Test Catalog

Test Id : HEVQU

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Hepatitis E Virus RNA Detection and Quantification, Real-Time RT-PCR, Serum

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

Virologic detection and confirmation of hepatitis E virus (HEV) infection in individuals who are immunocompromised and are at risk for or suspected to have acute or chronic hepatitis E

 

Monitoring HEV RNA levels and determining eradication of chronic HEV infection in individuals who are immunocompromised

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Method Name
A short description of the method used to perform the test

Real-Time Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

HEV RNA Detect / Quant, S

Aliases
Lists additional common names for a test, as an aid in searching

Hepatitis E virus

HEV

HEV RNA Detection

HEV RNA Qualitative

HEV Qualitative

HEV RNA Quantitative

HEV RNA Quantification

HEV Quantitative

HEV Quantification

HEV RT-PCR

HEV PCR

HEV RNA Detection

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Specimen Type
Describes the specimen type validated for testing

Serum SST

Shipping Instructions

1. Freeze serum immediately, and ship specimen frozen on dry ice.

2. If shipment will be delayed for more 24 hours, freeze serum at -20 to -80 degrees C (up to 35 days) until shipment on dry ice.

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 1.8 mL

Collection Instructions:

1. Centrifuge blood collection tube per collection tube manufacturer's instructions (eg, centrifuge within 2 hours of collection for BD Vacutainer tubes).

2. Aliquot serum into plastic vial.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Forms

If not ordering electronically, complete, print, and send 1 of the following with the specimen:

-Gastroenterology and Hepatology Test Request (T728)

-Microbiology Test Request (T732)

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.8 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis OK
Gross lipemia OK

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Serum SST Frozen (preferred) 35 days ALIQUOT TUBE
Refrigerated 5 days ALIQUOT TUBE

Useful For
Suggests clinical disorders or settings where the test may be helpful

Virologic detection and confirmation of hepatitis E virus (HEV) infection in individuals who are immunocompromised and are at risk for or suspected to have acute or chronic hepatitis E

 

Monitoring HEV RNA levels and determining eradication of chronic HEV infection in individuals who are immunocompromised

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Hepatitis E virus (HEV) is a causative agent of acute self-limited or fulminant hepatitis. HEV has been responsible for large outbreaks of disease in developing countries, primarily through waterborne transmission. Hepatitis E also can occur in industrialized countries, usually as sporadic cases due to zoonotic infection transmitted by the fecal-oral route. A major natural reservoir of HEV is pigs.

 

In immunocompetent individuals, hepatitis E is mainly a self-limited infection, frequently nonsymptomatic, and does not result in chronic infection. However, in otherwise healthy pregnant patients, hepatitis E can be severe, resulting in significant morbidity and mortality. In individuals who are immunocompromised, such as organ transplant recipients, hepatitis E can be chronic with detectable HEV RNA levels in serum and plasma beyond 3 months after infection. HEV-specific IgM antibody is detectable by serologic testing by 4 weeks after infection in immunocompetent individuals, but it may not be detectable until 6 months after infection in patients who are immunosuppressed.

 

HEV RNA levels in serum or plasma are usually detectable in all infected individuals by 3 weeks after infection and become undetectable by 7 weeks in immunocompetent individuals. Due to the limitations of HEV serologic testing in patients who are immunosuppressed, molecular testing (eg, real-time reverse-transcriptase polymerase chain reaction assay) for HEV RNA in serum or plasma is an increasingly important tool in the diagnosis of acute or chronic HEV infection in these patients.

 

Currently, ribavirin is used as the antiviral agent of choice for organ transplant recipients with chronic HEV, and monitoring of HEV RNA levels in serum or plasma is used to assess response to such antiviral therapy. Significant decreases in HEV viral load or clearance of HEV RNA may be important predictors of virologic response during antiviral therapy.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Undetected

Interpretation
Provides information to assist in interpretation of the test results

The quantification range of this assay is 50 to 5,000,000 IU/mL (1.70 log to 6.70 log IU/mL), with a limit of detection (based on a 95% detection rate) of 20 IU/mL (1.40 log IU/mL).

 

An "Undetected" result indicates that hepatitis E virus (HEV) RNA is not detected in the serum specimen (see Cautions). Repeat testing in 1 to 2 months is recommended for those at risk of HEV infection. The limit of detection (based on a 95% detection rate) for this assay is 20 IU/mL.

 

A result of "<50 IU/mL" indicates that the HEV RNA level present in the serum specimen is below 50 IU/mL (1.70 log IU/mL), and the assay cannot accurately quantify the HEV RNA present below this level.

 

A quantitative value (reported in IU/mL and log IU/mL) indicates the HEV RNA level (ie, viral load) present in the serum specimen.

 

A result of ">5,000,000 IU/mL" indicates that the HEV RNA level present in the serum specimen is above 5,000,000 IU/mL (6.70 log IU/mL), and this assay cannot accurately quantify the HEV RNA present above this level.

 

An "Indeterminate" result suggests the presence of an atypical HEV target sequence. Since the HEV RNA sequence is atypical, repeat testing is unlikely to change this result and therefore is not recommended.

 

An "Equivocal" result indicates that the presence or absence of HEV RNA in the serum specimen could not be determined with certainty due to atypical real-time reverse transcriptase-polymerase chain reaction (RT-PCR) probe reactivity. Submission of a new specimen for testing is recommended.

 

An "Inconclusive" result indicates that the presence or absence of HEV RNA in the serum specimen could not be determined with certainty after repeat testing in the laboratory, possibly due to RT-PCR inhibition. Submission of a new specimen for testing is recommended.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

This assay is optimized for the detection and quantification of hepatitis E virus (HEV) genotypes 1 to 4, but due to unexpected mismatches between the real-time, reverse-transcription polymerase chain reaction primers and unusual or rare HEV target sequences, some serum specimens may yield "Undetected" results despite the presence of HEV RNA. Therefore, results should be interpreted with caution, considering the patient's risk factors for HEV infection, the analytical sensitivity of the assay, and possible source of the infecting HEV strain. Follow-up HEV RNA testing is recommended for patients with initially "Undetected" HEV RNA test results but at high risk for or suspected to have chronic hepatitis E.

 

In immunocompetent individuals, undetectable HEV RNA results indicate only the absence of HEV RNA in the specimen tested and do not exclude the diagnosis of HEV infection, given the relatively short duration of viremia (3 to 7 weeks after infection) in these individuals. Immunocompetent individuals with HEV infection would be expected to have repeatedly positive HEV-specific antibody test results (anti-HEV IgM and/or anti-HEV IgG).

 

Due to potential differences in assay performance, serial monitoring of HEV viral load in a given patient should be performed with the same molecular assay.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Aggarwal R. Diagnosis of hepatitis E. Nat Rev Gastroenterol Hepatol. 2013;10(1):24-33. doi:10.1038/nrgastro.2012.187

2. Kamar N, Rostaing L, Izopet J. Hepatitis E virus infection in immunosuppressed patients: natural history and therapy. Semin Liver Dis. 2013;33(1):62-70. doi:10.1055/s-0033-1338115

3. Kamar N, Lhome S, Abravanel F, et al. An early viral response predicts the virological response to ribavirin in hepatitis E virus organ transplant patients. Transplantation. 2015;99(10):2124-2131. doi:10.1097/TP.0000000000000850

Method Description
Describes how the test is performed and provides a method-specific reference

This assay utilizes real-time polymerase chain reaction (PCR) technology for the qualitative and quantitative detection of hepatitis E virus (HEV) RNA in human serum. Testing involves 3 major processes with the ELITe InGenius integrated system: automated extraction and purification of viral RNA; reverse transcription of viral target RNA sequence to generate complementary DNA (cDNA); and PCR amplification of a 69-base pair sequence in the 5' end of the HEV open reading frame (ORF) 2 that encodes the viral capsid protein, followed by real-time detection of fluorescent dye-labeled oligonucleotide probes that allow the specific and simultaneous detection and quantification of the target sequence as well as an MS2 internal control. The assay is calibrated to the First World Health Organization International Standard for HEV RNA, PEI code 6329/10.(Germer JJ, Ankoudinova I, Belousov YS, et al. Hepatitis E virus detection and quantification by an RT-PCR assay calibrated to the World Health Organization Standard for HEV RNA. J Clin Microbiol. 2017;55(5):1478-1487. doi:10.1128/JCM.02334-16)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Varies

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

1 to 10 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

2 months

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

87799

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
HEVQU HEV RNA Detect / Quant, S 69961-1
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
62929 HEV RNA Detect / Quant, S 69961-1

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | PHP Pdf | CMS Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports