Laboratory Test Guide

Hepatitis C Antibody without PCR reflex on reactive samples

General Information

Lab Name

Hepatitis C Ab w/o PCR

Lab Code

HCABX

Epic Name

Hepatitis C Antibody w/o 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.

For anti-HCV testing with PCR reflex for REACTIVE results, see Hepatitis C Antibody with Reflex to PCR [HCAB]. Reactive anti-HCV will reflex to Hepatitis C RNA, Quantitative [HCVQNT] for confirmation with an additional charge.

Components

Code	Name
HCABRX	Hepatitis C Ab Result w/o 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

Blood: 5 mL blood in GOLD TOP serum separator tube (SST).

Also acceptable: 5 mL blood in ORANGE TOP rapid serum tube (RST) or RED TOP tube

Quantity

requested: 1.0 mL serum
minimum: 0.5 mL serum

Processing

Blood: 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.

Outside Laboratories: 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.

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

Central Lab Virology (RVIR)

Performing Location(s)

CL	Virology, Renton 206-685-6656 1602 Raymond Ave SW Renton, WA 98057-3356	206-685-6656 opt 4