Preliminary evaluation of the performance and clinical application of a domestic quantitative RT-PCR assay for Detection of HIV-1 nucleic acid

TAN Jie; DENG Zhongping; ZHENG Fang; DING Feng; LIU Rangjiao; TIAN Xiangrong

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Journal of Hunan Normal University(Medical Science) ›› 2024, Vol. 21 ›› Issue (2) : 133-138.

Preliminary evaluation of the performance and clinical application of a domestic quantitative RT-PCR assay for Detection of HIV-1 nucleic acid

TAN Jie^1,3, DENG Zhongping^2,3,4, ZHENG Fang⁵, DING Feng³, LIU Rangjiao⁶, TIAN Xiangrong¹

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Abstract

Objective To preliminarily evaluate the detection performance and clinical applicability of a newly developed Real-Time Quantitative PCR Kit for HIV-1 RNA detection (referred to as Sansure HIV-1). Methods The genotype detection ability, limit of detection, specificity and quantitative detection accuracy of the Sansure HIV-1 were investigated by using WHO HIV-1 serum, National Standards of HIV-1 RNA and clinical samples positive for blood-borne infection pathogens collected by SANWAY Clinical Laboratories INC as samples. The remaining 374 of clinical samples tested by Roche Cobas TaqMan HIV-1 Version 2.0 (referred to as Cobas HIV-1) were collected to evaluate the clinical diagnosis performance of Sansure HIV-1. Statistical methods such as correlation and Bland-Altman analysis were used to compare the performance of the two assays. Results (1) The 10 cases of WHO Subtype Blood inventory detected by Sansure HIV-1 were all positive. (2) The absolute deviation between the logarithmic value of each sample concentration and the theoretical logarithmic value did not exceed ±0.4 log orders of magnitude. (3) The positive rates were 100% when the HIV-1 RNA National Standards were diluted to 50 IU/mL and 25 IU/mL, and the positive rate was 75% when diluted to 12.5 IU/mL. All clinically similar pathogen were tested negative using Sansure HIV-1, and no cross-reaction occurred. (4) The positive rates of Cobas HIV-1 and Sansure HIV-1 in testing 374 clinical samples were both 66.84% (250/374) . (5) Taking the Cobas HIV-1 test results as a reference, the positive consistency of the Sansure HIV-1 reached 99.20% (95%CI: 96.82%-99.86%) , and the negative consistency was 98.38% (95%CI: 93.71%-99.72%) , and the total consistency was 98.93% (95%CI: 94.04%-99.75%) . (6) The linear regression equation of 248 samples tested positive by both assays was y=0.8357x+0.7379, and the r was 0.8901 (P<0.0001) . (7) Further, Bland-Altman analysis showed the SD was 0.5606 (Log10 IU/ mL) , confirmed that the RT-PCR quantitative results detected by the two reagents were highly consistent. Conclusion The evaluated Sansure HIV-1 assay has good quantitative accuracy and good subtype detection coverage for HIV group M, Group O and group N with a detection sensitivity of 25 IU/mL. There is no cross-reaction with common clinical blood-borne pathogens. Sansure HIV-1 showed great consistency in terms of positive detection rate and quantitative results compared with Roche Cobas HIV-1 in testing clinical plasma samples, Considering cost-effectiveness and accessibility, the Sansure HIV-1 assay kit has good clinical applicability and can suitable for the requirements of most clinical applications.

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HIV-1 RNA / quantitative / limit of detection / specificity / consistency

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TAN Jie, DENG Zhongping, ZHENG Fang, DING Feng, LIU Rangjiao, TIAN Xiangrong. Preliminary evaluation of the performance and clinical application of a domestic quantitative RT-PCR assay for Detection of HIV-1 nucleic acid[J]. Journal of Hunan Normal University(Medical Science). 2024, 21(2): 133-138

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