Hepatitis C Antibody without PCR reflex on reactive samples

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General Information

Lab Name
Hepatitis C Ab w/o PCR
Lab Code
HCABX
Epic Ordering
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.

Synonyms
Components

Interpretation

Method

Chemiluminescence Immunoassay

Reference Range
See individual components
Guidelines

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

Handling Instructions
Quantity
requested: 1.0 mL serum
minimum: 0.5 mL serum

Processing

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
Frequency
Monday-Friday
Available STAT?
No

Billing & Coding

CPT codes
86803
LOINC
40726-2
Interfaced Order Code
UOW1908