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HIV Point-of-Care tests in Babies Study (BABY) - Operational evaluation of HIV Point-of-Care tests for very early infant HIV diagnostics in infants born to HIV infected mothers in Mbeya, Tanzania.
This in-vitro diagnostic (IVD) study in infants born to HIV infected mothers evaluates the reliability and operational feasibility of an HIV Point-of-Care (PoC) test for HIV early infant diagnosis (EID) in a public health setting at obstetric clinics in Mbeya, Tanzania.
Recruitment is planned to take place at 4 obstetric/maternity study sites in and around Mbeya over a time period of 12 months. The HIV PoC test will be validated against the Standard-of-Care diagnostic test, i.e. Dried Blood Spot (DBS) analyses.
The PoC test under investigation is the Xpert HIV-1 Qual produced by Cepheid, Sunnyvale, USA.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
NIMR - Mbeya Medical Research Centre
Ludwig-Maximilians - University of Munich
Published on BioPortfolio: 2015-09-14T03:14:51-0400
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