Rapid Test Kit CareStart™ Antigen Detection Covid-19 Antigen Nasopharyngeal Swab Sample 20 Tests

Product ships from MSFH with minimum 30 days dating

Nasopharyngeal / NP Swabs

This product has been authorized by the FDA under its Emergency Use Authorization

Customers should review requirements, including notification of public health authorities, as they are stated here: https://www.fda.gov/medical-devices/emergency-use-authorizations-medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices

Customers should review the Instructions For Use found here: https://www.fda.gov/media/142919/download

Customers should review the Fact Sheet for Providers found here: https://www.fda.gov/media/142917/download

Customers should make available to patients the Fact Sheet for Recipients found here: https://www.fda.gov/media/142918/download

Emergency use of this test is limited to authorized laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform high, moderate 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

Positive results indicate the presence of viral antigens, but the clinical correlation with patient history and other diagnostic information is necessary to determine infection status; Positive results do not rule out a bacterial infection or co-infection with other viruses

Negative results are 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

CareStart™ COVID-19 Antigen test is a lateral flow immunochromatographic assay for the detection of extracted nucleocapsid protein antigens specific to SARS-CoV-2 in nasopharyngeal swab specimens either directly collected or collected in BD universal transport media from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of symptom onset

Identify acute infection with 88.4% sensitivity and 100% specificity

Intended at POC setting (i.e., in patient care settings) by medical professionals with a CLIA waiver