From WHO website-" In early October, an invitation
Post# of 9144
Posted On: 11/19/2014 7:55:56 AM
From WHO website-" In early October, an invitation was sent to manufacturers, known to be working on diagnostic tests for Ebola virus, to submit documentation setting out the evidence they have compiled on the safety, quality and performance of the test. Information to be submitted includes the recommended specimen types; evidence of test performance, including sensitivity and specificity; suppliers of critical components or raw materials and services, and data on current inventory and manufacturing capacity and quality.
Sixteen sets of documentation were received by mid-October. These include conventional RT-PCR diagnostic kits, automated “desktop” PCR systems with integrated specimen processing, and new point-of-care tests that could – within minutes – detect Ebola virus infection with blood from a finger-prick instead of a full tube. The documentation is independently assessed for WHO by expert virologists; the performance of the most promising tests will be verified through a rapid laboratory evaluation using clinical specimens.
The emergency quality assessment mechanism is currently assessing the first 5 of the 16 documentation sets submitted to date. Australian, Belgian and Dutch reviewers are participating in the evaluation, together with staff from the WHO Prequalification of In Vitro Diagnostics Programme.
The overarching objective is to guide bulk procurement decisions by WHO and other partners that will get the best tests to West Africa within the next few months. "
Sixteen sets of documentation were received by mid-October. These include conventional RT-PCR diagnostic kits, automated “desktop” PCR systems with integrated specimen processing, and new point-of-care tests that could – within minutes – detect Ebola virus infection with blood from a finger-prick instead of a full tube. The documentation is independently assessed for WHO by expert virologists; the performance of the most promising tests will be verified through a rapid laboratory evaluation using clinical specimens.
The emergency quality assessment mechanism is currently assessing the first 5 of the 16 documentation sets submitted to date. Australian, Belgian and Dutch reviewers are participating in the evaluation, together with staff from the WHO Prequalification of In Vitro Diagnostics Programme.
The overarching objective is to guide bulk procurement decisions by WHO and other partners that will get the best tests to West Africa within the next few months. "
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