Evaluation of VIASURE Sexually Transmitted Diseases Real Time PCR Detection kit (CerTest Biotec) for the diagnostic of sexually transmitted infections / Evaluación de VIASURE® Sexually Transmitted Diseases Real-Time PCR Detection kit (CerTest Biotec) para el diagnóstico de las infecciones de transmisión sexual

Introduction: Sexually transmitted infections (STIs) are common in our environment, and trends have been increasing in the last few years. Different methods for STIs diagnosis have been applied by microbiology laboratories over years, but real-time PCR has improved this process. Our objective was to evaluate VIASURE Sexually Transmitted Diseases Real-Time PCR Detection kit (CerTestBiotec, S.L.) comparing with the real-time PCR technique used in our laboratory (Allplex™ STI7 Essential Assay, Seegene) which was considered as reference assay. Methods: A total of 948 samples from different sites (vaginal, endocervical, urethral, rectal, pharyngeal swabs and urine samples) were analyzed from July to September 2018. Results: A discordant result was obtained in 4.5% (43 samples). These discrepancies were mainly observed in threshold cycle (Ct) value next to the limit of detection. The k coefficient obtained shows a very high agreement between both methods with k values from 0.92 to 0.99. Conclusions: VIASURE Sexually Transmitted Diseases Real-Time PCR Detection kit provides a very good correlation with Allplex STI7 and therefore, it's a good tool for the diagnostic of STIs. Positive results with Ct value obtained from 35 and low amplification signal should be applied with caution and should be interpreted based on the patient's clinical data.(AU)

Introducción: Las infecciones de transmisión sexual (ITS) son frecuentes en nuestro entorno y con tendencia a aumentar. Las técnicas moleculares han mejorado su diagnóstico aportando sensibilidad y rapidez de resultados. Nuestro objetivo ha sido evaluar el nuevo kit de PCR a tiempo real VIASURE® Sexually Transmitted Diseases (CerTest Biotec, SL) comparándolo con la técnica de PCR a tiempo real empleada en nuestro laboratorio (AllplexTM STI7 Essential Assay, Seegene). Métodos: Se analizaron prospectivamente un total de 948 muestras de diferente localización (exudado vaginal, endocervical, uretral, rectal, faríngeo y orina) recibidas en nuestro laboratorio desde julio hasta septiembre de 2018. Resultados: En el 4,5% (43 muestras) se obtuvo un resultado discordante entre ambas técnicas. Estas discrepancias se observaron principalmente en ciclos próximos al límite de detección. El valor del coeficiente k osciló entre 0,92 a 0,99, mostrando una muy buena correlación entre técnicas. Conclusiones: VIASURE® Sexually Transmitted Diseases Real-Time PCR Detection kit es una buena herramienta para el diagnóstico de las ITS. Muestras con señal de amplificación en ciclos a partir de 35 y baja señal de fluorescencia, deben ser tratados con precaución e interpretarse en función de los datos clínicos del paciente.(AU)

Evaluation of VIASURE Sexually Transmitted Diseases Real Time PCR Detection kit (CerTest Biotec) for the diagnostic of sexually transmitted infections.

INTRODUCTION: Sexually transmitted infections (STIs) are common in our environment, and trends have been increasing in the last few years. Different methods for STIs diagnosis have been applied by microbiology laboratories over years, but real-time PCR has improved this process. Our objective was to evaluate VIASURE Sexually Transmitted Diseases Real-Time PCR Detection kit (CerTestBiotec, S.L.) comparing with the real-time PCR technique used in our laboratory (Allplex™ STI7 Essential Assay, Seegene) which was considered as reference assay. METHODS: A total of 948 samples from different sites (vaginal, endocervical, urethral, rectal, pharyngeal swabs and urine samples) were analyzed from July to September 2018. RESULTS: A discordant result was obtained in 4.5% (43 samples). These discrepancies were mainly observed in threshold cycle (Ct) value next to the limit of detection. The k coefficient obtained shows a very high agreement between both methods with k values from 0.92 to 0.99. CONCLUSIONS: VIASURE Sexually Transmitted Diseases Real-Time PCR Detection kit provides a very good correlation with Allplex STI7 and therefore, it's a good tool for the diagnostic of STIs. Positive results with Ct value obtained from 35 and low amplification signal should be applied with caution and should be interpreted based on the patient's clinical data.