Search

Background: The main objective of the present study was to compare the diagnostic performance of the commercial LightMix Modular Monkeypox Virus (MPXV) qPCR (TIB Molbiol, Germany) assay with the in-house nonvariola orthopox/monkeypox generic real-time PCR assay (ICMR-NIV, Pune) for the screening of (MPXV) cases at Medical Research Institute (MRI) in Sri Lanka. Furthermore, clinical and sociodemographic data of suspected /confirmed cases received at MRI for the MPXV screening were also analyzed. Methods: The diagnostic performance of the commercial LightMix Modular MPXV qPCR assay with the in-house nonvariola orthopox/monkeypox generic real-time PCR assay for the screening of suspected MXPV cases was evaluated using standard methods with minor modifications. Socio-demographic and clinical profiles of suspected and confirmed MPXV cases were also analyzed. Results: The commercial LightMix Modular MPXV assay was able to detect MPXV with 100% sensitivity and specificity with non-variola orthopox/monkeypox generic rtPCR assay. During the period of study, from the total of 25 samples tested, only 2 were MPXV-positive (males). The most common symptoms of suspected MPXV cases were lesions or rashes (92%). Conclusions: With the continually increasing number of cases, access to MPXV testing should be made more widely available. The commercial LightMix Modular MPXV (TIB Molbiol) qPCR assay offers comparable performance to the non-variola orthopox/monkeypox generic real time PCR assay for MPXV detection during the present outbreak.

Background: Recruitment and retention are critical in clinical studies but there are limited objective metrics of trial performance. We tested if development of trial performance metrics will allow for objective evaluation of study quality. Performance metrics were developed using data from the observational cohort (OBS) and randomized clinical trial (RCT) arms of the prospective Alcoholic Hepatitis Network., Methods: Yield-rate (%YR; eligible/screened), recruitment index (RI; mean recruitment time/patient), completion index (CI; average number of days to complete the follow-up/patient), and protocol adherence index (AI; average number of deviations/subject recruited) were determined., Results: 2250 patients (1168 for OBS; 1082 for RCT) were screened across 8 sites. Recruitment in the RCT (57% target) was similar to that in the OBS (59% target). Of those screened, 743 (63.6%) subjects in the OBS and 147 (13.6%) subjects in the RCT were enrolled in the study. In OBS study, 253 (34.1%) subjects, and in the RCT, 68 (46.3%) subjects, completed the study or reached a censoring event. Across all sites (range), YR for OBS was 63.6% (41.3-98.3%) and for RCT was 13.6% (5.5-92.6%); RI for OBS was 1.66 (8.79-19.85) and for RCT was 4.05 (19.76-36.43); CI for OBS was 4.87 (22.6-118.3) and for RCT was 8.75 (27.27-161.5); and AR for OBS was 0.56 (0.08-1.04) and for RCT was 1.55 (0.39-3.21. Factors related to participants, research design, study team, and research sponsors contributed to lower performance metrics., Conclusions: Objective measures of clinical trial performance allow for strategies to enhance study quality and development of site-specific improvement plans., Trial Registration Number: ClinicalTrials.gov NCT4072822 NCT03850899., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Inc. All rights reserved.)

MRI offers detailed diagnostic images without ionizing radiation; however, there are considerable safety concerns associated with high electromagnetic field strength. With increasing use of high and ultra high (7T) magnetic field strength, adequate patient preparation and screening for ferrous material is increasingly important. We review current safety standards for patient screening and preparation and how they are implemented at our institution. In addition, we describe a novel supplemental screening technique wherein the lights are dimmed in response to detected ferrous metal at the threshold of Zone IV., (Copyright © 2015 Elsevier Inc. All rights reserved.)