Clinical performance assessment of the sansure HIV-1 quantitative test system

The significant burden of Human Immunodeficiency Virus 1 (HIV-1) infections, particularly in low- and middle-income countries (LMICs), emphasizes the need for industries to develop cost-effective and reliable solutions for the detection and management of HIV. This study presents the findings from a clinical evaluation of the Sansure HIV-1 Quantitative test, applied alongside a fully automated nucleic acid extraction process. A total of 503 blood samples from HIV infected or high-risk people were tested using both the Sansure HIV-1 Quantitative test and the Cobas HIV-1 Quantitative test (the reference method), and the diagnostic accuracy was assessed by comparing the results. The Sansure HIV-1 Quantitative test showed a sensitivity of 98.3 % and a specificity of 98.5 %. Misclassification occurred in 1.6 % (8/503) of cases, which remains below the acceptable threshold of 5 %. The correlation and agreement with the reference method fell within acceptable parameters, with a correlation coefficient of 0.93. These data establish the suitability and accuracy of the Sansure HIV-1 Quantitative test for quantifying HIV-1 RNA (viral load) in clinical samples.