Laboratory Test Guide

Hepatitis C Antibody with Reflex to PCR

General Information

Lab Name

Hepatitis C Ab w/RFLX PCR

Lab Code

HCAB

Epic Name

Hepatitis C Antibody w/Reflex PCR

Description

The Qualitative detection of Hepatitis C virus IgG and IgM antibodies (anti-HCV) in human sera by the FDA approved Abbott ARCHITECT Anti-HCV test two-step chemiluminescent immunoassay.

In the first step, sample, assay diluent, and recombinant HCV antigen (rHCV) coated paramagnetic microparticles are combined. Anti-HCV present in the sample binds to the rHCV coated microparticles. In the second step, anti-human IgG/IgM acridinium-labeled conjugate is added, which binds to IgG and IgM anti-HCV. Then pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs).

The presence or absence of IgG/IgM anti-HCV in the sample is determined by comparing the chemiluminescent signal in the reaction to the cutoff signal determined from an ARCHITECT Anti-HCV calibration. Specimens with signal to cutoff (S/CO) values ≥ 1.00 are considered reactive for IgG/IgM anti-HCV. Specimens with S/CO values < 0.79 are considered nonreactive and specimens with S/CO values between 0.80 and 0.99 are Indeterminate.

Reactive anti-HCV will reflex to Hepatitis C RNA, Quantitative [HCVQNT] for confirmation with an additional charge.

For anti-HCV testing without PCR reflex for REACTIVE results, see Hepatitis C Antibody without PCR reflex on reactive samples [HCABX].

Synonyms

HABB, HABC, HCV

Components

Code	Name
HCABR	Hepatitis C Ab w/RFLX PCR
IN46	Hepatitis C Ab Interp

Interpretation

Method

Chemiluminescence Immunoassay

Reference Range

See individual components

Guidelines

Washington DOH Notifiable Conditions

Ordering & Collection

Specimen Type

Blood

Collection

All Locations: 2 tubes required if reflex testing is ordered

Preferred: 5 mL blood in GOLD SST tube plus 5 mL blood in PEARL PPT tube

Also acceptable: 5 mL blood in ORANGE RST or RED TOP tube plus a 5 mL PEARL PPT tube for reflexive testing.

Note: If no PEARL PPT is received, any reflexive molecular testing can be done on GOLD SST, LAVENDER or RED TOP Tube that has not been on automated lines.

Quantity

requested: 1.0 mL serum
minimum: 0.5 mL serum

Processing

GOLD SST tube: Specimens may be stored on or off the clot, red blood cells, or separator gel for up to 3 days at room temperature (15-30°C) or up to 7 days at 2-8°C. If testing will be delayed more than 3 days for specimens stored at room temperature or more than 7 days for specimens stored at 2-8°C, remove serum from the clot, red blood cells, or separator gel and store at -20°C or colder. Avoid more than three freeze/thaw cycles.

PEARL PPT tube: centrifuge within 6 hours of collection and freeze spun PEARL PPT tube at -20°C. Route frozen PEARL tubes to UW SPS -20°C freezer rack 80. [ok to freeze spun pearl top tubes on gel.]

Unacceptable samples: Cord blood, neonatal specimens, cadaver specimens, heat-inactivated specimens, or body fluids such as saliva, urine, amniotic fluid, or pleural fluid. Specimens with obvious microbial contamination or are grossly hemolyzed.

Performance

LIS Dept Code

Clinical Virology (CVIR)

Performing Location(s)

Other	Virology 206-685-8037 Virology Laboratory, Ste 320 1616 Eastlake Ave E. Seattle, WA 98102