WS 268-2019 in English

VALID

Diagnosis for gonorrhoea

Issued on:2019-01-02
Implemented on:2019-07-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $280.00
$272.00

Standard No:	WS 268-2019
Document status:	VALID
Title in English:	Diagnosis for gonorrhoea
Title in Chinese:	淋病诊断（发布稿）
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2019-01-02
Implemented on:	2019-07-01
Superseding:	WS 268-2007 Diagnostic criteria for Gonorrhea
ICS Classification:	11.020-Medical Sciences and health care facilities in general
Chinese Classification:	C59-
Professional Classification:	WS-Hygiene
Related Keywords:	differential diagnosis chapter multi-scenario differential diagnosis strategy chapter gonococcal nucleic acid detection technology nucleic acid detection method gonorrhoea introduction ws
Related Topics:	semi-quantitative diagnosis Diagnostic Analyzer Pathology Center Diagnosis Southeast diagnostic instrument diagnostic regulations Diagnosis Auxiliary Diagnosis Diagnosis Supplementary Diagnosis gonorrhea Pathogen Rapid Diagnosis shower disease diagnosis Diagnostic enzymes Pathological remote diagnosis Supplementary diagnosis automated diagnosis Neisseria gonorrhoeae super gonorrhea Reagent diagnostic peptide Disease diagnosis analysis diagnostic ion Foreign Pathological Diagnosis disease self-diagnosis diagnostic concept Diagnosis Routine Diagnosis Rapid and point-of-care diagnostics p4 Molecular Diagnostics Gonorrhea diagnosis diagnostic meaning Aspiration diagnosis companion diagnostic Pathological diagnosis of dermatopathic lymphadenitis Diagnosis of hyponatremic encephalopathy Kikuchi disease diagnosis

本标准规定了淋病的诊断依据、诊断原则、诊断和鉴别诊断。
本标准适用于全国各级各类医疗卫生机构及其医务人员对淋病的诊断。

Introduction

WS 268-2019 core update interpretation

Compared with the 2007 version, the 2019 version of the standard has undergone 5 major revisions: adding a new term definition system, improving the description of clinical manifestations, introducing gonococcal nucleic acid detection technology, reconstructing the diagnostic judgment criteria, and adding a differential diagnosis chapter. The addition of the nucleic acid detection method has increased the diagnostic sensitivity to more than 95%.

Comparison of diagnostic criteria frameworks

Dimensions	WS 268-2007	WS 268-2019
Laboratory methods	Smear staining + culture only	Add nucleic acid testing (Appendix B)
Case determination	4-level classification system	Simplified to 2 categories: suspected/confirmed
Specimen type	Mainly urogenital tract	Expanded to pharyngeal swabs, conjunctiva, etc.

Key technology implementation points

Nucleic acid detection operation specifications

According to the requirements of Appendix B, the fluorescence quantitative PCR instrument must meet the following requirements:

Amplification efficiency ≥ 90%
Lower limit of detection ≤ 50 copies/reaction
Intra-batch coefficient of variation < 5%

Attention should be paid when handling clinical samples: Urine specimens should be stored at 4°C for no more than 24 hours, and throat swabs should be stored in a matching inactivated preservation solution.

Multi-scenario differential diagnosis strategy

Chapter 6 of the standard clearly states that it needs to be differentiated from four types of diseases:

Chlamydia trachomatis infection: longer incubation period (1-3 weeks), urethral secretions are serous
Candidal vaginitis: characteristic tofu-like leucorrhea, microscopic examination shows pseudohyphae
Trichomonia vaginitis: foamy secretions, pH＞4.5
Bacterial vaginosis: positive amine test, clue cells＞20%

Special populations should pay attention: In case of neonatal ophthalmia, cervical secretions of the mother should be collected at the same time for parallel testing.

Clinical implementation recommendations

1. Standardized specimen collection: For males, the urethral swab should be inserted to a depth of 2-3 cm and rotated for 5-10 seconds; for females, cervical sampling should be avoided during the menstrual period
2. Methodological selection: