First evaluation of six nucleic acid amplification tests widely used in the diagnosis of Chlamydia trachomatis in Russia.
BACKGROUND
In Russia, nationally developed nucleic acid amplification tests (NAATs), which have never been validated to international commercially available NAATs, are mainly used in the diagnosis of Chlamydia trachomatis infection.


OBJECTIVE
To evaluate the performance characteristics of six NAATs widely used to diagnose C. trachomatis infection in Russia.


METHODS
In total, 446 consecutive symptomatic patients (319 females and 127 males) were included. Five polymerase chain reaction (PCR) assays and one real-time nucleic acid sequence-based amplification (NASBA) assay were evaluated on cervical and vaginal samples from females and on urethral and first voided urine samples from males. As reference methods, the Cobas Amplicor PCR, as the main 'gold standard' method, and LightMix 480HT PCR were used.


RESULTS
The overall prevalence of C. trachomatis infection was 12.6%. The Russian NAATs and the reference methods displayed a high level of concordance (97.9% to 99.2%). In comparison with the reference methods, the sensitivities, specificities, positive predictive values and negative predictive values of the Russian tests in different specimens ranged from 86.1% to 100%, 99.1% to 100%, 92.3% to 100% and 98.2% to 100%, respectively.


CONCLUSIONS
According to the reference methods, C. trachomatis NAATs developed and used in Russia have relatively good performance characteristics for both invasive and non-invasive samples. However, larger studies that include symptomatic and asymptomatic patients as well as genital and extra-genital samples, and in comparison with other internationally well-recognized, validated, and ideally Food and Drug Administration-approved C. trachomatis NAATs performed strictly according to the manufacturer's instructions, need to be conducted.
Shipitsyna
E
E
Laboratory of Microbiology, D.O. Ott Research Institute of Obstetrics and Gynaecology, St. Petersburg, Russia.
Zolotoverkhaya
E
E
Agné-Stadling
I
I
Krysanova
A
A
Savicheva
A
A
Sokolovsky
E
E
Domeika
M
M
Unemo
M
M
D002690:Chlamydia Infections / Q000175:diagnosis* / Q000382:microbiology; D002692:Chlamydia trachomatis / Q000235:genetics / Q000302:isolation & purification*; D005260:Female; D006801:Humans; D008297:Male; D021141:Nucleic Acid Amplification Techniques / Q000379:methods / Q000592:standards*; D016133:Polymerase Chain Reaction; D011237:Predictive Value of Tests; D012426:Russia; D012680:Sensitivity and Specificity