The detection of bacterial and fungal pathogens through molecular methods, such as 16S and 18S rRNA amplicon sequencing, is critical for identifying infections where traditional culture methods may be slow or inconclusive. The 16S rRNA gene is highly conserved among bacteria, making it an ideal target for broad-range bacterial detection, while the 18S rRNA gene serves as a reliable marker for fungal identification. These techniques allow for the rapid identification of microbial DNA directly from clinical specimens.

This fully CE-IVD nucleic acid extraction and broad-range detection assay, combined with species-level identification through sequencing of positive samples, is crucial for diagnosing infections in cases where empirical treatment may be insufficient or where timely identification can significantly improve patient outcomes. This approach is particularly valuable in diagnosing infections in sterile sites or in cases of invasive disease where the causative agent is not easily culturable. For further information on the benefits of molecular diagnostics in infection management, refer to current clinical guidelines on molecular pathogen detection.