Hepatitis C Virus (HCV) Genotyping, Nonreflex
| Hepatitis C Virus (HCV) Genotyping, Nonreflex | | | |
| Number | | 550475 |
| CPT | | 87902 |
| Synonyms | | HCV Subtype |
| Special Instructions | | A separate frozen specimen is required for each frozen test ordered. Only submit samples that contain a HCV viral load >600 IU/mL serum/plasma. |
| Specimen | | Serum or plasma, frozen |
| Volume | | 1 mL |
| Minimum Volume | | 0.5 mL |
| Container | | Screw-cap polypropylene frozen transport tube |
| Collection | | Collect specimen in gel-barrier tube, PPT™, yellow-top (ACD) tube, or lavender-top (EDTA) tube. Do not use green-top (heparin) tubes. Separate serum/plasma from whole blood within 6 hours of blood collection. Remove serum/plasma, transfer to a screw-cap polypropylene tube (not “pop top” or “snap cap”), and freeze. Specimens drawn into PPT™ need to be centrifuged within 6 hours and frozen. Ship frozen. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested. |
| Storage Instructions | | Maintain specimen frozen at -20°C. |
| Causes for Rejection | | Hemolysis; green-top (sodium heparin) tube; specimen not frozen on date of collection; PPT™ not centrifuged; specimen received in “pop-top” or “snap-cap” tube; specimen shipped at room temperature |
| Use | | This assay, for in vitro use, is intended for the genotyping of hepatitis C virus (HCV) in human serum and plasma. This test allows the genotyping of the six major HCV types and their most common subtypes. |
| Limitations | | This procedure may not be successful when the HCV viral load is <600 IU/mL serum/plasma. As a QC measure, viral load is confirmed on samples that fail genotyping. |
| Methodology | | Polymerase chain reaction (PCR) amplification and genotype determination |
| References | | Giannini C, Thiers V, Nousbaum JB, et al, “Comparative Analysis of Two Assays for Genotyping Hepatitis C Virus Based on Genotype-Specific Primers or Probes,” J Hepatol, 1995, 23(3):246-53. Mahaney K, Tedeschi V, Maertens G, et al, “Genotypic Analysis of Hepatitis C Virus in American Patients,” Hepatology, 1994, 20(6):1405-11. van Doorn LJ, Kleter B, Stuyver L, et al, “Analysis of Hepatitis C Virus Genotypes by a Line Probe Assay and Correlation With Antibody Profiles,” J Hepatol, 1994, 21(1):122-9. |
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