OBJECTIVE: To evaluate the accuracy of a point-of-care (POC) nucleic acid-based test (NAT) for early infant HIV diagnosis (EID) in primary health clinics in Mozambique. METHODS: POC and laboratory NAT EID tests were conducted on matched blood samples collected from 827 HIV-exposed infants younger than 18 months who were enrolled consecutively at 4 periurban primary health clinics and the central hospital in Maputo. Lancet heel draw blood collected by nurses was tested on site for HIV-1/-2 RNA on the Alere HIV NAT POC device and also used to create dried blood spots for later laboratory EID testing on the Roche Cobas Taqman/Ampliprep instrument. Results were used to determine the sensitivity, specificity, and agreement between the POC and laboratory NAT EID tests. RESULTS: The sensitivity and specificity of POC NAT EID testing were 98·5% (95% confidence interval (CI): 91.7 to 99.9, n = 65) and 99·9% (95% CI: 99.3 to 100, n = 762), respectively, compared with laboratory EID tests. Overall agreement was high (Cohen kappa = 0·981; 95% CI: 0.96 to 1.00). Positive (98·5%; 95% CI: 96·3 to 100) and negative 99.9% (95% CI: 99.7 to 100) test agreement was also high. CONCLUSIONS: Primary health care nurses accurately performed POC NAT EID testing within primary health care clinics. On-site nucleic acid-based EID testing is technically feasible in clinic settings and could be used in efforts to improve access to pediatric HIV antiretroviral treatment.
OBJECTIVE: To evaluate the accuracy of a point-of-care (POC) nucleic acid-based test (NAT) for early infant HIV diagnosis (EID) in primary health clinics in Mozambique. METHODS: POC and laboratory NAT EID tests were conducted on matched blood samples collected from 827 HIV-exposed infants younger than 18 months who were enrolled consecutively at 4 periurban primary health clinics and the central hospital in Maputo. Lancet heel draw blood collected by nurses was tested on site for HIV-1/-2 RNA on the Alere HIV NAT POC device and also used to create dried blood spots for later laboratory EID testing on the Roche Cobas Taqman/Ampliprep instrument. Results were used to determine the sensitivity, specificity, and agreement between the POC and laboratory NAT EID tests. RESULTS: The sensitivity and specificity of POC NAT EID testing were 98·5% (95% confidence interval (CI): 91.7 to 99.9, n = 65) and 99·9% (95% CI: 99.3 to 100, n = 762), respectively, compared with laboratory EID tests. Overall agreement was high (Cohen kappa = 0·981; 95% CI: 0.96 to 1.00). Positive (98·5%; 95% CI: 96·3 to 100) and negative 99.9% (95% CI: 99.7 to 100) test agreement was also high. CONCLUSIONS: Primary health care nurses accurately performed POC NAT EID testing within primary health care clinics. On-site nucleic acid-based EID testing is technically feasible in clinic settings and could be used in efforts to improve access to pediatric HIV antiretroviral treatment.
Authors: Simone C Frank; Jennifer Cohn; Lorna Dunning; Emma Sacks; Rochelle P Walensky; Sushant Mukherjee; Caitlin M Dugdale; Esther Turunga; Kenneth A Freedberg; Andrea L Ciaranello Journal: Lancet HIV Date: 2019-02-05 Impact factor: 12.767
Authors: Konstantinos Mitsakakis; Valérie D'Acremont; Sebastian Hin; Felix von Stetten; Roland Zengerle Journal: Microelectron Eng Date: 2018-10-05 Impact factor: 2.523
Authors: Joanne D Stekler; Kenneth Tapia; Janine Maenza; Claire E Stevens; George A Ure; Joshua D O'Neal; Aric Lane; James I Mullins; Robert W Coombs; Sarah Holte; Ann C Collier Journal: AIDS Res Hum Retroviruses Date: 2018-06-13 Impact factor: 2.205
Authors: Bharat S Parekh; Chin-Yih Ou; Peter N Fonjungo; Mireille B Kalou; Erin Rottinghaus; Adrian Puren; Heather Alexander; Mackenzie Hurlston Cox; John N Nkengasong Journal: Clin Microbiol Rev Date: 2018-11-28 Impact factor: 26.132