title: Comparison of microscopy, culture and in-house PCR and NASBA assays for diagnosis of Neisseria gonorrhoeae in Russia.
abstract: This study aimed to assess the laboratory diagnosis of Neisseria gonorrhoeae in St. Petersburg, Russia. In total, 334 consecutive symptomatic patients were enrolled. Cervical and urethral specimens from women (n=286) and urethral specimens from men (n=48) were analyzed by microscopy, culture and two in-house NAATs, i.e. polymerase chain reaction (PCR) and nucleic acid sequence-based amplification (NASBA), developed in Russia. All N. gonorrhoeae-positive samples were confirmed using porA pseudogene and 16S rRNA gene sequencing. All methods displayed 100% specificity, i.e. positive predictive values of 100%. Compared to the PCR (most sensitive method in the present study), in women the sensitivity of both microscopy and culture was 31.8%, and that of NASBA was 90.9%. In men, microscopy, culture and NASBA displayed a sensitivity of 75%, 50% and 100%, respectively. The negative predictive values of microscopy, culture, and NASBA were 97.3%, 97.3%, and 99.6% in women, and 97.8%, 95.7%, and 100% in men, respectively. According to the PCR, the prevalences of N. gonorrhoeae were 4.5% (women) and 8.3% (men). In conclusion, both the investigated Russian NAATs displayed a high sensitivity and specificity. However, in general the diagnosis of gonorrhoea in Russia is suboptimal and crucially requires validation, improvements and quality assurance.
authors.affiliation: D O Ott Research Institute of Obstetrics and Gynecology, St. Petersburg, Russia.
authors.forename: Elena
authors.initials: E
authors.lastname: Shipitsyna
authors.forename: Alexander
authors.initials: A
authors.lastname: Guschin
authors.forename: Anna
authors.initials: A
authors.lastname: Maximova
authors.forename: Mariya
authors.initials: M
authors.lastname: Tseslyuk
authors.forename: Alevtina
authors.initials: A
authors.lastname: Savicheva
authors.forename: Evgenij
authors.initials: E
authors.lastname: Sokolovsky
authors.forename: German
authors.initials: G
authors.lastname: Shipulin
authors.forename: Marius
authors.initials: M
authors.lastname: Domeika
authors.forename: Magnus
authors.initials: M
authors.lastname: Unemo
mesh_terms: D004269:DNA, Bacterial / Q000737:chemistry / Q000235:genetics; D005260:Female; D006069:Gonorrhea / Q000175:diagnosis / Q000453:epidemiology / Q000382:microbiology*; D006801:Humans; D015994:Incidence; D008297:Male; D009344:Neisseria gonorrhoeae / Q000235:genetics / Q000302:isolation & purification*; D016133:Polymerase Chain Reaction; D011237:Predictive Value of Tests; D012336:RNA, Ribosomal, 16S / Q000737:chemistry / Q000235:genetics; D012426:Russia / Q000453:epidemiology; D021161:Self-Sustained Sequence Replication; D012680:Sensitivity and Specificity; D014522:Urethral Diseases / Q000175:diagnosis / Q000453:epidemiology / Q000382:microbiology*; D002577:Uterine Cervical Diseases / Q000175:diagnosis / Q000453:epidemiology / Q000382:microbiology*
chemical_list: D004269:DNA, Bacterial; D012336:RNA, Ribosomal, 16S