YY/T 1237-2014Diagnostic kit for IgG antibody to Toxoplasma (ELISA) (English PDF)
弓形虫IgG抗体检测试剂(盒)（酶联免疫法）
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
June 17, 2014
Implementation date
July 1, 2015
Scope
YY/T 1237-2014 is the English-translated version of 弓形虫IgG抗体检测试剂(盒)（酶联免疫法）.
YY/T 1237-2014 is the Chinese pharmaceutical industry standard for the diagnostic kit that detects IgG antibody to Toxoplasma gondii by enzyme-linked immunosorbent assay.
It sets the requirements for the kit, the test methods, and the rules for marking, labelling, instructions for use, packaging, transport and storage.
The requirements cover the appearance of the kit, the negative and positive rates obtained on national or standardised reference sera, a minimum detection limit no higher than 5 IU/mL, precision and stability.
It applies to ELISA kits used to detect Toxoplasma IgG antibody in human serum and plasma. Issued on 17 June 2014, it has applied since 1 July 2015.
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Document preview — YY/T 1237-2014
National Standard of the People's Republic of China
- ICS
- 11.100
- Classification
- C 44
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Requirements
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
1 Scope
This standard specifies the Toxoplasma IgG antibody detection reagent (box) (enzyme-linked immunosorbent assay) requirements, test methods, marking, labeling, the use of said Specification, packaging, transportation and storage.
This standard applies to legal ELISA detection in human serum, plasma Toxoplasma IgG antibody detection reagent (box).
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 191 Packaging - Pictorial signs
3 Requirements
3.1 Appearance
The kit should look neat, text and clearly labeled, the liquid component should be clarified.
3.2 Reference product meets the negative rate
For examination by national reference or with standardized reference sera should meet the requirements.
3.3 Reference product meets the positive rate
For examination by national reference or with standardized reference sera should meet the requirements.
3.4 The minimum detection limit
For examination by national reference or with standardized reference sera should be no higher than 5IU/mL.
3.5 Precision
For examination by national reference or with standardized reference sera, CV should be no higher than 15% (n = 10).
3.6 Stability
37 °C for n days [n = product remaining Term (months) ÷ 1.6 (month/day)], the test results shall comply with the requirements of 3.2 to 3.5.
Test Method 4
4.1 Appearance
With normal or corrected vision was observed, the result should meet the requirements of 3.1.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 pages — is available in the English PDF.
Referenced standards
Normative references
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