A User-Friendly Point of Care Device, Glucose-6-Phosphate Dehydrogenase 

Grant Number: 1R43AI129057-01A1
Grant Agency and Type: NIH NIAID, Phase I SBIR
Amount: $191,220
Principal Investigator: Robert Harper
Disease Indication: Malaria

Malaria caused by Plasmodium vivax threatens over 2 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 is 8- aminoquinolines such as Primaquine or tafenoquine. However, clinicians often do not prescribe 8- aminoquinolines due to the high prevalence (8%) of individuals with various levels of inherited Glucose-6- phosphate dehydrogenase (G6PD) deficiencies, because these drugs can cause life-threatening acute hemolytic anemia in patients with moderate to severe G6PD deficits. There is an urgent need to quantify both Hgb and G6PD for patients stricken with malaria or prior to the administration of 8-aminoquinilones. All current quantitative methods for G6PD 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 G6PD directly from a fingerstick sample. Developing a robust, quantitative assay for field use in low resource areas is a high priority for overall malaria control and elimination.

Technology Solution 
In Vitro Diagnostic Systems (IVDS) will establish the feasibility of developing a POC test, the PreQuine Test, in which Hgb and G6PD levels can be quantitated simultaneously from a 30 µL blood fingerstick sample. In pilot studies, we have successfully assessed Hgb and G6PD levels using independent test strips. To develop a dual Hgb and G6PD test strip, we propose developing a lysing protocol to maximize liberation of Hgb and G6PD from blood samples (Aim 1), optimize Hgb and G6PD assay conditions (Aim 2) and then combine the Hgb and G6PD assays into a single test strip (Aim 3). The PreQuine Test results will be generated with a calibrated hand-held meter; demonstration of concordance of the results from the PreQuine Test strip and calibrated meter to a suitable reference method will indicate success.

Results and Commercialization Status
We achieved all of our Phase I Aims and filed for a Phase II application, 2R44AI129057-02A1

IVDS develops novel testing technologies for the healthcare, veterinary, and consumer markets. IVDS scientists have helped bring 10 FDA-approved products to market over their careers in diagnostics.
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