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First evaluation of six nucleic acid amplification tests widely used in the diagnosis of Chlamydia trachomatis in Russia. 2009

E Shipitsyna, and E Zolotoverkhaya, and I Agné-Stadling, and A Krysanova, and A Savicheva, and E Sokolovsky, and M Domeika, and M Unemo
Laboratory of Microbiology, D.O. Ott Research Institute of Obstetrics and Gynaecology, St. Petersburg, 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.

UI MeSH Term Description Entries
D008297 Male Males
D011237 Predictive Value of Tests In screening and diagnostic tests, the probability that a person with a positive test is a true positive (i.e., has the disease), is referred to as the predictive value of a positive test; whereas, the predictive value of a negative test is the probability that the person with a negative test does not have the disease. Predictive value is related to the sensitivity and specificity of the test. Negative Predictive Value,Positive Predictive Value,Predictive Value Of Test,Predictive Values Of Tests,Negative Predictive Values,Positive Predictive Values,Predictive Value, Negative,Predictive Value, Positive
D002690 Chlamydia Infections Infections with bacteria of the genus CHLAMYDIA. Infections, Chlamydia,Chlamydia Infection,Infection, Chlamydia
D002692 Chlamydia trachomatis Type species of CHLAMYDIA causing a variety of ocular and urogenital diseases.
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D012426 Russia A country located in north Asia bordering the Arctic Ocean, extending from Europe (the portion west of the Urals) to the North Pacific Ocean. The capital is Moscow. Russian S.F.S.R.,Russian Federation (Europe),Russian SFSR
D012680 Sensitivity and Specificity Binary classification measures to assess test results. Sensitivity or recall rate is the proportion of true positives. Specificity is the probability of correctly determining the absence of a condition. (From Last, Dictionary of Epidemiology, 2d ed) Specificity,Sensitivity,Specificity and Sensitivity
D016133 Polymerase Chain Reaction In vitro method for producing large amounts of specific DNA or RNA fragments of defined length and sequence from small amounts of short oligonucleotide flanking sequences (primers). The essential steps include thermal denaturation of the double-stranded target molecules, annealing of the primers to their complementary sequences, and extension of the annealed primers by enzymatic synthesis with DNA polymerase. The reaction is efficient, specific, and extremely sensitive. Uses for the reaction include disease diagnosis, detection of difficult-to-isolate pathogens, mutation analysis, genetic testing, DNA sequencing, and analyzing evolutionary relationships. Anchored PCR,Inverse PCR,Nested PCR,PCR,Anchored Polymerase Chain Reaction,Inverse Polymerase Chain Reaction,Nested Polymerase Chain Reaction,PCR, Anchored,PCR, Inverse,PCR, Nested,Polymerase Chain Reactions,Reaction, Polymerase Chain,Reactions, Polymerase Chain
D021141 Nucleic Acid Amplification Techniques Laboratory techniques that involve the in-vitro synthesis of many copies of DNA or RNA from one original template. DNA Amplification Technic,DNA Amplification Technique,DNA Amplification Techniques,Nucleic Acid Amplification Technic,Nucleic Acid Amplification Technique,RNA Amplification Technic,RNA Amplification Technique,RNA Amplification Techniques,Amplification Technics, Nucleic Acid,Amplification Techniques, Nucleic Acid,DNA Amplification Technics,Nucleic Acid Amplification Technics,Nucleic Acid Amplification Test,Nucleic Acid Amplification Tests,RNA Amplification Technics,Technics, Nucleic Acid Amplification,Techniques, Nucleic Acid Amplification,Amplification Technic, DNA,Amplification Technic, RNA,Amplification Technics, DNA,Amplification Technics, RNA,Amplification Technique, DNA,Amplification Technique, RNA,Amplification Techniques, DNA,Amplification Techniques, RNA,Technic, DNA Amplification,Technic, RNA Amplification,Technics, DNA Amplification,Technics, RNA Amplification,Technique, DNA Amplification,Technique, RNA Amplification,Techniques, DNA Amplification,Techniques, RNA Amplification

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