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Hepatitis C Virus RNA Real-Time PCR (138-7522)
Test Mnemonic:

 HCV PCR

Specimen Requirements:
Test Included:

Hepatitis C virus for  quantitiative testing.

Collection:

One pearl color  (PPT) top or gold (SST)Vacutainer; collect one tube for this test and do not combine with other test orders. Submit SST only when PPT tube is not available

Container:

PPT or SST

Minimum Volume:

4 ml

Storage/Transport:

Transport frozen

Specimen Preparation:

Within six hours of collection, centrifuge blood sample at 1,000 x g for 15 minutes. After centrifugation, remove plasma or serum from cells into a screw-cap polypropylene transport tube. Label as serum or plasma.

Stability:

 Separation must occur within 6 hours of collection, store frozen for up to  one month.

Causes for Rejection:

Incomplete or incorrect sample identification, insufficient sample volume, incorrect blood collection tube (Vacutainer), gross hemolysis, clots, prolonged time to processing

Reference Range:

Reported as:

HCV Not Detected or

HCV Detected &<12 IU/mL (1.08 Log IU/mL) or

12IU/mL (1.08 Log IU/mL) to 10 8 IU/mL (8.00 Log IU/mL) or

>10 8 IU/mL (8.00 Log IU/mL)Not detected

Turnaround Time:

3-10 days

Methodology:

Quantification of Hepatitis C virus RNA by Real time PCR

Performed:

Molecular Diagnostics Laboratory

Synonyms:

Hepatitis C Virus Real Time PCR; Hepatitis C Viral Load; Hepatitis C Virus Quantitative; HCV Real Time PCR; HCV Quantititative Viral Load

Clinical Indication:

To monitor HCV viral loads in active infections

Patient Preparation :

Routine venipuncture

CPT 4 Code:

 87522

Note:

Submit one PPT tube for each molecular assay requested due to volume needs for testing.

A result of "Not Detected" does not rule out the presence of PCR inhibitors in the patient specimen or hepatitis C virus RNA concentrations below the level of LLOQ.  Care should be taken when interpreting any single viral load determination. The test is intended for use in conjunction with clinical presentation and other laboratory results.

When ordering tests for which Medicare or Medicaid reimbursement will be sought, physicians should only order tests that are medically necessary for the diagnosis or treatment of the patient. Components of the organ or disease panels may be ordered individually. The diagnostic information must substantiate all tests ordered and must be in the form of an ICD-10 code or its verbal equivalent.
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