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

Reference Value: Undetected

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:

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 transcriptase-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.

Centrifuge sample and transfer serum to a separate plastic vial within 2 hours of collection. Freeze serum at -20°C while awaiting transport. Ship on dry ice.

Stability: Frozen (preferred): 35 days; Refrigerated: 5 days; Ambient: Unacceptable.

Centrifuge sample and transfer serum to a separate plastic vial within 2 hours of collection. Freeze serum at -20°C.

Login: SEND1-;FREEZE

• RSNDT1: MAYOSD
• RSTYP1: SRM
• RTSRQ1: ;Hepatitis E Virus RNA Detection and Quant, PCR (Mayo Test HEVQU)

Sendouts:

• Order Mayo Test: HEVQU.

Stability: Frozen (preferred): 35 days; Refrigerated: 5 days; Ambient: Unacceptable.