Successful Use of Near Point-of-Care Early Infant Diagnosis in NAMPHIA to Improve Turnaround Times in a National Household Survey.
Journal
Journal of acquired immune deficiency syndromes (1999)
ISSN: 1944-7884
Titre abrégé: J Acquir Immune Defic Syndr
Pays: United States
ID NLM: 100892005
Informations de publication
Date de publication:
01 08 2021
01 08 2021
Historique:
received:
29
03
2021
accepted:
07
04
2021
entrez:
24
6
2021
pubmed:
25
6
2021
medline:
6
11
2021
Statut:
ppublish
Résumé
In the population-based HIV impact assessment surveys, early infant diagnosis (EID) was provided to infants <18 months without a prior diagnosis. For the Namibia population-based HIV impact assessment (NAMPHIA), the GeneXpert platform was assessed for the feasibility of near POC EID testing compared with the standard Roche COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) platform. Quality assurance measures and turnaround time were compared to improve EID results reporting. NAMPHIA participants were screened for HIV exposure using Determine HIV-1/2 rapid test; samples reactive on Determine received EID testing on the GeneXpert instrument and Xpert HIV-1 Qual assay using whole blood. Results were confirmed at the Namibia Institute of Pathology using dried blood spots on the Roche CAP/CTM platform per national guidelines. Of the 762 screened infants, 61 (8.0%) were Determine-reactive and considered HIV-exposed. Of the 61 exposed infants, 2 were found to be HIV-infected whereas 59 were negative on both GeneXpert and Roche platforms, achieving 100% concordance. Average turnaround time was 3.4 days for the Xpert HIV-1 Qual assay, and average time from collection to testing was 1.0 days for GeneXpert compared with 10.7 days for Roche. No samples failed using GeneXpert whereas 1 sample failed using Roche and was repeated. Quality POC EID testing is feasible in a national survey through extensive training and external quality assurance measures. The use of decentralized POC EID for national testing would provide rapid diagnosis and improve TATs which may prevent loss to follow-up, ensure linkage to care, and improve clinical outcomes for infants.
Sections du résumé
BACKGROUND
In the population-based HIV impact assessment surveys, early infant diagnosis (EID) was provided to infants <18 months without a prior diagnosis. For the Namibia population-based HIV impact assessment (NAMPHIA), the GeneXpert platform was assessed for the feasibility of near POC EID testing compared with the standard Roche COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) platform. Quality assurance measures and turnaround time were compared to improve EID results reporting.
METHODS
NAMPHIA participants were screened for HIV exposure using Determine HIV-1/2 rapid test; samples reactive on Determine received EID testing on the GeneXpert instrument and Xpert HIV-1 Qual assay using whole blood. Results were confirmed at the Namibia Institute of Pathology using dried blood spots on the Roche CAP/CTM platform per national guidelines.
RESULTS
Of the 762 screened infants, 61 (8.0%) were Determine-reactive and considered HIV-exposed. Of the 61 exposed infants, 2 were found to be HIV-infected whereas 59 were negative on both GeneXpert and Roche platforms, achieving 100% concordance. Average turnaround time was 3.4 days for the Xpert HIV-1 Qual assay, and average time from collection to testing was 1.0 days for GeneXpert compared with 10.7 days for Roche. No samples failed using GeneXpert whereas 1 sample failed using Roche and was repeated.
CONCLUSION
Quality POC EID testing is feasible in a national survey through extensive training and external quality assurance measures. The use of decentralized POC EID for national testing would provide rapid diagnosis and improve TATs which may prevent loss to follow-up, ensure linkage to care, and improve clinical outcomes for infants.
Identifiants
pubmed: 34166314
doi: 10.1097/QAI.0000000000002706
pii: 00126334-202108011-00009
pmc: PMC8754064
mid: NIHMS1750998
doi:
Types de publication
Journal Article
Research Support, U.S. Gov't, P.H.S.
Langues
eng
Sous-ensembles de citation
IM
Pagination
S67-S72Subventions
Organisme : Intramural CDC HHS
ID : CC999999
Pays : United States
Organisme : CGH CDC HHS
ID : U2G GH001226
Pays : United States
Organisme : PEPFAR
Pays : United States
Informations de copyright
Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.
Déclaration de conflit d'intérêts
The authors have no funding or conflicts of interest to disclose.
Références
World Health Organization. HIV/AIDS Data and Statistics; 2017. Available at: https://www.who.int/hiv/data/en/ . Accessed January 12, 2020.
Violari A, Cotton MF, Gibb DM, et al. Early antiretroviral therapy and mortality among HIV-infected infants. New Engl J Med. 2008;359:2233–2244.
ICAP Columbia. Namibia Population-Based HIV Impact Assessment NAMPHIA 2017 Final Report; 2019. Available at: https://phia.icap.columbia.edu/namphia-final-report/ . Accessed December 9, 2020.
Namibia Ministry of Health and Social Services (MOHSS). National Guidelines for Antiretroviral Therapy. In: MOHSS5th ed. Windhoek, Namibia, Republic of Namibia, Ministry of Health and Social Services, Directorate of Special Programmes; 2016.
Jani IV, Meggi B, Mabunda N, et al. Accurate early infant HIV diagnosis in primary health clinics using a point-of-care nucleic acid test. J Acquir Immune Defic Syndr. 2014;67:e1–4.
Stevens WS, Ford N. Time to reduce CD4+ monitoring for the management of antiretroviral therapy in HIV-infected individuals. South Afr Med J. 2014;104:559–560.
Chatterjee A, Tripathi S, Gass R, et al. Implementing services for Early Infant Diagnosis (EID) of HIV: a comparative descriptive analysis of national programs in four countries. BMC Public Health. 2011;11:553.
Khamadi S, Okoth V, Lihana R, et al. Rapid identification of infants for antiretroviral therapy in a resource poor setting: the Kenya experience. J Trop Pediatr. 2008;54:370–374.
Mugambi ML, Deo S, Kekitiinwa A, et al. Do diagnosis delays impact receipt of test results? Evidence from the HIV early infant diagnosis program in Uganda. PLoS One. 2013;8:e78891.
Nuwagaba-Biribonwoha H, Werq-Semo B, Abdallah A, et al. Introducing a multi-site program for early diagnosis of HIV infection among HIV-exposed infants in Tanzania. BMC Pediatr. 2010;10:44.
Tejiokem MC, Faye A, Penda IC, et al. Feasibility of early infant diagnosis of HIV in resource-limited settings: the ANRS 12140-PEDIACAM study in Cameroon. PLoS One. 2011;6:e21840.
Newell ML, Brahmbhatt H, Ghys PD. Child mortality and HIV infection in Africa: a review. AIDS. 2004;18(Suppl 2):S27–S34.
Phelps BR, Ahmed S, Amzel A, et al. Linkage, initiation and retention of children in the antiretroviral therapy cascade: an overview. AIDS. 2013;27(Suppl 2):S207–S213.
UNFPA UUW. Children and AIDS: Fourth Stocktaking Report, 2009; 2009. Available at: www.unicef.org/publications/files/Children_and_AIDS_Fourth_Stocktaking_Report_EN_110609.pdf . Accessed January 12, 2020.
WHO Guidelines Approved by the Guidelines Review Committee. In: Consolidated Guidelines on the Use of Antiretroviral Drugs for Treating and Preventing HIV Infection: Recommendations for a Public Health Approach . Geneva, Switzerland: World Health Organization Copyright (c) World Health Organization 2013; 2013.
Organization WH. WHO Recommendations on the Diagnosis of HIV Infection in Infants and Children. Geneva, Switzerland: WHO Press; 2010.
Prendergast A, Tudor-Williams G, Jeena P, et al. International perspectives, progress, and future challenges of paediatric HIV infection. Lancet. 2007;370:68–80.
Read JS. Diagnosis of HIV-1 infection in children younger than 18 months in the United States. Pediatrics. 2007;120:e1547–1562.
Global AIDS Alliance. Scaling up access to early infant diagnostics: accelerating progress through public-private partnerships. Washington, DC: Global AIDS Alliance; 2008.
Bitilinyu-Bangoh J, Khunga R, Ortuño R, et al. Pilot Assessment of the Diagnostic Accuracy of Cepheid GeneXpert HIV-1 Qual for Early Infant Diagnosis. AIDS 2016 Abstract. South Africa, Durbin: 21st International AIDS Conference (AIDS 2016); 2016.
Carmona S, Wedderburn C, Macleod W, et al. Field Performance of Point-of-Care HIV Testing for Early Infant Diagnosis: Pooled Analysis from Six Countries from the EID Consortium. Paper presented at: AIDS 2016 Abstract 2016; Durban, South Africa.
Ceffa S, Luhanga R, Andreotti M, et al. Comparison of the Cepheid GeneXpert and Abbott M2000 HIV-1 real time molecular assays for monitoring HIV-1 viral load and detecting HIV-1 infection. J Virol Methods. 2016;229:35–39.
Garrett NJ, Drain PK, Werner L, et al. Diagnostic accuracy of the point-of-care Xpert HIV-1 viral load assay in a South African HIV clinic. J Acquir Immune Defic Syndr. 2016;72:e45–48.
Mtapuri-Zinyowera S, Ndlovu Z, Farjado E, et al. Diagnostic accuracy of Cepheid Xpert HIV-1 Qual for early infant diagnosis. 2016. Paper presented at: Conference on Retroviruses and Opportunistic Infections; Feburary 22–25, 2016; Boston, MA.
Bianchi F, Cohn J, Sacks E, et al. Evaluation of a routine point-of-care intervention for early infant diagnosis of HIV: an observational study in eight African countries. Lancet HIV. 2019;6:e373–e381.
WHO. WHO Prequalification of in Vitro Diagnostics Public Report. Product: Xpert HIV-1 Qual Assay; 2016. WHO prequalification of in vitro diagnostics public report. Product: Xpert HIV-1 Qual Assay.
O'Kane MJ, McManus P, McGowan N, et al. Quality error rates in point-of-care testing. Clin Chem. 2011;57:1267–1271.
Parikh CR. A point-of-care device for acute kidney injury: a fantastic, futuristic, or frivolous measure? Kidney Int. 2009;76:8–10.
Summerton AM, Summerton N. The use of desk-top cholesterol analysers in general practice. Public Health. 1995;109:363–367.
Briggs C, Guthrie D, Hyde K, et al. Guidelines for point-of-care testing: haematology. Br J Haematol. 2008;142:904–915.
ISO 22870:2006. ISO Point-of-Care Testing (POCT)—Requirements for Quality and Competence; 2006. Available at: http://www.iso.org/iso/catalogue_detail.htm?csnumber=35173 . Accessed January 12, 2020.
Nichols JH, Christenson RH, Clarke W, et al. Executive summary. The national academy of clinical biochemistry laboratory medicine practice guideline: evidence-based practice for point-of-care testing. Clinica Chim Acta Int J Clin Chem. 2007;379:14–28; discussion 29-30.
Patel H. A Comprehensive Approach to Assuring Quality of Laboratory Testing in HIV Surveys: Lessons Learned from Population-Based HIV Impact Project; 2020. In Submission.
Xpert® HIV-1 Qual [Package Insert]. Sunnyvale, CA: Cepheid 2015.
COBAS® AmpliPrep/COBAS® Taqman HIV-1 Qualitative Test, Version 2.0 [Package Insert]. Mannheim, Germany: Roche Molecular Systems Inc.
Nguyen S, Ramos A, Chang J, et al. Monitoring the quality of HIV-1 viral load testing through a proficiency testing program using dried tube specimens in resource-limited settings. J Clin Microbiol. 2015;53:1129–1136.
Parekh BS, Anyanwu J, Patel H, et al. Dried tube specimens: a simple and cost-effective method for preparation of HIV proficiency testing panels and quality control materials for use in resource-limited settings. J Virol Methods. 2010;163:295–300.
Ramos A, Nguyen S, Garcia A, et al. Generation of dried tube specimen for HIV-1 viral load proficiency test panels: a cost-effective alternative for external quality assessment programs. J Virol Methods. 2013;188:1–5.
Saito S, Duong YT, Metz M, et al. Returning HIV-1 viral load results to participant-selected health facilities in national Population-based HIV Impact Assessment (PHIA) household surveys in three sub-Saharan African Countries, 2015 to 2016. J Int AIDS Soc. 2017;20(Suppl 7):19–25.
Ibrahim M, Moyo S, Mohammed T, et al. Brief report: high sensitivity and specificity of the Cepheid Xpert HIV-1 qualitative point-of-care test among newborns in Botswana. J Acquir Immune Defic Syndr. 2017;75:e128–e131.
Opollo VS, Nikuze A, Ben-Farhat J, et al. Field evaluation of near point of care Cepheid GeneXpert HIV-1 Qual for early infant diagnosis. PLoS One. 2018;13:e0209778.
Bourne DE, Thompson M, Brody LL, et al. Emergence of a peak in early infant mortality due to HIV/AIDS in South Africa. AIDS (London, England). 2009;23:101–106.
Desai MA, Okal DO, Rose CE, et al. Effect of point-of-care CD4 cell count results on linkage to care and antiretroviral initiation during a home-based HIV testing campaign: a non-blinded, cluster-randomised trial. Lancet HIV. 2017;4:e393–e401.
Stevens WS, Gous NM, MacLeod WB, et al. Multidisciplinary point-of-care testing in South African primary health care clinics accelerates HIV ART initiation but does not alter retention in care. J Acquir Immune Defic Syndr. 2017;76:65–73.
Klarkowski D, O'Brien DP, Shanks L, et al. Causes of false-positive HIV rapid diagnostic test results. Expert Rev anti-infective Ther. 2014;12:49–62.
Shanks L, Klarkowski D, O'Brien DP. False positive HIV diagnoses in resource limited settings: operational lessons learned for HIV programmes. PLoS One. 2013;8:e59906.
Namibia Ministry of Health and Social Services (MOHSS). National strategic framework for HIV and AIDS response in Namibia. In: MOHSS. Windhoek, Namibia: Republic of Namibia, Ministry of Health and Social Services, Directorate of Special Programmes; 2013.
Agabu A, Baughman AL, Fischer-Walker C, et al. National-level effectiveness of ART to prevent early mother to child transmission of HIV in Namibia. PLoS One. 2020;15:e0233341.