T/HBAS 005-2023 Active Group standards

T/HBAS 005-2023 Enzyme-linked Immunosorbent Assay (ELISA) Kit with Fill-in Core Material

Publish Date: 2023-06-08 Implement Date: 2023-07-08 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/HBAS 005-2023

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Medicine, health, and labor protection

ICS Name: Laboratory medicine

Publish Date: 2023-06-08

Implement Date: 2023-07-08

Scope

Scope: This document specifies the terms and definitions, composition, technical requirements, and detection requirements for sandwich enzyme-linked immunosorbent assay (ELISA) kits. This document is applicable to sandwich ELISA kits. Main technical content: This project aims to conduct overall quantitative control of the main performance of sandwich ELISA kits for scientific research. Generally, there are quantitative detection kits and qualitative detection kits. The standard performance of quantitative detection kits includes appearance, linearity and range of the standard curve, precision, accuracy, sensitivity, and stability; the standard performance of qualitative detection kits includes appearance, compliance rate with positive reference samples, compliance rate with negative reference samples, minimum detection limit, repeatability, precision, and stability. Not only are performance requirements standardized, but the detection methods for performance are also standardized. Currently, in China, there are only national standards for clinical ELISA kits, and there are no corresponding national or industry standards for ELISA kits used in scientific research. Most manufacturers generally have their own internal standards, and it is difficult to compare the performance of kits from different manufacturers.