Selected article for: "clinical validation and diagnostic test"
Author: Bachman, Christine M.; Grant, Benjamin D.; Anderson, Caitlin E.; Alonzo, Luis F.; Garing, Spencer; Byrnes, Sam A.; Rivera, Rafael; Burkot, Stephen; Ball, Alexey; Stafford, James W.; Wang, Wenbo; Banik, Dipayan; Keller, Matthew D.; Cate, David M.; Nichols, Kevin P.; Weigl, Bernhard H.; Dewan, Puneet
Title: Clinical validation of an open-access SARS-COV-2 antigen detection lateral flow assay, compared to commercially available assays
  • Cord-id: s6dvy6xm
  • Document date: 2021_8_17
    • ID: s6dvy6xm
    Snippet: 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, underwe
    Document: 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.

    Search related documents:
    Co phrase search for related documents
    • access supply and low lmics middle income countries: 1
    • acute sars infection and additional case: 1, 2, 3
    • acute sars infection and los angeles: 1, 2
    • lmics middle income countries and low lmics middle income countries: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25