T/CAME 38-2021 in English

VALID

Performance validation of nucleic acid testing in blood screening

Issued on:2021-07-15
Implemented on:-
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $100.00
$97.00

Standard No:	T/CAME 38-2021
Document status:	VALID
Title in English:	Performance validation of nucleic acid testing in blood screening
Title in Chinese:	血液筛查核酸检测的性能验证
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2021-07-15
ICS Classification:	11.100-Laboratory medicine
Chinese Classification:	C44-Medical laboratory equipment
Professional Classification:	T/-Social Organization Standard
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本文件规定了血液筛查核酸检测的性能验证涉及的验证要求和验证方法。
本文件适用于采供血机构、医疗机构、疾控中心等核酸检测实验室使用。
注：本文件中血液筛查核酸检测主要指经输血传播感染病原体的核酸筛查与检测。

Introduction

Analysis of core requirements of the standard

Verification items	Technical indicators	Experimental design	Qualification criteria
Detection limit	1 times LOD concentration	20 repeated tests	≥19 positive times
Genotype coverage	3 times LOD concentration	20 genotype tests	100% detection rate
Repeatability	3 times LOD concentration	20 tests in 5 days	100% positive

Detailed explanation of key technical indicators

1. Detection limit verification

The standard requires the use of 1 times LOD concentration standard material for testing, and verification through 20 repeated experiments (6 times a day × 3 days + 2 times), and the positive detection rate must be ≥95% (19/20). This requirement is more stringent than the CLSI EP17-A guideline and reflects the high standard of blood transfusion safety.

2. Genotype coverage requirements

For the main HBV/HCV/HIV genotypes prevalent in my country (see Table 1), the standard specifically emphasizes the need to verify the detection capabilities of HBV type B/C, HCV type 1/2, and recombinant strains. The experimental design requires the use of samples with a concentration of 3 times the LOD for 20 consecutive tests to ensure that there are no genotype-dependent missed detections.

Implementation recommendations

Laboratory preparation phase

Establish a standard material traceability system to ensure accurate LOD concentration calibration
Prepare a verification panel containing interfering substances such as free hemoglobin (≥500mg/dL) and triglycerides (≥3000mg/dL)

Verification process control

It is recommended to adopt a modular verification solution:

Phase	Critical Control Point	Quality Control Requirements
Preliminary experiment	LOD confirmation	CV≤15%
Formal verification	Batch-to-batch consistency	ΔCt≤2.0

Standard evolution analysis

Compared with the 2019 version of the "Technical Operating Procedures for Blood Stations", the innovations of this standard are:

Added the verification requirement of genotype coverage to respond to the current prevalence of multiple genotypes in my country
Increased the number of samples for contamination detection from 10 to 100 (5 rounds × 20 cases)
Clearly defined the critical concentration threshold

More samples: DL/T 5154-2012 JC/T 2453-2018 QC/T 942-2021

Sample only — not a preview of T/CAME 38-2021

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