PhenoSense GT® Plus Integrase is the first commercial assay to provide comprehensive genotypic and phenotypic drug resistance information for four classes of antiretroviral drugs, including nucleoside/nucleotide, non-nucleoside, protease, and integrase inhibitors, in a single report. The addition of phenotypic to genotypic testing, as found in PhenoSense GT Plus Integrase, is noted in US Department of Health and Human Services (DHHS) guidelines as generally preferred for patients who may benefit from drug resistance testing due to known or suspected complex drug resistance patterns.1
Features of PhenoSense GT Plus Integrase
- The genotypic component evaluates the HIV-1 polymerase (pol) region, including the protease and integrase coding regions and amino acids 1-400 of reverse transcriptase.
- Utilizes Monogram’s proprietary HIV-1 genotypic interpretation database, which is comprised of a database of more than 100,000 matched HIV genotype-phenotype results, and Monogram’s proprietary HIV-1 genotypic database for integrase.
- The phenotypic component evaluates the HIV-1 polymerase (pol) region, which provides a direct, quantitative measurement of drug susceptibility for nucleoside reverse transcriptase inhibitors (NRTIs), nonnucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), and integrase inhibitors (INIs).
- The report includes a net assessment for each drug which resolves discordance (disagreement) between genotypic and phenotypic susceptibility results.
- Test results are available in approximately 14-18 days after receipt at Monogram Biosciences.
- Appropriate for the evaluation of patient specimens with HIV-1 viral loads ≥500 copies/mL.
PhenoSense GT Plus Integrase is also available as a reflex from a viral load test if the viral load result is ≥500 copies/mL. The LabCorp test numbers are 550711 (graphical viral load with reflex to PhenoSense GT Plus Integrase) or 550625 (nongraphical viral load with reflex to PhenoSense GT Plus Integrase). Reflex orders through Monogram do not have unique reflex order codes. Please note: PhenoSense GT Plus Integrase is not indicated when the HIV-1 viral load is <500 copies/mL plasma.*
*If the assay fails on the initial attempt, HIV-1 RNA quantitation will be performed. If the result is <500 copies/mL, the viral load will be reported and the client will be billed.