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Evaluation of the diagnostic performance and optimal cutoff value of a fourth-generation ELISA, VIDAS HIV-1/2 Duo Ultra assay, in a low-prevalence country
Diagnostic Microbiology and Infectious Disease ( IF 2.9 ) Pub Date : 2020-01-31 , DOI: 10.1016/j.diagmicrobio.2020.115011
Tulin Demir , Suleyman Yalcin , Selcuk Kilic

In this study, we described the largest analysis to date conducted with VIDAS® HIV Duo Ultra assay. Additionally, we analyzed the diagnostic performance and cutoff values (TV) of HIV Duo Ultra assay and total cost analysis for HIV testing. Of 11,642 enzyme-linked immunosorbent assay (ELISA)–positive samples referred to our center for confirmation, 2000 were positive with HIV Duo Ultra, and of these, 87% were HIV-1 positive and 0.6% were HIV-1 indeterminate with the confirmatory test. Overall, the false-positivity rate was 1.75% for HIV Duo Ultra assay. The sensitivity and specificity were 100% and 99.1%, respectively, when the TV was set at the recommended cutoff value. Even increasing the cutoff value four times, sensitivity and specificity remained high, pointing out that a TV of 0.99 is highly indicative of HIV positivity. Retesting samples with HIV Duo Ultra assay decreased 80% of the confirmatory tests, revealing a significant decrease of 78% in the total costs and reporting time.



中文翻译:

在低患病率国家评估第四代ELISA VIDAS HIV-1 / 2 Duo Ultra检测方法的诊断性能和最佳临界值

在这项研究中,我们描述了迄今为止使用VIDAS®HIV Duo Ultra分析进行的最大的分析。此外,我们分析了HIV Duo Ultra检测的诊断性能和临界值(TV),以及HIV检测的总成本分析。在转交给我们中心进行确认的11,642种酶联免疫吸附测定(ELISA)阳性样品中,2000例HIV Duo Ultra呈阳性,其中87%的HIV-1阳性和0.6%的HIV-1不确定。测试。总体而言,HIV Duo Ultra检测的假阳性率为1.75%。当将电视设置为推荐的临界值时,灵敏度和特异性分别为100%和99.1%。即使将临界值提高了四倍,敏感性和特异性仍然很高,指出0.99的电视高度表明HIV阳性。

更新日期:2020-04-20
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