scholarly journals Clinical Performance of the cobas Liat SARS-CoV-2 & Influenza AB for the Detection of SARS-CoV-2 in Nasal Samples

2022 ◽  
Author(s):  
Yusaku Akashi ◽  
Michiko Horie ◽  
Junichi Kiyotaki ◽  
Yuto Takeuchi ◽  
Kenichi Togashi ◽  
...  
Keyword(s):  
Infectious Diseases ◽  
Diagnostic Tests ◽  
Clinical Utility ◽  
Clinical Performance ◽  
Point Of Care ◽  
Concordance Rate ◽  
Molecular Diagnostic ◽  
Molecular Assays ◽  
High Concordance

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.

Analysis of the tendency of development of biosensors based on GaN

2021 ◽  
Author(s):  
S.I. Agasieva ◽  
E.A. Smetanin ◽  
A.R. Vechkanov ◽  
A.V. Gubanov
Keyword(s):  
Clinical Trials ◽  
Infectious Diseases ◽  
Diagnostic Tests ◽  
Diagnostic Testing ◽  
Healthcare Systems ◽  
Clinical Analysis ◽  
Molecular Diagnostic ◽  
Economic Damage ◽  
Disease Research ◽  
Local Healthcare

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.

scholarly journals Improving access to new diagnostics through harmonised regulation: priorities for action

2014 ◽  
Vol 3 (1) ◽  
Author(s):  
Ruth McNerney ◽  
Kimberly Sollis ◽  
Rosanna W. Peeling
Keyword(s):  
Developing Countries ◽  
Diagnostic Tests ◽  
Clinical Performance ◽  
Point Of Care ◽  
Poor Quality ◽  
International Standards ◽  
Regulatory Oversight ◽  
Adoption And Implementation ◽  
Post Market ◽  
Timely Access

A new generation of diagnostic tests is being developed for use at the point of care that could save lives and reduce the spread of infectious diseases through early detection and treatment. It is important that patients in developing countries have access to these products at affordable prices and without delay. Regulation of medical products is intended to ensure safety and quality whilst balancing the need for timely access to beneficial new products. Current regulatory oversight of diagnostic tests in developing countries is highly variable and weak regulation allows poor-quality tests to enter the market. However, inefficient orover zealous regulation results in unnecessary delays, increases costs and acts as a barrier to innovation and market entry. Setting international standards and streamlining the regulatory process could reduce these barriers. Four priority activities have been identified where convergence of standards and protocols or joint review of data would be advantageous: (1) adoption of a common registration file for pre-market approval; (2) convergence of quality standards for manufacturing site inspections; (3) use of common evaluation protocols, aswell as joint review of data, to reduce unnecessary duplication of lengthy and costly clinical performance studies; and (4) use of networks of laboratories for post-market surveillance in order to monitor ongoing quality of diagnostic devices. The adoption and implementation of such measures in developing countries could accelerate access to new diagnostic tests that are safe and affordable.

scholarly journals Infectious Diseases Society of America Guidelines on the Diagnosis of Coronavirus Disease 2019 (COVID-19): Serologic Testing

2020 ◽  
Author(s):  
Kimberly E Hanson ◽  
Angela M Caliendo ◽  
Cesar A Arias ◽  
Janet A Englund ◽  
Mary K Hayden ◽  
...  
Keyword(s):  
Infectious Diseases ◽  
Best Practice ◽  
Vaccine Development ◽  
Clinical Performance ◽  
Diagnostic Testing ◽  
Molecular Diagnostic ◽  
Past Infection ◽  
Serologic Tests ◽  
Serologic Testing ◽  
Grade Methodology

Abstract Background The availability of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serologic testing has rapidly increased. Current assays use a variety of technologies, measure different classes of immunoglobulin or immunoglobulin combinations, and detect antibodies directed against different portions of the virus. The overall accuracy of these tests, however, has not been well defined. The Infectious Diseases Society of America (IDSA) convened an expert panel to perform a systematic review of the coronavirus disease 2019 (COVID-19) serology literature and construct best-practice guidance related to SARS-CoV-2 serologic testing. This guideline is the fourth in a series of rapid, frequently updated COVID-19 guidelines developed by IDSA. Objective IDSA’s goal was to develop evidence-based recommendations that assist clinicians, clinical laboratories, patients, and policymakers in decisions related to the optimal use of SARS-CoV-2 serologic tests in a variety of settings. We also highlight important unmet research needs pertaining to the use of anti–SARS-CoV-2 antibody tests for diagnosis, public health surveillance, vaccine development, and the selection of convalescent plasma donors. Methods A multidisciplinary panel of infectious diseases clinicians, clinical microbiologists, and experts in systematic literature review identified and prioritized clinical questions related to the use of SARS-CoV-2 serologic tests. Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology was used to assess the certainty of evidence and make testing recommendations. Results The panel agreed on 8 diagnostic recommendations. Conclusions Information on the clinical performance and utility of SARS-CoV-2 serologic tests is rapidly emerging. Based on available evidence, detection of anti–SARS-CoV-2 antibodies may be useful for confirming the presence of current or past infection in selected situations. The panel identified 3 potential indications for serologic testing, including (1) evaluation of patients with a high clinical suspicion for COVID-19 when molecular diagnostic testing is negative and ≥2 weeks have passed since symptom onset, (2) assessment of multisystem inflammatory syndrome in children, and (3) conducting serosurveillance studies. The certainty of available evidence supporting the use of serology for either diagnosis or epidemiology was, however, graded as very low to moderate. For the most updated version of these guidelines, please go to https://www.idsociety.org/covid19guidelines.

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 ◽  
...  
Keyword(s):  
Diagnostic Tests ◽  
Clinical Utility ◽  
Molecular Diagnostic

scholarly journals CRISPR-Cas Systems for Diagnosing Infectious Diseases

2020 ◽  
Author(s):  
Anastasiya Kostyusheva ◽  
Sergey Brezgin ◽  
Yurii Babin ◽  
Irina Vasil'eva ◽  
Dmitry Kostyushev ◽  
...  
Keyword(s):  
Infectious Diseases ◽  
Molecular Diagnostics ◽  
Large Scale ◽  
Point Of Care ◽  
Disease Spread ◽  
Detection Methods ◽  
Epidemiological Surveillance ◽  
Molecular Diagnostic ◽  
Diagnostic Tools ◽  
Wide Range

Infectious diseases are a global health problem affecting billions of people. Developing rapid and sensitive diagnostic tools is key for successful patient management and curbing disease spread. Currently available diagnostics are very specific and sensitive but time-consuming and require expensive laboratory settings and well-trained personnel; thus, they are not available in resource-limited areas, for the purposes of large-scale screenings and in case of outbreaks and epidemics. Developing new, rapid, and affordable point-of-care diagnostic assays is urgently needed. This review focuses on CRISPR-based technologies and their perspectives to become platforms for point-of-care nucleic acid detection methods and as deployable diagnostic platforms that could help to identify and curb outbreaks and emerging epidemics. We describe the mechanisms and function of different classes and types of CRISPR-Cas systems, including pros and cons for developing molecular diagnostic tests and applications of each type to detect a wide range of infectious agents. Many Cas proteins (Cas9, Cas12, Cas13, Cas14) have been leveraged to create highly accurate and sensitive diagnostic tools combined with technologies of signal amplification and fluorescent, potentiometric, colorimetric, or lateral flow assay detection. In particular, the most advanced platforms -- SHERLOCK/v2, DETECTR, or CRISPR-Chip -- enable detection of attomolar amounts of pathogenic nucleic acids with specificity comparable to that of PCR but with minimal technical settings. Further developing CRISPR-based diagnostic tools promises to dramatically transform molecular diagnostics, making them easily affordable and accessible virtually anywhere in the world. The burden of socially significant diseases, frequent outbreaks, recent epidemics (MERS, SARS and the ongoing coronoviral nCov-2019 infection) urgently need the developing of express-diagnostic tools. Recently devised CRISPR-technologies represent the unprecedented opportunity to reshape epidemiological surveillance and molecular diagnostics.

scholarly journals Intensivists’ beliefs about rapid multiplex molecular diagnostic testing and its potential role in improving prescribing decisions and antimicrobial stewardship: a qualitative study

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Alyssa M. Pandolfo ◽  
Robert Horne ◽  
Yogini Jani ◽  
Tom W. Reader ◽  
Natalie Bidad ◽  
...  
Keyword(s):  
Molecular Diagnostics ◽  
Antimicrobial Stewardship ◽  
Diagnostic Tests ◽  
Pathogenic Bacteria ◽  
Point Of Care ◽  
Diagnostic Testing ◽  
Molecular Diagnostic ◽  
Antibiotic Prescribing ◽  
Test Results ◽  
Structured Interviews

Abstract Background Rapid molecular diagnostic tests to investigate the microbial aetiology of pneumonias may improve treatment and antimicrobial stewardship in intensive care units (ICUs). Clinicians’ endorsement and uptake of these tests is crucial to maximise engagement; however, adoption may be impeded if users harbour unaddressed concerns or if device usage is incompatible with local practice. Accordingly, we strove to identify ICU clinicians’ beliefs about molecular diagnostic tests for pneumonias before implementation at the point-of-care. Methods We conducted semi-structured interviews with 35 critical care doctors working in four ICUs in the United Kingdom. A clinical vignette depicting a fictitious patient with signs of pneumonia was used to explore clinicians’ beliefs about the importance of molecular diagnostics and their concerns. Data were analysed thematically. Results Clinicians’ beliefs about molecular tests could be grouped into two categories: perceived potential of molecular diagnostics to improve antibiotic prescribing (Molecular Diagnostic Necessity) and concerns about how the test results could be implemented into practice (Molecular Diagnostic Concerns). Molecular Diagnostic Necessity stemmed from beliefs that positive results would facilitate targeted antimicrobial therapy; that negative results would signal the absence of a pathogen, and consequently that having the molecular diagnostic results would bolster clinicians’ prescribing confidence. Molecular Diagnostic Concerns included unfamiliarity with the device’s capabilities, worry that it would detect non-pathogenic bacteria, uncertainty whether it would fail to detect pathogens, and discomfort with withholding antibiotics until receiving molecular test results. Conclusions Clinicians believed rapid molecular diagnostics for pneumonias were potentially important and were open to using them; however, they harboured concerns about the tests’ capabilities and integration into clinical practice. Implementation strategies should bolster users’ necessity beliefs while reducing their concerns; this can be accomplished by publicising the tests’ purpose and benefits, identifying and addressing clinicians’ misconceptions, establishing a trial period for first-hand familiarisation, and emphasising that, with a swift (e.g., 60–90 min) test, antibiotics can be started and refined after molecular diagnostic results become available.

scholarly journals How to best test suspected cases of COVID-19: an analysis of the diagnostic performance of RT-PCR and alternative molecular methods for the detection of SARS-CoV-2

2021 ◽  
Author(s):  
Adrian Mironas ◽  
David Jarrom ◽  
Evan Campbell ◽  
Jennifer Washington ◽  
Sabine Ettinger ◽  
...  
Keyword(s):  
Diagnostic Test ◽  
Test Performance ◽  
Clinical Utility ◽  
Diagnostic Performance ◽  
Point Of Care ◽  
Alternative Methods ◽  
Rt Pcr ◽  
Predictive Values ◽  
Molecular Assays ◽  
Test Result

AbstractAs COVID-19 testing is rolled out increasingly widely, the use of a range of alternative testing methods will be beneficial in ensuring testing systems are resilient and adaptable to different clinical and public health scenarios. Here, we compare and discuss the diagnostic performance of a range of different molecular assays designed to detect the presence of SARS-CoV-2 infection in people with suspected COVID-19. Using findings from a systematic review of 103 studies, we categorised COVID-19 molecular assays into 12 different test classes, covering point-of-care tests, various alternative RT-PCR protocols, and alternative methods such as isothermal amplification. We carried out meta-analyses to estimate the diagnostic accuracy and clinical utility of each test class. We also estimated the positive and negative predictive values of all diagnostic test classes across a range of prevalence rates. Using previously validated RT-PCR assays as a reference standard, 11 out of 12 classes showed a summary sensitivity estimate of at least 92% and a specificity estimate of at least 99%. Several diagnostic test classes were estimated to have positive predictive values of 100% throughout the investigated prevalence spectrum, whilst estimated negative predictive values were more variable and sensitive to disease prevalence. We also report the results of clinical utility models that can be used to determine the information gained from a positive and negative test result in each class, and whether each test is more suitable for confirmation or exclusion of disease. Our analysis suggests that several tests exist that are suitable alternatives to standard RT-PCR and we discuss scenarios in which these could be most beneficial, such as where time to test result is critical or, where resources are constrained. However, we also highlight methodological concerns with the design and conduct of many included studies, and also the existence of likely publication bias for some test classes. Our results should be interpreted with these shortcomings in mind. Furthermore, our conclusions on test performance are limited to their use in symptomatic populations: we did not identify sufficient suitable data to allow analysis of testing in asymptomatic populations.

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