High-level timeline of the development and availability of HIV drug resistance tests.

OLA: Oligonucleotide ligation assay. PANDAA: Pan-Degenerate Amplification and Adaptation. RUO: research use only. FDA: Food and Drug Administration. CE: conformité européenne.</p

Commercially available next-generation sequencing HIV drug resistance assays.

Commercially available next-generation sequencing HIV drug resistance assays.</p

Overview of the process followed to estimate the maximum potential market sized for HIVDR testing in LMIC (use case 1).

PLHIV: people living with HIV. ART: antiretroviral therapy. DTG: dolutegravir. CHAI: Clinton Health Access Initiative. EAC: enhanced adherence counselling.</p

Maximum market size for use case 2 (PI/r failures).

Maximum market size for use case 2 (PI/r failures).</p

Commercially available bulk/Sanger-based sequencing assays.

Commercially available bulk/Sanger-based sequencing assays.</p

Potential commercially available point of care HIV drug resistance assays.

Potential commercially available point of care HIV drug resistance assays.</p

Maximum market size for use case 1 (DTG failures).

Maximum market size for use case 1 (DTG failures).</p

MDRI estimates for Maxim and Sedia LAg assays by HIV-1 subtype and ODn threshold, using supplemental viral load threshold of >1,000c/mL.

MDRI estimates for Maxim and Sedia LAg assays by HIV-1 subtype and ODn threshold, using supplemental viral load threshold of >1,000c/mL.</p

Context-specific false-recent rate (FRR) against MDRI in three demonstrative surveillance scenarios.

A: Scenario similar to South African epidemic. B: Scenario similar to Kenyan epidemic. C: Concentrated epidemic scenario. A supplementary viral load threshold of >1,000c/mL is used throughout. We assume ARV exposure testing classifies all treated individuals as long-term. This assumption is relaxed in S4 Fig.</p

Calibrator reactivity and reproducibility of results assessed by repeat testing.

Calibrator reactivity and reproducibility of results assessed by repeat testing.</p