13 March 2013 Rapid screening test for gestational diabetes: public health need, market requirement, initial product design, and experimental results
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Abstract
Gestational diabetes is a global epidemic where many urban areas in Southeast Asia have found prevalence rates as high as 20%, exceeding the highest prevalence rates in the developed world. It can have serious and life-threatening consequences for mothers and babies. We are developing two variants of a new, simple, low-cost rapid test for screening for gestational diabetes mellitus for use primarily in low-resource settings. The pair of assays, both semiquantitative rapid diagnostic strip tests for glycated albumin, require neither fasting nor an oral glucose challenge test. One variant is an extremely simple strip test to estimate the level of total glycated albumin in blood. The other, which is slightly more complex and expensive, is a test that determines the ratio of glycated albumin to total albumin. The screening results can be used to refer women to receive additional care during delivery to avoid birth complications as well as counseling on diet and exercise during and after pregnancy. Results with the latter test may also be used to start treatment with glucose-lowering drugs. Both assays will be read visually. We present initial results of a preliminary cost-performance comparison model evaluating the proposed test versus existing alternatives. We also evaluated user needs and schematic paper microfluidics-based designs aimed at overcoming the challenge of visualizing relatively narrow differences between normal and elevated levels of glycated albumin in blood.
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Bernhard H Weigl, Bernhard H Weigl, Greg Zwisler, Greg Zwisler, Roger Peck, Roger Peck, Elizabeth Abu-Haydar, Elizabeth Abu-Haydar, "Rapid screening test for gestational diabetes: public health need, market requirement, initial product design, and experimental results", Proc. SPIE 8615, Microfluidics, BioMEMS, and Medical Microsystems XI, 86150L (13 March 2013); doi: 10.1117/12.2008326; https://doi.org/10.1117/12.2008326
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