The Performance of the Current Algorithm of HIV Diagnosis
,
Abstract
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 confir-mation test was reactive in 54.42% (80/147) of samples. The most common pattern (18.2%) in the con-firmation 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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7. Busch MP, Satten GA (1997). Time course of viremia and antibody seroconversion following human immunodeficiency vi-rus exposure. Am J Med, 102(5b):117-24; discussion 25-6.
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9. Keele BF, Giorgi EE, Salazar-Gonzalez JF, et al (2008). Identification and character-ization of transmitted and early founder virus envelopes in primary HIV-1 infec-tion. Proc Natl Acad Sci U S A, 105(21):7552-7.
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16. Malloch L, Kadivar K., Putz J, et al (2013). Comparative evaluation of the Bio-Rad Geenius HIV-1/2 Confirmatory Assay and the Bio-Rad Multispot HIV-1/2 Rapid Test as an alternative differentia-tion assay for CLSI M53 algorithm-I. Journal of Clinical Virology, 58:e85-e91.
17. Artus HI Virus-1 RG RT-PCR Kit Hand Book 03/2015, Available from: http://rcostoya.com/uploads/galerias/con814/hb-0129-005-1-artus-hiv1-rg-rtpcr-ce-kit-24-96.pdf
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19. Acar A, Kemahli S, Altunay H, et al (2010). HBV, HCV and HIV seroprevalence among blood donors in Istanbul, Tur-key: how effective are the changes in the national blood transfusion policies? Braz J Infect Dis, 14(1):41-6.
20. Şaşmaz C, Kurt A, Öner S, et al (2011). Hepatitis B, hepatitis C, HIV, and VDRL seroprevalence of blood donors in Mer-sin, Turkey. Turkish Journal of Medical Sci-ences, 41.
21. Kart Yaşar K. (2014). Seroprevalence of Hepatitis B, C and HIV/AIDS in Asylum Seekers in Istanbul. Journal of Microbiology and Infectious Diseases, 4:20-5.
22. Chacon L, Mateos ML, Holguin A, et al (2017). Relevance of cutoff on a 4th generation ELISA performance in the false positive rate during HIV diagnostic in a low HIV prevalence setting. J Clin Virol, 92:11-3.
23. Kim S, Lee J-H., Choi JY, et al (2010). False-Positive Rate of a “Fourth-Generation” HIV Antigen/Antibody Combination Assay in an Area of Low HIV Preva-lence. Clin Vaccine Immunol, 17(10):1642-4.
24. Rakovsky A, Gozlan Y, Bassal R, et al (2018). Diagnosis of HIV-1 infection: Performance of Xpert Qual and Geeni-us supplemental assays in fourth genera-tion ELISA-reactive samples. J Clin Virol, 101:7-10.
25. CDC HIV Factsheet False Positive Results, Available from: https://www.cdc.gov/hiv/pdf/testing/cdc-hiv-factsheet-false-positive-test-results.pdf
26. Crucitti T, Taylor D, Beelaert G, et al (2011). Performance of a rapid and sim-ple HIV testing algorithm in a multicen-ter phase III microbicide clinical trial. Clin Vaccine Immunol, 18(9):1480-5.
27. Weber B, Fall EH, Berger A, et al (1998). Reduction of diagnostic window by new fourth-generation human immunodefi-ciency virus screening assays. J Clin Mi-crobiol, 36(8):2235-9.
28. Lavoie S, Caswell D, Gill MJ, et al (2018). Heterophilic interference in specimens yielding false-reactive results on the Ab-bott 4th generation ARCHITECT HIV Ag/Ab Combo assay. J Clin Virol, 104:23-8.
29. Reid J, Van Zyl G, Linström M, et al (2020). High positive HIV serology results can still be false positive. IDCases, 21:e00849-e.
30. Nasrullah M, Wesolowski LG, Ethridge SF, et al (2016). Acute infections, cost and time to reporting of HIV test results in three U.S. State Public Health Laborato-ries. J Infect, 73(2):164-72.
31. Brennan CA, Yamaguchi J, Vallari A, et al (2013). ARCHITECT(R) HIV Ag/Ab Combo assay: correlation of HIV-1 p24 antigen sensitivity and RNA viral load using genetically diverse virus isolates. J Clin Virol, 57(2):169-72.
2. European Centre for Disease Prevention and Control, WHO Regional Office for Europe. HIV/AIDS surveillance in Eu-rope 2020, Available from: https://www.ecdc.europa.eu/sites/default/files/documents/hiv-surveillance-report-2020.pdf
3. Republic of Turkey Ministry of Health, General Directorate of Public Health, Department of Infectious Diseases /HIV AIDS Statistics. Available from: https://hsgm.saglik.gov.tr/tr/
4. Cohen MS, Chen YQ, McCauley M, et al (2016). Antiretroviral Therapy for the Prevention of HIV-1 Transmission. N Engl J Med, 375(9):830-9.
5. Miller WC, Rosenberg NE, Rutstein SE, et al (2010). Role of acute and early HIV infection in the sexual transmission of HIV. Curr Opin HIV AIDS, 5(4):277-82.
6. Wawer MJ, Gray RH, Sewankambo NK, et al (2005). Rates of HIV-1 transmission per coital act, by stage of HIV-1 infec-tion, in Rakai, Uganda. J Infect Dis, 191(9):1403-9.
7. Busch MP, Satten GA (1997). Time course of viremia and antibody seroconversion following human immunodeficiency vi-rus exposure. Am J Med, 102(5b):117-24; discussion 25-6.
8. Fiebig EW, Wright DJ, Rawal BD, et al (2003). Dynamics of HIV viremia and antibody seroconversion in plasma do-nors: implications for diagnosis and staging of primary HIV infection. Aids, 17(13):1871-9.
9. Keele BF, Giorgi EE, Salazar-Gonzalez JF, et al (2008). Identification and character-ization of transmitted and early founder virus envelopes in primary HIV-1 infec-tion. Proc Natl Acad Sci U S A, 105(21):7552-7.
10. Lee HY, Giorgi EE, Keele BF et al (2009). Modeling sequence evolution in acute HIV-1 infection. J Theor Biol, 261(2):341-60.
11. Masciotra S, McDougal JS, Feldman J, et al (2011). Evaluation of an alternative HIV diagnostic algorithm using specimens from seroconversion panels and per-sons with established HIV infections. J Clin Virol, 52 Suppl 1:S17-22.
12. Vermeulen M, Coleman C, Mitchel J, et al (2013). Comparison of human immuno-deficiency virus assays in window phase and elite controller samples: viral load distribution and implications for trans-mission risk. Transfusion, 53(10 Pt 2):2384-98.
13. CDC: Laboratory Testing for the Diagnosis of HIV Infection Updated Recommen-dations 2014, Available from: https://stacks.cdc.gov/view/cdc/23447
14. Republic of Turkey Ministry of Health, General Directorate of Public Health, Department of Infectious Diseases ''HIV diagnosis -Treatment guide 2019'', Available from: https://hsgm.saglik.gov.tr/depo/birimler/bulasici-hastaliklar-ve-erken-uyari-db/Dokumanlar/Rehberler/HIV-AIDS_Tani-Tedavi_Rehberi_2019.pdf
15. ABBOTT. ARCHITECT HIV Ag/Ab Combo Reagent Insert 2009, Available from: https://www.fda.gov/media/116836/download#:~:text=INTENDED%20USE-,The%20ARCHITECT%20HIV%20Ag%2FAb%20Combo%20assay%20is%20a%20chemilumines-cent,plasma%20(EDTA%20and%20heparin
16. Malloch L, Kadivar K., Putz J, et al (2013). Comparative evaluation of the Bio-Rad Geenius HIV-1/2 Confirmatory Assay and the Bio-Rad Multispot HIV-1/2 Rapid Test as an alternative differentia-tion assay for CLSI M53 algorithm-I. Journal of Clinical Virology, 58:e85-e91.
17. Artus HI Virus-1 RG RT-PCR Kit Hand Book 03/2015, Available from: http://rcostoya.com/uploads/galerias/con814/hb-0129-005-1-artus-hiv1-rg-rtpcr-ce-kit-24-96.pdf
18. Qiagen EZ1 Advanced XL User Manual, Available from: https://www.qiagen.com/us/resources/download.aspx?id=471d7f96-9a1d-4a31-b121-01b4367bae33&lang=en
19. Acar A, Kemahli S, Altunay H, et al (2010). HBV, HCV and HIV seroprevalence among blood donors in Istanbul, Tur-key: how effective are the changes in the national blood transfusion policies? Braz J Infect Dis, 14(1):41-6.
20. Şaşmaz C, Kurt A, Öner S, et al (2011). Hepatitis B, hepatitis C, HIV, and VDRL seroprevalence of blood donors in Mer-sin, Turkey. Turkish Journal of Medical Sci-ences, 41.
21. Kart Yaşar K. (2014). Seroprevalence of Hepatitis B, C and HIV/AIDS in Asylum Seekers in Istanbul. Journal of Microbiology and Infectious Diseases, 4:20-5.
22. Chacon L, Mateos ML, Holguin A, et al (2017). Relevance of cutoff on a 4th generation ELISA performance in the false positive rate during HIV diagnostic in a low HIV prevalence setting. J Clin Virol, 92:11-3.
23. Kim S, Lee J-H., Choi JY, et al (2010). False-Positive Rate of a “Fourth-Generation” HIV Antigen/Antibody Combination Assay in an Area of Low HIV Preva-lence. Clin Vaccine Immunol, 17(10):1642-4.
24. Rakovsky A, Gozlan Y, Bassal R, et al (2018). Diagnosis of HIV-1 infection: Performance of Xpert Qual and Geeni-us supplemental assays in fourth genera-tion ELISA-reactive samples. J Clin Virol, 101:7-10.
25. CDC HIV Factsheet False Positive Results, Available from: https://www.cdc.gov/hiv/pdf/testing/cdc-hiv-factsheet-false-positive-test-results.pdf
26. Crucitti T, Taylor D, Beelaert G, et al (2011). Performance of a rapid and sim-ple HIV testing algorithm in a multicen-ter phase III microbicide clinical trial. Clin Vaccine Immunol, 18(9):1480-5.
27. Weber B, Fall EH, Berger A, et al (1998). Reduction of diagnostic window by new fourth-generation human immunodefi-ciency virus screening assays. J Clin Mi-crobiol, 36(8):2235-9.
28. Lavoie S, Caswell D, Gill MJ, et al (2018). Heterophilic interference in specimens yielding false-reactive results on the Ab-bott 4th generation ARCHITECT HIV Ag/Ab Combo assay. J Clin Virol, 104:23-8.
29. Reid J, Van Zyl G, Linström M, et al (2020). High positive HIV serology results can still be false positive. IDCases, 21:e00849-e.
30. Nasrullah M, Wesolowski LG, Ethridge SF, et al (2016). Acute infections, cost and time to reporting of HIV test results in three U.S. State Public Health Laborato-ries. J Infect, 73(2):164-72.
31. Brennan CA, Yamaguchi J, Vallari A, et al (2013). ARCHITECT(R) HIV Ag/Ab Combo assay: correlation of HIV-1 p24 antigen sensitivity and RNA viral load using genetically diverse virus isolates. J Clin Virol, 57(2):169-72.
| Files | ||
| Issue | Vol 53 No 7 (2024) | |
| Section | Original Article(s) | |
| DOI | https://doi.org/10.18502/ijph.v53i7.16051 | |
| Keywords | ||
| HIV infection diagnosis Serodiagnosis Algorithms Testing HIV | ||
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How to Cite
1.
Gülmez A, Appak Özgür, Zeka AN, Esen N, Sayıner AA. The Performance of the Current Algorithm of HIV Diagnosis. Iran J Public Health. 2024;53(7):1569-1577.
