# Evaluation of the Rapid and Cartridge-Based STANDARD™ M10 STI Panel: Analytical and Clinical Performance for Multiplex STI Detection

## TL;DR

The STANDARD™ M10 STI Panel is a fast and accurate diagnostic tool for detecting multiple sexually transmitted infections, showing strong performance across various sample types.

## Contribution

The study evaluates the analytical and clinical performance of a new cartridge-based STI diagnostic assay with broad pathogen coverage and rapid results.

## Key findings

- The STANDARD™ M10 STI Panel demonstrated high sensitivity (89.5% to 100%) and specificity (98.2% to 100%) for STI detection.
- Agreement between the STANDARD™ M10 and Allplex™ assays was almost perfect (Cohen’s κ values from 0.91 to 1.00).
- The assay showed robust performance on alternative clinical matrices like vaginal swabs, beyond its validation for urine samples.

## Abstract

Sexually transmitted infections (STIs) remain a major global public health concern, with more than one million new cases acquired daily and increasing antimicrobial resistance compromising effective control strategies. Rapid, accurate and multiplex molecular diagnostics are therefore essential to support timely clinical management and public health surveillance. This study evaluated the analytical and clinical performance of the cartridge-based STANDARD™ M10 STI Panel (SD Biosensor, Republic of Korea), a fully automated, random-access real-time PCR assay capable of detecting eight STI-related pathogens within approximately 64 min. A total of 150 residual clinical specimens were retrospectively analysed, including vaginal, rectal, urethral and oropharyngeal swabs, as well as seminal fluids, and results were compared with those obtained using the Allplex™ STI Essential Assay (Seegene, Republic of Korea), which shares six common targets. The STANDARD™ M10 STI Panel demonstrated high diagnostic accuracy, with sensitivity ranging from 89.5% to 100%, specificity from 98.2% to 100% and overall accuracy between 98% and 100%. Agreement between the two assays was almost perfect, with Cohen’s κ values ranging from 0.91 to 1.00. Analytical sensitivity was further confirmed through verification of the limits of detection using quantified reference standards. Although validated for urine samples, the assay also showed robust performance on alternative clinical matrices, particularly vaginal swabs. Overall, these findings indicate that the STANDARD™ M10 STI Panel represents a reliable and practical tool for STI diagnosis, combining rapid turnaround time, minimal hands-on requirements and broad pathogen coverage in both centralized and near-patient testing settings.