FDA Okays New, Faster CBC Blood Test


The U.S. Food and Drug Administration just granted pre-market clearance for a complete blood count (CBC) test that can be used in more health care settings – doctor offices and medical clinics, for example – and provide faster results. The CBC is one of the most common tests ordered by physicians, and is used to detect conditions that require intervention, including infections.

The FDA action means that doctors and clinics that adopt the new test will eliminate the waiting period for CBC results, which can be 24 hours or longer when the test is performed by an off-site lab. The new test, called the XW-100 Automated Hematology Analyzer, can be performed by medical support staff and is intended for use in patients over age 2 who require a whole blood cell count and white blood cell count. When used with other clinical and laboratory findings, the results can improve the diagnosis of conditions like severe anemia (low red blood cell count). It is not approved for use in people with cancer or critically ill patients.

Prior to clearing the test for use in non-traditional settings, the FDA reviewed clinical data from a study involving 582 blood samples from patients 2 to 92 years old. Study results suggest the test is accurate when the manufacturer’s instructions are followed.

Sourced from: FDA