tested for HEV RNA. RNA testing may be requested with justification (immunosuppression, etc.).

Commercially available Real Time PCR (RealStar® HEV RT-PCR Kit - Altona Diagnostics, Germany) amplifying all HEV genotypes. HEV viral load quantification will be reported on all molecular detection requests.

19 calendar days. Positive anti-HEV IgM samples that are reflexed to HEV RNA testing have an extended turnaround time of 21 calendar days.

1. Florence Abravanel, Sabine Chapuy-Regaud, Sébastien Lhomme, Martine Dubois, Jean-Marie Peron, Laurent Alric, Lionel Rostaing, Nassim Kamar, Jacques Izopeta,Performance of Two Commercial Assays for Detecting Hepatitis E Virus RNA in Acute or Chronic Infection: 2013, J Clin Microbiol v.51, 1913-16.