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Volume 39, Issue 3

Original Article

Outcomes of Fourth-Generation HIV Screening and Confirmatory Testing at a Tertiary Care Center: Evaluation of 286,425 Patient Samples

Peri Sohrabi Molla Yousefi
Affiliations
  • Sağlık Bilimleri Üniversitesi İstanbul Haseki Eğitim ve Araştırma Hastanesi, Tıbbi Mikrobiyoloji Laboratuvarı, İstanbul, Türkiye
https://orcid.org/0000-0001-6346-1398
  • HIV infection
  • HIV infections
  • HIV testing
  • mass screening
  • nucleic acid amplification techniques
  • serologic tests
  • serological examination

Abstract

Objective: Fourth-generation human immunodeficiency virus (HIV) antigen/antibody assays reduce the diagnostic window; however, reactive results necessitate further evaluation. The objective of this study was to characterize the distribution of samples across the stages of HIV screening and confirmatory testing in a high-volume tertiary-care laboratory and to identify confirmed HIV infections.

Methods: This retrospective descriptive study analyzed 286,425 unique serum samples from patients aged 18 years or older, collected between May 2024 and January 2026. Initial screening was conducted using fourth-generation HIV antigen/antibody assays on the Atellica IM or ADVIA Centaur systems. Samples demonstrating repeated reactivity underwent further testing with the VIDAS HIV Duo Quick assay. VIDAS-reactive samples were referred to a reference laboratory for supplemental serological testing. HIV-1 RNA testing was performed using the NeuMoDx platform through June 2025 and the ELITe BeGenius platform from July 2025 onward. Data analyses were descriptive.

Results: Among the 286,425 patient samples, 4480 tested repeated reactivity on the initial screening platforms (1.56%; 95% confidence interval [CI], 1.52%–1.61%). Of these, 1378 samples (30.76%) remained reactive on VIDAS, while 3102 (69.24%) were VIDAS-nonreactive and did not undergo HIV-1 RNA testing or reference laboratory confirmation. HIV infection was confirmed in 188 of the 1378 referred samples (13.64%; 95% CI, 11.87%–15.57%), including 100 newly diagnosed cases and 88 with a prior HIV diagnosis. Final results for the remaining 1190 samples were unavailable. In total, 5050 HIV-1 RNA tests were performed during the study period.

Conclusion: Discordant reactivity was identified between the initial screening platforms and VIDAS. This discordance may be attributable to low pretest probability, variations in antigen/antibody capture designs and analytical thresholds, or nonspecific reactivity. Due to the absence of verification data for VIDAS-nonreactive samples and VIDAS-reactive samples without final results, sensitivity, specificity, and predictive values could not be determined.

  • 163-7
  • Peri Sohrabi Molla Yousefi
  • [email protected]
  • 10.36519/kd.2026.5735
  • August 31, 2026
  • September 18, 2026
  • September 29, 2026

  • SMY P. [Outcomes of fourth-generation HIV screening and confirmatory testing at a tertiary care center: Evaluation
    of 286,425 patient samples]. Klimik Derg. 2026;39(3):163–7. Turkish.
  • 21
  • 6
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  • This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License (CC BY-NC 4.0). CC BY-NC
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