Specificity was determined to be 95.3% (182/191) for the Genalyte Maverick. the Genalyte Maverick was comparable to that observed for the Roche Elecsys NC test, 79.3% (142/179) vs. 76.5% (137/179), respectively. Genalyte Maverick trended, without statistical significance, towards higher sensitivity as compared to the Roche Elecsys NC test in the 3-7 days (11/25 vs. 9/25, respectively) and 8-14 days (21/28 vs. 19/28, respectively) post-symptom onset sample units, but was identical in the 15 days post-symptom onset group (106/116 vs. 106/116, respectively). Therefore, the Genalyte Maverick serologic test had similar overall sensitivity to the Roche Elecsys NC assay, but may have slightly improved sensitivity for early seroconversion. The lower Genalyte Maverick specificity as compared to the Roche Elecsys NC assay as reported by other studies (>99%), may necessitate confirmatory screening of positive Genalyte Maverick results if implemented for clinical use. Keywords: Coronavirus, SARS-CoV-2, COVID-19, Serology 1.?Introduction The global pandemic from severe acute respiratory syndrome-coronoavirus-2 (SARS-CoV-2) necessitated the development of multiple laboratory methods to assess both active and prior coronavirus disease-2019 (COVID-19). While molecular and antigen detection assays are used to identify active viral replication, serologic assays to detect the body’s humoral immune response to SARS-CoV-2 are generally used to document previous contamination. The clinical power of SARS-CoV-2 serologic assessments are limited, but include investigating local and community seroprevalence, assessing whether individual patients were previously infected, and identification of COVID-19 convalescent plasma donors . While serologic screening can be utilized for determining immunity against other vaccine-preventable diseases [2, 3], a minimum antibody immunity threshold has not yet been established for SARS-CoV-2 and post-vaccination serologic screening is not currently recommended. Depending on their design, serologic assessments will detect IgM and/or IgG antibodies, with or without Rabbit Polyclonal to ARSA immunoglobulin differentiation, to SARS-CoV-2 in human blood. Seroconversion rates peak at 4-5 weeks post-symptom onset . The SARS-CoV-2 target proteins used in serologic assessments most commonly include recombinant, full or partial S (spike) or subunit 1/2 (S1, S2) proteins, S1 receptor binding domain name (RBD), or NC (nucleocapsid) protein. Several methodologies for serologic screening have been developed including chemiluminescence immunoassays, enzyme-linked immunosorbent assays (ELISA), and lateral circulation immunoassays for use in the central laboratory or at the point of care , , . Currently, over 70 serology assessments have received emergency use authorization (EUA) by the Food and Drug administration (FDA); 19 for high complexity testing only, 51 for high/moderate complexity screening, and 5 for high/moderate/waived complexity screening (https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas, accessed 4/13/2021). The Genalyte Maverick SARS-CoV-2 Multi-Antigen Serology Panel v2 received FDA EUA for use in high or moderate complexity laboratories on October 8, 2020 and is a qualitative detection system for antibodies to SARS-CoV-2. The panel includes detection of IgG and IgM against five SARS-CoV-2 antigens (full length NC, full length S, S1, S2 and RBD), the SARS-CoV NC antigen, the Middle East respiratory syndrome (MERS) S1 antigen, and two influenza A hemagglutinin (H) antigens (H1 and H3). The test is BMS-599626 unique among the available SARS-CoV-2 serology assays because it semi-quantitatively detects both IgM and IgG antibodies to multiple SARS-CoV-2 antigens and three other respiratory viruses. The system is BMS-599626 based on photonic ring resonance technology on a silicon chip, and using a machine learning algorithm, BMS-599626 simultaneously steps and interprets all reactions, releasing results within approximately 20 moments. BMS-599626 Here, we evaluated the test overall performance of the Genalyte SARS-CoV-2 serology panel against an automated reference method for detection of total antibodies against the SARS-CoV-2 NC antigen. 2.?Materials and methods 2.1. Specimens The SARS-CoV-2 antibody unfavorable sample set consisted of 143 pre-pandemic, residual sera collected in Rochester, MN between May 8, 2015 and November 30, 2019, and stored at -80C until thawed for the study. An additional 48 presumed SARS-CoV-2 antibody unfavorable sera were residual specimens obtained primarily on May 1-3, 2020 from asymptomatic patients undergoing pre-procedural SARS-CoV-2 NAAT screening and antibody screening. Presumed unfavorable sera were unfavorable by the EuroImmun Anti-SARS-CoV-2 IgG ELISA (Lubeck, Germany), and collected from.
Specificity was determined to be 95