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Hepatitis C Ab Reflex to HCV RNA PCR

Alternate Name: HCV Atellica

SAL Code:

925

CPT:

86803

Loinc:

13955-0

Turn Around Time:

24 hours

Setup:

Mon - Sun

Units:

Index

Department:

Hepatitis C

Methodology:

The Atellica IM aHCV assay is an indirect sandwich immunoassay. The sample is incubated with Solid Phase containing recombinant and synthetic peptide HCV antigens. Antigen antibody complexes will form if anti-HCV antibody is present in the sample. Lite Reagent containing mouse
monoclonal anti-human IgG antibody labeled with acridinium ester is used to detect anti-HCV IgG in the sample. A direct relationship exists between the amount of anti-HCV present in the patient sample and
the amount of relative light units (RLUs) detected by the system. A result of reactive, nonreactive, or equivocal is determined according to the Index Value established with the calibrators.

Specimen Requirements:

Primary Tube:

SST

Primary Substance:

Serum

Temperature

Period

Stable Fridge:

2 -8 C for up to 7 days

Clinical Info:

The Atellica® IM Hepatitis C (aHCV) assay is an in vitro diagnostic immunoassay for the qualitative determination of immunoglobulin G (IgG) antibodies to hepatitis C virus (HCV) in human pediatric (18 months–21 years) and adult serum or plasma (EDTA, lithium or sodium heparinized) using the Atellica® IM Analyzer. The assay may be used in conjunction with other serological and clinical information to aid in the diagnosis of individuals with symptoms of hepatitis and in individuals at risk for hepatitis C infection. This product is not for use for testing or screening pooled samples containing specimens from more than one individual, or otherwise in blood or plasma screening.

Test Limitations:

- The Atellica IM aHCV assay is limited to the detection of IgG antibodies to hepatitis C virus in human serum.
- Assay performance characteristics have not been established for the Atellica IM aHCV assay used in conjunction with other manufacturers' assays for specific HCV serological markers.
- 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 hepatitis C virus.
Atellica CI Analyzer aHCV 11204892_EN Rev. 03, 2024-06 9 / 28
- The calculated values for hepatitis C in a given specimen as determined by assays from different manufacturers can vary due to differences in assay methods and reagent specificity. The results reported by the laboratory to the physician must include the identity of the assay used. Values obtained with different assay methods cannot be used interchangeably. The reported antibody level cannot be correlated to an endpoint titer.
- A reactive anti-HCV result does not exclude co-infection by another hepatitis virus.
- The performance of the Atellica IM aHCV assay has not been established with cord blood, neonatal specimens, cadaver specimens, heat-inactivated specimens, or body fluids other than serum or plasma, such as saliva, urine, amniotic fluid, or pleural fluid.
- The performance of the assay has not been established for populations of immunocompromised or immunosuppressed patients.
- 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.
- Patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results. This assay is designed to minimize interference.

Test Information:

Components: