Strip test for glycated albumin screening

Organization: 
Program for Appropriate Technology in Health (PATH)
Organization Location: 
Seattle, WA USA

Rationale: Gestational Diabetes Mellitus (GDM) is a rapidly growing problem in many developing countries that demands appropriate diagnostic technology. GDM leads to serious complications for both mother and baby, and also predisposes both to developing Type 2 diabetes. Recommended screening for GDM is the Oral Glucose Challenge Test (OGCT). This requires fasting and several hours at the clinic for glucose measurements, leading to low patient compliance. Implementing the OGCT in developing countries has been only moderately successful in pilot studies.

Approach: A new biomarker, glycated albumin (GA), offers the potential to diagnose GDM within minutes without fasting. We propose adapting an existing laboratory assay for GA and implementing it as a semiquantitative rapid strip assay (RDT). PATH will develop the assay with samples obtained locally.

Objective and Impact: The proposed RDT for GA will allow us to determine with good sensitivity and moderate specificity if a pregnant woman is likely to develop diabetes. Combining biometric information and health history with the RDT result will improve specificity. The screening result can be used to counsel high-risk women on diet and exercise and additional care during delivery, or to provide them a follow-up OGCT and insulin. With the RDT for the new biomarker, health care systems can avoid the cost and inconvenience of having every pregnant woman go through an OGCT and can increase patient catchment for diabetes screening.

Innovation: The innovation is low-cost point-of-care RDT for a biomarker predictive of gestational diabetes risk.

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