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Rapid and reliable molecular detection of possible BJI pathogens may advance the diagnosis and effective management of bone and joint infections. The BioFire BJI Panel is a robust, accurate, and easy-to-use multiplex PCR test capable of detecting many aerobic and anaerobic bacteria, yeast, and AMR genes in synovial fluid specimens. Accurate and reproducible organism and AMR gene detection was observed with repeated testing of samples over several days (99.9% agreement with the expected results), and detection was not affected by potentially interfering substances nor by refrigerated sample storage. Sequence analysis and testing demonstrated clinically appropriate specificity and reactivity with a variety of isolates and different AMR gene types. The confirmed LoD for bacteria and yeast ranged from 100 - 10,000 CFU/mL. Testing was performed with Investigational Use Only kits. Reproducibility was evaluated in a multi-laboratory multi-variable study, and the impact of storage and potentially interfering substances on the accuracy of test results was also assessed. A collection of >350 isolates representing genetic and geographic diversity of analytes was tested near LoD to assess analytical reactivity, and more than 420 near-neighbor, commensal, pathogenic, or environmental off-panel species were evaluated for assay specificity.
#BIOFIRE DIAGNOSTICS SERIAL#
LoD for each analyte was estimated from serial dilutions and confirmed at the lowest titer with ≥95% detection. Analytical performance of the panel (Limit of Detection (LoD), analytical reactivity and specificity, interference, reproducibility), and specimen storage conditions are described. Finegoldia magna, Kingella kingae, Cutibacterium, Anaerococcus and Peptoniphilus species, and others) in about an hour. The panel aims to improve on current culture-based diagnostics, particularly for detection of anaerobes (e.g. The BioFire Bone and Joint Infection (BJI) Panel is a sample-to-answer test for the qualitative detection of nearly 40 different bacteria, yeast, and antimicrobial resistance (AMR) genes in synovial fluid (SF). A low-dose SMX-TMP regimen in the treatment of PJP should be considered a viable option as it could potentially decrease treatment discontinuation rates and reduce patient harm. This meta-analysis shows a significant decrease in adverse reactions and similar mortality rates with lower-dose SMX-TMP compared to conventional dosing. There was a significant decrease in the rate of adverse reactions for the low-dose group compared with the conventional-dose group (RR: 0.70, 95% CI, 0.53–0.91). Overall, there was no significant difference in mortality between low-dose and conventional-dose SMX-TMP groups (relative risk : 0.55, 95% confidence interval, 0.18–1.70). Outcomes evaluated in our meta-analysis include survival and adverse reactions.Īfter excluding studies that did not meet our inclusion criteria, four studies were analyzed for adverse reactions and three for mortality. MEDLINE and Embase databases were searched from inception to January 15, 2020, for studies in English evaluating low-dose SMX-TMP (<15 mg/kg/day) compared to conventional dosing for the treatment of PJP.
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We conducted a systematic review and meta-analysis of the existing literature according to PRISMA guidelines. Our objective of this meta-analysis was to evaluate the safety and efficacy of lower dose SMX-TMP for PJP pneumonia. Several studies have suggested similar mortality outcomes and an improved adverse effect profile using a lower dose (<15 mg/kg/day) SMX-TMP regimen. The conventional treatment of PJP is sulfamethoxazole-trimethoprim (SMX-TMP) dosed at 15–20 mg/kg/day of the trimethoprim component. Pneumocystis jirovecii pneumonia (PJP) is an opportunistic fungal infection causing significant morbidity and mortality in immunocompromised patients.