Performance of the NG OligoGen kit for the diagnosis of Neisseria gonorrhoeae: comparison with cobas 4800 assay.
PCR assays are nowadays between the most sensitive and reliable methods for screening and diagnosing sexually transmitted infections (STIs). The aim of this study was to analyze the reliability, accuracy, and usefulness of the new NG OligoGen kit in comparison with the cobas 4800 assay for the detection of Neisseria gonorrhoeae in clinical samples. A prospective study was designed for detection of N. gonorrhoeae including urine samples (n=152), rectal (n=80), endocervical (n=67), pharyngeal (n=41), and urethral swabs (n=5) that were sent from a regional STI clinic in Seville, Spain. Samples were collected from 255 (73.9%) men and 90 women. Sensitivity, specificity, positive and negative predicative values, and kappa value for N. gonorrhoeae detection using the NG OligoGen kit were 99.6%, 100%, 100%, 99.1%, and 0.99, respectively. Statistical data obtained in this study confirm the usefulness and reliable results of this new assay.
Unit of Infectious Disease and Clinical Microbiology, Valme University Hospital, Seville, Spain. Electronic address: manuel.parra.exts@juntadeandalucia.es.
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Parra-Sánchez
Unit of Infectious Disease and Clinical Microbiology, Valme University Hospital, Seville, Spain. Electronic address: sylvyes_@hotmail.com.
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García-Rey
Operon Inmuno & Molecular Diagnostics, Cuarte de Huerva, Zaragoza, Spain. Electronic address: a.marcuello@operon.es.
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Marcuello
Unit of Infectious Disease and Clinical Microbiology, Valme University Hospital, Seville, Spain. Electronic address: natilespa@gmail.com.
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Zakariya-Yousef
Unit of Infectious Disease and Clinical Microbiology, Valme University Hospital, Seville, Spain. Electronic address: samuel.bernal.sspa@juntadeandalucia.es.
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Bernal
Center of Sexually Transmitted Infections of Seville, Seville, Spain. Electronic address: isabel.pueyo.sspa@juntadeandalucia.es.
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Pueyo
Unit of Infectious Disease and Clinical Microbiology, Valme University Hospital, Seville, Spain. Electronic address: estrella.martin.sspa@juntadeandalucia.es.
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Martín-Mazuelos
Unit of Infectious Disease and Clinical Microbiology, Valme University Hospital, Seville, Spain. Electronic address: jcpalomares@us.es.
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Palomares
D000328:Adult; D001431:Bacteriological Techniques / Q000379:methods*; D005260:Female; D006069:Gonorrhea / Q000175:diagnosis*; D006801:Humans; D008297:Male; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D009344:Neisseria gonorrhoeae / Q000235:genetics / Q000302:isolation & purification*; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D013030:Spain
Diagnostic test; Neisseria gonorrhoeae; Sexually transmitted infections; Urine