Validation of CRownLab Pneumoplex for the Detection of Klebsiella pneumoniae and Acinetobacter baumannii Using RT-PCR in Patients With Sepsis at a Tertiary Hospital in Indonesia
Abstract
Objectives: Early diagnosis of bacterial sepsis remains a significant challenge in clinical practice, primarily due to the limitations of conventional methods such as blood culture, which require prolonged turnaround times and have low sensitivity. The real-time polymerase chain reaction (RT-PCR) method using CRownLab Pneumoplex was developed to enable rapid and simultaneous detection of pathogens. This study is aimed at evaluating the diagnostic validity of CRownLab Pneumoplex in detecting Klebsiella pneumoniae and Acinetobacter baumannii in patients with sepsis at a tertiary hospital in Indonesia.
Methods: This cross-sectional study involved 400 sepsis patients recruited between October 2024 and February 2025. Blood, sputum, urine, and pus specimens were collected from patients who met the inclusion and exclusion criteria. All samples were analyzed using culture methods as the gold standard and RT-PCR using CRownLab Pneumoplex. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and diagnostic accuracy were calculated.
Results: RT-PCR detection of K. pneumoniae demonstrated a sensitivity of 89.0%, specificity of 87.7%, PPV of 65.2%, NPV of 96.9%, and accuracy of 88.0%. For A. baumannii, sensitivity was 92.9%, specificity was 88.9%, PPV was 23.2%, NPV was 99.7%, and accuracy was 89.0%. Overall, combined detection yielded a sensitivity of 88.9%, specificity of 87.0%, PPV of 69.3%, NPV of 96.0%, and diagnostic accuracy of 87.5%. For…
How strong is the evidence?
Evidence Hub reads this as a cross-sectional, done in people. Its evidence level is 4 of 5 (Low · observational). Observational designs can show an association but not prove cause. Reported size: 400 participants or records.
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