YY/T 1817-2022Thyroglobulin testing kit (chemiluminescent immunoassay) (English PDF)
甲状腺球蛋白测定试剂盒(化学发光免疫分析法)
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
May 18, 2022
Implementation date
December 1, 2023
Scope
YY/T 1817-2022 is the English-translated version of 甲状腺球蛋白测定试剂盒(化学发光免疫分析法).
YY/T 1817-2022 is the Chinese pharmaceutical industry standard for the kit that measures thyroglobulin by chemiluminescence immunoassay, the marker followed after treatment for thyroid cancer.
It sets the requirements the kit must meet, the test methods, and the rules for labels, marking, instructions for use, packaging, transport and storage, the requirements covering appearance, traceability of the calibrator, accuracy, linearity, detection limit, precision, the hook effect at high concentrations and stability.
It applies to kits for the quantitative determination of thyroglobulin in human blood, enzymatic or non-enzymatic, on microplates, tubes, magnetic particles, microbeads or plastic beads, used manually or on an analyser. Issued on 18 May 2022, it has applied since 1 December 2023.
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Document preview — YY/T 1817-2022
National Standard of the People's Republic of China
- Classification
- C 44
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Requirements
Foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules of Standardization Documents" drafted.
1 Scope
This document specifies the requirements, test methods, labeling, labeling, instructions for use, packaging, transportation and storage.
This document applies to the assay kit for the quantitative detection of thyroglobulin in human blood based on the principle of chemiluminescence immunoassay, including Including enzymatic and non-enzymatic chemiluminescence immunoassay assay kits using microplates, tubes, magnetic particles, microbeads and plastic beads as carriers, including manual Manual operation method and automatic operation method of instruments.
2 Normative references
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document.
GB/T 191 Graphical signs of packaging, storage and transportation
GB/T 21415 Metrological traceability of measurement calibrators and control substance assignments in biological samples of in vitro diagnostic medical devices origin
GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2: In vitro diagnostic reagents for professional use
3 Terms and Definitions
There are no terms and definitions that need to be defined in this document.
4 Requirements
4.1 Appearance
Manufacturers should specify appropriate appearance requirements according to the packaging characteristics of the product. Generally, the components and properties of the kit should be included; internal and external packaging, labeling Clearly signed and other requirements.
4.2 Traceability
The manufacturer shall provide the source, assignment process and measurement uncertainty of the calibrators used in accordance with GB/T 21415 and related regulations content.
4.3 Linear
Within the linear interval given by the manufacturer (the lower limit is not higher than 2ng/mL, and the upper limit is not lower than.200ng/mL), the correlation coefficient (r) should not be small at 0.9900.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 191Graphical symbols marking for handling and storage of packages
- GB/T 21415In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
- GB/T 29791.2In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 2: In vitro diagnostic reagents for professional use
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Related Standards
GB/T 191-2025 — Graphical symbols marking for handling and storage of packages
GB/T 21415-2008 — In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials
GB/T 21415-2025 — In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
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