| HIV-1 Genotyping (8000100054) | ||
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| Test Mnemonic: | HIVGeno |
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| Specimen Requirements: | ||
| Collection: | One pearl color (PPT) top Vacutainer; collect one tube for this test and do not combine with other test orders. |
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| Container: | PPT |
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| Minimum Volume: | 4 ml |
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| Storage/Transport: | Transport frozen |
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| Specimen Preparation: | Within six hours of collection, centrifuge blood sample at 1000 x g for 15 minutes. After centrifugation, remove plasma from cells into a screw-top polypropylene transport tube before freezing plasma in situ in PPT tube. |
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| Stability: | • Separated plasma can be stored for up to 48 hours at 2° to 8°C. • For longer term storage, freeze samples at -80° to -20°C. Note: Plasma will not be frozen in situ in the BD PPT™ Tube due to intracellular DNA interferes. • Thaw only for use. Do not freeze and thaw more than four times prior to processing the specimens |
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| Causes for Rejection: | Incomplete and/or incorrect sample identification, insufficient sample volume, incorrect blood collection tube (Vacutainer), gross hemolysis, clots, prolonged time to processing, transport at rom temperature or refrigerated |
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| Reference Range: | See report |
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| Turnaround Time: | 14 days |
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| Methodology: | RT-PCR, Sanger sequencing |
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| Performed: | Molecular Diagnostics Laboratory |
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| Synonyms: | HIV-1 Drug Resistance; HIV Genotype; HIV Resistance Mutation Detection |
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| Clinical Indication: | This assay predicts HIV-1 resistance to nucleoside reverse transcriptase inhibitors and non-nucleoside reverse transcriptase inhibitors (NRTI, NNRTI), protease inhibitors (PI), and integrase strand transfer inhibitors (INSTI). HIV-1 reverse transcriptase, protease gene, and integrase genes are sequenced by Sanger sequencing using Applied Biosystems HIV-1 Genotyping kit. HIV-1 drug-resistance report is generated using Exatype Sanger software (Hyrax Biosciences). The test is intended for HIV-1 RNA positive plasma samples with viral load >=1000 copies/mL and minor allele frequencies >20-30%. An indeterminant results may be caused by HIV-1 viral RNA concentrations below 1000 copies/mL. This test should be used in conjunction with clinical presentation and other laboratory findings. This test was developed, and its performance characteristics determined by UTMB Pathology Molecular Diagnostics Laboratory. It has not been cleared or approved by the US Food and Drug Administration. The FDA does not require this test to go through premarket FDA review. This test is used for clinical purposes. It should not be regarded as investigational or for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high complexity clinical laboratory testing. The assay does not cover the entire reverse transcriptase gene region. Therefore, two paternal drug-resistance scoring mutations - amino acid position 318 (scoring for DOR, EFV, and NVP) and position 348 (scoring for NVP) - are excluded from the drug-resistance interpretation. |
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| Patient Preparation : | Routine venipuncture |
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| CPT 4 Code: | 87900, 87901, 87906 |
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| Note: |
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| 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. | ||