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  1. Article ; Online: Differences between quantification of genotype 3 hepatitis C virus RNA by Versions 1.0 and 2.0 of the COBAS AmpliPrep/COBAS TaqMan HCV Test.

    Pierce, Virginia M / Eversley, Jacqueline S / Tran, Thuy K / Rosenberg, Eric S

    Clinical chemistry and laboratory medicine

    2017  Volume 55, Issue 7, Page(s) 956–961

    Abstract: Background: Differences between the designs of hepatitis C virus (HCV) viral load assays can result in genotype-related variability in RNA quantification. We tested paired aliquots of plasma specimens from HCV-infected individuals using two versions (v1. ...

    Abstract Background: Differences between the designs of hepatitis C virus (HCV) viral load assays can result in genotype-related variability in RNA quantification. We tested paired aliquots of plasma specimens from HCV-infected individuals using two versions (v1.0 and v2.0) of the Roche COBAS AmpliPrep/COBAS TaqMan HCV Test (CAP/CTM HCV) and noted variability between results for a subset of specimens; we then sought to determine whether discrepant results were more prevalent among specific HCV genotypes.
    Methods: Archived and prospectively-collected plasma samples from 114 unique patients were tested using CAP/CTM HCV v1.0 and v2.0. The HCV genotype result for each patient was determined by retrospectively reviewing laboratory records.
    Results: All (46/46) specimens with quantifiable viral loads from patients with genotype 1 or 2 infection had CAP/CTM HCV v1.0 and v2.0 results that were within 0.5 log10 IU/mL; in contrast, only 3/11 (27.3%) from patients with HCV genotype 3 (mean difference, 0.56 log10 IU/mL higher with v2.0) and 0/3 (0%) from patients with HCV genotype 4 (mean difference, 0.91 log10 IU/mL higher with v2.0) had results within 0.5 log10 IU/mL. Among specimens with detectable HCV RNA below the lower limit of quantification with v1.0, greater proportions of genotype 3 (4/7, 57.1%) and genotype 4 (3/4, 75.0%) specimens than genotype 1 or 2 specimens (6/30, 20.0%) had v2.0 results within the quantifiable range.
    Conclusions: In patients infected with HCV genotype 3, sequential CAP/CTM HCV viral load results should be compared with caution and interpreted in the context of the specific assay version used.
    MeSH term(s) Genotype ; Hepacivirus/genetics ; Hepacivirus/physiology ; Humans ; Limit of Detection ; Nucleic Acid Amplification Techniques/methods ; RNA, Viral/analysis ; RNA, Viral/blood ; RNA, Viral/genetics ; Retrospective Studies ; Taq Polymerase/metabolism ; Viral Load
    Chemical Substances RNA, Viral ; Taq Polymerase (EC 2.7.7.-)
    Language English
    Publishing date 2017-06-27
    Publishing country Germany
    Document type Comparative Study ; Journal Article
    ZDB-ID 1418007-8
    ISSN 1437-4331 ; 1434-6621 ; 1437-8523
    ISSN (online) 1437-4331
    ISSN 1434-6621 ; 1437-8523
    DOI 10.1515/cclm-2016-0799
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Author Correction: Multiplexed CRISPR-based microfluidic platform for clinical testing of respiratory viruses and identification of SARS-CoV-2 variants.

    Welch, Nicole L / Zhu, Meilin / Hua, Catherine / Weller, Juliane / Mirhashemi, Marzieh Ezzaty / Nguyen, Tien G / Mantena, Sreekar / Bauer, Matthew R / Shaw, Bennett M / Ackerman, Cheri M / Thakku, Sri Gowtham / Tse, Megan W / Kehe, Jared / Uwera, Marie-Martine / Eversley, Jacqueline S / Bielwaski, Derek A / McGrath, Graham / Braidt, Joseph / Johnson, Jeremy /
    Cerrato, Felecia / Moreno, Gage K / Krasilnikova, Lydia A / Petros, Brittany A / Gionet, Gabrielle L / King, Ewa / Huard, Richard C / Jalbert, Samantha K / Cleary, Michael L / Fitzgerald, Nicholas A / Gabriel, Stacey B / Gallagher, Glen R / Smole, Sandra C / Madoff, Lawrence C / Brown, Catherine M / Keller, Matthew W / Wilson, Malania M / Kirby, Marie K / Barnes, John R / Park, Daniel J / Siddle, Katherine J / Happi, Christian T / Hung, Deborah T / Springer, Michael / MacInnis, Bronwyn L / Lemieux, Jacob E / Rosenberg, Eric / Branda, John A / Blainey, Paul C / Sabeti, Pardis C / Myhrvold, Cameron

    Nature medicine

    2023  Volume 30, Issue 1, Page(s) 307

    Language English
    Publishing date 2023-11-09
    Publishing country United States
    Document type Published Erratum
    ZDB-ID 1220066-9
    ISSN 1546-170X ; 1078-8956
    ISSN (online) 1546-170X
    ISSN 1078-8956
    DOI 10.1038/s41591-023-02684-y
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Multiplexed CRISPR-based microfluidic platform for clinical testing of respiratory viruses and identification of SARS-CoV-2 variants.

    Welch, Nicole L / Zhu, Meilin / Hua, Catherine / Weller, Juliane / Mirhashemi, Marzieh Ezzaty / Nguyen, Tien G / Mantena, Sreekar / Bauer, Matthew R / Shaw, Bennett M / Ackerman, Cheri M / Thakku, Sri Gowtham / Tse, Megan W / Kehe, Jared / Uwera, Marie-Martine / Eversley, Jacqueline S / Bielwaski, Derek A / McGrath, Graham / Braidt, Joseph / Johnson, Jeremy /
    Cerrato, Felecia / Moreno, Gage K / Krasilnikova, Lydia A / Petros, Brittany A / Gionet, Gabrielle L / King, Ewa / Huard, Richard C / Jalbert, Samantha K / Cleary, Michael L / Fitzgerald, Nicholas A / Gabriel, Stacey B / Gallagher, Glen R / Smole, Sandra C / Madoff, Lawrence C / Brown, Catherine M / Keller, Matthew W / Wilson, Malania M / Kirby, Marie K / Barnes, John R / Park, Daniel J / Siddle, Katherine J / Happi, Christian T / Hung, Deborah T / Springer, Michael / MacInnis, Bronwyn L / Lemieux, Jacob E / Rosenberg, Eric / Branda, John A / Blainey, Paul C / Sabeti, Pardis C / Myhrvold, Cameron

    Nature medicine

    2022  Volume 28, Issue 5, Page(s) 1083–1094

    Abstract: The coronavirus disease 2019 (COVID-19) pandemic has demonstrated a clear need for high-throughput, multiplexed and sensitive assays for detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and other respiratory viruses and their ... ...

    Abstract The coronavirus disease 2019 (COVID-19) pandemic has demonstrated a clear need for high-throughput, multiplexed and sensitive assays for detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and other respiratory viruses and their emerging variants. Here, we present a cost-effective virus and variant detection platform, called microfluidic Combinatorial Arrayed Reactions for Multiplexed Evaluation of Nucleic acids (mCARMEN), which combines CRISPR-based diagnostics and microfluidics with a streamlined workflow for clinical use. We developed the mCARMEN respiratory virus panel to test for up to 21 viruses, including SARS-CoV-2, other coronaviruses and both influenza strains, and demonstrated its diagnostic-grade performance on 525 patient specimens in an academic setting and 166 specimens in a clinical setting. We further developed an mCARMEN panel to enable the identification of 6 SARS-CoV-2 variant lineages, including Delta and Omicron, and evaluated it on 2,088 patient specimens with near-perfect concordance to sequencing-based variant classification. Lastly, we implemented a combined Cas13 and Cas12 approach that enables quantitative measurement of SARS-CoV-2 and influenza A viral copies in samples. The mCARMEN platform enables high-throughput surveillance of multiple viruses and variants simultaneously, enabling rapid detection of SARS-CoV-2 variants.
    MeSH term(s) COVID-19/diagnosis ; Humans ; Influenza, Human ; Microfluidics ; SARS-CoV-2/genetics
    Language English
    Publishing date 2022-02-07
    Publishing country United States
    Document type Journal Article ; Research Support, U.S. Gov't, Non-P.H.S. ; Research Support, U.S. Gov't, P.H.S. ; Research Support, Non-U.S. Gov't ; Research Support, N.I.H., Extramural
    ZDB-ID 1220066-9
    ISSN 1546-170X ; 1078-8956
    ISSN (online) 1546-170X
    ISSN 1078-8956
    DOI 10.1038/s41591-022-01734-1
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Development of a qualitative real-time RT-PCR assay for the detection of SARS-CoV-2: A guide and case study in setting up an emergency-use, laboratory-developed molecular assay

    Anahtar, Melis N. / Shaw, Bennett / Slater, Damien / Byrne, Elizabeth H / Botti-Lodovico, Yolanda / Adams, Gordon / Schaffner, Stephen F. / Eversley, Jacqueline S. / McGrath, Graham / Gogakos, Tasos / Lennerz, Jochen / Marble, Hetal Desai / Ritterhouse, Lauren L. / Batten, Julie / Georgantas, N. Zeke / Pellerin, Rebecca / Signorelli, Sylvia / Thierauf, Julia / Kemball, Molly /
    Happi, Christian / Grant, Donald S. / Ndiaye, Daouda / Siddle, Katherine J. / Mehta, Samar B / Harris, Jason B. / Ryan, Edward T / Pierce, Virginia M. / LaRocque, Regina C / Lemieux, Jacob / Sabeti, Pardis / Rosenberg, Eric / Branda, John / Turbett, Sarah E

    medRxiv

    Abstract: Developing and deploying new diagnostic tests is difficult, but the need to do so in response to a rapidly emerging pandemic such as COVID-19 is crucially important for an effective response. In the early stages of a pandemic, laboratories play a key ... ...

    Abstract Developing and deploying new diagnostic tests is difficult, but the need to do so in response to a rapidly emerging pandemic such as COVID-19 is crucially important for an effective response. In the early stages of a pandemic, laboratories play a key role in helping health care providers and public health authorities detect active infection, a task most commonly achieved using nucleic acid-based assays. While the landscape of diagnostics is rapidly evolving, polymerase chain reaction (PCR) remains the gold-standard of nucleic acid-based diagnostic assays, in part due to its reliability, flexibility, and wide deployment. To address a critical local shortage of testing capacity persisting during the COVID-19 outbreak, our hospital set up a molecular based laboratory developed test (LDT) to accurately and safely diagnose SARS-CoV-2. We describe here the process of developing an emergency-use LDT, in the hope that our experience will be useful to other laboratories in future outbreaks and will help to lower barriers to fast and accurate diagnostic testing in crisis conditions.
    Keywords covid19
    Language English
    Publishing date 2020-09-01
    Publisher Cold Spring Harbor Laboratory Press
    Document type Article ; Online
    DOI 10.1101/2020.08.26.20157297
    Database COVID19

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