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

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.

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Analysis of the tendency of development of biosensors based on GaN

Nanotechnology : the development , application - XXI Century ◽

10.18127/j22250980-202102-02 ◽

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.

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Influence of viral transport media and freeze-thaw cycling on the sensitivity of qRT-PCR detection of SARS-CoV-2 nucleic acids

Nanoscale ◽

10.1039/d1nr03933d ◽

2021 ◽

Author(s):

Cian Holohan ◽

Sophia Hanrahan ◽

Nathan Feely ◽

Peng Li ◽

John O'Connell ◽

...

Keyword(s):

Infectious Diseases ◽

Nucleic Acids ◽

Large Scale ◽

Diagnostic Testing ◽

Pcr Detection ◽

Molecular Diagnostic ◽

Freeze Thaw ◽

Qrt Pcr ◽

Viral Transport ◽

Molecular Diagnostic Testing

Objective The events of the last year have highlighted the complexity of implementing molecular diagnostic testing for infectious diseases at a large scale. The purpose of this study was to...

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

10.1101/2022.01.07.22268874 ◽

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.

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Molecular diagnostic testing for infectious diseases using TMA technology

Expert Review of Molecular Diagnostics ◽

10.1586/14737159.1.4.445 ◽

2001 ◽

Vol 1 (4) ◽

pp. 445-455 ◽

Cited By ~ 42

Author(s):

Craig S Hill

Keyword(s):

Infectious Diseases ◽

Diagnostic Testing ◽

Molecular Diagnostic ◽

Molecular Diagnostic Testing

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The Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19: Molecular Diagnostic Testing

Clinical Infectious Diseases ◽

10.1093/cid/ciab048 ◽

2021 ◽

Cited By ~ 1

Author(s):

Kimberly E Hanson ◽

Angela M Caliendo ◽

Cesar A Arias ◽

Mary K Hayden ◽

Janet A Englund ◽

...

Keyword(s):

Nucleic Acid ◽

Infectious Diseases ◽

Diagnostic Testing ◽

Molecular Diagnostic ◽

Evidence Based ◽

Solid Organ ◽

Care Hospital ◽

Nucleic Acid Testing ◽

Hematopoietic Stem ◽

Asymptomatic Individuals

Abstract Background Accurate molecular diagnostic tests are necessary for confirming a diagnosis of coronavirus disease 2019 (COVID-19). Direct detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acids in respiratory tract specimens informs patient, healthcare institution and public health level decision-making. The numbers of available SARS-CoV-2 nucleic acid detection tests are rapidly increasing, as is the COVID-19 diagnostic literature. Thus, the Infectious Diseases Society of America (IDSA) recognized a significant need for frequently updated systematic reviews of the literature to inform evidence-based best practice guidance. Objective The IDSA’s goal was to develop an evidence-based diagnostic guideline to assist clinicians, clinical laboratorians, patients and policymakers in decisions related to the optimal use of SARS-CoV-2 nucleic acid amplification tests. In addition, we provide a conceptual framework for understanding molecular diagnostic test performance, discuss the nuance of test result interpretation in a variety of practice settings and highlight important unmet research needs in the COVID-19 diagnostic testing space. Methods IDSA convened a multidisciplinary panel of infectious diseases clinicians, clinical microbiologists, and experts in systematic literature review to identify and prioritize clinical questions and outcomes related to the use of SARS-CoV-2 molecular diagnostics. 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 17 diagnostic recommendations. Conclusions Universal access to accurate SARS-CoV-2 nucleic acid testing is critical for patient care, hospital infection prevention and the public response to the COVID-19 pandemic. Information on the clinical performance of available tests is rapidly emerging, but the quality of evidence of the current literature is considered moderate to very low. Recognizing these limitations, the IDSA panel weighed available diagnostic evidence and recommends nucleic acid testing for all symptomatic individuals suspected of having COVID-19. In addition, testing is recommended for asymptomatic individuals with known or suspected contact with a COVID-19 case. Testing asymptomatic individuals without known exposure is suggested when the results will impact isolation/quarantine/personal protective equipment (PPE) usage decisions, dictate eligibility for surgery, or inform solid organ or hematopoietic stem cell transplantation timing. Ultimately, prioritization of testing will depend on institutional-specific resources and the needs of different patient populations.

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Gastroesophageal Reflux Disease: A Gastroenterologist's Perspective

Perspectives on Voice and Voice Disorders ◽

10.1044/vvd21.3.89 ◽

2011 ◽

Vol 21 (3) ◽

pp. 89-99

Author(s):

Michael F. Vaezi

Keyword(s):

Gastroesophageal Reflux Disease ◽

Gastroesophageal Reflux ◽

Reflux Disease ◽

Best Practice ◽

Clinical Care ◽

Diagnostic Testing ◽

Diagnostic Tools ◽

Swallowing Function ◽

Atypical Symptoms

Gastroesophageal reflux disease (GERD) is a commonly diagnosed condition often associated with the typical symptoms of heartburn and regurgitation, although it may present with atypical symptoms such as chest pain, hoarseness, chronic cough, and asthma. In most cases, the patient's reduced quality of life drives clinical care and diagnostic testing. Because of its widespread impact on voice and swallowing function as well as its social implications, it is important that speech-language pathologists (SLPs) understand the nature of GERD and its consequences. The purpose of this article is to summarize the nature of GERD and GERD-related complications such as GERD-related peptic stricture, Barrett's esophagus and adenocarcinoma, and laryngeal manifestations of GERD from a gastroenterologist's perspective. It is critical that SLPs who work with a multidisciplinary team understand terminology, diagnostic tools, and treatment to ensure best practice.

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The use of the objective structured clinical examination (OSCE) in a practice-based health discipline: Academic and student experience in paramedicine

Health Education in Practice: Journal of Research for Professional Learning ◽

10.33966/hepj.3.2.14225 ◽

2020 ◽

Vol 3 (2) ◽

Author(s):

Andy Bell ◽

Jennifer Kelly ◽

Peter Lewis

Keyword(s):

Clinical Examination ◽

Best Practice ◽

Assessment Tool ◽

Clinical Performance ◽

Reliability And Validity ◽

Specific Area ◽

Training Model ◽

Objective Structured Clinical Examination ◽

Evidence Based ◽

Effective Measure

Abstract:Purpose:Over the past two decades, the discipline of Paramedicine has seen expediential growth as it moved from a work-based training model to that of an autonomous profession grounded in academia. With limited evidence-based literature examining assessment in paramedicine, this paper aims to describe student and academic views on the preference for OSCE as an assessment modality, the sufficiency of pre-OSCE instruction, and whether or not OSCE performance is a perceived indicator of clinical performance.Design/Methods:A voluntary, anonymous survey was conducted to examine the perception of the reliability and validity of the Objective Structured Clinical Examination (OSCE) as an assessment tool by students sitting the examination and the academics that facilitate the assessment. Findings:The results of this study revealed that the more confident the students are in the reliability and validity of the assessment, the more likely they are to perceive the assessment as an effective measure of their clinical performance. The perception of reliability and validity differs when acted upon by additional variables, with the level of anxiety associated with the assessment and the adequacy of feedback of performance cited as major influencers. Research Implications:The findings from this study indicate the need for further paramedicine discipline specific research into assessment methodologies to determine best practice models for high quality assessment.Practical Implications:The development of evidence based best practice guidelines for the assessment of student paramedics should be of the upmost importance to a young, developing profession such as paramedicine.Originality/Value: There is very little research in the discipline specific area of assessment for paramedicine and discipline specific education research is essential for professional growth.Limitations:The principal researcher was a faculty member of one of the institutions surveyed. However, all data was non identifiable at time of data collection. Key WordsParamedic; paramedicine; objective structured clinical examinations; OSCE; education; assessment.

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Platforms for Production of Protein-Based Vaccines: From Classical to Next-Generation Strategies

Biomolecules ◽

10.3390/biom11081072 ◽

2021 ◽

Vol 11 (8) ◽

pp. 1072

Author(s):

Raquel Cid ◽

Jorge Bolívar

Keyword(s):

Infectious Diseases ◽

Mammalian Cells ◽

Vaccine Development ◽

Low Cost ◽

Cost Effective ◽

Insect Larvae ◽

Subunit Vaccines ◽

Effective Strategies ◽

Alternative Systems ◽

Inactivated Vaccines

To date, vaccination has become one of the most effective strategies to control and reduce infectious diseases, preventing millions of deaths worldwide. The earliest vaccines were developed as live-attenuated or inactivated pathogens, and, although they still represent the most extended human vaccine types, they also face some issues, such as the potential to revert to a pathogenic form of live-attenuated formulations or the weaker immune response associated with inactivated vaccines. Advances in genetic engineering have enabled improvements in vaccine design and strategies, such as recombinant subunit vaccines, have emerged, expanding the number of diseases that can be prevented. Moreover, antigen display systems such as VLPs or those designed by nanotechnology have improved the efficacy of subunit vaccines. Platforms for the production of recombinant vaccines have also evolved from the first hosts, Escherichia coli and Saccharomyces cerevisiae, to insect or mammalian cells. Traditional bacterial and yeast systems have been improved by engineering and new systems based on plants or insect larvae have emerged as alternative, low-cost platforms. Vaccine development is still time-consuming and costly, and alternative systems that can offer cost-effective and faster processes are demanding to address infectious diseases that still do not have a treatment and to face possible future pandemics.

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458. Molecular SARS-CoV-2 Testing During the COVID-19 Outbreak: Experiences of a Hospital in Southeast Michigan, USA

Open Forum Infectious Diseases ◽

10.1093/ofid/ofaa439.651 ◽

2020 ◽

Vol 7 (Supplement_1) ◽

pp. S296-S297

Author(s):

Trini A Mathew ◽

Jonathan Hopkins ◽

Diane Kamerer ◽

Shagufta N Ali ◽

Daniel Ortiz ◽

...

Keyword(s):

Clinical Features ◽

Diagnostic Testing ◽

Beaumont Hospital ◽

High Capacity ◽

Turnaround Time ◽

Molecular Diagnostic ◽

The Novel ◽

Repeat Testing ◽

Asymptomatic Patients ◽

Novel Coronavirus

Abstract Background The novel Coronavirus SARS CoV-2 (COVID-19) outbreak was complicated by the lack of diagnostic testing kits. In early March 2020, leadership at Beaumont Hospital, Royal Oak Michigan (Beaumont) identified the need to develop high capacity testing modalities with appropriate sensitivity and specificity and rapid turnaround time. We describe the molecular diagnostic testing experience since initial rollout on March 16, 2020 at Beaumont, and results of repeat testing during the peak of the COVID-19 pandemic in MI. Methods Beaumont is an 1100 bed hospital in Southeast MI. In March, testing was initially performed with the EUA Luminex NxTAG CoV Extended Panel until March 28, 2020 when testing was converted to the EUA Cepheid Xpert Xpress SARS-CoV-2 for quicker turnaround times. Each assay was validated with a combination of patient samples and contrived specimens. Results During the initial week of testing there was > 20 % specimen positivity. As the prevalence grew the positivity rate reached 68% by the end of March (Figure 1). Many state and hospital initiatives were implemented during the outbreak, including social distancing and screening of asymptomatic patients to increase case-finding and prevent transmission. We also adopted a process for clinical review of symptomatic patients who initially tested negative for SARS-CoV-2 by a group of infectious disease physicians (Figure 2). This process was expanded to include other trained clinicians who were redeployed from other departments in the hospital. Repeat testing was performed to allow consideration of discontinuation of isolation precautions. During the surge of community cases from March 16 to April 30, 2020, we identified patients with negative PCR tests who subsequently had repeat testing based on clinical evaluation, with 7.1% (39/551) returning positive for SARS- CoV2. Of the patients who expired due to COVID-19 during this period, 4.3% (9/206) initially tested negative before ultimately testing positive. Figure 1 BH RO testing Epicurve Figure 2: Screening tool for repeat COVID19 testing and precautions Conclusion Many state and hospital initiatives helped us flatten the curve for COVID-19. Our hospital testing experience indicate that repeat testing may be warranted for those patients with clinical features suggestive of COVID-19. We will further analyze these cases and clinical features that prompted repeat testing. Disclosures All Authors: No reported disclosures

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