Background: Reliable point-of-care (POC) diagnostics not requiring laboratory infrastructure could be a game changer in the COVID-19 pandemic, particularly in the Global South. We assessed performance, limit of detection (LOD) and ease-of-use of three antigen-detecting, rapid POC diagnostics (Ag-RDT) for SARS-CoV-2. Methods: This prospective, multi-centre diagnostic accuracy study, recruited participants suspected to have SARS-CoV2 in Germany and UK. Paired nasopharyngeal swabs (NP) or NP and/or oropharyngeal swabs (OP) were collected from participants (one for clinical real-time reverse transcription polymerase chain reaction (RT-PCR) and one for Ag-RDT testing). Performance of each of three Ag-RDTs was compared to RT-PCR overall, and according to predefined subcategories e.g. cycle threshold (CT)-value, days from symptom onset, etc. In addition, limited verification of analytical limit-of-detection (LOD) was determined. To understand the usability of each Ag-RDT a System Usability Scale (SUS) questionnaire and ease-of-use assessment were performed. Results: Between April 17th and August 25th, 2020, 2417 participants were enrolled, with 70 (3.0%) testing positive by RT-PCR. The best-performing test (SD Biosensor, Inc. STANDARD Q) was 76.6% [95% Confidence Interval (CI) 62.8-86.4] sensitive and 99.3% [CI 98.6-99.6] specific. A sub-analysis showed all samples with RT-PCR CT-values <25 were detectable by STANDARD Q. The test was considered easy-to-use (SUS 86/100) and suitable for POC. Bioeasy and Coris showed specificity of 93.1% [CI 91.0%-94.8%] and 95.8% [CI 93.4%-97.4%], respectively, not meeting the predefined target of ≥98%. Conclusion: There is large variability in performance of Ag-RDT tests with one test showing promise. Given the usability at POC, these tests are likely to have impact despite imperfect sensitivity; however further research and modelling are needed.

Background/Aims: The diagnosis of small cell lung carcinoma (SCLC) on bronchial biopsy is often problematical as a result of intense crush artefact. Several antibodies are now available to help in the diagnosis of SCLC and their value was assessed in this clinical situation. Methods/Results: Twenty cases of SCLC and 10 control cases (one non-Hodgkin lymphoma, three nonsmall cell carcinomas, one follicular reactive hyperplasia, and five chronic non-specific inflammations) with extensive crush artefact were stained using antibodies to CD56, MNF116, thyroid transcription factor 1 (TTF-1), and CD45. All SCLCs showed strong positive staining for CD56 in 75-100% of recognisable tumour cells, even in areas where there was extensive crush artefact. Eighteen of 20 cases were positive for TTF-1 and 16 of 20 were positive for MNF116 in the tumour cells, but both of these antibodies showed little or no staining in areas of crush artefact. Control cases comprising lymphoid cells were positive for CD45 in areas of crush artefact, but all cases of SCLC were negative. Conclusion: CD56, along with markers for cytokeratins-TTF-1, and CD45-are useful in the diagnosis of SCLC in biopsies with extensive crush artefact and can help confirm the diagnosis in cases where features are equivocal.

Background: Endoscopic valve therapy leads to an improvement of lung function, exercise tolerance, and quality of life in a selected cohort of patients with advanced emphysema. So far, only few data exist on the long-term outcome. Objectives: This analysis evaluated the impact of valve therapy on the survival of emphysema patients. Methods: Survival rates of emphysema patients who underwent valve therapy were assessed according to their radiological outcome following valve placement. Results: From 2005 to 2013, 449 emphysema patients (mean age 64 ± 7 years) underwent valve therapy and were followed for a mean time of 37.3 ± 21.3 months. A total of 128 patients (29%) developed complete lobar atelectasis, 34 out of these also experienced a pneumothorax; 50 patients (11%) developed pneumothorax without lobar atelectasis, and 261 patients (58%) target lobe volume reduction or no volume change. Patients with atelectasis showed significantly better baseline forced expiratory volume in 1 second (%), residual volume (L), total lung capacity (L), and transfer factor for carbon monoxide (%; all p < 0.05), but there was no significant difference in the BODE score (p = 0.195). Patients with valve-induced lobar atelectasis had a significant survival benefit compared to patients without atelectasis (p = 0.009; 5-year survival rate 65.3 vs. 43.9%). The advent of pneumothorax in 84 patients did not influence survival (p = 0.52). Conclusions: Lobar atelectasis following endoscopic valve therapy is associated with a survival benefit.

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Background: Treatment with lung volume reduction coils (LVRC) may be effective in patients with severe heterogeneous emphysema and incomplete fissures. Objective: We hypothesized that LVRC placement improves pulmonary function, exercise tolerance and quality of life in these patients. Methods: Twenty-six patients with chronic obstructive pulmonary disease (COPD), 13 males and 13 females, aged 66 ± 8 years with heterogeneous emphysema and incomplete fissures were included in this retrospective analysis. The coils were implanted unilaterally in the upper or lower lobe. Patients were followed up at 30, 90 and 180 days after treatment and changes in pulmonary function test and 6-minute-walk-test (6MWT) values as well as scores for the modified Medical Research Council (mMRC) dyspnea scale and the St. George's Respiratory Questionnaire (SGRQ) were recorded. Results: FEV₁ improved significantly at 90 days and tended to decrease at the 180-day follow-up (0.67 ± 0.17 vs. 0.78 ± 0.25 vs. 0.73 ± 0.21 liters, respectively, p < 0.001). The 6MWT score had improved significantly at 90 days and had tended to decrease at the 180-day follow-up (216 ± 107 vs. 262 ± 97 vs. 262 ± 112 m, respectively, p = 0.001). SGRQ was significantly improved at 90 days. Multivariate analysis showed that worse 6MWT performance at baseline was independently associated with a greater improvement in 6MWT at the 90-day follow-up. The total complication rate was 54% (n = 14) and included light hemorrhage in 6 patients, COPD exacerbation in 6, pneumothorax in 1 and both COPD exacerbation and pneumothorax in 1 patient. Conclusions: This is the first study to show that LVRC in patients with heterogeneous emphysema and incomplete fissures improves exercise capacity, quality of life and lung function up to 90 days after the intervention. Further studies are needed to assess the long-term effects of LVRC in these patients.

Both BODE index and FFMI, are related to the circulating levels of leptin in patients with COPD, suggesting a possible role for leptin in the systemic component of COPD. The additional association of FFMI with TNF-α may further support a role of systemic inflammation in muscle wasting in COPD.

Background and objective: Endoscopic valve therapy is a treatment modality in patients with advanced emphysema and absent interlobar collateral ventilation (CV). So far, long-term outcome following valve implantation has been insufficiently evaluated. The aim of this study was to investigate the real-world efficacy of this interventional therapy over 3 years. Methods: From 2006 to 2013, 256 patients with severe emphysema in whom absent CV was confirmed underwent valve therapy. The 3-year effectiveness was evaluated by pulmonary function testing (VC, FEV1, RV, TLC), 6-minute-walk test (6-MWT) and dyspnea questionnaire (mMRC). Long-term outcome was also assessed according to the radiological outcome following valve placement. Results: Of 256 patients treated with valves, 220, 200, 187, 100 and 66 patients completed the 3-month, 6-month, 1-year, 2-year and 3-year follow-up (FU) visit, respectively. All lung function parameters, 6-MWT and mMRC were significantly improved at 3- and 6-month FU. At 1-year FU, patients still experienced a significant improvement of all outcome parameters expect VC (L) and TLC (%). At 2 years, RV (L and %) and TLC (L and %) remained significantly improved compared to baseline. Three years after valve therapy, sustained significant improvement in mMRC was observed and the proportion of patients achieving a minimal clinically important difference from baseline in RV and 6-MWT was still 71% and 46%, respectively. Overall, patients with complete lobar atelectasis exhibited superior treatment outcome with 3-year responder rates to FEV1, RV and 6-MWT of 10%, 79% and 53%, respectively. Conclusions: Patients treated by valves experienced clinical improvement over 1 year following valve therapy. Afterwards, clinical benefit gradually declines more likely due to COPD progression. The reviews of this paper are available via the supplemental material section.

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