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Evaluation of VIASURE Sexually Transmitted Diseases Real Time PCR Detection kit (CerTest Biotec) for the diagnostic
Cristina Casañ López1, Belén Rivaya Sánchez1, Gema Fernández Rivas2
1Servicio de Microbiología, Laboratorio Clínico Metropolitana Norte, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.
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.
Insights
The VIASURE Sexually Transmitted Diseases Real-Time PCR Detection kit shows high agreement with the reference assay for diagnosing STIs. This real-time PCR test is a reliable tool for clinical laboratories, though results near the limit of detection require careful interpretation.
Area of Science:
- Clinical Microbiology
- Molecular Diagnostics
- Infectious Diseases
Background:
- Sexually transmitted infections (STIs) are a growing public health concern with increasing incidence.
- Traditional diagnostic methods for STIs have limitations; real-time PCR offers improved accuracy and speed.
- Real-time PCR has become a cornerstone in modern microbiology laboratories for sensitive and specific pathogen detection.
Purpose of the Study:
- To evaluate the performance of the VIASURE Sexually Transmitted Diseases Real-Time PCR Detection kit.
- To compare the VIASURE kit against an established reference real-time PCR assay (Allplex™ STI7 Essential Assay).
- To assess the utility of the VIASURE kit as a diagnostic tool for STIs.
Main Methods:
- Analysis of 948 clinical samples (vaginal, endocervical, urethral, rectal, pharyngeal swabs, and urine) collected between July and September 2018.
- Comparative evaluation using the VIASURE Sexually Transmitted Diseases Real-Time PCR Detection kit and the Allplex™ STI7 Essential Assay as the reference method.
- Assessment of discordant results and agreement using kappa (k) coefficient analysis.
Main Results:
- A high overall agreement was observed between the VIASURE kit and the reference assay, with kappa coefficients ranging from 0.92 to 0.99.
- Discordant results were found in 4.5% (43/948) of samples, primarily associated with threshold cycle (Ct) values near the limit of detection.
- The VIASURE kit demonstrated robust performance across various sample types.
Conclusions:
- The VIASURE Sexually Transmitted Diseases Real-Time PCR Detection kit exhibits excellent correlation with the Allplex STI7 assay, confirming its suitability for STI diagnostics.
- The kit is a valuable tool for clinical laboratories managing the increasing burden of STIs.
- Caution is advised when interpreting positive results with high Ct values (≥35) or low amplification signals, necessitating correlation with clinical data.
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