Rapid Test Kit BinaxNOW™ Professional Use Antigen Detection COVID-19 Ag Nasal Swab Sample 40 Tests

Product ships from MSFH with minimum 30 days dating

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 test 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

This test is authorized for use with direct anterior nasal (nares) swab samples from individuals with symptoms of COVID-19 within the first seven days of symptom onset when tested at least twice over three days with at least 48 hours between tests; this test is also authorized for use with direct anterior nasal (nares) swab samples from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested at least three times over five days with at least 48 hours between tests

Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities

Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status

Positive results do not rule out bacterial infection or co-infection with other viruses

Negative results should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed

Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions

The BinaxNOW COVID-19 Ag Card is intended for use by medical professionals or trained operators who are proficient in performing rapid lateral flow tests

Sensitivity (PPA) 84.6% (entire population)

Sensitivity (PPA) 95.6% (those with PCR cycle threshold [Ct] < 33)

Specificity (NPA) 98.5%

Supplemental data indicates that antigen tests have demonstrated positive percent agreement as high as 100% for symptomatic patients (3 serial tests, 2 days after first PCR positive) and as high as 88.9% for asymptomatic patients (3 serial tests, 6 days after first PCR positive)

Onboard extraction allows the swab to be directly inserted into the test card

Visually read results in 15 minutes - no instrument required

The BinaxNOW COVID-19 Ag Card does not differentiate between SARSCoV and SARS-CoV-2