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The Performance of the Current Algorithm of HIV Diagnosis
Abdurrahman Gulmez1, Ozgur Appak2, Arzu Nazli Zeka3
1Istanbul Basaksehir Cam and Sakura City Hospital, Medical Microbiology Laboratory, Istanbul, Turkey.
Insights
This study evaluated the HIV diagnostic algorithm, finding that the confirmation test allows for rapid results and early HIV diagnosis. Decentralizing validation tests could improve algorithm effectiveness.
Area of Science:
- * Medical Diagnostics
- * Virology
- * Immunology
Background:
- * Evaluation of a four-year-old HIV diagnostic algorithm.
- * Assessment of HIV antigen/antibody (Ag/Ab) tests, anti-HIV 1/2 confirmatory tests, and HIV-1 RNA tests.
- * Analysis of turnaround times for official HIV test result approval.
Purpose of the Study:
- * To assess the performance and suitability of the current HIV diagnostic algorithm.
- * To examine the relationship between different HIV testing methods (Ag/Ab, confirmation, RNA PCR).
- * To determine the time efficiency of each step in the diagnostic process.
Main Methods:
- * Retrospective analysis of HIV testing data from Izmir Dokuz Eylül University (May 2017 - June 2021).
- * Evaluation of HIV Ag/Ab ELISA, anti-HIV 1/2 confirmation tests, and HIV-1 RNA PCR.
- * ROC analysis to determine optimal cut-off values for ELISA.
Main Results:
- * HIV Ag/Ab ELISA showed reactivity in 0.30% of samples; 54.42% were reactive in confirmation tests.
- * Mean reporting time for confirmation tests was 3h 50min; HIV-1 RNA PCR averaged over 12 days.
- * ELISA S/CO >13.16 yielded high sensitivity (97.59%) and specificity (97.59%) for confirmation.
Conclusions:
- * The current algorithm, particularly the confirmation test, facilitates rapid HIV diagnosis and timely antiretroviral therapy initiation.
- * Decentralization of validation tests is recommended for enhanced algorithm effectiveness.
- * The study highlights the efficiency of the existing diagnostic pathway for HIV management.
Background:
We aimed to evaluate the performance of the current algorithm the HIV diagnosis that has been performed for four years. Results of HIV Ag/Ab tests, anti-HIV 1/2 confirmatory tests, HIV-1 RNA tests and the time for official results to be approved were evaluated.
Methods:
The relationship of HIV Ag/Ab tests, anti-HIV 1/2 confirmation tests and HIV-1 RNA PCR tests, their result times and suitability to the algorithm were examined at Izmir Dokuz Eylül University between May 2017 and June 2021.
Results:
HIV Ag/Ab ELISA was reactive repetitively in 165/54628 (0.30%) serum samples. Anti-HIV 1/2 confirmation test was reactive in 54.42% (80/147) of samples. The most common pattern (18.2%) in the confirmation tests was the positivity of the antibodies against gp160 - gp41 envelope glycoproteins together. The mean reporting time of the confirmation test result was 3h 50 min after the ELISA test. The mean reporting time of the HIV-1 RNA PCR was 12.79 d (±10.22) after the ELISA test and 12.63 (± 10.12) day after the confirmation test. In ROC analysis, the estimated rate of the ELISA test for the confirmation test was highest when S/CO was >13.16 (sensitivity: 97.59 %, specificity: 97.59%).
Conclusion:
The confirmation test in the current algorithm enabled the rapid test results, early diagnosis of HIV and early antiretroviral therapy. To use the new algorithm effectively, decentralization of the validation tests would be appropriate.
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