"This field evaluation is instrumental because it proves our device is a viable alternative to currently available urine point of care devices," said Kevin Clark, CEO of NOWDiagnostics. "We are thrilled to have our tests evaluated by this widely respected institution and to have shown the effectiveness of our tests."
NOWDiagnostics manufactures and sells a line of unique blood-based rapid tests that allow health care providers to conduct simple-to-use, highly accurate tests for a variety of ailments and conditions. Currently, the company manufactures the ADEXUSDx® hCG test for distribution in the United States, which is the test the University of Kentucky evaluated.
Principal investigator of the study was Dr. Nerenz, who served as an Assistant Professor in the Department of Pathology and Laboratory Medicine and the Director of Point-of-Care Testing at the University of Kentucky Medical Center. He is now an Assistant Professor of Pathology and Laboratory Medicine and Assistant Director of Clinical Chemistry at the Dartmouth-Hitchcock Medical Center. His recent work has focused on the evaluation of qualitative hCG device performance and the impact of misleading test results on patient care.
NOWDiagnostics' tests allow for a one-step process that provides results in minutes using only a single drop of whole blood with no laboratory needed. The NOWDx test removes many concerns associated with urine-based testing, such as increased risk of false negatives, by facilitating blood-based testing at the POC.
Currently, POC hCG testing at the University of Kentucky is performed using urine specimens, but urine-based testing is not without flaws, as Nerenz noted in the Journal of Applied Laboratory Medicine report.
"Unfortunately, urine qualitative hCG devices are subject to false negative results in early pregnancy when urinary hCG concentrations fall below the devices' limit of detection and after week six of pregnancy due to the "hook effect" caused by high concentrations of hCG variants," Nerenz wrote. "Furthermore, collection of urine often delays testing in trauma patients, dehydrated women or those who choose not to provide a urine specimen out of distrust of medical professionals. As an alternative approach, quantitative hCG measurement in plasma or serum can detect pregnancy earlier than urine-based methods and eliminates the risk of false negative results caused by hCG variants found only in urine."
The field evaluations validated the ADEXUSDx® test as an acceptable method for point-of-care testing using capillary (finger stick) blood. This is important because samples do not have to be taken using a traditional blood draw and the samples do not have to be transported to a central, complex laboratory.
"Despite its superior analytical performance, quantitative plasma/serum hCG testing has not been widely adopted for the rapid determination of pregnancy status because it requires transporting the specimen to a central laboratory, processing and analysis, all of which contribute to an unacceptably long turnaround time," Nerenz wrote. "A device that could be used at the POC using a whole blood specimen would harness the benefits of plasma/serum-based testing while providing reduced turnaround time relative to central laboratory testing."
NOWDiagnostics is also currently developing additional ADEXUSDx® tests in a variety of categories, including food intolerance, common infectious disease, STDs, cardiology, toxicology, and screening (from thyroid dysfunction to pregnancy).
ABOUT NOWDIAGNOSTICS INC.
NOWDiagnostics Inc., based in Springdale, Ark., is a leader in innovative diagnostics testing. Its ADEXUSDx® product line features a lab at your fingertip, using only a single drop of blood to test for a variety of common conditions, illnesses, and diseases with results in a matter of minutes. By eliminating the need to send tests to off-site laboratories, NOWDiagnostics has the potential to decrease by days the waiting period to determine test results. The company's Springdale, Ark., facility was officially registered with the U.S. Food and Drug Administration in December 2014. The company is currently offering an hCG (pregnancy) test in the United States and Europe, and two cardiac (heart attack) tests and three toxicology tests in Europe. Additional tests are in the development pipeline, including sexually transmitted diseases, more cardiac (heart attack), food intolerances, common infectious diseases, and a variety of screening tests. For more information about NOWDiagnostics, visit www.nowdx.com. For more information about the ADEXUSDx® hCG test, including, among other things, its intended use, features, benefits and limitations, and directions for use, visit http://nowdx.com/adexusdx-hcg-test/.
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SOURCE NOWDiagnostics Inc.