Abstract
We aimed to validate the performance of ddPCR-GNB, a plasma droplet digital PCR panel targeting the four most common gram-negative bacteria, for patients with suspected bloodstream infection (BSI). Patients suspected of having BSIs were prospectively enrolled. The results of blood culture and ddPCR-GNB were compared, and cases with discordant results were arbitrated on the basis of additional microbiological results and clinical evidence. A total of 1,041 patients were enrolled. Blood culture and ddPCR-GNB results were positive for targeted bacteria in 6.3% and 31.7% of patients, respectively. The overall per-patient sensitivity and specificity of ddPCR-GNB for proven BSIs were 98.5% (95% CI, 91.9% to 99.9%) and 72.8% (95% CI, 69.9% to 75.5%), respectively; the negative predictive value was 99.9% (95% CI, 99.2% to 100%). The discordant results included 265 cases (25.5%) with negative companion blood culture results but positive ddPCR-GNB results and one case vice versa. A total of 23.7% of the cases were attributed to probable (n = 126) or possible (n = 121) BSIs. If both probable and possible BSIs were assumed to be true positives, the per-patient specificity of ddPCR-GNB would be 97.5%. The ddPCR-GNB panel demonstrated excellent microbial diagnostic performance in identifying targeted bacteria for patients with suspected BSI. IMPORTANCE: This is the first multicentral study to validate the clinical performance of ddPCR in etiological diagnosis of bloodstream infection. The results showed that ddPCR has high sensitivity and increased detection rate compared with blood culture. The study proved the potential of the ddPCR method in microbial diagnoses.