Covid-19 RX Rapid Test
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Test Kit QuickVue® Professional Use SARS Antigen Nasal Swab Sample 25 Tests
- For use under an Emergency Use Authorization (EUA) only: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
- Product ships from McKesson 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
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Rapid Test Kit BD Veritorâ„¢ System Infectious Disease Immunoassay SARS-CoV-2 Nasal Swab Sample 30 Tests
- For use with the BD Veritorâ„¢ Plus Analyzer running Firmware version 5.4 or later
- Product ships from McKesson with minimum 30 days dating
- The BD Veritorâ„¢ System for Rapid Detection of SARS-CoV-2 is for use under an Emergency Use Authorization ONLY: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
- 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
- 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
- Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities
- Negative results should be treated as presumptive, 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
- Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary, for patient management
- The BD Veritor System for Rapid Detection of SARS-CoV-2 is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of in vitro diagnostic procedures, and proper infection control procedures and individuals similarly trained in point of care settings
- In the United States, the BD Veritor™ System for Rapid Detection of SARS-CoV-2 is only for use under the Food and Drug Administration’s Emergency Use Authorization
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BinaxNOW COVID-19 Ag Positive Control Kit (10/ct)
he BinaxNOW™ COVID-19 Ag Card* is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset. 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.
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Clarity COVID-19 Antigen Rapid Test Cassette, (25 ct)
- FDA Emergency Use Authorized, CLIA Waived and POCT approved.
- Relative Sensitivity 87.5%
- Relative Specificity: >98.9%
- Fast and Easy – Positive results as fast as 5 minutes
- Test Naso-Pharyngeal Swab immediately, or store at room temperature and test within 1 hour.
- Naso-Pharyngeal Swab stored in a dry tube at 2-8c can be tested within 24 hours.
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Rapid Test Kit CareStartâ„¢ Antigen Detection Covid-19 Antigen Nasal Swab Sample (20 Tests)
- Product ships from McKesson with minimum 30 days dating
- Anterior Nares / AN 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
- 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
- CareStartâ„¢ COVID-19 Antigen test is a lateral flow immunochromatographic assay for the detection of extracted nucleocapsid protein antigens specific to SARS-CoV-2 in anterior nare (nasal 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 87.2% sensitivity and 100% specificity
- Intended at POC setting (i.e., in patient care settings) by medical professionals with a CLIA waiver
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CareStart Antigen Test Covid-19 Rapid Test Kit (RX onLy) (20/bx)
Test type:Â Lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2
Specimen type:Â anterior nasal (AN)
Turnaround time:Â 10 minutes
CLIA complexity:Â Waived, Moderate, or High complexityFDA status:Â Emergency Use Authorization (EUA) granted20 tests per boxSKU# RCHM-02071NP
