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<h3>Background</h3> HIV is characterized by a high degree of genetic diversity, presenting a challenge for the development of assays for initial diagnosis and subsequent monitoring of therapy response. Alinity m HIV-1 was developed on the Alinity m System, a fully automated, random/continuous access analyzer, to achieve accurate quantitation across groups, subtypes and circulating recombinant forms (CRF), concurrent HIV-1 confirmation and viral load monitoring in plasma, confirmation in serum. <h3>Methods</h3> Abbott’s Global Surveillance program was utilized to identify the most conserved target regions across HIV-1 variants. The assay targets two HIV-1 genomic regions and utilizes partially double-stranded probes, RNA-specific sample preparation chemistry, unit-dose lyophilized amplification reagents, and patented ReadiFlex™ sample processing logistics to deliver a time-to-first-result of 115 minutes. The Alinity m HIV-1 assay was evaluated for key performance attibutes. <h3>Results</h3> Alinity m HIV-1 demonstrated linearity from 10 to 20,000,000 Copies/mL and demonstrated a within-laboratory SD of ≤0.13 Log Copies/mL from 2.3 to 7.4 Log Copies/mL. Probit analysis demonstrated that the assay detected HIV-1 RNA with 95% probability at 13.88 Copies/mL using 3rd WHO HIV-1 Standard (subtype B). The assay exhibited ≥95% detection for HIV-1 group M subtypes, groups O and N at 20 Copies/mL. Correlation between Alinity m HIV-1 and Abbott RealTi<i>m</i>e HIV-1 assays demonstrated a mean bias of -0.03 Log Copies/mL (95% CI: <b>-</b>0.05 to 0.00). Confirmatory method agreement between Alinity m HIV-1 assay and comparator HIV-1 assay was 100%. <h3>Conclusion</h3> The Alinity m HIV-1 assay utilizes a state of the art instrument system and dual-target assay design to deliver highly sensitive detection of diverse HIV-1 groups/subtypes and accurate quantitation across a wide dynamic range while facilitating rapid turnaround time (115 minutes) and workflow flexibility. By providing confirmation and baseline viral load measurement in one test, the assay reduces the number of steps required for initial diagnosis of infection. <h3>Disclosure</h3> No significant relationships.