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  1. Book: Respiratory infections

    Loeffelholz, Michael J.

    (Clinics in laboratory medicine ; 34,2)

    2014  

    Author's details ed. Michael J. Loeffelholz
    Series title Clinics in laboratory medicine ; 34,2
    Collection
    Language English
    Size XI, S. 197 - 442 : graph. Darst.
    Publisher Elsevier
    Publishing place Philadelphia, Pa
    Publishing country United States
    Document type Book
    HBZ-ID HT018339398
    ISBN 978-0-323-29924-4 ; 0-323-29924-5
    Database Catalogue ZB MED Medicine, Health

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  2. Article ; Online: Practical Challenges of Point-of-Care Testing.

    Ortiz, Daniel A / Loeffelholz, Michael J

    Clinics in laboratory medicine

    2023  Volume 43, Issue 2, Page(s) 155–165

    Abstract: The practical challenges of point-of-care testing (POCT) include analytical performance and quality compared with testing performed in a central laboratory and higher cost per test compared with laboratory-based tests. These challenges can be addressed ... ...

    Abstract The practical challenges of point-of-care testing (POCT) include analytical performance and quality compared with testing performed in a central laboratory and higher cost per test compared with laboratory-based tests. These challenges can be addressed with new test technology, consensus, and practice guidelines for the use of POCT, instituting a quality management system and data connectivity in the POCT setting, and studies that demonstrate evidence of clinical and economic value of POCT.
    MeSH term(s) Point-of-Care Testing ; Laboratories ; Point-of-Care Systems
    Language English
    Publishing date 2023-03-22
    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.2023.02.002
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Evaluation of High-Throughput Serological Tests for SARS-CoV-2.

    Loeffelholz, Michael J

    Journal of clinical microbiology

    2020  Volume 58, Issue 11

    Abstract: Serologic methods are an important part of a clinical laboratory's portfolio of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) tests and are essential to the broader response to coronavirus infectious disease 2019 (COVID-19), including ... ...

    Abstract Serologic methods are an important part of a clinical laboratory's portfolio of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) tests and are essential to the broader response to coronavirus infectious disease 2019 (COVID-19), including epidemiological studies and vaccine development. There are currently a number of commercial SARS-CoV-2 antibody tests with emergency use authorization (EUA) from the U.S. Food and Drug Administration. In this issue of the
    MeSH term(s) Antibodies, Viral ; Betacoronavirus ; COVID-19 ; COVID-19 Testing ; Clinical Laboratory Techniques ; Coronavirus Infections/diagnosis ; Humans ; Immunoassay ; Immunoglobulin G ; Nucleocapsid ; Pandemics ; Pneumonia, Viral ; SARS Virus ; SARS-CoV-2 ; Serologic Tests ; Spike Glycoprotein, Coronavirus
    Chemical Substances Antibodies, Viral ; Immunoglobulin G ; Spike Glycoprotein, Coronavirus
    Keywords covid19
    Language English
    Publishing date 2020-10-21
    Publishing country United States
    Document type Journal Article ; Comment
    ZDB-ID 390499-4
    ISSN 1098-660X ; 0095-1137
    ISSN (online) 1098-660X
    ISSN 0095-1137
    DOI 10.1128/JCM.02179-20
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Taxonomic Changes for Human Viruses, 2020 to 2022.

    Relich, Ryan F / Loeffelholz, Michael J

    Journal of clinical microbiology

    2022  Volume 61, Issue 1, Page(s) e0033722

    Abstract: The classification of viruses remains relevant to several disciplines, including clinical virology. Since the original publication of this review in 2019, many known viruses have undergone taxonomic revisions, and several novel human and animal viruses ... ...

    Abstract The classification of viruses remains relevant to several disciplines, including clinical virology. Since the original publication of this review in 2019, many known viruses have undergone taxonomic revisions, and several novel human and animal viruses have been described. Here, we provide an update to our previous reviews of taxonomic changes for disease-causing viruses of humans, covering changes that occurred between 2020 and 2022. As with previous editions, this update was informed by recent advances in virus taxonomy made by the International Committee on Taxonomy of Viruses; the changes and additions noted herein are not all-inclusive.
    MeSH term(s) Humans ; Viruses/classification
    Language English
    Publishing date 2022-12-21
    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.00337-22
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Considerations regarding Interpretation of Positive SARS-CoV-2 Molecular Results with Late Cycle Threshold Values.

    Mitchell, Stephanie L / Loeffelholz, Michael J

    Journal of clinical microbiology

    2022  Volume 60, Issue 9, Page(s) e0050122

    Abstract: COVID-19 disease lies on a spectrum, ranging from completely asymptomatic to mild disease to severe and critical disease. Studies have shown that prolonged shedding or sporadic detection of SARS-CoV-2 RNA can occur long after symptom resolution. Adding ... ...

    Abstract COVID-19 disease lies on a spectrum, ranging from completely asymptomatic to mild disease to severe and critical disease. Studies have shown that prolonged shedding or sporadic detection of SARS-CoV-2 RNA can occur long after symptom resolution. Adding to these clinical complexities is the demand for testing for SARS-CoV-2 at all stages of diseases, frequently driven by screening of asymptomatic persons, something that traditionally has not been performed for other viral respiratory diseases. This can lead to positive results from nucleic acid amplification tests (NAATs), such as RT-PCR, with late cycle threshold (CT) values near the test's limit of detection. In this commentary, we review unique attributes of COVID-19 and causes of NAAT late CT values. We provide interpretation considerations as well as strategies to aid in test interpretation.
    MeSH term(s) COVID-19/diagnosis ; COVID-19 Testing ; Humans ; Nucleic Acid Amplification Techniques/methods ; RNA, Viral/genetics ; SARS-CoV-2/genetics
    Chemical Substances RNA, Viral
    Language English
    Publishing date 2022-06-06
    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.00501-22
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: Taxonomic Changes for Human and Animal Viruses, 2018 to 2020.

    Loeffelholz, Michael J / Fenwick, Bradley W

    Journal of clinical microbiology

    2021  Volume 59, Issue 2

    Abstract: The classification of viruses is relevant to a number of scientific and clinical disciplines, including the practice of diagnostic virology. Here, we provide an update to our previous review of taxonomic changes for disease-causing viruses in humans and ... ...

    Abstract The classification of viruses is relevant to a number of scientific and clinical disciplines, including the practice of diagnostic virology. Here, we provide an update to our previous review of taxonomic changes for disease-causing viruses in humans and vertebrate animals, covering changes between 2018 and 2020. Recent advances in virus taxonomy structure by the International Committee on Taxonomy of Viruses inform this update.
    MeSH term(s) Animals ; Humans ; Viruses/genetics
    Language English
    Publishing date 2021-01-21
    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.01932-20
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: Detection of SARS-CoV-2 at the point of care.

    Loeffelholz, Michael J / Tang, Yi-Wei

    Bioanalysis

    2021  Volume 13, Issue 15, Page(s) 1213–1223

    Abstract: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the etiologic agent of COVID-19. Testing for SARS-CoV-2 infection is a critical element of the public health response to COVID-19. Point-of-care (POC) tests can drive patient management ... ...

    Abstract Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the etiologic agent of COVID-19. Testing for SARS-CoV-2 infection is a critical element of the public health response to COVID-19. Point-of-care (POC) tests can drive patient management decisions for infectious diseases, including COVID-19. POC tests are available for the diagnosis of SARS-CoV-2 infections and include those that detect SARS-CoV-2 antigens as well as amplified RNA sequences. We provide a review of SARS-CoV-2 POC tests including their performance, settings for which they might be used, their impact and future directions. Further optimization and validation, new technologies as well as studies to determine clinical and epidemiological impact of SARS-CoV-2 POC tests are needed.
    MeSH term(s) COVID-19/diagnosis ; COVID-19/pathology ; Humans ; Point-of-Care Systems/standards ; SARS-CoV-2/pathogenicity
    Language English
    Publishing date 2021-07-22
    Publishing country England
    Document type Journal Article
    ISSN 1757-6199
    ISSN (online) 1757-6199
    DOI 10.4155/bio-2021-0078
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article: Evaluation of High-Throughput Serological Tests for SARS-CoV-2

    Loeffelholz, Michael J

    J. clin. microbiol

    Abstract: ... T. S. Givens, M. Lapé-Nixon, N. J. Clarke, et al. (J Clin Microbiol 58:e01742-20, https://doi.org/10 ...

    Abstract Serologic methods are an important part of a clinical laboratory's portfolio of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) tests and are essential to the broader response to coronavirus infectious disease 2019 (COVID-19), including epidemiological studies and vaccine development. There are currently a number of commercial SARS-CoV-2 antibody tests with emergency use authorization (EUA) from the U.S. Food and Drug Administration. In this issue of the Journal of Clinical Microbiology, H. E. Prince, T. S. Givens, M. Lapé-Nixon, N. J. Clarke, et al. (J Clin Microbiol 58:e01742-20, https://doi.org/10.1128/JCM.01742-20, 2020) report the results of their evaluation of the agreement of 4 high-throughput EUA tests for SARS-CoV-2 IgG: Abbott Architect, DiaSorin Liaison, Euroimmun, and Ortho Vitros. They showed excellent agreement between the tests and rare false-positive reactivity for all tests.
    Keywords covid19
    Publisher WHO
    Document type Article
    Note WHO #Covidence: #730754
    Database COVID19

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  9. Article ; Online: Evaluation of High-Throughput Serological Tests for SARS-CoV-2

    Loeffelholz, Michael J.

    Journal of Clinical Microbiology

    2020  Volume 58, Issue 11

    Abstract: ... Prince, T. S. Givens, M. Lapé-Nixon, N. J. Clarke, et al. (J Clin Microbiol 58:e01742-20, https://doi.org ...

    Abstract ABSTRACT Serologic methods are an important part of a clinical laboratory’s portfolio of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) tests and are essential to the broader response to coronavirus infectious disease 2019 (COVID-19), including epidemiological studies and vaccine development. There are currently a number of commercial SARS-CoV-2 antibody tests with emergency use authorization (EUA) from the U.S. Food and Drug Administration. In this issue of the Journal of Clinical Microbiology , H. E. Prince, T. S. Givens, M. Lapé-Nixon, N. J. Clarke, et al. (J Clin Microbiol 58:e01742-20, https://doi.org/10.1128/JCM.01742-20 , 2020) report the results of their evaluation of the agreement of 4 high-throughput EUA tests for SARS-CoV-2 IgG: Abbott Architect, DiaSorin Liaison, Euroimmun, and Ortho Vitros. They showed excellent agreement between the tests and rare false-positive reactivity for all tests.
    Keywords Microbiology (medical) ; covid19
    Language English
    Publisher American Society for Microbiology
    Publishing country us
    Document type Article ; Online
    ZDB-ID 390499-4
    ISSN 1098-660X ; 0095-1137
    ISSN (online) 1098-660X
    ISSN 0095-1137
    DOI 10.1128/jcm.02179-20
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  10. Article ; Online: Maintaining point of care testing capacity and pandemic preparedness in the post-COVID-19 era.

    Rakeman-Cagno, Jennifer L / Persing, David H / Loeffelholz, Michael J

    Expert review of molecular diagnostics

    2023  Volume 24, Issue 3, Page(s) 147–151

    Abstract: Introduction: Testing at the point of care (we also refer to the 'point of need'), with rapid, actionable results reported to the patient and provider within hours can impact the individual as well as public health. Faster testing is good for patients ... ...

    Abstract Introduction: Testing at the point of care (we also refer to the 'point of need'), with rapid, actionable results reported to the patient and provider within hours can impact the individual as well as public health. Faster testing is good for patients and public health outcomes during 'peace time' (outside of the pandemic setting).
    Areas covered: Testing at the point of need was important during the COVID-19 pandemic to meet testing capacity demands, providing actionable results, and for providing testing within communities to increase access for all populations. Resources were acquired and built up dramatically during the pandemic as part of the response. With the end of the COVID-19 public health emergency and transition back to 'peace time' some testing sites have successfully shifted to using this capacity for testing for other critical needs, like sexually transmitted infection (STI) testing, and response to other seasonal diseases and for outbreak response.
    Expert opinion: The increased testing capacity added to handle unprecedented testing volume during the COVID-19 pandemic can be repurposed for other critical infectious diseases during 'peace time' (post-COVID-19 pandemic). This maintains testing capacity for the next pandemic.
    MeSH term(s) Humans ; COVID-19/diagnosis ; COVID-19/epidemiology ; SARS-CoV-2 ; COVID-19 Testing ; Pandemics ; Pandemic Preparedness ; Point-of-Care Testing
    Language English
    Publishing date 2023-09-24
    Publishing country England
    Document type Journal Article
    ZDB-ID 2112530-2
    ISSN 1744-8352 ; 1473-7159
    ISSN (online) 1744-8352
    ISSN 1473-7159
    DOI 10.1080/14737159.2023.2260743
    Database MEDical Literature Analysis and Retrieval System OnLINE

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