Rapid Blood Test Allows for Earlier Detection of Pregnancy

Early detection of pregnancy is important for caregivers in order to avoid certain medications and procedures that could harm a fetus, but unfortunately, clinics are experiencing too many false-negative results from point-of-care urine-based tests.

An immunoassay used for the qualitative detection of human chorionic gonadotropin (hCG) in human whole blood, plasma or serum is now available and the test is used as an early detection aid for pregnancy for health care professionals in a variety of clinical and critical care settings.

The assay has now been Clinical Laboratory Improvement Amendments (CLIA) registered and classified by the US Food and Drug Administration (FDA; Silver Springs, MD, USA). The new hCG test is the first single-step, capillary blood hCG test requiring no equipment to receive FDA 510(k) clearance. The hCG test can detect pregnancy approximately two to eight days earlier than commonly available urine-based tests. The hCG test results are available 10 minutes after the test is used.

The ADEXUSDx hCG Test is a from a product line manufactured by NOWDiagnostics Inc. (Springdale, AR, USA). The patented technology allows physicians to easily and accurately receive results within minutes by using a single drop of capillary or whole blood. Testing is a single-step process that can identify common conditions, illnesses and diseases with the same or better accuracy, sensitivity, specificity and precision as a predicate device in a full-scale laboratory. The diagnostic test kits can be processed in as little as 5 to 15 minutes, onsite in-clinic and by staff technicians and nurses.

Kevin Clark, CEO and president and of NOWDiagnostics Inc., said, “It's too important for the safety of the mother and fetus to not have accurate pregnancy results in our emergency rooms and clinics. Our hCG test can save lives and reduce liability for health care providers. We see a great opportunity to save hospitals and clinics time, money and resources by providing them a lab in the palm of their hands.”

Related Links:
US Food and Drug Administration
NOWDiagnostics Inc.