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Test Code aHCV Hepatitis C Antibody Screen with Reflex to Hepatitis C Virus RNA by PCR

Additional Codes

Cerner

NextGen

Hepatitis C Ab Screen w/Reflex to HCV RNA by PCR

Hepatitis C Ab Screen w/Reflex to HCV RNA by PCR

Alternate Name(s)

Anti-HCV

HCV Antibody

Hepatitis C Virus Antibody

Hepatitis C Ab

Non-A, Non-B Hepatitis

Methodology

Immunometric

Patient Preparation

None

Collection Instructions

  • Standard phlebotomy practices.
  • Centrifuge specimens and remove serum from cells within 2 hours of collection.

Specimen Requirements

Container

Specimen Type

Tube

Serum

 or 

SST

Preferred

 or  or 

 

Stability

Storage

Temperature

Stability

Room Temperature

18-28°C

< 8 hours

Refrigerated

 2-8°C

≤ 48 hours

Frozen

≤ -20 °C

28 days, thaw only once

Rejection Criteria

Gross Hemolysis

Result Reporting and Reference Values

Reference Range: Negative

Reflex Testing

Hepatitis C Virus (HCV) RNA Detection and Quantification by Real-Time Reverse Transcription-PCR, Serum will be reflexed for a Reactive result.

Limitations

  • No known interferences.
  • The results from this or any other diagnostic kit should be used and interpreted only in the context of the overall clinical picture.
  • A negative test result does not exclude the possibility of exposure to or infection with HCV. HCV antibodies may be undetectable in some stages of the infection and in some clinical conditions. Follow CDC recommendations for supplemental testing of reactive samples.
  • Results from immunosuppressed individuals should be interpreted with caution.
  • The prevalence of the analyte will affect the test’s predictive value.
  • Heterophilic antibodies in serum samples may cause interference with immunoassays. These antibodies may be present in blood samples from individuals regularly exposed to animals or who have been treated with animal serum products.
  • The cross-reactivity of the VITROS Anti-HCV test with other flaviviruses known to cause hepatic disease has not been established.
  • The cross-reactivity of the VITROS Anti-HCV test with antibodies to S. Cerevisiae has not been established.

Useful For

VITROS Immunodiagnostic Products Anti-HCV Reagent Pack detects IgG to hepatitis C virus (anti-HCV) in human serum using the VITROS XT 7600 Integrated Systems. Three recombinant hepatitis C virus encoded antigens are used. Assay results, in conjunction with other laboratory results and clinical information, can provide presumptive evidence of infection with hepatitis C virus in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis C infection. In addition, this assay can be used to screen for hepatitis C infection in pregnant women to identify neonates who are at risk of acquiring HCV during the prenatal period.