Zhimin Tim Cao1, Julianne Cook Botelho2, Robert Rej3, Hubert Vesper2, J Rex Astles4. 1. Wadsworth Center, New York State Department of Health, Albany, NY, United States of America; College of Arts and Sciences, University at Albany, State University of New York, Albany, NY, United States of America. 2. Centers for Disease Control and Prevention, Atlanta, GA, United States of America. 3. Wadsworth Center, New York State Department of Health, Albany, NY, United States of America; Department of Biomedical Sciences, School of Public Health, University at Albany, State University of New York, Albany, NY, United States of America. 4. Centers for Disease Control and Prevention, Atlanta, GA, United States of America. Electronic address: jda4@cdc.gov.
Abstract
BACKGROUND: We reported observations on analytical performance in testosterone measurements of various methods/assays from the study carried out using accuracy-based proficiency testing (PT) during 2012-2013. In 2016, we re-evaluated analytical performance of testosterone assays using accuracy-based PT to assess effectiveness of CDC efforts toward standardization. METHODS: Five single-donor human serum samples from female and male adult donors were analyzed for testosterone by New York State Department of Health-certified clinical laboratories using 16 immunoassays and LC-MS/MS methods. Target values were determined using the CDC reference measurement procedure. RESULTS: Testosterone targets for the 5 samples were 43.5, 160, 294, 457, and 534 ng/dL. The biases of individual result of the 65 participant laboratories against the target for each sample were calculated. Of participants, 87.7% had ≥4 of the 5 results within the minimum allowable total error limits (± 25.1%), a 14.7% increase from the previous study. The improved PT scores were attributed to better analytical accuracy and precision, and laboratories' selection of more accurate assays/methods. CONCLUSIONS: Improved analytical accuracy and precision for testosterone assays were demonstrated over a 3.5-year period after the first CDC-directed accuracy-based proficiency testing. Additional effort is needed to improve accuracy/precision of measurements, especially at low concentrations. Published by Elsevier Inc.
BACKGROUND: We reported observations on analytical performance in testosterone measurements of various methods/assays from the study carried out using accuracy-based proficiency testing (PT) during 2012-2013. In 2016, we re-evaluated analytical performance of testosterone assays using accuracy-based PT to assess effectiveness of CDC efforts toward standardization. METHODS: Five single-donorhuman serum samples from female and male adult donors were analyzed for testosterone by New York State Department of Health-certified clinical laboratories using 16 immunoassays and LC-MS/MS methods. Target values were determined using the CDC reference measurement procedure. RESULTS:Testosterone targets for the 5 samples were 43.5, 160, 294, 457, and 534 ng/dL. The biases of individual result of the 65 participant laboratories against the target for each sample were calculated. Of participants, 87.7% had ≥4 of the 5 results within the minimum allowable total error limits (± 25.1%), a 14.7% increase from the previous study. The improved PT scores were attributed to better analytical accuracy and precision, and laboratories' selection of more accurate assays/methods. CONCLUSIONS: Improved analytical accuracy and precision for testosterone assays were demonstrated over a 3.5-year period after the first CDC-directed accuracy-based proficiency testing. Additional effort is needed to improve accuracy/precision of measurements, especially at low concentrations. Published by Elsevier Inc.
Authors: Junyan Shi; Rachel Bird; Michael W Schmeling; Andrew N Hoofnagle Journal: J Chromatogr B Analyt Technol Biomed Life Sci Date: 2021-10-04 Impact factor: 3.318
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