WS/T 513-2016 in English

The WS/T 513-2016 standard was issued by the former National Health and Family Planning Commission, which standardizes the laboratory diagnosis process and clinical judgment criteria for genital Chlamydia trachomatis infection and is applicable to medical institutions at all levels. The standard clearly divides diagnosis into two categories: confirmed diagnosis and asymptomatic infection, and for the first time includes nucleic acid testing as a basis for diagnosis.

1. Specimen collection standards

• Male urethral swab: insert 2-4cm and rotate for collection
• Female cervical swab: avoid the vaginal wall and obtain columnar epithelial cells
• Urine specimen: collect first urine in the morning or 15mL after 2-4 hours of abstinence

2. Laboratory diagnosis

1. Initial screening: rapid antigen test (outpatient point-of-care test)
2. Confirmation: nucleic acid test or cell culture
3. Efficacy evaluation: it is recommended to use the same test method for before-and-after comparison

Pregnant women

Cervical cell brush sampling is prohibited, and it is recommended to use nucleic acid test to avoid false negatives. Studies have shown that infection during pregnancy may increase the risk of premature birth by 2-3 times.

Asymptomatic infection

Can be diagnosed if any of the following is met:

• Positive nucleic acid test
• Repeated positive antigen test
• Positive cell culture

Grading of medical institutions

Testing process optimization

It is recommended to adopt a "initial screening-confirmation" two-stage testing strategy:

1. Initial screening positive samples need to be reviewed using different principles and methods
2. The critical value results of nucleic acid testing should be repeated
3. Establish specimen storage specifications (4℃≤24h, -20℃ long-term)