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Test Code HEPCRNAQL HCV RNA Qualitative assay by RT-PCR

Performing Laboratory

Northwell Health Laboratories

Methodology

Real-Time Reverse Transcription-Polymerase Chain Reaction (RT-PCR) Abbott M2000

Note:  If the HCV quantitative test is being used for initial diagnosis of HCV infection, a low viral load result (<100 IU/mL) should be interpreted with caution. It is recommended that HCV serology be ordered to confirm diagnosis and/or repeat quantitative test on a new specimen. .

Specimen Required

Specimen must arrive same day as drawn.

 

Draw blood in a PPT™ VACUTAINER(S)®. Spin down, separate, immediately freeze 5 mL of plasma in original VACUTAINER(S)®. Send specimen frozen.

 

or

 

Draw blood in 2 Lavender-top(EDTA) tubes. Refrigerate during transport.  This specimen should be collected solely for HCV PCR testing and not used for other laboratory tests.

 

or

 

One Gold top tube Refrigerated during transport-Spun. This specimen should be collected solely for HCV PCR testing and not used for other laboratory tests.

Reference Values

Not detected

 

The limit of detection: 12 IU/mL.

 

Not Detected:  HCV RNA is not detected; possibly indicates resolved past infection or a false                              reactive antibody result. 

 

Detected:         HCV RNA is detected; indicates hepatitis C virus infection.

 

CDC guidelines and New York State require confirmation of reactive hepatitis C antibody screening tests. Results should be viewed in the context of clinical history and other lab tests. An indeterminate result indicates that HCV RNA result is inconclusive; please consider retesting with a new sample.   The performance characteristics of this assay have been determined by North-LIJ Laboratories. The U.S. Food and Drug Administration (FDA) has not approved or cleared this test, however, FDA clearance or approval is not currently required for clinical use.

Test Classification and CPT Coding

CPT Code:87521

Day(s) and Time(s) Performed

Monday- Friday (three times a week)

Computer Interface Code

PDM# 6350035