Laboratory evaluation of the Alere q point-of-care system for early infant HIV diagnosis

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dc.contributor.authorHsiao, Nei-yuanen_ZA
dc.contributor.authorDunning, Lornaen_ZA
dc.contributor.authorKroon, Maxen_ZA
dc.contributor.authorMyer, Landonen_ZA
dc.date.accessioned2016-04-13T12:33:27Z
dc.date.available2016-04-13T12:33:27Z
dc.date.issued2016en_ZA
dc.description.abstractIntroduction Early infant diagnosis (EID) and prompt linkage to care are critical to minimise the high morbidity and mortality associated with infant HIV infection. Attrition in the "EID cascade" is common; however, point-of-care (POC) EID assays with same-day result could facilitate prompt linkage of HIV-infected infant to treatment. Despite a number of POC EID assays in development, few have been independently evaluated and data on new technologies are urgently needed to inform policy. METHODS: We compared Alere q 1/2 Detect POC system laboratory test characteristics with the local standard of care (SOC), Roche CAP/CTM HIV-1 qualitative PCR in an independent laboratory-based evaluation in Cape Town, South Africa. Routinely EID samples collected between November 2013 and September 2014 were each tested by both SOC and POC systems. Repeat testing was done to troubleshoot any discrepancy between POC and SOC results. RESULTS: Overall, 1098 children with a median age of 47 days (IQR, 42-117) were included. Birth PCR (age <7 days) comprised of 8% (n = 92) tests while 56% (n = 620) of children tested as part of routine EID (ages 6-14 weeks). In the overall direct comparison, Alere q Detect achieved sensitivity of 95.5% (95% CI, 91.7-97.9%) and a specificity of 99.8% (95% CI, 99.1-100%). Following repeat testing of discordant samples and exclusion of any inconclusive results, the POC assay sensitivity and specificity were 96.9% (95% CI 93.4-98.9%) and 100% (lower 95% CI 98%) respectively. Among birth PCR tests the POC assay had slightly lower sensitivity (93.3% vs 96.5% in routine EID) and higher assay error rate (10% vs 5% in samples of older children, p = 0.04). CONCLUSION: Our results indicate this POC assay performs well for EID in the laboratory. The high specificity and thus high positive predictive value would suggest a positive POC result may be adequate for immediate infant ART initiation. While POC testing for EID may have particular utility for birth testing at delivery facilities, the lower sensitivity and error rate requires further attention, as does field implementation of POC EID technologies in other clinical care settings.en_ZA
dc.identifier.apacitationHsiao, N., Dunning, L., Kroon, M., & Myer, L. (2016). Laboratory evaluation of the Alere q point-of-care system for early infant HIV diagnosis. <i>PLoS One</i>, http://hdl.handle.net/11427/18848en_ZA
dc.identifier.chicagocitationHsiao, Nei-yuan, Lorna Dunning, Max Kroon, and Landon Myer "Laboratory evaluation of the Alere q point-of-care system for early infant HIV diagnosis." <i>PLoS One</i> (2016) http://hdl.handle.net/11427/18848en_ZA
dc.identifier.citationHsiao, N. Y., Dunning, L., Kroon, M., & Myer, L. (2016). Laboratory evaluation of the Alere q point-of-care system for early infant HIV diagnosis. PloS one, 11(3), e0152672. doi:10.1371/journal.pone.0152672en_ZA
dc.identifier.ris TY - Journal Article AU - Hsiao, Nei-yuan AU - Dunning, Lorna AU - Kroon, Max AU - Myer, Landon AB - Introduction Early infant diagnosis (EID) and prompt linkage to care are critical to minimise the high morbidity and mortality associated with infant HIV infection. Attrition in the "EID cascade" is common; however, point-of-care (POC) EID assays with same-day result could facilitate prompt linkage of HIV-infected infant to treatment. Despite a number of POC EID assays in development, few have been independently evaluated and data on new technologies are urgently needed to inform policy. METHODS: We compared Alere q 1/2 Detect POC system laboratory test characteristics with the local standard of care (SOC), Roche CAP/CTM HIV-1 qualitative PCR in an independent laboratory-based evaluation in Cape Town, South Africa. Routinely EID samples collected between November 2013 and September 2014 were each tested by both SOC and POC systems. Repeat testing was done to troubleshoot any discrepancy between POC and SOC results. RESULTS: Overall, 1098 children with a median age of 47 days (IQR, 42-117) were included. Birth PCR (age <7 days) comprised of 8% (n = 92) tests while 56% (n = 620) of children tested as part of routine EID (ages 6-14 weeks). In the overall direct comparison, Alere q Detect achieved sensitivity of 95.5% (95% CI, 91.7-97.9%) and a specificity of 99.8% (95% CI, 99.1-100%). Following repeat testing of discordant samples and exclusion of any inconclusive results, the POC assay sensitivity and specificity were 96.9% (95% CI 93.4-98.9%) and 100% (lower 95% CI 98%) respectively. Among birth PCR tests the POC assay had slightly lower sensitivity (93.3% vs 96.5% in routine EID) and higher assay error rate (10% vs 5% in samples of older children, p = 0.04). CONCLUSION: Our results indicate this POC assay performs well for EID in the laboratory. The high specificity and thus high positive predictive value would suggest a positive POC result may be adequate for immediate infant ART initiation. While POC testing for EID may have particular utility for birth testing at delivery facilities, the lower sensitivity and error rate requires further attention, as does field implementation of POC EID technologies in other clinical care settings. DA - 2016 DB - OpenUCT DO - 10.1371/journal.pone.0152672 DP - University of Cape Town J1 - PLoS One LK - https://open.uct.ac.za PB - University of Cape Town PY - 2016 T1 - Laboratory evaluation of the Alere q point-of-care system for early infant HIV diagnosis TI - Laboratory evaluation of the Alere q point-of-care system for early infant HIV diagnosis UR - http://hdl.handle.net/11427/18848 ER - en_ZA
dc.identifier.urihttp://dx.doi.org/10.1371/journal.pone.0152672en_ZA
dc.identifier.urihttp://hdl.handle.net/11427/18848
dc.identifier.vancouvercitationHsiao N, Dunning L, Kroon M, Myer L. Laboratory evaluation of the Alere q point-of-care system for early infant HIV diagnosis. PLoS One. 2016; http://hdl.handle.net/11427/18848.en_ZA
dc.language.isoengen_ZA
dc.publisherPublic Library of Scienceen_ZA
dc.publisher.departmentDivision of Virologyen_ZA
dc.publisher.facultyFaculty of Health Sciencesen_ZA
dc.publisher.institutionUniversity of Cape Town
dc.rightsThis is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.en_ZA
dc.rights.holder© 2016 Hsiao et alen_ZA
dc.rights.urihttp://creativecommons.org/licenses/by/4.0en_ZA
dc.sourcePLoS Oneen_ZA
dc.source.urihttp://journals.plos.org/plosoneen_ZA
dc.subject.otherInfantsen_ZA
dc.subject.otherAntiretroviral therapyen_ZA
dc.subject.otherHIV diagnosis and managementen_ZA
dc.subject.otherHIVen_ZA
dc.subject.otherPolymerase chain reactionen_ZA
dc.subject.otherChildrenen_ZA
dc.subject.otherHIV infectionsen_ZA
dc.subject.otherHIV-1en_ZA
dc.titleLaboratory evaluation of the Alere q point-of-care system for early infant HIV diagnosisen_ZA
dc.typeJournal Articleen_ZA
uct.type.filetypeText
uct.type.filetypeImage
uct.type.publicationResearchen_ZA
uct.type.resourceArticleen_ZA
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