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.
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.
Authors: Koen D Quint; Daan T Geraets; Henk A M van den Munckhof; Maurits N C de Koning; Vitaly Smelov; Willem J G Melchers; Henry J C de Vries; Servaas A Morré; Chris J M Meijer; Dirk C J G van Alewijk; Leen-Jan van Doorn; Wim G V Quint Journal: J Mol Diagn Date: 2011-03 Impact factor: 5.568
Authors: C A Pace; D Lioznov; D M Cheng; S E Wakeman; A Raj; A Y Walley; S M Coleman; C Bridden; E Krupitsky; J H Samet Journal: Int J STD AIDS Date: 2012-12 Impact factor: 1.359
Authors: Valentina Feodorova; Edgar Sultanakhmedov; Yury Saltykov; Sergey Zaitsev; Sergey Utz; Michael Corbel; Charlotte Gaydos; Thomas Quinn; Vladimir Motin Journal: Open Microbiol J Date: 2018-10-18