Abbott receives FDA clearance for Whole Blood Rapid Test

April 3, 2024- Abbott’s i-STAT TBI cartridge has received clearance from the U.S. Food and Drug Administration (FDA) to be used with whole blood, allowing doctors to help assess patients with suspected concussion at the patient’s bedside and obtain lab-quality results in 15 minutes. Previously, the tests to help with the assessment of TBI were only cleared for use with plasma or serum, requiring samples to be sent to a lab for processing and testing.

This new clearance will enable testing to be performed in an array of new healthcare settings beyond hospital emergency departments including urgent care clinics with a certificate to perform moderate complexity tests. This is an important step toward a future where testing could be done outside traditional healthcare settings, such as on the sidelines of sporting events.

The whole blood test on a portable instrument helps clinicians evaluate patients 18 years of age and older who present with suspected mild traumatic brain injury or mTBI, commonly known as concussion. The ability to perform the test with a whole blood sample means testing can take place at healthcare settings without a lab which helps to accelerate the evaluation of head traumas.

With this clearance, the i-STAT TBI test can be used to help evaluate patients up to 24 hours after injury, an important advancement since those injured often wait before seeking care.

Learn More

safe online pharmacy for viagra cheap kamagra oral jelly online