title: Diagnostic Accuracy of the HemoCue Hb 301, STAT-Site MHgb and URIT-12 Point-of-Care Hemoglobin Meters in a Central Laboratory and a Community Based Clinic in Durban, South Africa.
abstract: In South Africa, various point-of-care hemoglobin meters are used. However, the regulatory framework for approval, implementation and oversight of use of point-of-care hemoglobin meters is suboptimal. We assessed the diagnostic accuracy of the HemoCue Hb 301, STAT-Site MHgb and URIT-12 point-of-care hemoglobin meters, compared to a central laboratory based reference assay, in a central laboratory and a community based clinic in Durban, South Africa. Differences in performance of the point-of-care assays, compared to the reference assay, were more pronounced in the community based clinic. Results were reasonable for the HemoCue Hb 301, but poor for the STAT-Site MHgb and the URIT-12. Poor test performance of point-of-care hemoglobin meters, and inadequate evaluations and oversight in South Africa, leads to suboptimal clinical care and clinical research, and increased costs. There is a need for proper evaluation and quality assurance of point-of-care tests, the results of which should be made widely available to key stakeholders.
authors.affiliation: HIV Pathogenesis Programme, Doris Duke Medical Research Institute, University of KwaZulu-Natal, Durban, South Africa.
authors.forename: Manjeetha
authors.initials: M
authors.lastname: Jaggernath
authors.affiliation: Global Clinical and Viral Laboratory, Durban, South Africa.
authors.forename: Rumallen
authors.initials: R
authors.lastname: Naicker
authors.affiliation: Global Clinical and Viral Laboratory, Durban, South Africa.
authors.forename: Savathree
authors.initials: S
authors.lastname: Madurai
authors.affiliation: Simon Fraser University, Burnaby, BC, Canada.|British Columbia Centre for Excellence in HIV/AIDS, Vancouver, BC, Canada.|Ragon Institute of MGH, MIT and Harvard, Charlestown, MA, United States of America.
authors.forename: Mark A
authors.initials: MA
authors.lastname: Brockman
authors.affiliation: HIV Pathogenesis Programme, Doris Duke Medical Research Institute, University of KwaZulu-Natal, Durban, South Africa.|KwaZulu-Natal Research Institute for Tuberculosis and HIV, University of KwaZulu-Natal, Durban, South Africa.|Ragon Institute of MGH, MIT and Harvard, Charlestown, MA, United States of America.|Max Planck Institute for Infection Biology, Berlin, Germany.
authors.forename: Thumbi
authors.initials: T
authors.lastname: Ndung'u
authors.affiliation: HIV Pathogenesis Programme, Doris Duke Medical Research Institute, University of KwaZulu-Natal, Durban, South Africa.|International AIDS Vaccine Initiative (IAVI), New York, NY, United States of America.
authors.forename: Huub C
authors.initials: HC
authors.lastname: Gelderblom
mesh_terms: D000293:Adolescent; D000328:Adult; D000740:Anemia / Q000097:blood* / Q000175:diagnosis*; D006454:Hemoglobins / Q000378:metabolism*; D006764:Hospitals, Community; D006801:Humans; D008297:Male; D008875:Middle Aged; D019095:Point-of-Care Systems; D013019:South Africa / Q000453:epidemiology
chemical_list: D006454:Hemoglobins