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- W2321850210 abstract "The suitability of rapid HIV test kits for use in resource-limited countries has been challenged. This includes the provision of inferior kits by manufacturers, compromised test kits when they arrive in-country, and damaged kits when they reach the end user. For the past 2 years, we have been working with the Partnership for Supply Chain Management to provide assistance in addressing these issues for rapid test kits. Thus far, our evaluations have been directed to assessing test kits for their performance characteristics once they have arrived in-country. At the in-country warehouse, before distribution to the laboratories, a sample of kit lots were sent to our laboratory to assess their suitability. For HIV rapid kits, we have evaluated >150 and found several concerns. In Africa, we were faced with a situation where several lots of an HIV test kit passed our evaluation, but failed an evaluation in the country’s National Reference Laboratory. Subsequently, the country refused to allow these lots of kits to be used, resulting in thousands of test kits being quarantined and causing an enormous economic concern for the purchaser of these kits. Subsequently, both our laboratory and the CDC re-evaluated these lots and again found them to be suitable for use. Finally, one of our staff was sent to this country to evaluate the capabilities at the National Reference Laboratory and perform another evaluation on these kit lots in-country. The kits, again, passed, and recommendations were provided to the Reference Laboratory. This project highlights the need to assess the suitability of rapid test kits in Africa and the need for continuous monitoring of all aspects to prevent negative economic consequences." @default.
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- W2321850210 date "2013-04-01" @default.
- W2321850210 modified "2023-10-17" @default.
- W2321850210 title "ST107 Suitability and Approval of HIV Rapid Test Kits after Arrival In-Country" @default.
- W2321850210 doi "https://doi.org/10.1097/01.qai.0000429269.90467.68" @default.
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