Quality assessment for STI laboratory-based diagnostics
Syphilis and gonorrhoea are common sexually transmitted infections (STIs). Early detection and accurate diagnosis are critical for controlling their spread and ensuring effective treatment. External quality assessment (EQA), including proficiency testing, play vital roles in ensuring that laboratories maintain high standards of accuracy in diagnosing these infections. EQA uses methods to objectively check the laboratory’s performance using a qualified external facility. Proficiency testing is part of EQA focusing on the personnel’s ability to perform tests correctly. By participating in quality assessment programmes, laboratories and health-care workers contribute to the global effort to improve STI diagnosis, monitor antimicrobial resistance and safeguard public health.
Neisseria gonorrhoeae culture: WHO-supported external quality assessment
A set of 15 coded cultures are provided to reference laboratories in countries by a WHO collaborating centre for antimicrobial susceptibility testing. Recommended frequency of EQA is twice a year in the first year and annually in subsequent years (if recommended based on previous performance). These cultures include strains representing both susceptible and resistant N. gonorrhoeae isolates. Laboratories must return results by a specified date, and feedback is given within 60 days. If testing discrepancies are found (less than 80% agreement with the modal minimum inhibitory concentration), the laboratory is notified and required to address the issues. If two consecutive unsatisfactory assessments occur, higher oversight from ministries of health and WHO can be implemented, and corrective actions should be reported within 30 days. In cases of continued issues, additional testing sets may be provided, with a troubleshooting approach tailored to specific difficulties.
For more information on the EQA programmes or to apply, please write to hiv-aids@who.int.
Syphilis Serology Proficiency Programme
Proficiency testing is important because it is a means of verifying the accuracy and reliability of laboratory testing. Quality control measures in syphilis serology are designed to ensure that reliable and reproducible test results are obtained within a laboratory and among different laboratories performing the same tests. The Syphilis Serology Proficiency Programme measures the proficiency of participating laboratories in performing the various non-treponemal and treponemal tests used in the diagnosis of syphilis. Data from a survey completed by the participating laboratories are used to improve the services provided to users worldwide.
How to apply?
Criteria for entry
- the participating laboratory must be a National Reference Laboratory or a designated laboratory by the Ministry of Health;
- complete an application form;
- provide current and detailed syphilis testing algorithm(s) used in-country;
- provide manufacturer package inserts for syphilis tests used on biological samples;
- provide point of contact, valid physical mailing address (not P.O. box), e-mail and telephone number;
- handle biological samples using appropriate biohazard procedures;
- commit to test samples and return quarterly results in a timely manner (via email); and
- provide a copy of a valid import permit (if required by country).
Laboratories which meet these criteria can complete the application form below and send it to syphiliswhopt@cdc.gov. They will be notified if they meet the criteria to participate in the programme.
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Application form (PDF, 309 kB)
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Instructions (PDF, 39 kB)
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Results form (PDF, 329 kB)
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Interpreting your scores (PDF, 120 kB)
How does the programme work?
Participating laboratories will receive a panel of samples 3 times a year. Results are sent back to the WHO Collaborating Centre for STD Diagnostics and Surveillance in Atlanta, United States of America.
Results
Participating laboratories’ results are due 4 weeks after the sample ship date. Reports are graded and returned within 2 weeks.
Grading
To determine the relative efficiency of each laboratory's performance of a testing procedure as compared to the performance of the same procedure by reference laboratories, three reference laboratories in the United States of America are used:
- Georgia Public Health Laboratory;
- Texas Department of State Health Services; and
- Division of STD Prevention, Laboratory Reference and Research Branch at the Centers for Disease Control and Prevention in Atlanta, Georgia.
Criteria for acceptable performance
- ≥80% agreement with results of reference laboratories on individual samples;
- filling out results form completely: 5%; and
- returning results by cut-off date: 5%.
Criteria for removal from programme
- failure to submit at least 2 reports in a calendar year; and
- returned packages and laboratory doesn’t notify the WHO Collaborating Centre of non-receipt.
Reporting of results
Performance results for all participating laboratories will be reported using a confidential laboratory code.
For more information related to this programme, please write to syphiliswhopt@cdc.gov.