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Screening Tests To Detect Chlamydia trachomatis and Neisseria gonorrhoeae Infections - 2002

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Summary

Testing Technologies

• Laboratory-Based Tests 
  • Culture
  • Nucleic acid amplification tests (NAATs)
  • Nucleic acid hybridization (DNA probe) tests
  • Nucleic acid genetic transformation test
  • Enzyme immunoassay (EIA) tests
  • Direct fluorescent antibody (DFA) tests
  • Serology
• Point-of-Care Tests
  • C. trachomatis point-of-care tests
  • Gram stain for N. gonorrhoeae

C. trachomatis and N. gonorrhoeae Test Performance When Used for Screening

• C. trachomatis Tests for Screening Women and Men
  • Sensitivity
  • Specificity and positive predictive value
• N. gonorrhoeae Tests for Screening Women and Men 
  • Sensitivity
  • Specificity and positive predictive value

Selecting Screening Tests

• Performance Perspective for Selecting Screening Tests 
  • Screening women for C. trachomatis and N. gonorrhoeae genito-urinary tract infections
  • Screening men for C. trachomatis and N. gonorrhoeae urethral infections
  • Screening women or men with possible rectal or pharyngeal exposure to C. trachomatis or N. gonorrhoeae infection
• Additional Considerations in Selecting a Screening Test
  • Economic analysis
  • Laboratory environment
  • Need for additional testing to support a C. trachomatis or N. gonorrhoeae diagnosis
  • Consideration of point-of-care testing
• Methods to Enhance Performance or Reduce Costs
  • Selective Screening To Increase the Percentage of Positive Tests
  • Gray-Zone Testing To Improve Test Performance
  • Pooling specimens to reduce costs
  • Additional testing to improve test specificity
  • Co-testing for C. trachomatis and N. gonorrhoeae to reduce costs
  • Using LET to Select for C. trachomatis or N. gonorrhoeae Tests

Collecting, Transporting, and Storing Specimens

• Collecting and Transporting Specimens for Screening 
  • Specimen collection recommendations applicable to culture and non-culture tests
  • Specific requirements for C. trachomatis culture
  • Specific requirements for N. gonorrhoeae culture
  • Adequacy of endocervical specimens
• Collecting Specimens for Indications Other than Screening

Laboratory Implementation of NAATs

Test of Cure, Treatment Failure, and Antimicrobial Resistance

Sexual Assault and Sexual Abuse

References

Appendix A - Indications for Chlamydia trachomatis Testing and Test Selection by Specimen Type

Appendix B - Indications for Neisseria gonorrhoeae Testing and Test Selection by Specimen Type

Appendix C - Conducting Studies to Evaluate Chlamydia trachomatis and Neisseria gonorrhoeae Tests, Including Studies Required by the Regulations of the Clinical Laboratory Improvement Amendments of 1988 for Verifying or Establishing Test Performance Characteristics

Appendix D - Recommendations for Transport and Storage of Specimens for Chlamydia trachomatis and Neisseria gonorrhoeae Testing by Testing Procedure Type

Appendix E - Chlamydia trachomatis Screening Recommendations

Appendix F - Characteristics of Neisseria and Related Species of Human Origin

Consultants

 

 

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