YY/T 1789.5-2023In vitro diagnostic test systems - Performance evaluation method - Part 5: Analytical specificity (English PDF)

1 Scope

This document specifies methods for evaluating the analytical specific performance of in vitro diagnostic test systems:

This document is intended for use by manufacturers in evaluating the analytical specificity of in vitro diagnostic test systems for quantitative testing, based on quantitative measurements and passing

Qualitative in vitro diagnostic test systems (such as enzyme-linked immunosorbent assay for pathogenic microorganism antigens or antibody detection kits) for threshold judgment results

Assay specificity evaluation:

This document does not apply to in vitro diagnostic test systems in which results are reported as nominal and ordinal scales, e:g: for blood cell identification, microbiological

Performance evaluation of in vitro diagnostic test systems for substance identification, nucleic acid sequence identification, and urine particle identification:

This document does not apply to performance verification in medical laboratories, nor does it apply to product type inspection:

2 Normative references

The contents of the following documents constitute the essential provisions of this document through normative references in the text: Among them, dated references

For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to this document:

GB/T 29791:1-2013 Information provided by manufacturers of in vitro diagnostic medical devices (labelling) Part 1: Terms, definitions and common enquiries

YY/T 1441 General Requirements for Performance Evaluation of In Vitro Diagnostic Medical Devices

WS/T 416-2013 Guidelines for interference experiments

3 Terms and Definitions

The following terms and definitions apply to this document:

3:1 interference

System effect of a measurement caused by an influencing quantity which does not itself generate a signal in the measuring system, but which causes a change in the indication increase or decrease:

NOTE: Interference to the measurement results is related to the concept of assay specificity: The more specific a measurement procedure is relative to the other components of the sample, the less susceptible it is to these

Analytical interference of compounds:

[Source: GB/T 29791:1-2013, A:3:2]

3:2

The capability of a measurement system, using a specified measurement procedure, to give measurement results for one or more measurands that are independent of each other and of the received

Any other quantity in the system being measured:

Example: The ability of a measurement system to measure plasma creatinine concentration undisturbed by glucose, uric acid, ketone bodies, or protein concentrations using the alkaline picric acid procedure: