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  1. Article ; Online: Can Testing Predict SARS-CoV-2 Infectivity? The Potential for Certain Methods To Be Surrogates for Replication-Competent Virus.

    Binnicker, Matthew J

    Journal of clinical microbiology

    2021  Volume 59, Issue 11, Page(s) e0046921

    Abstract: Since the beginning of the COVID-19 pandemic, molecular methods (e.g., real-time PCR) have been the primary means of diagnosing the disease. It is now well established that molecular tests can continue to detect SARS-CoV-2 genomic RNA for weeks or months ...

    Abstract Since the beginning of the COVID-19 pandemic, molecular methods (e.g., real-time PCR) have been the primary means of diagnosing the disease. It is now well established that molecular tests can continue to detect SARS-CoV-2 genomic RNA for weeks or months following the resolution of clinical illness. This has prompted public health agencies to recommend a symptom- and/or time-based strategy for discontinuation of isolation precautions, which, for hospitalized patients, results in significant use of personal protective equipment. Due to the inability of current molecular diagnostic assays to differentiate between the presence of remnant viral RNA (i.e., noninfectious) and replication-competent (i.e., infectious) virus, there has been interest in determining whether laboratory tests can be used to predict an individual's likelihood of transmitting the virus to others. This review will highlight what is currently known about the potential for existing assays, such as real-time PCR and antigen tests, to predict active viral infection. In addition, data on the performance of new methods, such as molecular tests targeting viral RNA intermediates (e.g., subgenomic RNA), will be discussed.
    MeSH term(s) COVID-19 ; Humans ; Pandemics ; Public Health ; RNA, Viral/genetics ; SARS-CoV-2
    Chemical Substances RNA, Viral
    Language English
    Publishing date 2021-08-04
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 390499-4
    ISSN 1098-660X ; 0095-1137
    ISSN (online) 1098-660X
    ISSN 0095-1137
    DOI 10.1128/JCM.00469-21
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  2. Article ; Online: Can the Severe Acute Respiratory Syndrome Coronavirus 2 Polymerase Chain Reaction Cycle Threshold Value and Time From Symptom Onset to Testing Predict Infectivity?

    Binnicker, Matthew J

    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

    2020  Volume 71, Issue 10, Page(s) 2667–2668

    MeSH term(s) COVID-19 ; Clinical Laboratory Techniques ; Communicable Diseases ; Humans ; Real-Time Polymerase Chain Reaction ; SARS-CoV-2
    Keywords covid19
    Language English
    Publishing date 2020-06-05
    Publishing country United States
    Document type Editorial ; Comment
    ZDB-ID 1099781-7
    ISSN 1537-6591 ; 1058-4838
    ISSN (online) 1537-6591
    ISSN 1058-4838
    DOI 10.1093/cid/ciaa735
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  3. Article ; Online: Emergence of a Novel Coronavirus Disease (COVID-19) and the Importance of Diagnostic Testing: Why Partnership between Clinical Laboratories, Public Health Agencies, and Industry Is Essential to Control the Outbreak.

    Binnicker, Matthew J

    Clinical chemistry

    2020  Volume 66, Issue 5, Page(s) 664–666

    MeSH term(s) Betacoronavirus ; COVID-19 ; COVID-19 Testing ; Clinical Laboratory Techniques ; Coronavirus Infections/diagnosis ; Drug Industry ; Humans ; Pandemics ; Pneumonia, Viral/diagnosis ; Public Health ; Public-Private Sector Partnerships ; SARS-CoV-2
    Keywords covid19
    Language English
    Publishing date 2020-02-20
    Publishing country England
    Document type Journal Article
    ZDB-ID 80102-1
    ISSN 1530-8561 ; 0009-9147
    ISSN (online) 1530-8561
    ISSN 0009-9147
    DOI 10.1093/clinchem/hvaa071
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  4. Article: From the Common Cold to a Chaotic Contagion: the Potential for Coronaviruses To Cause Outbreaks of Severe Respiratory Disease Representing a Global Health Threat.

    Binnicker, Matthew J

    Clinical microbiology newsletter

    2020  Volume 42, Issue 12, Page(s) 95–103

    Abstract: Coronaviruses are a family of RNA viruses that typically cause mild respiratory disease in humans. However, over the past 20 years, three novel/variant coronaviruses have spilled over from animals into humans and have been associated with severe ... ...

    Abstract Coronaviruses are a family of RNA viruses that typically cause mild respiratory disease in humans. However, over the past 20 years, three novel/variant coronaviruses have spilled over from animals into humans and have been associated with severe respiratory illness. In late 2002, severe acute respiratory syndrome (SARS) coronavirus (CoV) emerged in China and, over the following year, went on to cause approximately 8,100 cases and 774 deaths. A decade later, a cluster of severe pneumonia cases occurred on the Arabian Peninsula, marking the beginning of the Middle East respiratory syndrome (MERS)-CoV outbreak, which has resulted in nearly 2,500 confirmed cases and 850 deaths. Now in 2020, we are in the midst of a global pandemic caused by SARS-CoV-2, which, at the time of this writing, has claimed the lives of over 83,500 people and has been confirmed in over 1,500,000 cases. These outbreaks highlight the pathogenic potential of CoVs and the importance of infection prevention and diagnostic testing to reduce the spread of infectious diseases representing a global health threat.
    Language English
    Publishing date 2020-06-03
    Publishing country United States
    Document type Journal Article
    ZDB-ID 985782-5
    ISSN 1873-4391 ; 0196-4399
    ISSN (online) 1873-4391
    ISSN 0196-4399
    DOI 10.1016/j.clinmicnews.2020.05.004
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    Zs.A 2064: Show issues Location:
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  5. Article ; Online: Challenges and Controversies to Testing for COVID-19.

    Binnicker, Matthew J

    Journal of clinical microbiology

    2020  Volume 58, Issue 11

    Abstract: The coronavirus disease (COVID-19) pandemic has placed the clinical laboratory and testing for SARS-CoV-2 front and center in the worldwide discussion of how to end the outbreak. Clinical laboratories have responded by developing, validating, and ... ...

    Abstract The coronavirus disease (COVID-19) pandemic has placed the clinical laboratory and testing for SARS-CoV-2 front and center in the worldwide discussion of how to end the outbreak. Clinical laboratories have responded by developing, validating, and implementing a variety of molecular and serologic assays to test for SARS-CoV-2 infection. This has played an essential role in identifying cases, informing isolation decisions, and helping to curb the spread of disease. However, as the demand for COVID-19 testing has increased, laboratory professionals have faced a growing list of challenges, uncertainties, and, in some situations, controversy, as they have attempted to balance the need for increasing test capacity with maintaining a high-quality laboratory operation. The emergence of this new viral pathogen has raised unique diagnostic questions for which there have not always been straightforward answers. In this commentary, the author addresses several areas of current debate, including (i) the role of molecular assays in defining the duration of isolation/quarantine, (ii) whether the PCR cycle threshold value should be included on patient reports, (iii) if specimen pooling and testing by research staff represent acceptable solutions to expand screening, and (iv) whether testing a large percentage of the population is feasible and represents a viable strategy to end the pandemic.
    MeSH term(s) Betacoronavirus/genetics ; Betacoronavirus/immunology ; Betacoronavirus/isolation & purification ; COVID-19 ; COVID-19 Testing ; Clinical Laboratory Services/standards ; Clinical Laboratory Techniques ; Coronavirus Infections/diagnosis ; Coronavirus Infections/prevention & control ; Humans ; Mass Screening ; Medical Laboratory Personnel/standards ; Molecular Diagnostic Techniques/standards ; Pandemics/prevention & control ; Pneumonia, Viral/diagnosis ; Pneumonia, Viral/prevention & control ; Polymerase Chain Reaction/standards ; Quarantine/standards ; SARS-CoV-2 ; Sensitivity and Specificity ; Specimen Handling
    Keywords covid19
    Language English
    Publishing date 2020-10-21
    Publishing country United States
    Document type Journal Article
    ZDB-ID 390499-4
    ISSN 1098-660X ; 0095-1137
    ISSN (online) 1098-660X
    ISSN 0095-1137
    DOI 10.1128/JCM.01695-20
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  6. Article ; Online: Analytic and Clinical Performance of Major Commercial Severe Acute Respiratory Syndrome Coronavirus 2 Molecular Assays in the United States.

    Campbell, Michelle R / Binnicker, Matthew J

    Clinics in laboratory medicine

    2022  Volume 42, Issue 2, Page(s) 129–145

    Abstract: The rapid development of commercially available molecular assays in response to the COVID-19 pandemic has been essential in identifying positive cases and guiding state and national response plans. With over 200 SARS-CoV-2 molecular tests having received ...

    Abstract The rapid development of commercially available molecular assays in response to the COVID-19 pandemic has been essential in identifying positive cases and guiding state and national response plans. With over 200 SARS-CoV-2 molecular tests having received emergency use authorization by the US Food and Drug Administration, numerous studies have been conducted to evaluate these methods and compare their analytical and clinical performance. By applying the lessons learned from the rapid development of molecular assays in response to the COVID-19 pandemic, the diagnostic industry will be better prepared to respond to future outbreaks of novel infectious diseases.
    MeSH term(s) COVID-19/diagnosis ; COVID-19/epidemiology ; Disease Outbreaks ; Humans ; Pandemics ; SARS-CoV-2 ; United States/epidemiology
    Language English
    Publishing date 2022-02-21
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 604580-7
    ISSN 1557-9832 ; 0272-2712
    ISSN (online) 1557-9832
    ISSN 0272-2712
    DOI 10.1016/j.cll.2022.02.001
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  7. Article ; Online: Current regulatory landscape for viral point-of-care testing in the United States.

    Shirley, Joshua D / Bennett, Shannon A / Binnicker, Matthew J

    Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology

    2023  Volume 164, Page(s) 105492

    Abstract: Historically, the diagnosis of viral infections has been accomplished using a combination of laboratory-based methods, including culture, serology, antigen-based tests, and molecular (e.g., real-time PCR) assays. Although these methods provide an ... ...

    Abstract Historically, the diagnosis of viral infections has been accomplished using a combination of laboratory-based methods, including culture, serology, antigen-based tests, and molecular (e.g., real-time PCR) assays. Although these methods provide an accurate way to detect viral pathogens, testing in a centralized laboratory may delay results, which could impact patient diagnosis and management. Point-of-care tests, including antigen- and molecular-based assays, have been developed to assist with the timely diagnosis of several viral infections, such as influenza, respiratory syncytial virus, and COVID-19. Despite the ability of point-of-care tests to provide rapid results (i.e., <30 min), there are issues to consider prior to their routine use, including test performance and specific regulatory requirements. This review will provide a summary of the regulatory landscape of point-of-care tests for viral infections in the United States, and address important considerations such as site certification, training and inspection readiness.
    MeSH term(s) Humans ; United States ; COVID-19/diagnosis ; Molecular Diagnostic Techniques/methods ; Point-of-Care Testing ; Virus Diseases/diagnosis ; Respiratory Syncytial Virus, Human/genetics ; Sensitivity and Specificity ; Point-of-Care Systems
    Language English
    Publishing date 2023-05-17
    Publishing country Netherlands
    Document type Journal Article ; Review
    ZDB-ID 1446080-4
    ISSN 1873-5967 ; 1386-6532
    ISSN (online) 1873-5967
    ISSN 1386-6532
    DOI 10.1016/j.jcv.2023.105492
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  9. Article: Emergence of a Novel Coronavirus Disease (COVID-19) and the Importance of Diagnostic Testing: Why Partnership between Clinical Laboratories, Public Health Agencies, and Industry Is Essential to Control the Outbreak

    Binnicker, Matthew J

    Clin Chem

    Keywords covid19
    Publisher WHO
    Document type Article
    Note WHO #Covidence: #1412
    Database COVID19

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  10. Article ; Online: Emergence of a Novel Coronavirus Disease (COVID-19) and the Importance of Diagnostic Testing

    Binnicker, Matthew J

    Clinical Chemistry

    Why Partnership between Clinical Laboratories, Public Health Agencies, and Industry Is Essential to Control the Outbreak

    2020  Volume 66, Issue 5, Page(s) 664–666

    Keywords Clinical Biochemistry ; Biochemistry, medical ; covid19
    Language English
    Publisher Oxford University Press (OUP)
    Publishing country uk
    Document type Article ; Online
    ZDB-ID 80102-1
    ISSN 1530-8561 ; 0009-9147
    ISSN (online) 1530-8561
    ISSN 0009-9147
    DOI 10.1093/clinchem/hvaa071
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