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A Simple Sensitive Molecular Platform for Malaria Diagnosis: The Direct on Blood PCR-NALFIA System

Friday, 19 September 2014 at 16:15

Add to Calendar ▼2014-09-19 16:15:002014-09-19 17:15:00Europe/LondonA Simple Sensitive Molecular Platform for Malaria Diagnosis: The Direct on Blood PCR-NALFIA SystemPoint-of-Care Diagnostics World Congress in San Diego, California, USASan Diego, California, USASELECTBIOenquiries@selectbiosciences.com

Molecular tools allow for specific/sensitive malaria diagnosis, but current formats, like PCR with gel-electrophoresis, are difficult to implement in resource poor settings. Therefore, a simple, fast, sensitive/specific molecular diagnostic platform, the direct on blood PCR combined with nucleic acid lateral flow immunoassay (NALFIA) to detect amplified PCR products of Pan-Plasmodium and human GAPDH (internal control) was developed and evaluated under laboratory conditions, a multi country ring trial and two malaria endemic countries. Analytical sensitivity/specificity of PCR-NALFIA in a single laboratory evaluation was >95% and able to detect 1 parasite/µl blood [1]. All laboratories in the ring trial reported ease of use of the system and could successfully perform the protocol. Overall laboratory inter variability was low and the agreement of reported results was high. Overall test sensitivity and specificity was >95% [2]. Field evaluations in disease endemic countries, Thailand and Burkina Faso, were performed. In Burkina Faso sensitivity was 94,8% and specificity 82,4% compared to microscopy and 93,3% and 91.4% compared to RDT. In Thailand the sensitivity and specificity was 93,4% and 90,9 respectively compared to microscopy and 95,6% and 87.1 % compared to RDT. These numbers are under estimation of test performance as the results are not PCR corrected.