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, cilt.97, sa.1, 2020 (SCI-Expanded, Scopus)
- Yayın Türü: Makale / Tam Makale
- Cilt numarası: 97 Sayı: 1
- Basım Tarihi: 2020
- Doi Numarası: 10.1016/j.diagmicrobio.2020.115011
- Dergi Adı: Diagnostic Microbiology and Infectious Disease
- Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus, Academic Search Premier, Aquatic Science & Fisheries Abstracts (ASFA), BIOSIS, CAB Abstracts, EMBASE, Environment Index, MEDLINE, Veterinary Science Database
- Anahtar Kelimeler: HIV, Fourth-generation ELISA, ROC analysis, MIDAS (R) HIV Duo Ultra assay
- Sağlık Bilimleri Üniversitesi Adresli: Evet
Özet
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.