WS/T 505-2017 in English
VALIDGuideline for evaluation of qualitative test performance
- Issued on:2017-09-06
- Implemented on:2018-03-01
- File Format:PDF
- Delivery:Via email within 5 business days
$418.00
本标准规定了定性测定性能的评价方法。本标准描述的定性测定仅限于只有两种检测结果（例如：阳性/阴性、有反应的/无反应的）的方法。对于结果报告为阴性、+1、+2、+3、+4或滴度的半定量方法，本标准所涉及的精密度和方法学比较试验仅可用于其临界值。
本标准适用于开展各种类型定性检测的实验室，以及需对定性诊断试剂盒检测性能进行研究或描述的生产厂家、监管机构和实验室检查人员。
Introduction
Analysis of the Standard Framework
| Core Chapters | Key Technical Points | Clinical Application |
|---|---|---|
| Definition of Terms | Clarification of 23 key terms such as sensitivity, specificity, and Cut-off value | Unification of laboratory reporting standards |
| Evaluation Methods | ROC Curve Analysis, C5-C95 Interval Validation Method | Test System Performance Verification |
| Quality Control | ±20% Deviation Acceptance Criteria | Establishment of daily quality control rules |
Key technical requirements
C5-C95 interval validation case
Taking HBsAg detection as an example, when the Cut-off value is set to 0.05IU/mL:
- The C50±20% interval (0.04-0.06IU/mL) must meet a ≥90% compliance rate
- Samples outside the interval should be clearly distinguished as positive or negative
Implementation recommendations
Laboratory application path
- Establish a library of 40 positive and negative control samples
- Use a 2×2 table to verify consistency with the gold standard
- Perform ROC curve analysis regularly (recommended every 6 months)
Special note: When the PPV/NPV difference is greater than 10%, the detection system needs to be recalibrated
Technology evolution analysis
This standard integrates the requirements of NCCLS EP12-A2 and proposes for the first time:
- Dual verification mechanism for diagnostic accuracy (gold standard + clinical samples)
- Statistical verification method based on confidence interval
- Acceptable range of quantitative indicators (e.g., sensitivity ≥85%)
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