New CBC Test Allows for Testing in More Settings, Reduced Processing Time

This broadened test access will allow for faster availability of results
This broadened test access will allow for faster availability of results

The Food and Drug Administration (FDA) has cleared the XW-100 Automated Hematology Analyzer, a complete blood cell count (CBC) test intended for use in patients ≥2 years old who require a whole blood cell count and white blood cell differential. 

The device was granted a waiver under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) which allows it to be used by a variety of settings, including physicians' offices, clinics or other types of healthcare facilities with a CLIA Certificate of Waiver.

To support the use of this device in CLIA-waived settings with non-medical personnel, the analyzer provides simple instructions for operator actions when results are flagged or outside of a specified range. In addition, the number of hematology parameters has been reduced to 12 to ensure accurate testing in this setting. 

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The device was cleared based on data from a study conducted on 582 patients samples (age range: 2 to 92 years old). The study compared the XW-100 test results collected by non-medical personnel in CLIA-waived settings to a hematology analyzer in an accredited clinical laboratory. Results showed accurate testing can be effectively conducted by non-medical personnel by following the instructions for use. 

The XW-100 Automated Hematology Analyzer should not be used to diagnose or monitor oncology patients, children <2 years old, or in chronically ill or critically ill patients.

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