scholarly journals Generating and evaluating evidence of the clinical utility of molecular diagnostic tests in oncology

2015 ◽  
Vol 18 (8) ◽  
pp. 780-787 ◽  
Author(s):  
Patricia Deverka ◽  
Donna A. Messner ◽  
Robert McCormack ◽  
Gary H. Lyman ◽  
Margaret Piper ◽  
...  
2022 ◽  
Author(s):  
Yusaku Akashi ◽  
Michiko Horie ◽  
Junichi Kiyotaki ◽  
Yuto Takeuchi ◽  
Kenichi Togashi ◽  
...  

Background and Objective: Point-of-care type molecular diagnostic tests have been used for detecting SARS-CoV-2, although their clinical utility with nasal samples has yet to be established. This study evaluated the clinical performance of the cobas Liat SARS-CoV-2 & Influenza AB (Liat) in nasal samples. Methods: Nasal and nasopharyngeal samples were collected and were tested using the Liat, the cobas 6800 system and the cobas SARS-CoV-2 & Influenza AB (cobas), and a method developed by National Institute of Infectious Diseases, Japan (NIID). Results: A total of 814 nasal samples were collected. The Liat assay was positive for SARS-CoV-2 in 113 (13.9%). The total, positive, and negative concordance rate between the Liat and cobas/NIID assays were 99.3%/98.4%, 99.1%/100%, and 99.3%/98.2%, respectively. Five samples were positive only using the Liat assay. Their Ct values ranged from 31.9 to 37.2. The Ct values of the Liat assay were significantly lower (p < 0.001) but were correlated (p < 0.001) with those of other molecular assays. In the participants who tested positive for SARS-CoV-2 on the Liat assay using nasopharyngeal samples, 88.2% of their nasal samples also tested positive using the Liat assay. Conclusion: The Liat assay showed high concordance with other molecular assays in nasal samples. Some discordance occurred in samples with Ct values > 30 on the Liat assay.


2020 ◽  
Vol 41 (S1) ◽  
pp. s278-s279
Author(s):  
Maiko Kondo ◽  
Matthew Simon ◽  
Esther Babady ◽  
Angela Loo ◽  
David Calfee

Background: In recent years, several rapid molecular diagnostic tests (RMDTs) for infectious diseases diagnostics, such as bloodstream infections (BSIs), have become available for clinical use. The extent to which RMDTs have been adopted and how the results of these tests have been incorporated into clinical care are currently unknown. Methods: We surveyed members of the Society for Healthcare Epidemiology of America Research Network to characterize utilization of RMDT in hospitals and antimicrobial stewardship program (ASP) involvement in result communication and interpretation. The survey was administered using Qualtrics software, and data were analyzed using Stata and Excel software. Results: Overall, 57 responses were received (response rate, 59%), and 72% were from academic hospitals; 50 hospitals (88%) used at least 1 RMDT for BSI (Fig. 1). The factors most commonly reported to have been important in the decision to adopt RMDT were improvements in antimicrobial usage (82%), clinical outcomes (74%), and laboratory efficiency (52%). Among 7 hospitals that did not use RMDT for BSI, the most common reason was cost of new technology. In 50 hospitals with RMDT for BSI, 54% provided written guidelines for optimization or de-escalation of antimicrobials based upon RMDT results. In 40 hospitals (80%), microbiology laboratories directly notified a healthcare worker of the RMDT results: 70% provided results to a physician, nurse practitioner, or physician assistant; 48% to the ASP team; and 33% to a nurse. Furthermore, 11 hospitals (22%) had neither guidelines nor ASP intervention. In addition, 24 hospitals (48%) reported performing postimplementation evaluation of RMDT impact. Reported findings included reduction in time to antibiotic de-escalation (75%), reduction in length of stay (25%), improved laboratory efficiency (20%), and reduction in mortality and overall costs (12%). Among the 47 hospitals with both RMDT and ASP, 79% reported that the ASP team routinely reviewed blood culture RMDT results, and 53.2% used clinical decision support software to do so. Finally, 53 hospitals (93%) used 1 or more RMDT for non–bloodstream infections (Fig. 1). Fewer than half of hospitals provided written guidelines to assist clinicians in interpreting these RMDT results. Conclusions: RMDTs have been widely adopted by participating hospitals and are associated with positive self-reported clinical, logistic, and financial outcomes. However, nearly 1 in 4 hospitals did not have guidelines or ASP interventions to assist clinicians with optimization of antimicrobial prescribing based on RMDT results for BSI. Also, most hospitals did not have guidelines for RMDT results for non-BSI. These findings suggest that opportunities exist to further enhance the potential benefits of RMDT.Funding: NoneDisclosures: None


Author(s):  
S.I. Agasieva ◽  
E.A. Smetanin ◽  
A.R. Vechkanov ◽  
A.V. Gubanov

Statement of the problem of this article - one of the most important problems is protection from especially dangerous infectious diseases. The use of biosensors in clinical trials will significantly reduce the time for obtaining the results of analyzes, thereby speeding up the appointment of treatment to patients. The purpose of the article is to present modern designs of biosensors based on gallium nitride, the possibilities of their application and characteristics. Consider the principles of operation, areas of application and characteristics. As a result, the design of modern biosensors and modern trends in their use from various sources of literature in recent years are shown. Biosensors, principles of their action, areas of application and characteristics are considered, which will reduce the possible socio-economic damage from temporary disability for sick citizens due to the rapid and timely implementation of anti-epidemic measures. Practical value: the proposed biosensors are of interest as devices for detecting diseases. The use of biosensors in clinical disease research has several potential advantages over other clinical analysis methods, including increased analysis speed and flexibility, multipurpose analysis capability, automation, reduced diagnostic testing costs, and the ability to integrate molecular diagnostic tests into local healthcare systems.


2013 ◽  
Vol 3 (4) ◽  
pp. 269
Author(s):  
Patrick M.M. Bossuyt ◽  
Johannes B. Reitsma ◽  
Kristian Linnet ◽  
Karel G.M. Moons

2013 ◽  
Vol 47 (4) ◽  
pp. 193-201 ◽  
Author(s):  
Swapnil Parchand ◽  
Vishali Gupta

ABSTRACT Intraocular tuberculosis remains a major diagnostic challenge and it is extremely important to establish the diagnosis as the specific treatment helps in reducing the recurrences, thus reducing ocular morbidity. The present review aims to describe the global epidemiology and pathogenesis of intraocular tuberculosis with clinical spectrum and different presentations. The challenges in establishing the diagnosis with role of conventional tests like PPD skin test as well as current diagnostic tests including interferon gamma release assay and molecular diagnostic tests are discussed. The treatment requires anti-tuberculosis therapy with the use of concomitant corticosteroids and carries good prognosis provided the treatment is started in the early stage. How to cite this article Parchand S, Gupta V, Gupta A, Sharma A. Intraocular Tuberculosis. J Postgrad Med Edu Res 2013;47(4):193-201.


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