During this time frame, Roche Diagnostics, the vendor for the main clinical chemistry automated line in the UIHC core laboratory, also announced the development of a SARS-CoV-2 total antibodies assay, having a EUA for the assay approved on May 4, 2020. serologic screening is still limited and growing. In this statement, we describe the experience of selecting, validating, and implementing SARS-CoV-2 serologic screening for clinical purposes at an academic medical center inside a rural state. Successful implementation involved close collaboration between pathology, infectious diseases, and outpatient clinics. The most common clinician concerns were appropriateness/energy of screening, patient costs/insurance protection, and assay specificity. In analyzing test utilization, serologic screening in the 1st month after go-live was almost entirely outpatient and appeared to be strongly driven by CR2 patient interest (including health care workers while others in high-risk occupations for exposure to SARS-CoV-2), with little evidence the results impacted medical decision-making. Test quantities for serology declined continuously through October 31, 2020, with inpatient purchasing presuming a continuously higher percentage of the total. Inside a 5-month period, SARS-CoV-2 serology test quantities amounted to only 1 1.3% of that of reverse transcriptase polymerase chain reaction. Unlike reverse transcriptase polymerase chain reaction, supply chain difficulties and reagent availability were not major issues for serology screening. We also discuss the most recent challenge of requirements for SARS-CoV-2 screening in international travel protocols. Overall, our encounter at an academic medical center demonstrates SARS-CoV-2 serology screening assumed a limited clinical role. strong class=”kwd-title” Keywords: antibodies, immunoglobulin G, immunoglobulin M, SARS-CoV-2, serology, utilization Intro Coronavirus disease 2019 (COVID-19), caused by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), was officially classified by the World Health Corporation (WHO) like a pandemic on March 11, 2020.1-3 As of this writing, an estimated 64 300 000 instances and 1 500 000 deaths have been attributed to SARS-CoV-2 throughout the world.4,5 Diagnostic screening in patients who have symptoms consistent with COVID-19 or who have had close contact with infected persons offers mainly relied on reverse transcriptase polymerase chain reaction (RT-PCR) on a variety of respiratory tract specimen types.1,6 Antigen checks are an alternative with reduce sensitivity, especially for asymptomatic disease, as well as reduce specificity.7 Serologic assays that detect antibodies against SARS-CoV-2 symbolize an additional source.7,8 In contrast to the widespread use of serologic assays for the analysis of some other viral infections (e.g., hepatitis B and C), serologic assays have historically not played a major part in the medical analysis of coronaviruses. The value of SARS-CoV-2 serological assays for medical analysis and management is still growing. Guidance from general public health, infectious disease, and microbiology companies offers consistently proposed that antibody screening has the most founded value for epidemiology and seroprevalence studies, selection of convalescent plasma donors, 3-Methylcytidine and evaluation of candidate vaccine effectiveness.9-12 The Infectious Disease Society of America (IDSA) published consensus recommendations for SARS-COV-2 serologic screening in May 2020.13 In addition to use in study, proposed clinical uses for serologic screening include analysis of individuals in the later course of suspected COVID-19, where top respiratory RT-PCR may be bad or low positive or when a variety of a lower respiratory tract specimen is not feasible. Multiple publications have discussed the 3-Methylcytidine limitations of SARS-COV-2 serology assays.14-17 In the early phases of the COVID-19 pandemic, lack of commercially available serologic assays remaining laboratory-developed tests while the only option for clinical or study laboratories, often to support uses such as recognition of convalescent plasma donors.14,15 As commercial vendors came into the market, enzyme-linked immunosorbent assays (ELISAs) and point-of-care kits (many using lateral flow immunoassays) emerged. Ultimately, diagnostic vendors developed 3-Methylcytidine SARS-COV-2 serologic assays suitable for automated medical immunoassay analyzers generally used in hospital-based and research medical laboratories. The availability of automated assays makes large-scale serosurveys and epidemiology studies to assess the extent of the pandemic logistically less difficult.18-20 In the United States, SARS-CoV-2 serologic assays required Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) but 3-Methylcytidine originally were covered less than section IV.D (pathway D) of the FDA Policy for Diagnostic Checks for Coronavirus Disease-2019, which minimally required commercial manufacturers to only notify the FDA of their validated product.21 This led to the rapid marketing of.