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PLEASE READ THE BELOW ASSIGNMENT AND STATE 7 PROS AND 7 CONS SUPPORTING CLIAC.
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PLEASE READ THE BELOW ASSIGNMENT AND STATE 7 PROS AND 7 CONS SUPPORTING CLIAC.
AND STATE 7 PROS AND 7 CONS SUPPORTING FDA:
PLEASE USE THE SAME REFERENCE STYLE FROM THE BELOW ASSIGNMENT ” ”
ALSO, ADDITIONA INFORMATION CAN BE FOUND IN THE FOLLOWING WEBSITE:
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm583997.htmLinks to an external site.
“As with many aspects of healthcare, the landscape of CLIA-waived testing has changed greatly since the COVID-19 pandemic.1 There was much greater demand for faster, local testing, especially for infectious diseases.1 The FDA criteria for the determination of testing complexity are: (1) knowledge required to conduct the test, (2) experience and training, (3) testing materials, (4) procedural steps, (5) quality control practices, (6) troubleshooting and maintenance, and (7) interpretation of results.1 The criteria are assigned values 1-3 and values of more than 12 are considered high complexity and values less than 12 are considered moderate complexity.1 The determination of a “waived test” is made by the FDA on the basis that the testing method is designed to have a very low likelihood of inaccurate results and that improper interpretation does not pose a reasonable risk to the patient as determined by the Secretary of Health and Human Services.1
The XW-100 analyzer is the first CLIA-waived CBC analyzer.2 The instrument was designed to be low complexity and qualify for CLIA-waived testing.2 The instrument is intended for use in outpatient clinics and is expected to be operated by individuals with no clinical laboratory training.2 The instrument is expected to be used mainly for patients that are expected to have normal CBC results and it is not recommended for abnormal patients.2 Results may not be accurate for patients less than 2 years old or oncology patients.2 Additionally, the WBC differential is only 3-parts and does not count eosinophils and basophils.2 If more complex results are expected, these patients should be tested using a higher-complexity analyzer.2
I understand the push towards CLIA-waived tests for ease of use and speed of results, but the expertise that medical laboratory scientists provide should not be underestimated. I think that waived testing will be important in the future of the clinical lab, but the involvement of laboratory scientists is essential to ensure results of similar quality to traditional testing.1 While there are many benefits to waived testing, I believe that they should be utilized with great caution. It may be beneficial to test a portion of the testing population in duplicate to ensure the accuracy of results. The percentage of samples found to be inside the allowable error was 98.8%, so maybe 3% of the samples tested every week should be referred for duplicate testing using a more complex analyzer.2″
References:
1. Lu J, Butler-Wu SM. Home and Clinical Laboratory Improvement Amendments–Waived Testing for Infectious Diseases—How Do These Fit in the Testing Landscape? Clinics in laboratory medicine. 2024;44(1):13-21. doi:10.1016/j.cll.2023.10.005
2. Wu AHB, Sellers J. XW-100: First FDA CLIA-Waived CBC Analyzer Designed for Physician Office Use. The journal of applied laboratory medicine. 2019;3(5):839-846. doi:10.1373/jalm.2018.0273
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