Field evaluation of near point of care Cepheid GeneXpert HIV-1 Qual for early infant diagnosis

Valarie Sarah Opollo, Alliance Nikuze, Jihane Ben-Farhat, Emily Anyango, Felix Humwa, Boaz Oyaro, Stephen Wanjala, Willis Omwoyo, Maxwel Majiwa, Victor Akelo, Clement Zeh, David Maman, Valarie Sarah Opollo, Alliance Nikuze, Jihane Ben-Farhat, Emily Anyango, Felix Humwa, Boaz Oyaro, Stephen Wanjala, Willis Omwoyo, Maxwel Majiwa, Victor Akelo, Clement Zeh, David Maman

Abstract

Background: Access to point-of-care HIV testing shortens turn-around times, time to diagnosis and reduces loss to follow-up hence minimizing barriers to early linkage to care and treatment among HIV infected infants. Currently samples for early infant HIV diagnosis are sent to centralized testing facilities which are few and located only at specific regions in Kenya. However, there are Point of Care (POC) early infant diagnosis [EID] technologies elsewhere such as SAMBA and ALERE-Q that are yet to be evaluated in Kenya despite the urgent need for data to inform policy formulation regarding EID. The Cepheid GeneXpert HIV-1 Qual (GeneXpert) technology for POC EID offers a great opportunity to minimize HIV associated morbidity, mortality and loss to follow-up through decentralization of early infant HIV testing to the clinics. This technology also allows for same-day results thus facilitating prompt linkage to care.

Methods: We evaluated the GeneXpert HIV Qual EID POC in Homabay County against the standard of care platform, Roche CAP/CTM HIV-1 qualitative PCR, using dried blood spots (DBS). Between February-July 2016, DBS samples were collected from HIV exposed children <18 months of age enrolled in a cross-sectional study. Samples were collected by qualified nurse counselors, and were tested by trained technicians using field based GeneXpert and conventional laboratory based Roche CAP/CTM HIV-1 qualitative PCR. Sensitivity and specificity were determined.

Results: Overall, 3,814 mother/infant pairs were included in the study, out of which 921 infants were HIV exposed as per the mothers' HIV status and based on the infant's HIV rapid test. A total of 969 PCR tests were performed, out of which 30 (3.3%) infants were concordantly positive using both platforms. GeneXpert HIV-1 Qual yielded a sensitivity of 94.1% and specificity of 99.8% with an overall error rate of 0.7%.

Conclusion: Our findings show that GeneXpert HIV-1 Qual performs well compared to CAP/CTM using DBS samples, suggesting that this technology may be adopted in decentralized laboratories as a near POC device. It may contribute to prompt diagnosis of HIV exposed infants hence enabling early linkage to care, thus advancing further gains in EID.

Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1. Inclusion flow chart It shows…
Fig 1. Inclusion flow chart It shows the characteristics of the study population, including children and women who were part of the study.
Fig 2. Discordant results It shows the…
Fig 2. Discordant results It shows the 9 discordant cases observed in the study, the resolutions made to address them and the final outcome.

References

    1. NASCOP;NACC. Kenya HIV Estimates Report. 2015.
    1. UNAIDS. Global data from UNAIDS, AIDS by the Numbers. 2016.
    1. UNAIDS. On the fast-track to an AIDS-free generation: The incredible journey of the Global Plan towards the elimination of new HIV infections among children by 2015 and keeping their mothers alive. 2015.
    1. Bourne DE, Thompson M, Brody LL, Cotton M, Draper B, Laubscher R, et al. Emergence of a peak in early infant mortality due to HIV/AIDS in South Africa. AIDS. 2009;23(1):101–6.
    1. Dunn D, Woodburn P, Duong T, Peto J, Phillips A, Gibb D, et al. Current CD4 cell count and the short-term risk of AIDS and death before the availability of effective antiretroviral therapy in HIV-infected children and adults. J Infect Dis. 2008;197(3):398–404. 10.1086/524686
    1. Ghadrshenas A, Ben Amor Y, Chang J, Dale H, Sherman G, Vojnov L, et al. Improved access to early infant diagnosis is a critical part of a child-centric prevention of mother-to-child transmission agenda. AIDS. 2013;27 Suppl 2:S197–205.
    1. Marston M, Becquet R, Zaba B, Moulton LH, Gray G, Coovadia H, et al. Net survival of perinatally and postnatally HIV-infected children: a pooled analysis of individual data from sub-Saharan Africa. Int J Epidemiol. 2011;40(2):385–96. 10.1093/ije/dyq255
    1. Munyagwa M, Baisley K, Levin J, Brian M, Grosskurth H, Maher D. Mortality of HIV-infected and uninfected children in a longitudinal cohort in rural south-west Uganda during 8 years of follow-up. Trop Med Int Health. 2012;17(7):836–43. 10.1111/j.1365-3156.2012.03000.x
    1. Newell ML, Brahmbhatt H, Ghys PD. Child mortality and HIV infection in Africa: a review. AIDS. 2004;18 Suppl 2:S27–34.
    1. Newell ML, Coovadia H, Cortina-Borja M, Rollins N, Gaillard P, Dabis F, et al. Mortality of infected and uninfected infants born to HIV-infected mothers in Africa: a pooled analysis. Lancet. 2004;364(9441):1236–43. 10.1016/S0140-6736(04)17140-7
    1. Pharr JR, Obiefune MC, Ezeanolue CO, Osuji A, Ogidi AG, Gbadamosi S, et al. Linkage to Care, Early Infant Diagnosis, and Perinatal Transmission Among Infants Born to HIV-Infected Nigerian Mothers: Evidence From the Healthy Beginning Initiative. Journal of Acquired Immune Deficiency Syndromes (1999). 2016;72(Suppl 2):S154–S60.
    1. UNITAID/WHO G, Switzerland. HIV/AIDS diagnostic technology landscape. 2012.
    1. Thompson MA, Mugavero MJ, Amico KR, Cargill VA, Chang LW, Gross R, et al. Guidelines for improving entry into and retention in care and antiretroviral adherence for persons with HIV: evidence-based recommendations from an International Association of Physicians in AIDS Care panel. Ann Intern Med. 2012;156(11):817–33, W-284, W-5, W-6, W-7, W-8, W-9, W-90, W-91, W-92, W-93, W-94. 10.7326/0003-4819-156-11-201206050-00419
    1. Ciaranello AL, Park JE, Ramirez-Avila L, Freedberg KA, Walensky RP, Leroy V. Early infant HIV-1 diagnosis programs in resource-limited settings: opportunities for improved outcomes and more cost-effective interventions. BMC Med. 2011;9:59 10.1186/1741-7015-9-59
    1. Hsiao NY, Stinson K, Myer L. Linkage of HIV-infected infants from diagnosis to antiretroviral therapy services across the Western Cape, South Africa. PLoS One. 2013;8(2):e55308 10.1371/journal.pone.0055308
    1. UNAIDS. How AIDS Changed Every Thing. MDG 6: 15 Years, 15 Lessons of Hope from the AIDS response. Geneva 2015. 2015.
    1. Chohan BH, Emery S, Wamalwa D, John-Stewart G, Majiwa M, Ng'ayo M, et al. Evaluation of a single round polymerase chain reaction assay using dried blood spots for diagnosis of HIV-1 infection in infants in an African setting. BMC Pediatr. 2011;11:18 10.1186/1471-2431-11-18
    1. Rollins N, Mzolo S, Moodley T, Esterhuizen T, van Rooyen H. Universal HIV testing of infants at immunization clinics: an acceptable and feasible approach for early infant diagnosis in high HIV prevalence settings. AIDS. 2009;23(14):1851–7. 10.1097/QAD.0b013e32832d84fd
    1. Rosen S, Fox MP. Retention in HIV care between testing and treatment in sub-Saharan Africa: a systematic review. PLoS Med. 2011;8(7):e1001056 10.1371/journal.pmed.1001056
    1. Creek TL, Sherman GG, Nkengasong J, Lu L, Finkbeiner T, Fowler MG, et al. Infant human immunodeficiency virus diagnosis in resource-limited settings: issues, technologies, and country experiences. Am J Obstet Gynecol. 2007;197(3 Suppl):S64–71.
    1. Sherman GG, Matsebula TC, Jones SA. Is early HIV testing of infants in poorly resourced prevention of mother to child transmission programmes unaffordable? Trop Med Int Health. 2005;10(11):1108–13. 10.1111/j.1365-3156.2005.01495.x
    1. Haleyur Giri Setty MK, Hewlett IK. Point of Care Technologies for HIV. AIDS Research and Treatment. 2014;2014:497046 10.1155/2014/497046
    1. Pai NP, Vadnais C, Denkinger C, Engel N, Pai M. Point-of-care testing for infectious diseases: diversity, complexity, and barriers in low- and middle-income countries. PLoS Med. 2012;9(9):e1001306 10.1371/journal.pmed.1001306
    1. Jani IV, Meggi B, Mabunda N, Vubil A, Sitoe NE, Tobaiwa O, 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(1):e1–4. 10.1097/QAI.0000000000000250
    1. Wynberg E, Cooke G, Shroufi A, Reid SD, Ford N. Impact of point-of-care CD4 testing on linkage to HIV care: a systematic review. J Int AIDS Soc. 2014;17:18809 10.7448/IAS.17.1.18809
    1. Hsiao NY, Dunning L, Kroon M, Myer L. Laboratory Evaluation of the Alere q Point-of-Care System for Early Infant HIV Diagnosis. PLoS One. 2016;11(3):e0152672 10.1371/journal.pone.0152672
    1. KNBS. The 2009 Kenya Population and Housing Census 2010.
    1. National AIDS and STI Control Programme. Kenya AIDS Indicator Survey—Preliminary Report, September 2013. 2012.
    1. Kimanga DO, Ogola S, Umuro M, Ng’ang’a A, Kimondo L, Murithi P, et al. Prevalence and Incidence of HIV Infection, Trends, and Risk Factors Among Persons Aged 15–64 Years in Kenya: Results From a Nationally Representative Study. Journal of acquired immune deficiency syndromes (1999). 2014;66(Suppl 1):S13–S26.
    1. World Health Organisation. Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach June 2013. World Health Organisation, Geneva, 2013. 2013.
    1. WHO. WHO recommendations on the diagnosis of HIV infection in infants and children. 2010.
    1. .
    1. Ceffa S, Luhanga R, Andreotti M, Brambilla D, Erba F, Jere H, 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;229:35–9. 10.1016/j.jviromet.2015.12.007
    1. Ibrahim M, Moyo S, Mohammed T, Mupfumi L, Gaseitsiwe S, Maswabi K, 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(5):e128–e31. 10.1097/QAI.0000000000001384
    1. Technau KG, Kuhn L, Coovadia A, Murnane PM, Sherman G. Xpert HIV-1 point-of-care test for neonatal diagnosis of HIV in the birth testing programme of a maternity hospital: a field evaluation study. Lancet HIV. 2017;4(10):e442–e8. 10.1016/S2352-3018(17)30097-8
    1. Murtagh MM. UNITAID Technical Report. Geneva, Switzerland: WHO; 2011. HIV/AIDS diagnostics landscape. 2011.
    1. .
    1. Murray TY, Sherman GG, Nakwa F, MacLeod WB, Sipambo N, Velaphi S, et al. Field Evaluation of Performance of Alere and Cepheid Qualitative HIV Assays for Pediatric Point-of-Care Testing in an Academic Hospital in Soweto, South Africa. J Clin Microbiol. 2017;55(11):3227–35. 10.1128/JCM.01021-17

Source: PubMed

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

3
Subskrybuj