Test Details
Methodology
Cobas® AmpliPrep/Cobas® TaqMan® HIV-1 Test, Version 2.0 and polymerase chain reaction (PCR) amplification and DNA sequencing
Result Turnaround Time
4 - 6 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 greater than or equal to 500 copies/mL or reflex to GenoSure Archive® if viral load is less than 500 copies/mL. The GenoSure PRIme® and GenoSure Archive® assays detect 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
If reflex test is performed, additional charges/CPT code(s) may apply.
Limitations
This procedure should only be used for patients with a documented HIV-1 infection.
Specimen Requirements
Specimen
Plasma and whole blood
Volume
5 mL plasma and 4 mL EDTA whole blood
Minimum Volume
3.5 mL plasma and 3 mL EDTA whole blood
Container
Lavender-top (EDTA) tube, screw-capped polypropylene frozen transport tube
Collection Instructions
Both frozen plasma and frozen whole blood are required for this profile. Draw three lavender-top (EDTA) tubes. Do not use green-top (heparin) tubes.
Plasma: Centrifuge two tubes within six hours of collection. Remove plasma, transfer plasma to screw-cap polypropylene transport tubes (not "pop-top" or "snap-cap"), and freeze. Ship specimen frozen.
Whole blood: Do not centrifuge. Freeze tube immediately after draw. Ship specimen frozen.
To avoid delays in turnaround time, when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested.
Stability Requirements
Frozen: 6 weeks
Storage Instructions
Freeze.
Causes for Rejection
Insufficient volume; heparinized plasma; specimen not frozen
LOINC® Map
Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
---|---|---|---|---|---|---|
550920 | RNA PCR Graph Rfx PRIme/Arch | 20447-9 | 550445 | HIV-1 RNA by PCR | copies/mL | 20447-9 |
550920 | RNA PCR Graph Rfx PRIme/Arch | 20447-9 | 550446 | log10 HIV-1 RNA | log10copy/mL | 29541-0 |
550920 | RNA PCR Graph Rfx PRIme/Arch | 20447-9 | 550703 | Reflex to PRIme or Archive | N/A | |
550920 | RNA PCR Graph Rfx PRIme/Arch | 20447-9 | 511958 | 80563-0 | ||
Order Code | 550920 | |||||
Order Code Name | RNA PCR Graph Rfx PRIme/Arch | |||||
Order Loinc | 20447-9 | |||||
Result Code | 550445 | |||||
Result Code Name | HIV-1 RNA by PCR | |||||
UofM | copies/mL | |||||
Result LOINC | 20447-9 | |||||
Order Code | 550920 | |||||
Order Code Name | RNA PCR Graph Rfx PRIme/Arch | |||||
Order Loinc | 20447-9 | |||||
Result Code | 550446 | |||||
Result Code Name | log10 HIV-1 RNA | |||||
UofM | log10copy/mL | |||||
Result LOINC | 29541-0 | |||||
Order Code | 550920 | |||||
Order Code Name | RNA PCR Graph Rfx PRIme/Arch | |||||
Order Loinc | 20447-9 | |||||
Result Code | 550703 | |||||
Result Code Name | Reflex to PRIme or Archive | |||||
UofM | ||||||
Result LOINC | N/A | |||||
Order Code | 550920 | |||||
Order Code Name | RNA PCR Graph Rfx PRIme/Arch | |||||
Order Loinc | 20447-9 | |||||
Result Code | 511958 | |||||
Result Code Name | ||||||
UofM | ||||||
Result LOINC | 80563-0 |
Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
---|---|---|---|---|---|---|
Reflex 1 | 552039 | GenoSure PRIme(R) | 552019 | 51969-4 | ||
Reflex 1 | ||||||
Order Code | 552039 | |||||
Order Name | GenoSure PRIme(R) | |||||
Result Code | 552019 | |||||
Result Name | ||||||
UofM | ||||||
Result LOINC | 51969-4 |
Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
---|---|---|---|---|---|---|
Reflex 1 | 552039 | GenoSure PRIme(R) | 552021 | HIV GenoSure PRIme(R) | 80689-3 | |
Reflex 1 | ||||||
Order Code | 552039 | |||||
Order Name | GenoSure PRIme(R) | |||||
Result Code | 552021 | |||||
Result Name | HIV GenoSure PRIme(R) | |||||
UofM | ||||||
Result LOINC | 80689-3 |
Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
---|---|---|---|---|---|---|
Reflex 1 | 552039 | GenoSure PRIme(R) | 552022 | HIV GenoSure PRIme(R) Interp | 62364-5 | |
Reflex 1 | ||||||
Order Code | 552039 | |||||
Order Name | GenoSure PRIme(R) | |||||
Result Code | 552022 | |||||
Result Name | HIV GenoSure PRIme(R) Interp | |||||
UofM | ||||||
Result LOINC | 62364-5 |
Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
---|---|---|---|---|---|---|
Reflex 1 | 551798 | GenoSure Archive(R) | 551774 | 80695-0 | ||
Reflex 1 | ||||||
Order Code | 551798 | |||||
Order Name | GenoSure Archive(R) | |||||
Result Code | 551774 | |||||
Result Name | ||||||
UofM | ||||||
Result LOINC | 80695-0 |
Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
---|---|---|---|---|---|---|
Reflex 1 | 551798 | GenoSure Archive(R) | 551777 | HIV GenoSure Archive | 93047-9 | |
Reflex 1 | ||||||
Order Code | 551798 | |||||
Order Name | GenoSure Archive(R) | |||||
Result Code | 551777 | |||||
Result Name | HIV GenoSure Archive | |||||
UofM | ||||||
Result LOINC | 93047-9 |
Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
---|---|---|---|---|---|---|
Reflex 1 | 551798 | GenoSure Archive(R) | 551778 | HIV GenoSure Archive | 80693-5 | |
Reflex 1 | ||||||
Order Code | 551798 | |||||
Order Name | GenoSure Archive(R) | |||||
Result Code | 551778 | |||||
Result Name | HIV GenoSure Archive | |||||
UofM | ||||||
Result LOINC | 80693-5 |
Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
---|---|---|---|---|---|---|
Reflex 1 | 551798 | GenoSure Archive(R) | 551779 | HIV GenoSure Archive Interp | 80694-3 | |
Reflex 1 | ||||||
Order Code | 551798 | |||||
Order Name | GenoSure Archive(R) | |||||
Result Code | 551779 | |||||
Result Name | HIV GenoSure Archive Interp | |||||
UofM | ||||||
Result LOINC | 80694-3 |