WS/T 360-2024 in English

VALID

Guideline for enumeration of peripheral blood lymphocyte subsets by flow cytometry

Issued on:2024-04-02
Implemented on:2024-09-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $250.00
$243.00

Standard No:	WS/T 360-2024
Document status:	VALID
Title in English:	Guideline for enumeration of peripheral blood lymphocyte subsets by flow cytometry
Title in Chinese:	流式细胞术检测外周血淋巴细胞亚群指南
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2024-04-02
Implemented on:	2024-09-01
Superseding:	WS/T 360-2011 Guidelines for peripheral lymphocyte subsets by flow cytometry
ICS Classification:	11.020-Medical Sciences and health care facilities in general
Chinese Classification:	C50-Sanitation in general
Professional Classification:	WS-Hygiene
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本标准规定了流式细胞术检测外周血淋巴细胞亚群：T淋巴细胞（包括CD4+T细胞和CD8+T细胞）、B淋巴细胞和NK细胞的技术要求。
本标准适用于医疗机构临床实验室开展流式细胞术检测外周血淋巴细胞亚群。

Introduction

Core changes in the standard revision

Dimensions	2011 Edition	2024 Edition
Technical Solution	Four-color analysis as the main approach	Newly added Six-color analysis solution (Appendix C)
Quality Control Requirements	Basic Performance Verification	Added Flow Cytometer Sensitivity/Linearity Verification (5.1)
Clinical Applicability	Includes a chapter on clinical significance	Focus on technical specifications and delete clinical significance content

Key requirements for detection systems

1. Antibody combination scheme

The standard clearly requires the use of at least CD45 combined with four-color scheme:

Basic combination: CD45/CD3/CD4/CD8 + CD45/CD3/CD19/CD16&56
Six-color upgraded scheme: CD45/CD3/CD4/CD8/CD19/CD16&56 (single tube detection)

2. Instrument performance verification

Parameters	Requirements	Verification frequency
Fluorescence sensitivity	FITC≤200 MESF, PE≤100 MESF	After major maintenance
Channel linearity	r≥0.98	Annual verification
Carryover rate	≤0.5%	When methodology changes

Implementation suggestions

1. Laboratory upgrade path

Methodological transition: Four-color laboratories should gradually establish six-color analysis capabilities
Data comparability: ≥5 sample comparisons are required during the period of parallel use of the new and old methods
Staff training: focus on strengthening class=instrument>Fluorescence compensation and gating strategy training

2. Key points of quality control

Typical case: In the CD4 monitoring of HIV patients in a tertiary hospital, the following methods were adopted:

Two concentration levels of quality control products were run daily
The voltage stability was monitored using the Levy-Jennings plot
The CD4+ absolute value of 200 cells/μL was set as the medical decision level

The detection CV was <8%, which significantly reduced the risk of clinical misjudgment.

Technology Evolution Analysis

This revision reflects three major technological advances:

Popularization of multicolor analysis: Six-color scheme improves the specificity of NK cell detection
Automation integration: Added validation requirements for automatic sample preparation systems (7.1.4)
Standardization improvement: Clarified SI (staining index) calculation formula (3.6)

More samples: JC/T 2453-2018 NB/T 47013.2-2015 YD/T 3934-2021

Sample only — not a preview of WS/T 360-2024

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