ARUP's Laboratory Test Directory
| 0098757: Hepatitis C Virus RNA Quantitative bDNA |
| Test Mnemonic: HCV RNA BC | |
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Methodology: Branched Chain DNA
Performed: Tue, Fri Reported: 2-5 days |
| Specimen Required: | |
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Collect: One 7 mL SST, PPT, lavender (EDTA), or pink (K2EDTA).
Transport: 1 mL serum or plasma, frozen. (Min: 0.2 mL) Submit specimen in an ARUP Standard Transport Tube. Specimens collected in a PPT should be submitted in original container. Submit specimen according to Biological Substance, Category B, shipping guidelines. Pediatric Collection/Transport: 0.1 mL serum or plasma, frozen. Submit specimen according to Biological Substance, Category B, shipping guidelines. Remarks: CRITICAL FROZEN. Separate specimens must be submitted when multiple tests are ordered. Separate serum or plasma from cells within two hours. Do not store PPT whole blood at 2-8°C. Unacceptable Conditions: Nonfrozen, heparinized, thawed or refrozen specimens. Polystyrene tubes. Stability: Ambient: 2 hours (on cells); Plasma or serum removed from cells within 2 hours can be refrigerated and frozen as follows: Refrigerated: 12 hours; Frozen (-20°C): 3 days; (-70°C): 4 months |
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| Reference Interval: |
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Less than 615 IU/mL Less than 2.8 log IU/mL |
| Interpretive Data: | |
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Assay methodology is branched chain DNA as performed using the FDA approved VERSANT® HCV RNA 3.0 assay (bDNA). This is a signal-amplification nucleic acid probe assay for the direct quantification of HCV RNA in the plasma or serum of HCV-infected individuals. The reference interval for this assay is less than 2.8 log IU (615 IU) of HCV RNA/mL. The analytical measurement range of this assay is 2.8 to 6.9 log IU/mL (615 to 7,690,000 IU/mL). Specificity of this assay has been determined by manufacturer to be greater than 98%. Low positive values may occasionally be seen in samples from patients who are HCV seronegative or whose HCV viral load is actually below the threshold of assay detection (615 HCV IU/mL). Caution should be taken in the interpretation of any single viral load determination. A result of less than 615 HCV IU/mL does not rule out the presence of inhibitors in the patient specimen or hepatitis C virus RNA concentrations below the limit of detection by the assay. This assay should not be used for blood donor screening, associated re-entry protocols, or for screening Human Cell, Tissues and Cellular Tissue-Based Products (HCT/P). |
| Note: | |
| A qualitative PCR assay with a detection limit of 50 HCV RNA IU/mL, Hepatitis C Virus RNA Qualitative PCR (0098264), is available for the assessment of lower levels of HCV viremia. |
| CPT Code(s): | |
| 87522 |