Anti- HCV (ab) with Reflex to Viral Load

Brief Description

The Anti-HCV assay is a chemiluminescence Immunoassay (CLIA) for the qualitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to hepatitis C virus (anti-HCV) in human adult serum.

The Abbott Real–Time HCV assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for the quantification of Hepatitis C Virus (HCV) in human serum from HCV infected individuals.

Laboratory Unit

Immunology

Methodology

• Chemiluminescence Immunoassay (CLIA)
• RT-PCR

Specimen Collection

Serum:

Collect in gold top SST tube, centrifuge

Collect in tiger top SST tube, centrifuge

Storage/Transport

Serum separated from the clot can be maintained at refrigerated temperature (2-8°C) during transit for no more than 72 hours after collection.  Serum separated from the clot can be aliquoted, stored frozen (-20°C or colder) for up to 60 days or -70°C or colder after 60 days and shipped with dry ice.

• FRM-QA 4 Refrigeration Outfit Guide

Acceptable Specimen Type(s)

Serum

Test Request

• GPHL Apollo Web Portal
• Web Portal Instructions
• For manual orders, download the GPHL Submission Form

Possible Results

• CLIA:
  • Reactive
  • Nonreactive
  • Equivocal
  • Unsatisfactory
• RT-PCR:
  • HCV RNA copies/ml
  • Not detected
  • Unsatisfactory

Reference Range

• Nonreactive: CLIA
• Not detected: RT-PCR

Unacceptable Conditions

• Missing testing requisition
• Missing minimum of 2 patient identifiers
• Improper labeling
• Improper storage/transport of specimen
• No specimen received (empty collection tube).
• Wrong specimen type
• Low volume, QNS
• Not approved for testing by the indicated method
• Grossly hemolyzed, lipemic, turbid, or contaminated
• Specimen broken, damaged, or leaking upon arrival
• Specimen received unspun
• Specimens left at ambient temperature
• Specimens not frozen within 72 hours
• Specimens not collected in SST tubes for viral load testing 

Interfering Substances

• CLIA:
  • Fibrin, red blood cells, and other particulate matter
• RT-PCR:
  • Lipemic, Hemolyzed, Icteric, Microbial growth, or contaminated specimens

Result Reported

• 5-7 business days (Ab)
• 7-14 business – (Viral Load)

Fees

No Charge

LOINC/Order Codes

75886-2 (Order code: 1480)