Abbott's Pregnancy Blood Test Gets FDA Nod

April 30, 2015

Abbott’s i-Stat Total β-hCG pregnancy blood test has won FDA regulatory approval, the Abbott Park, Ill., devicemaker announced Thursday.

The first-of-its-kind blood test rapidly and accurately detects the human chorionic gonadotropin hormone commonly associated with pregnancy, the company says. By measuring very low levels of hCG in the blood stream using two to three droplets, the test can determine if a woman is in the early stages of pregnancy within 10 minutes.

Previously, medical professionals had to rely on urine-based testing, but this can pose a problem for a woman in an emergency setting. For example, she could be dehydrated, experiencing pain or unconscious. In these settings, the sooner a doctor can know a woman’s pregnancy status the better, since this factor must be taken into account during clinical decision-making, the devicemaker says.

The system can measure hCG in whole blood or plasma more quickly than urine tests. By displaying results that specify the amount of the hormone present, the i-Stat test could potentially cut down on false-negative readings.

The blood test also is available in Canada, Europe, the Middle East, South Africa, Australia and New Zealand. — Jason Scott