Abstract
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is the causative agent of COVID-19 disease. RT-qPCR has been the primary method of diagnosis; however, the required infrastructure is lacking in many developing countries and the virus has remained a global challenge. More inexpensive and immediate test methods are required to facilitate local, regional, and national management strategies to re-open world economies. Here we have developed a SARS-CoV-2 antigen test in an inexpensive lateral flow format to generate a chromatographic result identifying the presence of the SARS-CoV-2 antigen, and thus an active infection, within a patient anterior nares swab sample. Our 15-min test requires no equipment or laboratory infrastructure to administer with a limit of detection of 2.0 × 102 TCID50/mL and 87.5% sensitivity, 100% specificity when tested against 40 known positive and 40 known negative patient samples established by a validated RT-qPCR test.
Highlights
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is the causative agent of COVID-19 disease
We have described the development of a SARS-CoV-2 antigen rapid diagnostic tests (RDTs) with preliminary performance data that meets acceptance criteria for sensitivity and specificity as outlined by the Food and Drug Administration (FDA) in their Emergency Use Authorization (EUA) guidance documents and is among the most sensitive lateral flow assays that do not require a reader
A summary of other Emergency Use Authorization (EUA) issued antigen tests for SARS-CoV-2 collected in October of 2020 from the Food and Drug Administration (FDA) website demonstrated a range of Limit of Detection (LOD) from 1.0 × 1 02 TCID50/mL to 4.5 × 1 05 TCID50/ mL15
Summary
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is the causative agent of COVID-19 disease. RDTs have been successfully implemented in the control of HIV and malaria[5], and while not as useful for diagnosing asymptomatic patients with low viral load[6], RDTs are quickly becoming an essential tool in the SARS-CoV-2 testing arsenal to keep world economies open[7]. Even in developed countries like the United States, the Center for Disease Control and Prevention (CDC) estimated that there were 10 times as many COVID-19 cases than reported[9] This means despite the high analytical sensitivity of RT-qPCR testing, when used as a surveillance testing regimen it has at best a 10% sensitivity to detect the circulating infections in the p opulation[8]. We have developed a SARS-CoV-2 antigen RDT that is instrument free and easy-to-use at the point of care with 15 min testing time intended to be used in concert with approved RT-qPCR methods
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