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Tytuł:
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Clinical validation of an open-access SARS-COV-2 antigen detection lateral flow assay, compared to commercially available assays.
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Autorzy:
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Bachman CM; Global Health Labs, Inc, Bellevue, Washington, United States of America.
Grant BD; Global Health Labs, Inc, Bellevue, Washington, United States of America.
Anderson CE; Global Health Labs, Inc, Bellevue, Washington, United States of America.
Alonzo LF; Global Health Labs, Inc, Bellevue, Washington, United States of America.
Garing S; Global Health Labs, Inc, Bellevue, Washington, United States of America.
Byrnes SA; Global Health Labs, Inc, Bellevue, Washington, United States of America.
Rivera R; Global Health Labs, Inc, Bellevue, Washington, United States of America.
Burkot S; Global Health Labs, Inc, Bellevue, Washington, United States of America.
Ball A; Global Health Labs, Inc, Bellevue, Washington, United States of America.
Stafford JW; Global Health Labs, Inc, Bellevue, Washington, United States of America.
Wang W; Global Health Labs, Inc, Bellevue, Washington, United States of America.
Banik D; Global Health Labs, Inc, Bellevue, Washington, United States of America.
Keller MD; Global Health Labs, Inc, Bellevue, Washington, United States of America.
Cate DM; Global Health Labs, Inc, Bellevue, Washington, United States of America.
Nichols KP; Global Health Labs, Inc, Bellevue, Washington, United States of America.
Weigl BH; Global Health Labs, Inc, Bellevue, Washington, United States of America.
Dewan P; Global Health Labs, Inc, Bellevue, Washington, United States of America.
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Źródło:
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PloS one [PLoS One] 2021 Aug 17; Vol. 16 (8), pp. e0256352. Date of Electronic Publication: 2021 Aug 17 (Print Publication: 2021).
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Typ publikacji:
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Comparative Study; Journal Article; Research Support, Non-U.S. Gov't
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Język:
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English
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Imprint Name(s):
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Original Publication: San Francisco, CA : Public Library of Science
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MeSH Terms:
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Immunoassay*
Antigens, Viral/*analysis
COVID-19/*diagnosis
SARS-CoV-2/*metabolism
Area Under Curve ; COVID-19/virology ; Humans ; Nasopharynx/virology ; Point-of-Care Systems ; RNA, Viral/analysis ; RNA, Viral/metabolism ; ROC Curve ; Real-Time Polymerase Chain Reaction ; SARS-CoV-2/isolation & purification ; Sensitivity and Specificity
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References:
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Sci Adv. 2021 Jan 1;7(1):. (PMID: 33219112)
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Substance Nomenclature:
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0 (Antigens, Viral)
0 (RNA, Viral)
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Entry Date(s):
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Date Created: 20210817 Date Completed: 20210825 Latest Revision: 20240403
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Update Code:
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20240403
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PubMed Central ID:
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PMC8370603
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DOI:
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10.1371/journal.pone.0256352
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PMID:
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34403456
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Rapid tests for SARS-COV-2 infection are important tools for pandemic control, but current rapid tests are based on proprietary designs and reagents. We report clinical validation results of an open-access lateral flow assay (OA-LFA) design using commercially available materials and reagents, along with RT-qPCR and commercially available comparators (BinaxNOW® and Sofia®). Adult patients with suspected COVID-19 based on clinical signs and symptoms, and with symptoms ≤7 days duration, underwent anterior nares (AN) sampling for the OA-LFA, Sofia®, BinaxNOW ™, and RT-qPCR, along with nasopharyngeal (NP) RT-qPCR. Results indicate a positive predictive agreement with NP sampling as 69% (60% -78%) OA-LFA, 74% (64% - 82%) Sofia®, and 82% (73% - 88%) BinaxNOW™. The implication for these results is that we provide an open-access LFA design that meets the minimum WHO target product profile for a rapid test, that virtually any diagnostic manufacturer could produce.
Competing Interests: No authors have competing interests.
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