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.

中文翻译：

---

VIASURE性传播疾病实时PCR检测试剂盒（CerTest Biotec）用于诊断性传播感染的评估

介绍

性传播感染 (STI) 在我们的环境中很常见，并且在过去几年中呈上升趋势。多年来，微生物实验室已经应用了不同的 STI 诊断方法，但实时 PCR 改进了这一过程。我们的目标是评估 VIASURE性传播疾病实时 PCR 检测试剂盒 (CerTestBiotec, SL) 与我们实验室使用的实时 PCR 技术（Allplex™ STI7 Essential Assay，Seegene）进行比较，后者被视为参考检测。

方法

2018 年 7 月至 9 月，共分析了来自不同部位（阴道、宫颈管、尿道、直肠、咽拭子和尿液样本）的 948 个样本。

结果

4.5%（43 个样品）的结果不一致。这些差异主要在检测限附近的阈值循环 (Ct) 值中观察到。获得的k系数表明两种方法之间的一致性非常高，k值从 0.92 到 0.99。

结论

VIASURE性传播疾病实时 PCR 检测试剂盒与 Allplex STI7 具有非常好的相关性，因此是诊断 STI 的好工具。35 获得的 Ct 值和低放大信号的阳性结果应谨慎应用，并应根据患者的临床数据进行解释。