| HCV Quantitative Assay by NAAT (8000100164) | |
|---|---|
| Test Mnemonic: | HCV-NAAT |
| Specimen Requirements: | |
| Collection: | Plasma preparation tube (PPT) Serum separator tube (SST) |
| Container: | Plasma preparation tube (PPT) Serum separator tube (SST) |
| Minimum Volume: | Original Tube - 2 mL of plasma or serum 13 x 100 Specimen Aliquot Tube - 1.5 mL of plasma or serum |
| Storage/Transport: | Refrigerate (2-8ºC) up to 5 days; Samples should be frozen (-20ºC) and tested within 60 days. |
| Specimen Preparation: | Within 24 hours of collection, centrifuge. |
| Stability: | Refrigerate (2-8ºC) up to 5 days; Samples should be frozen (-20ºC) and tested within 60 days. |
| Causes for Rejection: | Improper collection. Specimen container unlabeled or labeled incorrectly. No date and time of collection or collector information on order. |
| Reference Range: | HCV Not Detected HCV Detected: 10-100,000,000 IU/mL |
| Turnaround Time: | 5 days |
| Methodology: | Nucleic acid amplification by transcription-mediated amplification, target capture, and dual kinetic assay. |
| Performed: | |
| Lab: | Clinical Microbiology |
| Synonyms: | HCV Viral Load; HCV Quantitative; Hepatitis C Quantitative test |
| Clinical Indication: | Detection of HCV in serum or plasma specimens. |
| Patient Preparation : | Routine venipuncture for blood. |
| CPT 4 Code: | 87522 |
| Note: | The Aptima HCV Quant Dx assay is an FDA-approved real-time transcription mediated amplification (TMA) test used for both detection and quantification of hepatitis C virus (HCV) RNA in human serum and plasma from HCV-infected individuals. It is intended for use as an aid in the diagnosis of active HCV infection and the management of HCV-infected patients undergoing HCV antiviral drug therapy. It is not approved for use as a screening test for the presense of HCV RNA in blood or blood products. The quantitative range of this assay is 1.00-8.00 log IU/mL or 10 - 100,000,000 IU mL. An interpretation of "Not Detected" does not rule out the presence of inhibitors in the patient specimen of HCV RNA concentration below the level of detection of the test. Care should be taken when interpreting any single viral load determination. Detected, not Quantifiable: HCV RNA detected, but at a level below 10 IU/mL (1.0 log IU/mL). HCV RNA concentration is below the lower limit of quantitation of the assay. Indeterminate: Error indicated in the generation of the result. Please submit a new specimen for repeat testing if clinically indicated. |
| 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. | |