Evaluation of the Panbio™ COVID-19 IgG rapid test device performance.

Background: The Panbio™ COVID-19 IgG Rapid Test Device ("Panbio™") detects IgG antibodies against the SARS-CoV-2 spike protein from viral infection or vaccination. Objectives: To determine the diagnostic sensitivity and specificity of the Panbio™ professional use test, using fingerstick whole blood and venous plasma. Study design: Fingerstick whole blood and venous plasma from each participant were tested with Panbio™ and compared against the SARS-CoV-2 IgG II assay on the Abbott Architect™ platform (Europe) or the equivalent AdviseDx SARS-CoV-2 IgG II Abbott Alinity i™ platform (US). 447 evaluable participants were enrolled across 6 US and 9 European clinical centers. Results: For unvaccinated participants with PCR-confirmed infection ≥21 days post-symptom onset, the Panbio™ sensitivity with fingerstick whole blood was 92.6 % (95 % CI: 85.9, 96.7), and the specificity was 97.0 % (95 % CI: 93.1, 99.0). For venous plasma, the sensitivity was 90.0 % (95 % CI: 79.5, 96.2) for participants with PCR-confirmed infection and symptom onset 22-180 days ago; the specificity was 96.3 % (92.2, 98.6). For vaccinated participants, the sensitivity was 98.4 % (95 % CI: 91.2, 100.0) for fingerstick whole blood and 96.7 % (95 % CI: 88.7, 99.6) for venous plasma. Conclusion: The Panbio™ test had high sensitivity and specificity for detecting IgG against the SARS-CoV-2 spike protein.

Using quality improvement methods to improve door-to-balloon time at an academic medical center.

OBJECTIVES: 1) Describe a quality improvement (QI) process to decrease door-to-balloon time (D2B); 2) Explain implementation of evidence-based strategies to improve D2B. BACKGROUND: The ACC/AHA 2006 guideline target for ST-elevation myocardial infarction (STEMI) is a D2B of 90 minutes (min). QI methods can be used to identify areas for improvement, measure current processes, and provide rapid-cycle feedback about which strategies are effective. METHODS: We studied all STEMI patients presenting to Vanderbilt University Medical Center from July 2005 through November 2006. A process flow chart was created and all D2B process steps were analyzed. In February 2006, evidence-based strategies were implemented to address bottlenecks and decrease D2B. Statistical process control (SPC) was used to monitor D2B time in real-time. RESULTS: Targeted changes led to a 44 min decrease (p < 0.001) in overall median D2B time from 108 min (interquartile range [IQR] = 94-122 min) to 64 min (IQR = 56-94 min). Subinterval time periods for emergency department (ED)-to-electrocardiogram (ECG) time decreased by 7 min (p = 0.008), ECG-to-cardiac catheterization laboratory (CCL) time decreased by 18 min (p = 0.01), and CCL-to-balloon time decreased by 4 min (p = 0.19). After implementation, SPC charts revealed a 50% decrease in the central mean line and narrower control limits indicating more reliable performance. CONCLUSIONS: Using QI methods of flow-charting, identifying bottlenecks, targeting strategies to bottleneck areas, and real-time monitoring with SPC and rapid-cycle feedback, D2B processes can be systematically redesigned for improvement. QI methods can be used by individual institutions to customize and implement strategies for their particular context.

Murine complement interactions with Pseudomonas aeruginosa and their consequences during pneumonia.

Complement is necessary for defense against lung infection with Pseudomonas aeruginosa in mice. We studied in vitro interactions between complement and P. aeruginosa and in vivo effects of complement depletion to better understand this relationship. In vitro, P. aeruginosa strain UI-18 was resistant to killing by mouse serum. However, C3 opsonized the organism (via the alternative and mannose binding lectin [MBL] pathways), and C5 convertase activity on the bacterial surface was demonstrated. In vivo, compared with normal mice, complement-deficient mice experienced higher mortality and failed to sterilize their bronchoalveolar space within 24 h of inoculation. These changes did not seem to be a result of decreased inflammation because complement-deficient mice had normal neutrophil recruitment, greater lung myeloperoxidase content, and, by 24 h, a 35-fold higher level of the CXC chemokine KC. Lung static pressure-volume curves were abnormal in infected animals but were significantly more so in complement deficient mice. These data indicate that although P. aeruginosa is resistant to serum killing, C3 opsonization and C5 convertase assembly occur on its surface. This interaction in vivo plays a central role in host survival beyond just recruitment and activation of phagocytes and may serve to limit the inflammatory response to and tissue injury resulting from bacterial infection.