BS ISO 17822:2020 pdf free.In vitro diagnostic test systems – Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens一Laboratory quality practice guide.
BS ISO 17822 This document describes the particular clinical laboratory practice requirements to ensure the quality of detection, identification and quantification of microbial pathogens using nucleic acid amplification tests (NAAT).It is intended for use by laboratories that develop, and/or implement and use, or perform NAAT for medical, research or health-related purposes. This document does not apply to the development of in vitro diagnostic (IVD] medical devices by manufacturers. However, it does include verification and validation of such devices and/or the corresponding processes when implemented and used by the laboratories.
2 Normative references The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 15189, Medical laboratories一Requirements for quality and competence ISO 15190, Medical laboratories一Requirements for safety calibration operation that, under specified conditions, in a first step, established a relation between the quantity values with measurement uncertainties provided by measurement standards and corresponding indications with associated measurement uncertainties and, in second step, uses this information to establish a relation for obtaining a measurement result from an indication Note 1 to entry: according to US Code of Federal Regulations, calibration is a process of testing and adjusting an instrument or test system to establish a correlation between the measurement response and the concentration or amount of the substance that is being measured by the test procedure (modified from 42CFR 493.1218)|20].
[SOURCE: VIM; JCGM 200; 2012]clinical sensitivity diagnostic sensitivity <laboratory medicine> ability of an in vitro diagnostic examination procedure to identify the presence of a target marker associated with a specific disease or condition Note 1 to entry: Also defined as percent positivity in samples (3.44] where the target marker is known to be present. Note 2 to entry: Diagnostic sensitivity is expressed as a percentage (number fraction multiplied by 100), calculated as 100 x the number of true positive values (TP]) divided by the sum of the number of true positive values (TP) plus the number of false negative values (FP), or 100 x TP/(TP + FN]. This calculation is based on a study design where only one sample (3.44) is taken from each subject. Note 3 to entry: The target condition is defined by criteria independent of the examination procedure under consideration. BS ISO 17822 pdf download.