FDA makes effortless common blood cell count test for patients and providers


To identify the disorders in individuals suffering, the first step that physicians perform is collecting your blood sample to conduct common blood cell count test. The common blood count test (CBC) is a blood test used to evaluate your overall health and detect a wide range of disorders

In common blood count test there are certain factors to be examined considered as main blood components like Red blood cell, white blood cell, platelets.

These blood tests tells the count of blood cells, the values differs according to age and gender.

Red blood cells

source: google

Red blood cells: These blood cells carry oxygen containing hemoglobin which transfers oxygen. They are also called erythrocytes.

In men: 4.32-5.72 million cells/mcL
In women: 3.90-5.03 million cells/mcL

White blood cells

source: google

The white blood cells (WBC) help to fight against infections by attacking bacteria, viruses, and germs that invade the body. White blood cells originate in the bone marrow and circulate throughout the bloodstream.

Normal levels in individual 3,500 to 10,500 cells/mcL


source: google

The platelets are cells present in blood which reduces the flow of blood during injuries and wounds by clotting.

150,000 to 450,000/mcL

New regulation by FDA on CBC Tests

The U.S. Food and Drug Administration decided to categorize the a complete blood cell count (CBC) and to establish the blood examinations in more health care centers to make each and every ones availability for test. By implementing strategies the results obtained fast to examine the patients

A device known as XW-100 Automated Hematology Analyzer for common blood cell count test using for children under 2 years of age and the older people for analyzing white blood cell count and white blood cell differential these results obtained from other clinical and laboratories to make people aware of infections and serious conditions. The device functions by using a blood sample to determine and measure 12 different blood characteristics and provides patients with a blood component profile as overall health assessment.

Moreover, the automated analyzer device granted as waiver under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform common blood cell count test. This program performs works under Centers for Medicare & Medicaid Services (CMS) and manages the laboratories across US. The type of CLIA certificate obtained by laboratory depends on the complexity of the tests it performs. Meanwhile, CLIA rules explains three levels of test complexity waived tests, moderate complexity tests and high complexity tests.

Laboratories certified more than 180,000 to perform waived testing

source: google

Although, the analyzer provides simple instructions for operator actions during results indicating outside of a specified range. To ensure accurate testing in this setting and to eliminate results that are most susceptible to inaccuracy or require additional testing, the number of hematology parameters reduced to 12.

However, the tests performed by the device substantially equivalent to the 2015 model. The submitted data demonstrated the low risk of false results and more easy to use by untrained operators.

Further, the FDA examined data on 582 samples of common blood cell count test collected from patients ranging from 2 to 92 years old. The study compared test results collected by non-medical personnel. In CLIA-waived settings to a hematology analyzer in an accredited clinical laboratory. Common blood cell count test Results analyzed following manufacturer’s instructions for use, accurate testing effectively conducted by untrained personnel.

Finally, the FDA granted premarket clearance and a CLIA waiver for the XW-100 Automated Hematology Analyzer to Sysmex America, Inc.