title: Reproducibility and specificity concerns associated with nucleic acid amplification tests for detecting Chlamydia trachomatis.
abstract: Commercial nucleic acid amplification tests (NAATs) have become one of the most frequently used tests for detecting Chalmydia trachomatis. However, published studies have raised important concerns regarding the NAAT evaluation process in general and their reproducibility and clinical specificity in particular. This is because for many infectious diseases including chlamydia, a true gold standard simply does not exist and, as a result, estimation of test performance parameters in the absence of a gold standard is a difficult and challenging task. In this manuscript, we will attempt to address some issues pertaining to the evaluation of NAATs including NAAT reproducibility, test validity, and the manner in which positive NAAT results are confirmed. Finally, we will discuss some of the potential clinical and public health implications of testing by NAATs.
authors.affiliation: Division of STD Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA. ahadgu@cdc.gov
authors.forename: A
authors.initials: A
authors.lastname: Hadgu
authors.forename: M
authors.initials: M
authors.lastname: Sternberg
mesh_terms: D002690:Chlamydia Infections / Q000175:diagnosis*; D002692:Chlamydia trachomatis / Q000235:genetics / Q000302:isolation & purification*; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D021141:Nucleic Acid Amplification Techniques / Q000379:methods*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity