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Hepatitis E Virus (HEV) Quantitative Real-time RT-PCR

Test Code: 3800
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Clinical Utility

Diagnostic testing for Hepatitis E Virus (HEV) is important in patients for which other causes of acute hepatitis have been excluded, since HEV infection is clinically indistinguishable from other types of acute viral hepatitis. Diagnosis is based upon the detection of anti-HEV antibodies or detection of HEV nucleic acid; a combination of these two approaches is preferred particularly in acute cases of HEV infection.1 Detection of multiple HEV genotypes is clinically relevant since HEV genotypes 1, 2, 3 and 4 have all been implicated in human disease, and viral quantitation has a role in monitoring response to therapy.2

1. Baylis SA, Hanschmann K-M, Blumel J, NublingC M, et al. 2011. Standardization of Hepatitis E Virus (HEV) Nucleic Acid Amplification Technique-Based Assays: an Initial Study To Evaluate a Panel of HEV Strains and Investigate Laboratory Performance. J Clin Microbiol 49(4):1234-1239.

2. Ahmed A, Ali IA, Ghazal H, Fazili J, Nusrat S. 2015. Mystery of Hepatitis E Virus: Recent Advances in Its Diagnosis and Management. International J of Hepatology, article ID 872431.

 

Procedure

Extraction of nucleic acid from specimen, followed by reverse transcription of viral RNA, then amplification and detection of cDNA using real-time, quantitative PCR. An internal control is added to ensure the extraction was performed correctly and the PCR reaction was not inhibited. This test has not been cleared or approved for diagnostic use by the U.S. Food and Drug Administration.

Specificity

Detects all known genotypes (1 to 4) in one assay. The primers and probes used in this assay are specific and inclusive for all 4 known HEV genotype strains based on similarity search algorithms. Additionally, potential cross-reactivity was evaluated with various pathogens that could cause similar symptoms or pathogens related to HEV due to sequence identity.

Same day (within 8 - 12 hours from receipt of specimen), Monday through Saturday.

Specimen Type Order Code CPT Code NY Approved Volume Assay Range Special Instructions
fecal 3808 87798 Yes Size of pea, or 2 mL liquid stool Detected/Not Detected
  • Collect and place in a sterile, screw top tube.
  • Store frozen and ship on dry ice for overnight delivery.
plasma 3801 87799 Yes 2 mL (min. 0.5 mL) 430 IU/mL to 4.3x10e8 IU/mL
  • Collect 4-5 mL whole blood in EDTA or ACD tube.
  • Centrifuge and transfer 2 mL plasma to sterile, screw top tube.
  • Can be shipped at ambient or frozen temperature Monday through Friday.
  • Specimens shipped at ambient temperature must be received within 96 hrs of collection.
serum 3810 87799 Yes

2 mL (min. 0.5 mL)

430 IU/mL to 4.3x10e8 IU/mL

  • Collect 4-5 mL whole blood in red top tube.
  • Centrifuge and transfer 2 mL serum to sterile, screw top tube.
  • Can be shipped at ambient or frozen temperature Monday through Friday.
  • Specimens shipped at ambient temperature must be received within 96 hrs of collection.

430 IU/mL to 4.3x10e8 IU/mL

Shipping

Ship Monday through Friday. Friday shipments must be labeled for Saturday delivery. All specimens must be labeled with patient's name and collection date. A Viracor Eurofins test requisition form must accompany each specimen. Multiple tests can be run on one specimen. Ship specimens FedEx Priority Overnight® to: Viracor Eurofins, 1001 NW Technology Dr, Lee's Summit, MO 64086.

Causes for Rejection

Specimens beyond their acceptable length of time from collection as listed in the specimen handling, or specimen types other than those listed.

Specimens are approved for testing in New York only when indicated in the Specimen Information field above. The CPT codes provided are based on Viracor Eurofins' interpretation of the American Medical Association's Current Procedural Terminology (CPT) codes and are provided for informational purposes only. CPT coding is the sole responsibility of the billing party. Questions regarding coding should be addressed to your local Medicare carrier. Viracor Eurofins assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.

References

1. Abravanel F et al. Characteristics of Autochthonous Hepatitis E Virus Infection in Solid-Organ Transplant Recipients in France. 2010. The Journal of Infectious Diseases; 202: 835–844

2. Abravanel F et al. Genotype 3 Diversity and Quantification of Hepatitis E Virus RNA. 2012. Journal of Clinical Microbiology; 50: 897-902.

3. Abravanel F et al. Performance of Two Commercial Assays for Detecting Hepatitis E Virus RNA in Acute or Chronic Infections. 2013. Journal of Clinical Microbiology; 51: 1913-1916.

4. Baylis S et al. Standardization of Hepatitis E Virus (HEV) Nucleic Acid Amplification Technique-Based Assays: an Initial Study to Evaluate a Panel of HEV Strains and Investigate Laboratory Performance. 2011. Journal of Clinical Virology; 49: 1234-1239.

5. Baylis S et al. World Health Organization International Standard to Harmonize Assays for Detection of Hepatitis E Virus RNA. 2013. Emerging Infectious Diseases; 19: 729-735

6. Cao D and Meng XJ. Molecular biology and replication of hepatitis E virus. 2012. Nature-Emerging Microbes and Infections; 1.

7. Dalton HR et al. Hepatitis E: an emerging infection in developed countries. 2008. Lancet Infectious Diseases; 8: 698-709.

8. Gurley ES et al. Outbreak of Hepatitis E in Urban Bangladesh Resulting in Maternal and Perinatal Mortality. 2014. Clinical Infectious Diseases doi: 10.1093/cid/ciu383.

9. Hewitt PE et al. Hepatitis E virus in blood components: a prevalence and transmission study in southeast England. 2014. Lancet; 384: 1766–73.

10. Kamar N, Dalton R, Abravanel F and Izopetb J. Hepatitis E Virus Infection. 2014. Clinical Microbiology Reviews; 27:116-138.

11. Krain LJ, Nelson KE and Labriquea AB. Host Immune Status and Response to Hepatitis E Virus Infection. 2014. Clinical Microbiology Reviews; 27: 139-165.

12. Lhomme S et al. Hepatitis E Virus Quasispecies and the Outcome of Acute Hepatitis E in Solid-Organ Transplant Patients. 2012. Journal of Virology; 86: 100006-10014.

13. Mokhtari C et al. Comparison of real-time RT-PCR assays for hepatitis E virus RNA detection. 2013. Journal Clinical Virology; 58: 36-40.

14. Schlosser B et al. Liver transplant from a donor with occult HEV infection induced chronic hepatitis and cirrhosis in the recipient. 2012. Journal of Hepatology; 56: 500-502

15. Smith DB; Purdy MA and Simmonds P. Genetic Variability and the Classification of Hepatitis E Virus. 2013. Journal of Virology; 87: 4191-41-69.

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