For accurate diagnosis of COVID-19, serology can be a great supplement to molecular detection. Serology testing is a powerful way to monitor the progression of the pandemic by seroprevalence studies and as a tool in diagnostics. Thorough validation is needed to facilitate the potential of serology testing Most commonly, they detect IgM, IgG or both antibodies, but some detect total antibody or IgA. The majority of these tests fall within two categories: either a qualitative, rapid immunochromatographic assay (15–20 min), or a slower semi-quantitative enzyme-linked immunoassay (ELISA)/chemiluminescent immunoassay (CLIA) (a few hours). As of 10th of October 2020, the Foundation for Innovative New Diagnostics lists 342 commercial immunoassays for detecting antibodies (Foundation for Innovative New Diagnostics SARS-CoV-2 diagnostic pipeline 2020), but only 49 have currently been granted an Emergency Use Authorization by the FDA (FDA 2020). Before long, however, companies, institutions and research laboratories started flooding the market with serological kits for detection of past (or present) SARS-CoV-2 infection. The tests have high specificities but varying sensitivities, mostly due to sampling difficulties, including choice of specimen, and timing of peak viral load, which can lead to false-negative results. Following the release of viral genome sequences of SARS-CoV-2 in January (Zhang 2020), molecular detection kits for real-time RT-PCR were soon developed and became the gold standard for diagnosing COVID-19 by confirming the presence of SARS-CoV-2 RNA. Since the outbreak of COVID-19 in Wuhan in December 2019, the virus has, as of October 10th 2020, spread globally with 36 616 555 confirmed cases and 1063 429 deaths worldwide (World Health Organization Coronavirus disease 2020). ![]() SARS-CoV-2 Antibodies (NCVIGG, NCVIGQ), The qualitative detection of anti-Nucleocapsid IgG (NCVIGG) and the quantitative detection of anti-Spike IgG (NCVIGQ) antibodies.Coronavirus infections, serology, seroepidemiologic studies, antibodies, diagnosis, serologic tests INTRODUCTION are able to perform blood draws for testing with a valid provider order. We recommend outside providers arrange to have their patients' blood drawn at their usual clinical draw sites and sent to the lab, preferably after contacting Client Support Services at to facilitate testing.įor patients who do not regularly seek care within UW Medicine, our phlebotomists at the University of Washington Medical Center-Northwest Campus (UWMC-NW) and UWMC-NW Outpatient Medical Center (OPMC) located on Meridian Ave. Ordering: We are pleased to perform serology testing for all patients who have a valid provider order. Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals. Nonreactive (Negative, <50.0 AU/mL) results do not rule out SARS-CoV-2 infection, particularly in those who have recently been in contact with the virus. Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.Ī table of quantitative anti-spike levels for otherwise healthy, recently vaccinated individuals by week of vaccination to aid in interpretation of test results is available in Table 3 in this pre-print. Reactive (Positive, ≥50.0 AU/mL) results may be due to immunization or past or present infection with SARS-CoV-2. ![]() The Abbott Architect SARS-CoV-2 IgG II assay, run under an emergency use authorization from the FDA, is quantitative test designed to detect IgG antibodies to the spike protein of SARS-CoV-2 in serum and plasma from individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
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