WS/T 235-2016 in English

VALID

Diagnosis of condyloma acuminatum

Issued on:2016-11-29
Implemented on:2017-06-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $160.00
$156.00

Standard No:	WS/T 235-2016
Document status:	VALID
Title in English:	Diagnosis of condyloma acuminatum
Title in Chinese:	尖锐湿疣诊断
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2016-11-29
Implemented on:	2017-06-01
Superseding:	WS 235-2003 Diagnostic criteria and principles of management of condyloma acuminatum
ICS Classification:	11.020-Medical Sciences and health care facilities in general
Chinese Classification:	C59-
Professional Classification:	WS-Hygiene
Related Keywords:	clinical diagnosis cases standard revision revision dimensions acuminatum introduction core changes standard mandatory recommended technical content including treatment principles focus nucleic acid test analysis
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本标准规定了尖锐湿疣的诊断原则、诊断依据、诊断分类和鉴别诊断。
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尖锐湿疣的诊断。

Introduction

Core changes in the standard revision

Revision dimensions	2003 edition	2016 edition
Nature of the standard	Mandatory	Recommended
Technical content	Including treatment principles	Focus on diagnostic technology
Detection method	Acetic acid white test	Newly added HPV nucleic acid test

Analysis of key technical points

1. Diagnostic gold standard system

The standard has established a three-level diagnostic system: clinical diagnosis cases (clinical manifestations + epidemiological history) and confirmed cases (must meet laboratory tests). Among them, the positive rate of HPV nucleic acid test can reach more than 95%, which is significantly better than the traditional acetic acid white test (false positive rate 15-20%).

2. Pathological feature matrix

Histological features	Typical manifestations	Clinical significance
Vacuolated cells	Perinuclear halos or whole cytoplasmic vacuoles	Diagnostic specificity>90%
Papillomatous hyperplasia	Extension and widening of epidermal processes	Need to be combined with other features

Laboratory testing technical specifications

Key points for HPV nucleic acid testing

Based onreal-time fluorescence PCR as an example:

Specimen processing: The scraped material needs to be washed with physiological saline and centrifuged (12,000rpm×5min)
DNA extraction: Heat at 100℃ for 10min to inactivate inhibitors
Quality control requirements: Must include β-globin internal reference gene

Typical problem: About 5% of the samples have PCR inhibition, which needs to be solved by DNA dilution or re-extraction.

Implementation recommendations

Optimization of diagnostic process: It is recommended to first perform HPV typing test, and then select pathological examination
Result interpretation: HPV16/18 positive patients need to be followed up, even if they are asymptomatic
Quality control: Pathological examination should ensure that the slice thickness is ≤4μm