Test Details
Methodology
Cobas® AmpliPrep/Cobas® TaqMan® HIV-1 Test, Version 2.0
Result Turnaround Time
5 - 13 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Test Includes
Reflex to genotype (at additional charge) if viral load is >500 copies/mL
Use
Detect and quantitate HIV-1 in plasma with reflex to genotype (at additional charge) if viral load is >500 copies/mL. GenoSure® MG test detects mutations in the HIV viral genes that encode the HIV protease and polymerase (reverse transcriptase). Mutations in these genes have been associated with resistance to antiretroviral drugs.
Special Instructions
This procedure does not provide serial monitoring; it is intended for one-time use only. If serial monitoring is required, please order test 550422.
Limitations
Assay range: 20−10,000,000 copies/mL
Specimen Requirements
Specimen
Plasma, frozen
Volume
6 mL
Minimum Volume
4 mL (Note: This volume does not allow for repeat testing.)
Container
Ship in a screw-cap polypropylene frozen transport tube.
Collection Instructions
Collect specimen in three lavender-top (EDTA) tubes or three PPT™ tubes. Do not use green-top (heparin) tubes. Centrifuge specimen within six hours of collection. Transfer plasma to one or more screw-cap polypropylene transport tube(s). "Snap-cap" or "pop-top" tubes should be avoided and may result in specimen rejection. Immediately freeze specimen at -20°C. Do not place samples on dry ice until completely frozen. Ship specimens 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
Freeze. Stable at room temperature for one day or refrigerated for five days. Freeze for long-term storage.
Causes for Rejection
Hemolysis; green-top (heparin) tube; quantity not sufficient for analysis; frozen PPT™
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 550432 | RNA, PCR (NonGraph) rfx/Geno | 20447-9 | 551308 | HIV-1 RNA by PCR | copies/mL | 20447-9 |
| 550432 | RNA, PCR (NonGraph) rfx/Geno | 20447-9 | 551314 | log10 HIV-1 RNA | log10copy/mL | 29541-0 |
| 550432 | RNA, PCR (NonGraph) rfx/Geno | 20447-9 | 551272 | Genotype Assay | N/A | |
| Order Code | 550432 | |||||
| Order Code Name | RNA, PCR (NonGraph) rfx/Geno | |||||
| Order Loinc | 20447-9 | |||||
| Result Code | 551308 | |||||
| Result Code Name | HIV-1 RNA by PCR | |||||
| UofM | copies/mL | |||||
| Result LOINC | 20447-9 | |||||
| Order Code | 550432 | |||||
| Order Code Name | RNA, PCR (NonGraph) rfx/Geno | |||||
| Order Loinc | 20447-9 | |||||
| Result Code | 551314 | |||||
| Result Code Name | log10 HIV-1 RNA | |||||
| UofM | log10copy/mL | |||||
| Result LOINC | 29541-0 | |||||
| Order Code | 550432 | |||||
| Order Code Name | RNA, PCR (NonGraph) rfx/Geno | |||||
| Order Loinc | 20447-9 | |||||
| Result Code | 551272 | |||||
| Result Code Name | Genotype Assay | |||||
| UofM | ||||||
| Result LOINC | N/A |
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 551568 | Reflex to GenoSure(R) MG | 551693 | 49573-9 | ||
| Reflex 1 | ||||||
| Order Code | 551568 | |||||
| Order Name | Reflex to GenoSure(R) MG | |||||
| Result Code | 551693 | |||||
| Result Name | ||||||
| UofM | ||||||
| Result LOINC | 49573-9 | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 551568 | Reflex to GenoSure(R) MG | 551656 | HIV GenoSure(R) | 93047-9 | |
| Reflex 1 | ||||||
| Order Code | 551568 | |||||
| Order Name | Reflex to GenoSure(R) MG | |||||
| Result Code | 551656 | |||||
| Result Name | HIV GenoSure(R) | |||||
| UofM | ||||||
| Result LOINC | 93047-9 | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 551568 | Reflex to GenoSure(R) MG | 551656 | HIV GenoSure(R) | 93047-9 | |
| Reflex 1 | ||||||
| Order Code | 551568 | |||||
| Order Name | Reflex to GenoSure(R) MG | |||||
| Result Code | 551656 | |||||
| Result Name | HIV GenoSure(R) | |||||
| UofM | ||||||
| Result LOINC | 93047-9 | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 551568 | Reflex to GenoSure(R) MG | 551656 | HIV GenoSure(R) | 93047-9 | |
| Reflex 1 | ||||||
| Order Code | 551568 | |||||
| Order Name | Reflex to GenoSure(R) MG | |||||
| Result Code | 551656 | |||||
| Result Name | HIV GenoSure(R) | |||||
| UofM | ||||||
| Result LOINC | 93047-9 | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 551568 | Reflex to GenoSure(R) MG | 551657 | HIV GenoSure(R) | 53798-5 | |
| Reflex 1 | ||||||
| Order Code | 551568 | |||||
| Order Name | Reflex to GenoSure(R) MG | |||||
| Result Code | 551657 | |||||
| Result Name | HIV GenoSure(R) | |||||
| UofM | ||||||
| Result LOINC | 53798-5 | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 551568 | Reflex to GenoSure(R) MG | 551566 | Tracking | N/A | |
| Reflex 1 | ||||||
| Order Code | 551568 | |||||
| Order Name | Reflex to GenoSure(R) MG | |||||
| Result Code | 551566 | |||||
| Result Name | Tracking | |||||
| UofM | ||||||
| Result LOINC | N/A | |||||