Price range: $80.00 through $2,880.00
Please provide your CLIA # prior to purchasing
POC (CLIA-WAIVED) COVID-19 Rapid Antigen Test Kit
Results in 15-20 minutes
Minimum Order 1 box (25 tests)
Contents
Identifies acute infection with a 92.31% sensitivity and 99.04% specificity
Selected by NIH for the Rapid Acceleration of Diagnostics, for US production of the GenBody COVID-19 Ag test. The GenBody COVID-19 Ag is an immunochromatographic rapid diagnostic test (RDT) intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasopharyngeal (NP) or anterior nasal (AN) swab specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first six days of symptom onset, or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests.
Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high or waived complexity tests. This product is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance or Certificate of Accreditation. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities.
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