With the development of laboratory methods and clinical medicine, accurately detecting and reporting the value of samples with a low concentration or amounts of an analyte with interest has become important. Therefore, establishing and evaluating the detection capabilities that maximally satisfy both medical needs and the criteria for uncertainty is essential in evaluating the performance of laboratory methods as well as in vitro diagnostic medical devices. The detection capabilities can be divided into three categories: limit of blank (LoB), limit of detection (LoD), and limit of quantitation (LoQ). Although Clinical Laboratory Standards Institute EP17, a practical guideline for detection capabilities, is provided, many laboratories have not applied it in practice. Therefore, this review article aims to provide practical help to domestic clinical pathologists, residents, medical technologists, and related industry workers by presenting basic concepts and explanations for validating and verifying the detection capabilities and easily describing them in practical terms through some examples. This review deals with the definitions and concepts related to detection capabilities, and LoB, LoD, and LoQ validation and verification process. This review is expected to improve the quality of diagnostic tests in Korea by expanding the understanding of the detection capabilities in each clinical laboratory and related industry and establishing and evaluating them through these established protocols.

Detection capability, Limit of blank, Limit of detection, Limit of quantitation, Validation, Verification