Test Details
Methodology
Cobas® AmpliPrep/Cobas® TaqMan® HIV-1 Test, Version 2.0
Result Turnaround Time
17 - 25 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.
Use
Detect and measure HIV-1 in plasma with reflex to GenoSure PRIme® if viral load is ≥500 copies/mL. GenoSure PRIme® assay detects mutations in the HIV viral genes that encode for HIV protease, reverse transcriptase and integrase. Mutations in these genes have been associated with resistance to antiretroviral drugs.
Special Instructions
Submit the patient's Social Security number for serial monitoring. To order this test without serial monitoring, use test 550655. Submit a separate frozen specimen for each test requested.
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
Lavender-top (EDTA) or plasma preparation tubes (PPT™). Ship in two or more screw-cap polypropylene frozen transport tubes.
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. A separate frozen sample is required for GenoSure PRIme portion of the test. Frozen sample preferred for viral load assay but also 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; nonfrozen specimens; specimens exposed to repeated freeze/thaw cycles; quantity not sufficient for analysis; frozen PPT™
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 550630 | RNA, PCR(Graph)rfx/GenoPRI | 550407 | HIV-1 RNA by PCR | copies/mL | 20447-9 | |
| 550630 | RNA, PCR(Graph)rfx/GenoPRI | 550409 | log10 HIV-1 RNA | log10copy/mL | 29541-0 | |
| 550630 | RNA, PCR(Graph)rfx/GenoPRI | 550631 | HIV GenoSure PRIme(R) | N/A | ||
| 550630 | RNA, PCR(Graph)rfx/GenoPRI | 511958 | 80563-0 | |||
| Order Code | 550630 | |||||
| Order Code Name | RNA, PCR(Graph)rfx/GenoPRI | |||||
| Order Loinc | ||||||
| Result Code | 550407 | |||||
| Result Code Name | HIV-1 RNA by PCR | |||||
| UofM | copies/mL | |||||
| Result LOINC | 20447-9 | |||||
| Order Code | 550630 | |||||
| Order Code Name | RNA, PCR(Graph)rfx/GenoPRI | |||||
| Order Loinc | ||||||
| Result Code | 550409 | |||||
| Result Code Name | log10 HIV-1 RNA | |||||
| UofM | log10copy/mL | |||||
| Result LOINC | 29541-0 | |||||
| Order Code | 550630 | |||||
| Order Code Name | RNA, PCR(Graph)rfx/GenoPRI | |||||
| Order Loinc | ||||||
| Result Code | 550631 | |||||
| Result Code Name | HIV GenoSure PRIme(R) | |||||
| UofM | ||||||
| Result LOINC | N/A | |||||
| Order Code | 550630 | |||||
| Order Code Name | RNA, PCR(Graph)rfx/GenoPRI | |||||
| Order Loinc | ||||||
| Result Code | 511958 | |||||
| Result Code Name | ||||||
| UofM | ||||||
| Result LOINC | 80563-0 |
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 551711 | Reflex to GenoSure PRIme(R) | 551703 | 51969-4 | ||
| Reflex 1 | ||||||
| Order Code | 551711 | |||||
| Order Name | Reflex to GenoSure PRIme(R) | |||||
| Result Code | 551703 | |||||
| Result Name | ||||||
| UofM | ||||||
| Result LOINC | 51969-4 | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 551711 | Reflex to GenoSure PRIme(R) | 551701 | HIV GenoSure PRIme(R) | 93047-9 | |
| Reflex 1 | ||||||
| Order Code | 551711 | |||||
| Order Name | Reflex to GenoSure PRIme(R) | |||||
| Result Code | 551701 | |||||
| Result Name | HIV GenoSure PRIme(R) | |||||
| UofM | ||||||
| Result LOINC | 93047-9 | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 551711 | Reflex to GenoSure PRIme(R) | 551702 | HIV GenoSure PRIme(R) | 80689-3 | |
| Reflex 1 | ||||||
| Order Code | 551711 | |||||
| Order Name | Reflex to GenoSure PRIme(R) | |||||
| Result Code | 551702 | |||||
| Result Name | HIV GenoSure PRIme(R) | |||||
| UofM | ||||||
| Result LOINC | 80689-3 | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 551711 | Reflex to GenoSure PRIme(R) | 551706 | HIV GenoSure PRIme(R) Interp | 62364-5 | |
| Reflex 1 | ||||||
| Order Code | 551711 | |||||
| Order Name | Reflex to GenoSure PRIme(R) | |||||
| Result Code | 551706 | |||||
| Result Name | HIV GenoSure PRIme(R) Interp | |||||
| UofM | ||||||
| Result LOINC | 62364-5 | |||||