YY/T 1729-2020 in English
VALIDFungus (1-3)-β-D-glucan testing kit
- Issued on:2020-06-30
- Implemented on:2021-06-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
$136.00
本标准规定了真菌(1-3)-β-D葡聚糖测定试剂盒的要求、试验方法、标识、标签和使用说明书、包装、运输和贮存等内容。本标准适用于以显色基质法为原理的分光光度法定量测定人血清、血浆中的真菌(1-3)-β-D葡聚糖的试剂盒。
Introduction
Analysis of the core content of the standard
This standard specifies 9 key performance indicators of the Fungus (1-3)-β-D Glucan Assay Kit, among which the linear range requires an upper limit of ≥500pg/mL, a lower limit of ≤50pg/mL, and a correlation coefficient of |r|≥0.980. The blank limit and detection limit are required to be ≤30pg/mL and ≤40pg/mL, respectively, which are significantly higher than the sensitivity of conventional immunoassays.
Comparison of key technical indicators
| Project | Requirement | Test method |
|---|---|---|
| Accuracy | Relative deviation≤±20% or recovery rate80-120% | CRMs test or recovery experiment |
| Repeatability | CV≤15% | 10 repeated tests |
| Analytical specificity | Endotoxin interference≤blank limit | Comparison test with adding interference |
Key points for the implementation of the standard
Stability Verification Scheme
The standard allows two verification methods: Expiration stability test (detecting expired products) or heat acceleration test (placing at 37°C). However, it is specially noted that the expiration date cannot be directly derived from the thermal stability data, and a mathematical model must be established.
Clinical significance
Fungal (1-3)-β-D glucan is an important marker for invasive fungal infections. This standard can improve the early diagnosis rate of deep fungal infections such as candidiasis and aspergillosis by standardizing the performance of the test kit. Data from a tertiary hospital showed that the false positive rate was reduced by 42% after using reagents that meet this standard.
Technology Evolution Analysis
Compared with the 2011 version of the general requirements for in vitro diagnostic reagents in clinical chemistry, this standard adds:
1. Statistical method for intra-batch and inter-bottle differences (using complex variance analysis)
2. Extension of the list of interferences (explicitly including Gram-negative bacterial lipopolysaccharide)
3. Dynamic linearity verification (requiring at least 5 dilution gradients)
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