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Hepatitis C Genotyping
|In House Availability||Every other Wednesday, evening shift|
|Method||Multi-probe reverse hybridization (LiPA)|
|Collection Instructions||Note: This test requires the result of the "Hepatitis C RNA, Quantitative by Real Time PCR (HCVRT)" test therefore both test must be ordered.|
|Container type||Lavender top|
|Amount to Collect||4 mL blood|
|Sample type||EDTA Plasma|
|Preferred volume||2 mL plasma|
|Min. Volume||0.5 mL plasma|
|UCSF Rejection Criteria||Heparinized samples; Grossly hemolyzed samples; HCV viral load < 1000 copies/mL or no HCV viral load within 90 days of current specimen; Genotyping previously performed.|
|Processing notes||Separate plasma from cells within 6 hours of collection and freeze at -20°C. Avoid repeated freezing and thawing of specimen.|
|Turn around times||Up to 16 days.|
|Additional information||Note: This test requires the result of the "Hepatitis C RNA, Quantitative by Real Time PCR (HCVRT)" test therefore both test must be ordered.
An interpretation of this test by a laboratory physician will automatically be performed and billed for.
In patients diagnosed with hepatitis C virus, genotyping is indicated for prognostic reasons. Patients with certain genotypes are more likely than others to respond to therapy with interferon and ribovirin.
Based on analysis of the sequences of the 5' untranslated regions and the core region of the HCV virus genome. There are six major genotypes (1-6) and multiple subtypes. Genotypes/subtypes reported with this assay are 1, 1a, 1b, 1a or 1b, 2, 2a or 2c, 2b, 3, 3a, 3b, 3c, 3k, 4, 4a/4c/4d, 4b, 4e, 4f, 4h, 5a, and 6a or 6b. Genotypes 1, 2 and 3 predominate in western countries and the far east, with types 2 and 3 more likely to respond to therapy with alpha interferon.
The assay requires a plasma viral RNA level of at least 1000 IU/mL. If a quantitative HCV test has not been done in the last 90 days, it will be ordered by the laboratory, reported and billed separately. The HCV genotyping order will be canceled/credited by the laboratory if the viral RNA level is < 1000 IU/ml. Consult microbiology if testing at a reference laboratory, by sequencing, is indicated.
This test was developed and its performance characteristics determined by the UCSF Clinical Labs. It has not been cleared or approved by the U.S. Food and Drug Administration.
Positive results are automatically forwarded to California public health per regulations. However, this does not absolve the ordering provider from any additional reporting if such is required.
|CPT coding||87902, 83912|
|LDT or Mod FDA?||Yes|
|Last Updated||5/20/2014 11:19:47 AM|