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 × 10 2 TCID 50 /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.
【저자키워드】 Health care, Diseases, 【초록키워드】 SARS-CoV-2, equipment, Infection, Local, virus, coronavirus 2, Laboratory, Antigen, COVID-19 disease, lateral flow, sensitivity, specificity, RT-qPCR, management, Patient, limit of detection, SARS-CoV-2 antigen, respiratory, National, positive, RT-qPCR test, TCID, country, swab sample, tested, remained, required, generate, facilitate, nare, administer, the SARS-CoV-2, 【제목키워드】 Rapid diagnostic test, SARS-CoV-2 antigen, resource,