Caution Is Required When Using Non-Food and Drug Administration-Cleared Assays to Diagnose Sexually Transmitted Infections in Children

J Pediatr. 2019 Mar;206:280-282. doi: 10.1016/j.jpeds.2018.10.038. Epub 2018 Nov 19.


Nucleic acid amplification testing is the gold-standard for Chlamydia trachomatis and Neisseria gonorrhoeae testing in adults. We present 3 pediatric cases in which testing resulted in probable false-positive results. Clinicians should avoid tests without clearance from a regulatory agency and should maintain consistent communication with laboratories.

Publication types

  • Case Reports

MeSH terms

  • Child
  • Child Abuse, Sexual / diagnosis
  • Child, Preschool
  • Diagnostic Test Approval
  • Female
  • Humans
  • Male
  • Nucleic Acid Amplification Techniques
  • Sensitivity and Specificity
  • Sexually Transmitted Diseases / diagnosis*
  • Sexually Transmitted Diseases / microbiology*