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Updated: Aug 26, 2025
Author Spotlight: Advancing Rapid Detection of Respiratory Pathogens Using Microfluidic Chip
Published on: March 29, 2024
Novel fast pathogen diagnosis method for severe pneumonia patients in the intensive care unit: randomized clinical
Yan Wang1, Xiaohui Liang2, Yuqian Jiang2
1Department of Critical Care Medicine, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, China.
Background:
Severe pneumonia is one of the common acute diseases caused by pathogenic microorganism infection, especially by pathogenic bacteria, leading to sepsis with a high morbidity and mortality rate. However, the existing bacteria cultivation method cannot satisfy current clinical needs requiring rapid identification of bacteria strain for antibiotic selection. Therefore, developing a sensitive liquid biopsy system demonstrates the enormous value of detecting pathogenic bacterium species in pneumonia patients.
Methods:
In this study, we developed a tool named Species-Specific Bacterial Detector (SSBD, pronounce as 'speed') for detecting selected bacterium. Newly designed diagnostic tools combining specific DNA-tag screened by our algorithm and CRISPR/Cas12a, which were first tested in the lab to confirm the accuracy, followed by validating its specificity and sensitivity via applying on bronchoalveolar lavage fluid (BALF) from pneumonia patients. In the validation I stage, we compared the SSBD results with traditional cultivation results. In the validation II stage, a randomized and controlled clinical trial was completed at the ICU of Nanjing Drum Tower Hospital to evaluate the benefit SSBD brought to the treatment.
Results:
In the validation stage I, 77 BALF samples were tested, and SSBD could identify designated organisms in 4 hr with almost 100% sensitivity and over 87% specific rate. In validation stage II, the SSBD results were obtained in 4 hr, leading to better APACHE II scores (p=0.0035, ANOVA test). Based on the results acquired by SSBD, cultivation results could deviate from the real pathogenic situation with polymicrobial infections. In addition, nosocomial infections were found widely in ICU, which should deserve more attention.
Conclusions:
SSBD was confirmed to be a powerful tool for severe pneumonia diagnosis in ICU with high accuracy.
Funding:
National Natural Science Foundation of China. The National Key Scientific Instrument and Equipment Development Project. Project number: 81927808.
Clinical Trial Number:
This study was registered at https://clinicaltrials.gov/ (NCT04178382).
Insights
A new Species-Specific Bacterial Detector (SSBD) rapidly identifies pneumonia-causing bacteria in 4 hours. This sensitive liquid biopsy system improves patient outcomes by enabling faster antibiotic selection for severe pneumonia.
Area of Science:
- Molecular Biology
- Medical Diagnostics
- Infectious Diseases
Background:
- Severe pneumonia, often caused by bacteria, leads to sepsis with high mortality.
- Current bacterial identification methods are too slow for timely antibiotic selection.
- Rapid and sensitive detection of bacterial pathogens is crucial for pneumonia treatment.
Purpose of the Study:
- To develop and validate a novel diagnostic tool for rapid and accurate identification of bacterial species in severe pneumonia patients.
- To assess the clinical utility of the developed tool in guiding antibiotic therapy and improving patient outcomes.
Main Methods:
- Developed the Species-Specific Bacterial Detector (SSBD) using DNA-tag screening and CRISPR/Cas12a technology.
- Validated SSBD accuracy, sensitivity, and specificity using laboratory tests and bronchoalveolar lavage fluid (BALF) samples.
- Conducted a randomized controlled clinical trial in an ICU setting to evaluate SSBD's impact on patient treatment.
Main Results:
- SSBD identified target organisms in 77 BALF samples within 4 hours with nearly 100% sensitivity and over 87% specificity.
- Clinical trial demonstrated SSBD's rapid results led to improved APACHE II scores (p=0.0035).
- Identified discrepancies between SSBD and traditional cultivation, highlighting polymicrobial infections and the prevalence of nosocomial infections.
Conclusions:
- The Species-Specific Bacterial Detector (SSBD) is a highly accurate and powerful tool for diagnosing severe pneumonia in ICUs.
- SSBD facilitates timely pathogen identification, potentially improving clinical management and patient prognosis.
- The study underscores the need for advanced diagnostic methods in combating severe pneumonia and sepsis.
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