Development of an international external quality assurance program for HIV-1 incidence using the Limiting Antigen Avidity assay
Autoři:
Sheila M. Keating aff001; Wes Rountree aff003; Eduard Grebe aff001; Andrea L. Pappas aff003; Mars Stone aff001; Dylan Hampton aff001; Christopher A. Todd aff003; Marek S. Poniewierski aff003; Ana Sanchez aff003; Cassandra G. Porth aff003; Thomas N. Denny aff003; Michael P. Busch aff001;
Působiště autorů:
Vitalant Research Institute, San Francisco, CA, United States of America
aff001; Department of Laboratory Medicine, University of California, San Francisco, CA, United States of America
aff002; Duke Human Vaccine Institute, Duke University, Durham, NC, United States of America
aff003
Vyšlo v časopise:
PLoS ONE 14(9)
Kategorie:
Research Article
prolekare.web.journal.doi_sk:
https://doi.org/10.1371/journal.pone.0222290
Souhrn
Laboratory assays for identifying recent HIV-1 infections are widely used for estimating incidence in cross-sectional population-level surveys in global HIV-1surveillance. Adequate assay and laboratory performance are required to ensure accurate incidence estimates. The NIAID-supported External Quality Assurance Program Oversight Laboratory (EQAPOL) established a proficiency testing program for the most widely-used incidence assay, the HIV-1 Limiting Antigen Avidity EIA (LAg), with US Centers for Disease Control and Prevention (CDC)-approved kits manufactured by Sedia Biosciences Corporation and Maxim Biomedical. The objective of this program is to monitor the performance of participating laboratories. Four rounds of blinded external proficiency (EP) panels were distributed to up to twenty testing sites (7 North American, 5 African, 4 Asian, 2 South American and 2 European). These panels consisted of ten plasma samples: three blinded well-characterized HIV-1-seropositive samples that were included as replicates and an HIV-negative control. The seropositive samples spanned the dynamic range of the assay and are categorized as either recent or long-term infection. Participating sites performed the assay according to manufacturers’ instructions and completed an online survey to gather information on kit manufacturer, lot of kit used, laboratory procedures and the experience of technicians. On average, fifteen sites participated in each round of testing, with an average of four sites testing with only the Maxim assay, seven testing with only the Sedia assay and five sites utilizing both assays. Overall, the Sedia and Maxim assays yielded similar infection status categorization across the laboratories; however, for most of the nine HIV+ samples tested, there were significant differences in the optical density readouts, ODn (N = 8) and OD (N = 7), between LAg kit manufacturers (p < 0.05 based on mixed effects models. The EQAPOL LAg program is important for monitoring laboratory performance as well as detecting variations between manufacturers of HIV-1incidence assays.
Klíčová slova:
Biology and life sciences – Biochemistry – Organisms – Engineering and technology – Proteins – Anatomy – Medicine and health sciences – Microbiology – Medical microbiology – Microbial pathogens – Pathology and laboratory medicine – Pathogens – Physiology – Infectious diseases – Viral pathogens – Immunodeficiency viruses – HIV – Retroviruses – Lentivirus – Viruses – RNA viruses – Immunology – Immune physiology – Body fluids – Blood – Immune system proteins – HIV-1 – Antibodies – Viral diseases – HIV infections – Epidemiology – HIV epidemiology – Serology – Systems engineering – Quality assurance
Zdroje
1. Janssen RS, Satten GA, Stramer SL, Rawal BD, O’Brien TR, Weiblen BJ, et al. New Testing Strategy to Detect Early HIV-1 Infection for Use in Incidence Estimates for Clinical and Prevention Purposes. JAMA. 1998;281: 1893.
2. Busch MP, Pilcher CD, Mastro TD, Kaldor J, Vercauteren G, Rodriguez W, et al. Beyond detuning: 10 years of progress and new challenges in the development and application of assays for HIV incidence estimation: AIDS. 2010;24: 2763–2771. doi: 10.1097/QAD.0b013e32833f1142 20975514
3. Murphy G, Pilcher CD, Keating SM, Kassanjee R, Facente SN, Welte A, et al. Moving towards a reliable HIV incidence test–current status, resources available, future directions and challenges ahead. Epidemiology and Infection. 2017;145: 925–941. doi: 10.1017/S0950268816002910 28004622
4. Brookmeyer R. Measuring the HIV/AIDS Epidemic: Approaches and Challenges. Epidemiologic Reviews. 2010;32: 26–37. doi: 10.1093/epirev/mxq002 20203104
5. Beyrer C, Nelson K. Loss to follow-up effect in investigations of HIV-1 incidence. 1997;349: 649–650.
6. Hallett TB, Ghys P, Bärnighausen T, Yan P, Garnett GP. Errors in ‘BED’-Derived Estimates of HIV Incidence Will Vary by Place, Time and Age. Galvani AP, editor. PLoS ONE. 2009;4: e5720. doi: 10.1371/journal.pone.0005720 19479050
7. Highleyman L. Detuned assay used to track recent infections. BETA. 1999;12: 6, 78.
8. Rawal B, Degula A, Lebedeva L, Janssen R, Hecht F, Sheppard H, et al. Development of a New Less-Sensitive Enzyme Immunoassay for Detection of Early HIV-1 Infection. Jaids Journal of Acquired Immune Deficiency Syndromes. 2003;33: 349–355. 12843746
9. Parekh BS, Hanson DL, Hargrove J, Branson B, Green T, Dobbs T, et al. Determination of Mean Recency Period for Estimation of HIV Type 1 Incidence with the BED-Capture EIA in Persons Infected with Diverse Subtypes. AIDS Research and Human Retroviruses. 2011;27: 265–273. doi: 10.1089/aid.2010.0159 20954834
10. Laeyendecker O, Rothman RE, Henson C, Horne BJ, Ketlogetswe KS, Kraus CK, et al. The Effect of Viral Suppression on Cross-Sectional Incidence Testing in the Johns Hopkins Hospital Emergency Department: JAIDS Journal of Acquired Immune Deficiency Syndromes. 2008;48: 211–215. doi: 10.1097/QAI.0b013e3181743980 18520680
11. Murphy G, Charlett A, Osner N, Gill ON, Parry JV. Reconciling HIV incidence results from two assays employed in the serological testing algorithm for recent HIV seroconversion (STARHS). Journal of Virological Methods. 2003;113: 79–86. doi: 10.1016/s0166-0934(03)00222-2 14553893
12. Young CL, Hu DJ, Byers R, Vanichseni S, Young NL, Nelson R, et al. Evaluation of a Sensitive/Less Sensitive Testing Algorithm Using the bioMérieux Vironostika-LS Assay for Detecting Recent HIV-1 Subtype B’ or E Infection in Thailand. AIDS Research and Human Retroviruses. 2003;19: 481–486. doi: 10.1089/088922203766774522 12882657
13. Mei JV, Kennedy M, Linley L, Hanson D, Schiffer J, Ethridge S, et al. Standardization and Monitoring of Laboratory Performance and Quality Assurance by Use of the Less-Sensitive HIV Incidence Assay: Seven Years of Results. J Acquir Immune Defic Syndr. 2011;58: 7.
14. Murphy G, Parry JV. Assays for the detection of recent infections with human immunodeficiency virus type 1. Euro Surveill. 2008;13.
15. Suligoi B, Massi M, Galli C, Sciandra M, Di Sora F, Pezzotti P, et al. Identifying recent HIV infections using the avidity index and an automated enzyme immunoassay. J Acquir Immune Defic Syndr. 2003;32: 424–428. 12640201
16. Suligoi B, Rodella A, Raimondo M, Regine V, Terlenghi L, Manca N, et al. Avidity Index for anti-HIV antibodies: comparison between third- and fourth-generation automated immunoassays. J Clin Microbiol. 2011;49: 2610–2613. doi: 10.1128/JCM.02115-10 21543577
17. Keating SM, Hanson D, Lebedeva M, Laeyendecker O, Ali-Napo NL, Owen SM, et al. Lower-Sensitivity and Avidity Modifications of the Vitros Anti-HIV 1+2 Assay for Detection of Recent HIV Infections and Incidence Estimation. Journal of Clinical Microbiology. 2012;50: 3968–3976. doi: 10.1128/JCM.01454-12 23035182
18. Duong YT, Qiu M, De AK, Jackson K, Dobbs T, Kim AA, et al. Detection of Recent HIV-1 Infection Using a New Limiting-Antigen Avidity Assay: Potential for HIV-1 Incidence Estimates and Avidity Maturation Studies. Landay A, editor. PLoS ONE. 2012;7: e33328. doi: 10.1371/journal.pone.0033328 22479384
19. Kassanjee R, Pilcher CD, Keating SM, Facente SN, McKinney E, Price MA, et al. Independent assessment of candidate HIV incidence assays on specimens in the CEPHIA repository: AIDS. 2014;28: 2439–2449. doi: 10.1097/QAD.0000000000000429 25144218
20. Kassanjee R, Welte A, McWalter TA, Keating SM, Vermeulen M, Stramer SL, et al. Seroconverting Blood Donors as a Resource for Characterising and Optimising Recent Infection Testing Algorithms for Incidence Estimation. Gray CM, editor. PLoS ONE. 2011;6: e20027. doi: 10.1371/journal.pone.0020027 21694760
21. Rountree W, Vandergrift N, Bainbridge J, Sanchez AM, Denny TN. Statistical methods for the assessment of EQAPOL proficiency testing: ELISpot, Luminex, and Flow Cytometry. Journal of Immunological Methods. 2014;409: 72–81. doi: 10.1016/j.jim.2014.01.007 24456626
22. Blaizot S, Kim AA, Zeh C, Riche B, Maman D, De Cock KM, et al. Estimating HIV Incidence Using a Cross-Sectional Survey: Comparison of Three Approaches in a Hyperendemic Setting, Ndhiwa Subcounty, Kenya, 2012. AIDS Res Hum Retroviruses. 2017;33: 472–481. doi: 10.1089/AID.2016.0123 27824254
23. Kim AA, Rehle T. Short Communication: Assessing Estimates of HIV Incidence with a Recent Infection Testing Algorithm That Includes Viral Load Testing and Exposure to Antiretroviral Therapy. AIDS Res Hum Retroviruses. 2018;34: 863–866. doi: 10.1089/AID.2017.0316 29926735
24. Soodla P, Simmons R, Huik K, Pauskar M, Jogeda E-L, Rajasaar H, et al. HIV incidence in the Estonian population in 2013 determined using the HIV-1 limiting antigen avidity assay. HIV Med. 2018;19: 33–41. doi: 10.1111/hiv.12535 28762652
25. Justman JE, Mugurungi O, El-Sadr WM. HIV Population Surveys—Bringing Precision to the Global Response. New England Journal of Medicine. 2018;378: 1859–1861. doi: 10.1056/NEJMp1801934 29768142
26. Sharma S, Schlusser KE, Torre PDL, Tambussi G, Draenert R, Pinto AN, et al. The benefit of immediate compared to deferred ART on CD4+ Cell count recovery in early HIV infection. AIDS. 2019; doi: 10.1097/QAD.0000000000002219 31157663
27. Ostrowski M, Benko E, Yue FY, Kim CJ, Huibner S, Lee T, et al. Intensifying Antiretroviral Therapy With Raltegravir and Maraviroc During Early Human Immunodeficiency Virus (HIV) Infection Does Not Accelerate HIV Reservoir Reduction. Open Forum Infect Dis. 2015;2: ofv138. doi: 10.1093/ofid/ofv138 26512359
28. Murphy G, Pilcher CD, Keating SM, Kassanjee R, Facente SN, Welte A, et al. Moving towards a reliable HIV incidence test—current status, resources available, future directions and challenges ahead. Epidemiol Infect. 2017;145: 925–941. doi: 10.1017/S0950268816002910 28004622
29. Schlusser KE, Konikoff J, Kirkpatrick AR, Morrison C, Chipato T, Chen P-L, et al. Short Communication: Comparison of Maxim and Sedia Limiting Antigen Assay Performance for Measuring HIV Incidence. AIDS Research and Human Retroviruses. 2017;33: 555–557. doi: 10.1089/aid.2016.0245 28318310
30. Sempa JB, Welte A, Busch MP, Hall J, Hampton D, et al. Performance comparison of the Maxim and Sedia Limiting Antigen Avidity assays for HIV incidence surveillance. PLOS ONE 14(7): e0220345. doi: 10.1371/journal.pone.0220345 31348809
Článok vyšiel v časopise
PLOS One
2019 Číslo 9
- Metamizol jako analgetikum první volby: kdy, pro koho, jak a proč?
- Nejasný stín na plicích – kazuistika
- Masturbační chování žen v ČR − dotazníková studie
- Těžké menstruační krvácení může značit poruchu krevní srážlivosti. Jaký management vyšetření a léčby je v takovém případě vhodný?
- Fixní kombinace paracetamol/kodein nabízí synergické analgetické účinky
Najčítanejšie v tomto čísle
- Graviola (Annona muricata) attenuates behavioural alterations and testicular oxidative stress induced by streptozotocin in diabetic rats
- CH(II), a cerebroprotein hydrolysate, exhibits potential neuro-protective effect on Alzheimer’s disease
- Comparison between Aptima Assays (Hologic) and the Allplex STI Essential Assay (Seegene) for the diagnosis of Sexually transmitted infections
- Assessment of glucose-6-phosphate dehydrogenase activity using CareStart G6PD rapid diagnostic test and associated genetic variants in Plasmodium vivax malaria endemic setting in Mauritania