Last data update: Jun 03, 2024. (Total: 46935 publications since 2009)
Records 1-2 (of 2 Records) |
Query Trace: Osmanov S [original query] |
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Ensuring quality: a key consideration in scaling-up HIV-related point-of-care testing programs
Fonjungo PN , Osmanov S , Kuritsky J , Ndihokubwayo JB , Bachanas P , Peeling RW , Timperi R , Fine G , Stevens W , Habiyambere V , Nkengasong JN . AIDS 2016 30 (8) 1317-23 OBJECTIVE: The objective of the World Health Organization (WHO)/U.S. President's Emergency Plan for AIDS Relief (PEPFAR) consultation was to discuss innovative strategies, offer guidance and develop a comprehensive policy framework for implementing quality-assured HIV-related point-of-care testing (POCT). METHODS: The consultation was attended by representatives from international agencies (WHO, UNICEF, UNITAID, Clinton Health Access Initiative [CHAI]), USAID, Centers for Disease Control and Prevention [CDC]/PEPFAR Cooperative Agreement Partners, and experts from more than 25 countries including policy makers, clinicians, laboratory experts and program implementers. MAIN OUTCOMES: There was strong consensus among all participants that ensuring access to quality of POCT represents one of the key challenges for the success of HIV prevention, treatment and care programs. The following four strategies were recommended: 1) implement a newly proposed concept of a sustainable quality assurance cycle that includes (a) careful planning; (b) definition of goals and targets; (c) timely implementation; (d) continuous monitoring; (e) improvements and adjustments, where necessary; and (f) a detailed evaluation; 2) the importance of supporting a cadre of workers (e.g. volunteer quality corps [Q-Corps]) with the role to ensure that the quality assurance cycle is followed and sustained; 3) implementation of the new strategy should be seen as a step-wise process, supported by development of appropriate policies and tools; and 4) joint partnership under the leadership of the Ministries of Health to ensure sustainability of implementing novel approaches. CONCLUSIONS: The outcomes of this consultation have been well received by program implementers in the field. The recommendations also laid the groundwork for developing key policy and quality documents for the implementation of HIV-related POCT. |
Performance of an early infant diagnostic test, AmpliSens DNA-HIV-FRT, using dried blood spots collected from children bBorn to human immunodeficiency virus-infected mothers in Ukraine
Chang J , Tarasova T , Shanmugam V , Azarskova M , Nguyen S , Hurlston M , Sabatier J , Zhang G , Osmanov S , Ellenberger D , Yang C , Vitek C , Liulchuk M , Nizova N . J Clin Microbiol 2015 53 (12) 3853-8 An accurate accessible test for early infant diagnosis (EID) is crucial for identifying HIV-infected infants and linking them to treatment. To improve EID services in Ukraine, dried blood spot (DBS) samples obtained from 237 HIV-exposed children (≤18 months of age) in six regions in Ukraine in 2012 to 2013 were tested with the AmpliSens DNA-HIV-FRT assay, the Roche COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) HIV-1 Qual test, and the Abbott RealTime HIV-1 Qualitative assay. In comparison with the paired whole-blood results generated from AmpliSens testing at the oblast HIV reference laboratories in Ukraine, the sensitivity was 0.99 (95% confidence interval [CI], 0.95 to 1.00) for the AmpliSens and Roche CAP/CTM Qual assays and 0.96 (95% CI, 0.90 to 0.98) for the Abbott Qualitative assay. The specificity was 1.00 (95% CI, 0.97 to 1.00) for the AmpliSens and Abbott Qualitative assays and 0.99 (95% CI, 0.96 to 1.00) for the Roche CAP/CTM Qual assay. McNemar analysis indicated that the proportions of positive results for the tests were not significantly different (P > 0.05). Cohen's kappa (0.97 to 0.99) indicated almost perfect agreement among the three tests. These results indicated that the AmpliSens DBS and whole-blood tests performed equally well and were comparable to the two commercially available EID tests. More importantly, the performance characteristics of the AmpliSens DBS test meets the World Health Organization EID test requirements; implementing AmpliSens DBS testing might improve EID services in resource-limited settings. |
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