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Analytical Validation of a Next-Generation Sequencing Assay for the Detection of Microbial Pathogens in Human Plasma

Summary

Researchers developed a new blood test that can detect hundreds of different fungal and bacterial infections using advanced sequencing technology. The test works by searching for pathogen DNA in blood samples and is much faster than traditional culture methods. This could help doctors quickly identify what infection a patient has and start the right treatment sooner, which is especially important for patients with weakened immune systems.

Background

Fungal and acid-fast bacteria infections can be serious complications for immunosuppressed patients. Current diagnostics suffer from low sensitivity/specificity, are invasive, have long turnaround times, or require prior knowledge of the pathogen. An unbiased NGS approach can detect pathogen cfDNA in patient blood samples.

Objective

To develop and validate a hybrid capture NGS assay using over 30,000 probes to detect more than 600 fungal and select acid-fast bacteria species in plasma samples.

Results

ROC analysis established cutoffs achieving approximately 96% analytical specificity and 1,200 molecules/mL sensitivity. Accuracy testing correctly identified 98% of 40 contrived samples with 100% intra-assay and 93% inter-assay precision. Several species were detected in initial clinical samples but remained below reportable cutoff values.

Conclusion

The analytical validation demonstrates the analytical performance of hybrid capture NGS in human plasma for detecting fungal and AFB pathogens. This approach provides an unbiased, sensitive, and specific method for pathogen identification in immunosuppressed patients.
  • Published in:Open Forum Infectious Diseases,
  • Study Type:Analytical Validation Study,
  • Source: 10.1093/ofid/ofae631.2285
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