Sensitive quantitative assays for human chronic gonadotropin (hCG) have broad utility in women's health care beyond detection of pregnancy. They can be useful in predicting spontaneous abortions and aid in the detection of ectopic pregnancy and multiple gestation. Perhaps more importantly, a rapid-turnaround whole blood quantitative hCG test is crucial in the emergency room when a women presents with severe abdominal pain. The attending physician rapidly needs to determine if the cause is related to the kidney, liver, gall bladder, appendix, or to an ectopic pregnancy. Metrika will demonstrate the feasibility of an extended range immuno- chemistry for a Digital Response Quantitative hCG Rapid Test. This test will be rapid (less than 5 minutes to a result), single-use, and disposable, capable of quantitatively measuring hCG with laboratory accuracy and precision. In its final form, the test device will be about the size of a credit card and will combine inexpensive microelectronics and dry reagent immunochemistry into a totally self-contained package. The key issues for feasibility will be achieving a very wide dynamic range (unique to hCG) in addition to high sensitivity, precision, accuracy, and specificity, in a low cost lateral wicking immunoassay test device. Achieving these goals without blood sample pre-treatment or dilution will require innovation in the areas of dry reagent immunoassay chemistry, manufacturing, and signal generation and detection technology, previously unknown in single-use tests. Metrika will apply innovative and proprietary solutions to resolving these issues and will assess their feasibility within the Phase I project.
The commercial application of the Digital Response Quantitative hCG Rapid Test are in the urgent point of care sites where access to a rapid quantitative analysis is limited or non-existent. Obstetricians/ Gynecologists and emergency room physicians will use the test which will yield significant economic and patient benefits, including improving the efficiency of healthcare delivery at the point of care.
