The failure of routine rapid HIV testing: a case study of improving low sensitivity in the field

dc.contributor.authorWolpaw, Benjaminen_ZA
dc.contributor.authorMathews, Catherineen_ZA
dc.contributor.authorChopra, Mickeyen_ZA
dc.contributor.authorHardie, Dianaen_ZA
dc.contributor.authorde Azevedo, Virginiaen_ZA
dc.contributor.authorJennings, Karenen_ZA
dc.contributor.authorLurie, Marken_ZA
dc.date.accessioned2015-10-28T07:09:15Z
dc.date.available2015-10-28T07:09:15Z
dc.date.issued2010en_ZA
dc.description.abstractBACKGROUND:The rapid HIV antibody test is the diagnostic tool of choice in low and middle-income countries. Previous evidence suggests that rapid HIV diagnostic tests may underperform in the field, failing to detect a substantial number of infections. A research study inadvertently discovered that a clinic rapid HIV testing process was failing to detect cases of established (high antibody titer) infection, exhibiting an estimated 68.7% sensitivity (95% CI [41.3%-89.0%]) over the course of the first three weeks of observation. The setting is a public service clinic that provides STI diagnosis and treatment in an impoverished, peri-urban community outside of Cape Town, South Africa. METHODS: The researchers and local health administrators collaborated to investigate the cause of the poor test performance and make necessary corrections. The clinic changed the brand of rapid test being used and later introduced quality improvement measures. Observations were made of the clinic staff as they administered rapid HIV tests to real patients. Estimated testing sensitivity was calculated as the number of rapid HIV test positive individuals detected by the clinic divided by this number plus the number of PCR positive, highly reactive 3rd generation ELISA patients identified among those who were rapid test negative at the clinic. RESULTS: In the period of five months after the clinic made the switch of rapid HIV tests, estimated sensitivity improved to 93.5% (95% CI [86.5%-97.6%]), during which time observations of counselors administering tests at the clinic found poor adherence to the recommended testing protocol. Quality improvement measures were implemented and estimated sensitivity rose to 95.1% (95% CI [83.5%-99.4%]) during the final two months of full observation. CONCLUSIONS: Poor testing procedure in the field can lead to exceedingly low levels of rapid HIV test sensitivity, making it imperative that stringent quality control measures are implemented where they do not already exist. Certain brands of rapid-testing kits may perform better than others when faced with sub-optimal use.en_ZA
dc.identifier.apacitationWolpaw, B., Mathews, C., Chopra, M., Hardie, D., de Azevedo, V., Jennings, K., & Lurie, M. (2010). The failure of routine rapid HIV testing: a case study of improving low sensitivity in the field. <i>BMC Health Services Research</i>, http://hdl.handle.net/11427/14482en_ZA
dc.identifier.chicagocitationWolpaw, Benjamin, Catherine Mathews, Mickey Chopra, Diana Hardie, Virginia de Azevedo, Karen Jennings, and Mark Lurie "The failure of routine rapid HIV testing: a case study of improving low sensitivity in the field." <i>BMC Health Services Research</i> (2010) http://hdl.handle.net/11427/14482en_ZA
dc.identifier.citationWolpaw, B. J., Mathews, C., Chopra, M., Hardie, D., de Azevedo, V., Jennings, K., & Lurie, M. N. (2010). The failure of routine rapid HIV testing: a case study of improving low sensitivity in the field. BMC health services research, 10(1), 73.en_ZA
dc.identifier.ris TY - Journal Article AU - Wolpaw, Benjamin AU - Mathews, Catherine AU - Chopra, Mickey AU - Hardie, Diana AU - de Azevedo, Virginia AU - Jennings, Karen AU - Lurie, Mark AB - BACKGROUND:The rapid HIV antibody test is the diagnostic tool of choice in low and middle-income countries. Previous evidence suggests that rapid HIV diagnostic tests may underperform in the field, failing to detect a substantial number of infections. A research study inadvertently discovered that a clinic rapid HIV testing process was failing to detect cases of established (high antibody titer) infection, exhibiting an estimated 68.7% sensitivity (95% CI [41.3%-89.0%]) over the course of the first three weeks of observation. The setting is a public service clinic that provides STI diagnosis and treatment in an impoverished, peri-urban community outside of Cape Town, South Africa. METHODS: The researchers and local health administrators collaborated to investigate the cause of the poor test performance and make necessary corrections. The clinic changed the brand of rapid test being used and later introduced quality improvement measures. Observations were made of the clinic staff as they administered rapid HIV tests to real patients. Estimated testing sensitivity was calculated as the number of rapid HIV test positive individuals detected by the clinic divided by this number plus the number of PCR positive, highly reactive 3rd generation ELISA patients identified among those who were rapid test negative at the clinic. RESULTS: In the period of five months after the clinic made the switch of rapid HIV tests, estimated sensitivity improved to 93.5% (95% CI [86.5%-97.6%]), during which time observations of counselors administering tests at the clinic found poor adherence to the recommended testing protocol. Quality improvement measures were implemented and estimated sensitivity rose to 95.1% (95% CI [83.5%-99.4%]) during the final two months of full observation. CONCLUSIONS: Poor testing procedure in the field can lead to exceedingly low levels of rapid HIV test sensitivity, making it imperative that stringent quality control measures are implemented where they do not already exist. Certain brands of rapid-testing kits may perform better than others when faced with sub-optimal use. DA - 2010 DB - OpenUCT DO - 10.1186/1472-6963-10-73 DP - University of Cape Town J1 - BMC Health Services Research LK - https://open.uct.ac.za PB - University of Cape Town PY - 2010 T1 - The failure of routine rapid HIV testing: a case study of improving low sensitivity in the field TI - The failure of routine rapid HIV testing: a case study of improving low sensitivity in the field UR - http://hdl.handle.net/11427/14482 ER - en_ZA
dc.identifier.urihttp://hdl.handle.net/11427/14482
dc.identifier.urihttp://dx.doi.org/10.1186/1472-6963-10-73
dc.identifier.vancouvercitationWolpaw B, Mathews C, Chopra M, Hardie D, de Azevedo V, Jennings K, et al. The failure of routine rapid HIV testing: a case study of improving low sensitivity in the field. BMC Health Services Research. 2010; http://hdl.handle.net/11427/14482.en_ZA
dc.language.isoengen_ZA
dc.publisherBioMed Central Ltden_ZA
dc.publisher.departmentDepartment of Public Health and Family Medicineen_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 Licenseen_ZA
dc.rights.holder2010 Wolpaw et al; licensee BioMed Central Ltd.en_ZA
dc.rights.urihttp://creativecommons.org/licenses/by/2.0en_ZA
dc.sourceBMC Health Services Researchen_ZA
dc.source.urihttp://www.biomedcentral.com/bmchealthservres/en_ZA
dc.subject.otherHIV Infectionsen_ZA
dc.subject.otherMass Screeningen_ZA
dc.subject.otherQuality Controlen_ZA
dc.subject.otherReagent Kits, Diagnosticen_ZA
dc.titleThe failure of routine rapid HIV testing: a case study of improving low sensitivity in the fielden_ZA
dc.typeJournal Articleen_ZA
uct.type.filetypeText
uct.type.filetypeImage
uct.type.publicationResearchen_ZA
uct.type.resourceArticleen_ZA
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