YY/T 1722-2020 in English

VALID

Prealbumin testing kit (immune turbidity method)

Issued on:2020-06-30
Implemented on:2021-12-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $180.00
$175.00

Standard No:	YY/T 1722-2020
Document status:	VALID
Title in English:	Prealbumin testing kit (immune turbidity method)
Title in Chinese:	前白蛋白测定试剂盒（免疫比浊法）
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2020-06-30
Implemented on:	2021-12-01
ICS Classification:	11.100-Laboratory medicine
Chinese Classification:	C44-Medical laboratory equipment
Professional Classification:	YY-Pharmaceutics
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本标准规定了前白蛋白测定试剂盒（免疫比浊法）的要求、试验方法、标签和使用说明书、包装、运输和贮存。本标准适用于免疫比浊法对人类血清或血浆中的前白蛋白进行定量检测的试剂盒，包括手工和半自动、全自动生化分析仪上使用的试剂。本标准不适用于干化学方法的前白蛋白测定试剂盒。

Introduction

Analysis of the core content of the standard

1. Scope of application

This standard applies to immunoturbidimetric prealbumin detection kits, including manual and automated detection systems. The key performance indicators verification must meet the following requirements:

Verification items	Acceptance criteria	Test concentration range
Linear range	30-550mg/L	Correlation coefficient≥0.990
Precision	CV≤5%	150mg/L±30mg/L
Accuracy	Bias±15%	Reference material verification

2. Key Technical Requirements

2.1 Methodological Validation

The immunoturbidimetric method needs to be validated for the hook effect, and there should be no prozone phenomenon when the sample concentration is ≥1500mg/L. A typical case shows that a certain brand of reagent still maintains a linear response at a high value sample of 2000mg/L.

2.2 Performance indicators

Detection limit : ≤15mg/L (blank mean + 2SD)
Quantification limit : ≤30mg/L (recovery rate 80-120%)
Linear deviation : low concentration range (30-200mg/L) ±20mg/L, high concentration range (200-550mg/L) ±10%

3. Quality control requirements

The standard references CLSI EP series documents to establish a quality control system:

Quality control type	Frequency	Acceptance standard
Intra-batch precision	Each batch of reagents	CV≤5%
Inter-day precision	20 consecutive days	CV≤10%
Calibration verification	Monthly/change batch number	Deviation≤±15%

The implementation case in a tertiary hospital showed that when using 150mg/L and 300mg/L dual-level quality control products, the monthly CV was controlled within the range of 3.2-4.8%.

4. Implementation Suggestions

4.1 Standardized Operations

It is recommended to establish an SOP that includes the following elements:

Sample processing specifications (centrifugation conditions, storage temperature)
Calibrator traceability path (use of CRM standard materials)
Interferent management (bilirubin ≤20mg/dL, hemoglobin ≤500mg/dL)

4.2 Methodological Comparison

When accepting new reagents, a comparison test of 40 clinical samples should be carried out, with the following requirements:

Correlation coefficient r≥0.975
Deviation in the low concentration segment ≤20mg/L
Deviation in the high concentration segment ≤10%

5. Analysis of Standard Evolution

Main improvements compared to the 2015 version:

Project	2015 version	2020 version
Linearity verification	5 concentration points	7 concentration points
Precision requirements	CV≤8%	CV≤5%
Interference test	Unspecified concentration	Specify the critical value of interferents

More samples: GB 50021-2001(2009) GB 18306-2015 NB/T 47013.2-2015

Sample only — not a preview of YY/T 1722-2020

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