Blood-Based Pregnancy Test Receives FDA Clearance

The FDA today cleared Abbott’s i-Stat Total ß-hCG test, a first-of-its-kind pregnancy test that can determine a woman’s pregnancy status by analyzing her blood.

While it is critical for doctors to know whether or not a woman is pregnant as soon as possible in emergency situations, traditional urine-based pregnancy tests can be difficult to administer if a patient is dehydrated or unconscious. By instead using 2 to 3 drops of blood to determine pregnancy, the ß-hCG test can avoid these complications, providing doctors with results within 10 minutes and helping them make clinical decisions.

“In today's health care environment, clinicians are faced with a growing number of people who are seeking care,” said Abbot vice president Sharon Bracken in a press release. “Abbott's ß-hCG blood test serves as a new tool to help physicians determine pregnancy status quickly and accurately, right at the bedside, to help provide quality treatment.”

The test can detect whether a woman is in the early stages of pregnancy by measuring the level of human chorionic gonadotropin (hCG), a hormone that is often used as an indicator of pregnancy, in a patient’s blood. In addition to simply determining whether or not a patient is pregnant, the test can also specify the amount of hCG present, which may help identify how far along a woman is in pregnancy while potentially reducing false-negative results.

“During a medical emergency, every minute matters," said Scott Pennington, RN, BSN, director of Critical Care Services at Gulf Coast Regional Medical Center in Panama City, Florida, in a press release. “A fast blood test to help determine if a woman is pregnant can help doctors and nurses quickly decide appropriate care, which could potentially save lives.”