Human Immunodeficiency Virus 1 (HIV-1) PhenoSense Integrase® (Monogram® Integrase Inhibitor Resistance)

Also known as: PhenoSense Integrase®, Raltegravir

Clinical Use

Use

The PhenoSense Integrase® assay is a phenotypic resistance test used to determine the susceptibility of a patient's HIV to integrase inhibitors. Integrase inhibitors block HIV replication by preventing the virus from integrating into the host cell's DNA. Raltegravir (Isentress®) is the first approved drug in this class of HIV antiretroviral drugs.

Special Instructions

Not provided.

Limitations

The PhenoSense Integrase® test should be used for patients with documented HIV-1 infection with viral loads ≥500 copies/mL. It should be interpreted alongside other clinical and laboratory findings and not be used as the sole criterion for patient management. Additionally, interactions between protease-reverse transcriptase (PR-RT) and integrase may impact the complete virus fitness but are not well-characterized, indicating a potential limitation in the context of comprehensive viral fitness assessment.

Test Details

Methodology

PCR-based (PCR)

Biomarkers

Elvitegravir

Other

Fold Change

Mutation • Categorical (e.g., Positive / Negative / Indeterminate)

Raltegravir

Other

Fold Change

Mutation • Categorical (e.g., Positive / Negative / Indeterminate)

LOINC Codes

Order Codes

45182-3 - HIV Phenotyp Islt
61199-6 - HIV1 integrase gene Mut Det Islt
77202-0 - Laboratory comment Report

Result Codes

45182-3 - HIV Phenotyp Islt
61199-6 - HIV1 integrase gene Mut Det Islt
77202-0 - Laboratory comment Report

Result Turnaround Time

19-23 days

Specimen

Plasma

Volume

3 mL

Minimum Volume

Not provided

Container

Lavender-top (EDTA) or plasma preparation tube (PPT™)

Collection Instructions

Collect specimen in two lavender-top (EDTA) tubes or two PPT™ tubes. Centrifuge within six hours of collection, transfer plasma to polypropylene screw-capped tubes, and freeze. Ship frozen.