# Application of microfluidic chip-based multiplex PCR in diagnosing reproductive tract pathogens among patients with premature rupture of membranes

## TL;DR

This study shows that a microfluidic chip-based PCR method is highly effective for diagnosing reproductive tract infections in patients with premature rupture of membranes.

## Contribution

The study introduces a novel microfluidic chip-based multiplex PCR method for rapid and accurate detection of multiple reproductive tract pathogens.

## Key findings

- The method achieved high sensitivity (95.6%) and specificity (98.2%) for pathogen detection.
- Escherichia coli was the most frequently detected pathogen (28.0%).
- ROC analysis showed excellent diagnostic performance with AUC values between 0.93 and 0.98.

## Abstract

To evaluate the diagnostic performance of a microfluidic chip-based multiplex PCR method for detecting common reproductive tract pathogens in patients with premature rupture of membranes (PROM).

A total of 200 patients with PROM were recruited from January 2020 to December 2024. Clinical samples were collected and analyzed using a microfluidic chip-based multiplex PCR method to detect six common reproductive tract pathogens. Clinical etiological diagnosis was used as the reference standard to assess the diagnostic efficacy of the method. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and consistency were calculated using 2 × 2 contingency tables. Receiver operating characteristic (ROC) curve analysis was performed to further evaluate the diagnostic performance.

The mean age of the patients was 30.5 years ± 4.2 years, and the mean gestational age was 32.7 ± 3.4 weeks. The most frequently detected pathogen was Escherichia coli (28.0%), followed by Candida albicans (21.0%) and Chlamydia trachomatis (19.0%). The microfluidic chip-based multiplex PCR method demonstrated high sensitivity (95.6%), specificity (98.2%), PPV (94.2%), and NPV (97.8%). ROC curve analysis revealed excellent diagnostic performance for all pathogens, with area under the curve (AUC) values ranging from 0.93 to 0.98.

The microfluidic chip-based multiplex PCR method provides a highly sensitive, specific, and reliable diagnostic tool for detecting reproductive tract pathogens in patients with PROM.