"World Heath Care Congress Affordable Health Innovations Exhibit and Awards" 7th Annual World Health Care Congress 2010

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In resource-limited settings, blood samples collected from infants are transported from rural collection sites to urban laboratories for HIV testing via Polymerase Chain Reaction (PCR). Conventional PCR testing, which can cost as much as 50 USD per test, requires 4-5 hours processing time, complex equipment, and trained personnel. Results are often not returned to collection sites for weeks, which leads to loss to follow-up, delays initiating therapy, and high mortality rates amongst undiagnosed infants. To overcome these challenges, we are developing a point-of-care PCR test which uses our Fast Isolation of Nucleic Acid (FINA) technology that: (1) makes results available in the same visit; (2) is simple to perform at collection sites with minimal infrastructure, and (3) will be less expensive. FINA employs a novel DNA extraction method that is fast and accurate (99% and 100% clinical sensitivity and specificity, respectively). FINA utilizes a portable PCR analyzer and three single-use disposables: a blood collection device, separator device, and an assay card. The blood collection and separator devices extract DNA from whole blood onto a filter, which is then inserted into the assay card. Reagents are stored on-board the card in a foil blister and lyophilized assay pellet, eliminating the need for refrigeration and pipetting. A barcode on the assay card facilitates patient identification and checks for reagent expiration. The assay card is inserted into the battery-operated analyzer, which can also be powered by a car battery. It can be used in rural clinics and mobile units without extensive maintenance.

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