title: Evaluation of six nucleic acid amplification tests used for diagnosis of Neisseria gonorrhoeae in Russia compared with an international strictly validated real-time porA pseudogene polymerase chain reaction.
abstract: BACKGROUND
  In Russia, laboratory diagnosis of gonorrhoea has been mainly based on microscopy only and, in some settings, relatively rare suboptimal culturing. In recent years, Russian developed and manufactured nucleic acid amplification tests (NAAT) have been implemented for routine diagnosis of Neisseria gonorrhoeae. However, these NAATs have never been validated to any international well-recognized diagnostic NAAT.
  
  
  OBJECTIVE
  This study aims to evaluate the performance characteristics of six Russian NAATs for N. gonorrhoeae diagnostics.
  
  
  METHODS
  In total, 496 symptomatic patients were included. Five polymerase chain reaction (PCR) assays and one real-time nucleic acid sequence based amplification (NASBA) assay, developed by three Russian companies, were evaluated on urogenital samples, i.e. cervical and first voided urine (FVU) samples from females (n = 319), urethral and FVU samples from males (n = 127), and extragenital samples, i.e. rectal and pharyngeal samples, from 50 additional female patients with suspicion of gonorrhoea. As reference method, an international strictly validated real-time porA pseudogene PCR was applied.
  
  
  RESULTS
  The prevalence of N. gonorrhoeae was 2.7% and 16% among the patients providing urogenital and extragenital samples, respectively. The Russian NAATs and the reference method displayed high level of concordance (99.4-100%). The sensitivities, specificities, positive predictive values and negative predictive values of the Russian tests in different specimens were 66.7-100%, 100%, 100%, and 99.4-100%, respectively.
  
  
  CONCLUSIONS
  Russian N. gonorrhoeae diagnostic NAATs comprise relatively good performance characteristics. However, larger studies are crucial and, beneficially, the Russian assays should also be evaluated to other international highly sensitive and specific, and ideally Food and Drug Administration approved, NAATs such as Aptima Combo 2 (Gen-Probe).
authors.affiliation: Laboratory of Microbiology, D.O. Ott Research Institute of Obstetrics and Gynaecology, St. Petersburg, Russia.
authors.forename: E
authors.initials: E
authors.lastname: Shipitsyna
authors.forename: E
authors.initials: E
authors.lastname: Zolotoverkhaya
authors.forename: S O
authors.initials: SO
authors.lastname: Hjelmevoll
authors.forename: A
authors.initials: A
authors.lastname: Maximova
authors.forename: A
authors.initials: A
authors.lastname: Savicheva
authors.forename: E
authors.initials: E
authors.lastname: Sokolovsky
authors.forename: V
authors.initials: V
authors.lastname: Skogen
authors.forename: M
authors.initials: M
authors.lastname: Domeika
authors.forename: M
authors.initials: M
authors.lastname: Unemo
mesh_terms: D000293:Adolescent; D000328:Adult; D005260:Female; D006069:Gonorrhea / Q000175:diagnosis* / Q000382:microbiology; D006801:Humans; D008297:Male; D009344:Neisseria gonorrhoeae / Q000235:genetics*; D021141:Nucleic Acid Amplification Techniques / Q000379:methods*; D016133:Polymerase Chain Reaction / Q000379:methods*; D018272:Porins / Q000235:genetics*; D011544:Pseudogenes; D012426:Russia; D012680:Sensitivity and Specificity; D055815:Young Adult
chemical_list: D018272:Porins; C057699:porin protein, Neisseria