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.Statisti-cal 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 mag-nitude.(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 as-says 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.
HIV-1 RNAquantitativelimit of detectionspecificityconsistency
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