MALVERN, PA — The Clinical and Laboratory Standards Institute (CLSI) has published EP12—Evaluation of Qualitative, Binary Output Examination Performance, 3rd Ed. EP12 provides product design guidance and protocols for performance evaluation of the establishment and implementation stages of the Test Life Phases Model of examinations covered in CLSI’s EP19 report—A Framework for Using CLSI Documents to Evaluate Medical Laboratory Test Methods.
EP12 characterizes a target condition (TC) with only two possible outputs (eg, positive or negative, present or absent, reactive or nonreactive). EP12 is written for both manufacturers of qualitative, binary, results-reporting or output examinations (referred to as qualitative, binary examinations throughout) and medical laboratories that create laboratory-developed, binary examinations (both termed developers). These protocols are also intended to help users verify examination performance in their own testing environment.
EP12 includes supplemental information on:
- Determining lower limit of detection for analyte detection, qualitative examinations based on PCR methods.
- Next-generation sequencing precision evaluation.
- Observer precision studies.
“Qualitative, binary output examinations include simple home tests for detecting the COVID-19 virus to complex next-generation sequencing for diagnosing a specific cancer,” said Jeffrey R. Budd, PhD, Chairholder of EP12. “The third edition of CLSI EP12 describes the different types of these tests, how to accurately provide yes/no results for each, and how to assess their analytical and clinical performance. It covers binary, qualitative examinations whether they have an internal continuous response or not. The new standard also describes how to measure reagent stability, assess the effects of interfering substances, and verify performance in the laboratory.”
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