ANALYTICAL DIAGNOSTIC SOLUTIONS INC — Department of Health and Human Services SBIR Phase I: NIAID

Description

Malaria caused by Plasmodium vivax threatens over billion people globally and sickens tens of millions annually Radical cure for P vivax malaria includes therapy aimed both at the acute attack blood schizontocidal and against future attacks hypnozoitocidal The only hypnozoitocide available are aminoquinolines such as primaquine or tafenoquine However clinicians often do not prescribe aminoquinolines due to the high prevalence of individuals with various levels of inherited Glucose phosphate dehydrogenase G PDH deficiencies because these drugs can cause life threatening acute hemolytic anemia in patients with moderate to severe G PDH deficits There is an urgent need to quantify both Hgb and G PDH for patients stricken with malaria or prior to the administration of aminoquinilones All current quantitative methods for G PDH determination are laboratory based spectrophotometric methods requiring diluents reagents pipettes and trained personnel There are currently no commercially available point of care POC tests that can quantify both Hgb and G PDH directly from a finger stick sample Developing a robust quantitative assay for field use in low resource areas is a high priority for overall malaria control and elimination In this proposal In Vitro Diagnostic Systems IVDS will establish the feasibility of developing a POC test the PreQuine Test in which Hgb and G PDH levels can be quantitated simultaneously from a L blood stick sample In pilot studies we have successfully assessed Hgb and G PDH levels using independent test strips To develop a dual Hgb and G PDH test strip we propose develop a lysing protocol to maximize liberation of Hgb and G PDH from blood samples Aim optimize Hgb and G PDH assay conditions Aim and then combine the Hgb and G PDH assays into a single test strip Aim The PreQuine Test results will be compared to results obtained with a calibrated hand held meter demonstration of concordance of the results from the PreQuine Test strip and calibrated meter to reference samples will indicate success In Phase II we will establish real time and long term stability of the PreQuine Test implement a meter temperature compensation program conduct pre clinical testing as well as field testing and use NCLIS guidelines for performance testing The ability to identify G PDH deficient individuals using a rapid POC test and also to monitor patients for G PDH levels and Hgb levels during therapy would have great impact on malaria treatment strategies Project Narrative Malaria caused by Plasmodium vivax threatens over billion people globally Although radical cure for P vivax malaria include aminoquinolines clinicians often do not prescribe aminoquinolines due to the high prevalence of individuals with various levels of inherited Glucose phosphate dehydrogenase G PDH deficiencies because these drugs can cause life threatening acute hemolytic anemia in patients with moderate to severe G PD deficits In this Phase I application propose the development of a point of care POC device which can provide a cost effective user friendly and rapid platform to simultaneously quantitate Hgb and G PDH levels from finger stick blood samples which will enable clinicians to monitor patients for G PDH levels and Hgb levels during therapy