Hepatitis C Ab w/Reflex HCV RNA, Quant, RT-PCR

Test Code

HEPC

Alias/See Also

Performed at Sonora Quest Laboratory (SQL test code 8587)
Performed on site for BCCH
Performed at WyMCC for TCH, WMC and PCMH
Performed at NCMC for OCH

CPT Codes
86803

Preferred Specimen

For all sites:
HCV Ab: 1.0 mL serum from a serum seperator tube (SST) - minimum volume: 0.5 mL

HCV RNA, Quant, RT-PCR: 2.0 mL plasma from lavendar-top (EDTA) tube - minimum volume: 1.0 mL

Instructions

HCV Ab: centrifuge the serum seperator tube (SST). Do not pour off the seum.

HCV RNA, Quant, RT-PCR: Centrifuge and transfer plasma from whole blood within 24 hours of collection to a screw-cap plastic tube.

See link below for specimen details, methodology, setup schedule and reference ranges.

Transport Temperature

Refrigerated (2-8 C)

Specimen Stability

HCV Ab (SERUM)
Refrigerated (2-8 C): 7 days
Frozen (-20 C): 6 months

HCV RNA, QT, RT-PCR (PLASMA)
Refrigerated (2-8 C): 6 days
Frozen (-60 C): 6 months

Methodology
HCV Ab: Indirect 2-wash sandwich immunoassay
HCV RNA: RT-PCR

Setup Schedule

Evenings: Monday through Friday
Nights: Monday through Sunday

Report Available

1-3 days

Limitations

HCV Ab assay

The HCV Ab assay is limited to the detection of IgG antibodies.
Values obtained with different assay methods cannot be use interchangeably.
The performance characteristics of this assay have not been established with cord blood, neonatal specimens, cadaver specimens, or body fluids other than sera.

HCV RNA

This test has only been validated for use with EDTA plasma and serum. Testing of other samples may result in accurate results.
Quantitation of HCV RNA is dependent on the number of virus particles present in the sample and may be effected by sample collection methods, patient factors (i.e., age, presence of symptoms), and/or stage of infection.
Though, rare, mutations within the highly conserved regions of a viral genome covered by the cobas HCV may affect primer and/or probe binding resulting in the under-quantitation of virus or failure to detect the presence of virus.

Reference Range

HCV Ab: Non-reactive (index value <0.80)

Clinical Significance

HCV is the major etiologic agent of chronic non-A, non-B hepatitis. The presence of antibodies to HCV indicates that an individual may have been infected with HCV or may be capable of transmitting HCV. Infection with HCV results in a chronic infection in 50 to 80% of cases. The "window" between HCV acquistion and seroreactivity is highly variable; up to six months.

Additional Information
Hepatitis C Ab w/Reflex HCV RNA, Quant, RT-PCR

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.