First evaluation of six nucleic acid amplification tests widely used in the diagnosis of Chlamydia trachomatis in Russia
Article first published online: 22 DEC 2008
© 2008 The Authors. Journal compilation © 2008 European Academy of Dermatology and Venereology
Journal of the European Academy of Dermatology and Venereology
Volume 23, Issue 3, pages 268–276, March 2009
How to Cite
Shipitsyna, E., Zolotoverkhaya, E., Agné-Stadling, I., Krysanova, A., Savicheva, A., Sokolovsky, E., Domeika, M. and Unemo, M. (2009), First evaluation of six nucleic acid amplification tests widely used in the diagnosis of Chlamydia trachomatis in Russia. Journal of the European Academy of Dermatology and Venereology, 23: 268–276. doi: 10.1111/j.1468-3083.2008.03038.x
- Issue published online: 9 FEB 2009
- Article first published online: 22 DEC 2008
- Received: 8 March 2008; Accepted 3 July 2008
- Chlamydia trachomatis;
- LightMix 480HT;
- nucleic acid amplification tests (NAATs);
- Roche Cobas Amplicor;
- sensitivity and specificity
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.
Materials and 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.
Conflicts of interest