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Thorax 06/03/2020 18:00
Rationale. Mutations in the cystic fibrosis transmembrane regulator ( CFTR ) gene form the basis of cystic fibrosis (CF). There remains an important knowledge gap in CF as to how diminished CFTR activity leads to the dominant inflammatory response within CF airways. Objectives. To investigate if extracellular vesicles (EVs) contribute to inflammatory signalling in CF. Methods. EVs released from CFBE41o-, CuFi-5, 16HBE14o- and NuLi-1 cells were characterised by nanoparticle tracking analysis (NTA). EVs isolated from bronchoalveolar lavage fluid (BALF) from 30 people with CF (PWCF) were analysed by NTA and mass spectrometry and compared with controls. Neutrophils were isolated from the blood of 8 PWCF to examine neutrophil migration in the prese.
Thorax 06/03/2020 18:00
In this comparative biomarker study, we analysed 1768 serial sputum samples from 178 patients at 4 sites in Southeast Africa. We show that tuberculosis Molecular Bacterial Load Assay (TB-MBLA) reduces time-to-TB-bacillary-load-result from days/weeks by culture to hours and detects early patient treatment response. By day 14 of treatment, 5% of patients had cleared bacillary load to zero, rising to 58% by 12th week of treatment. Fall in bacillary load correlated with mycobacterial growth indicator tube culture time-to-positivity (Spearmans r=–0.51, 95% CI (–0.56 to –0.46), p <0.0001). Patients with high pretreatment bacillary burdens (above the cohort bacillary load average of 5.5log 10 eCFU/ml) were less likely to convert-to-negative by 8th.
Business Wire 06/03/2020 17:54
POMONA, Calif.--(BUSINESS WIRE)-- #inspections--As of March 18th, 2020, the FDA suspended routine onsite domestic inspections until further notice in response to the COVID-19 pandemic. The FDA has signaled that they will implement alternative methods in order to continue inspections, including using remote applications. FDA will be releasing a revision to their Inspection Manual to address their remote inspection procedures and requirements. PSC Software™ recognizes the urgent need to continue both FDA inspec.

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