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Biostatistics Commons

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Capstone Experience

2020

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Full-Text Articles in Biostatistics

Equivalency Testing For Two Formulations Of A Clinical Laboratory Control Material, Jessica M. Hart May 2020

Equivalency Testing For Two Formulations Of A Clinical Laboratory Control Material, Jessica M. Hart

Capstone Experience

Clinical laboratory control materials are an integral part of legally-mandated and highly regulated quality control protocols in all clinical laboratories. These controls ensure accurate performance of the laboratory testing and instrumentation used to produce medical test results for millions of patients. It is of clinical and public health interest to ensure the diagnostic test results which affect so many people are regulated by the most accurate and precise controls.

Formulation changes in control materials have the potential to impact laboratory quality control. In this study, data from two formulations of a hematology control were compared to assess equivalency of the …