A Point-of-Care Device for Simultaneous G6PD and Hemoglobin

Grant Number:1746309
Grant Agency and Type: National Science Foundation, Phase I SBIR
Amount: $225,000
Principal Investigator: Robert Harper
Disease Indication: Malaria

This SBIR Phase I project sought to develop an optical detection system to quantitate Hgb and G6PD from a test strip. This would transform treatment regimens for individuals suffering from malaria infections. Malaria, particularly caused by Plasmodium vivax (P. vivax) and Plasmodium oval  (P. oval) remains a potential cause of morbidity and mortality amongst the 2.85 billion people living at risk of infection. The only drug currently available for treatment therapy for P. vivax and P. oval is Primaquine, which can cause life-threatening anemia in individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Clinicians often do not prescribe Primaquine due to the high prevalence (8%) of individuals who are born with G6PD deficiency. The World Health Organization (WHO) and the Program for Appropriate Technology in Health (PATH) are urgently searching for a reliable assay for the diagnosis of G6PD deficiency to effectively treat patients and aid in the eradication of P. vivax and P. oval malaria. This novel assay will quantify G6PD and hemoglobin (Hgb) concentrations simultaneously from a fingerstick sample. This system comprises a single test strip coupled with a new prototype reflectance-based meter and cell phone application with Bluetooth connectivity to incorporate a patient’s I.D., test results, global tracking, and history of treatment. It is projected that this point-of-care assay will be used to screen >23 million people for G6PD within 5 years.

Technology Solution
The proposed novel platform will quantify both Glucose-6-Phosphate Dehydrogenase (G6PD) and hemoglobin (Hgb) concentrations simultaneously from a single finger stick sample using a point-of-care (POC) prototype reflectance-based meter. There is currently no such device on the market, which is urgently needed to screen patients being treated for P. vivax and P. oval malaria. A significant portion (8%) of the world population is G6PD deficient, which places these individuals at risk for life-threatening anemia after treatment with current therapeutics such as Primaquine against malaria. The POC assay utilizes a novel lysis and reagent layer membrane platform to enable a reflectance-based meter to measure non-overlapping wavelengths to quantify G6PD and Hgb concentrations. In this proposal, a functional prototype reflectance-based meter and data collection software will be constructed and compared to readings obtained using the current gold standard method (Konica Minolta spectrophotometer).  The POC assay will then be validated through performance testing using a G6PD-deficient whole blood specimen bank provided by the Program for Appropriate Technology in Health (PATH). Data obtained from 20 samples using the proposed assay will be compared to the World Health Organization’s (WHO) approved spectrophotometric method for measuring G6PD, and an FDA approved method for measuring Hgb. Success will be indicated by an R2 > 0.95, which demonstrates linear correlation, as well as a demonstration that 90% of the differences in individual measurements fall within 2 SD of the mean difference. A POC assay that can simultaneously screen patients for both G6PD deficiency and Hgb levels will allow clinicians to treat patients with P. vivax and P. oval malaria infections effectively and aid in the eradication of malaria.

Results and Commercialization Status
IVDS is continuing to develop a reflectance-based optical system with 3 LEDs to read three analytes. The meter is approximately 2” x 3” in width and length. The meter will have Bluetooth connectivity, QAR code, RFID, and a cell phone application. We are expecting to have the working prototype in September of  2020.

In Vitro Diagnostic Solutions (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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