Rapid Test Kit Status Antigen Detection COVID-19 / Flu A and B Nasopharyngeal Swab Sample 25 Tests
- Status COVID-19 / FLU A and B test has been granted emergency use authorization (EUA) by the FDA for use at the point-of-care setting: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations \n
- During the duration of the emergency this test can be performed in a patient care setting that is operating under a CUA Waiver, Certificate of Compliance or Certificate of Accreditation \n
- Status COVID-19/Flu test is a lateral flow immunoassay intended for the in vitro rapid, simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV-2, influenza A and influenza B directly from nasopharyngeal swab specimens obtained from individuals, who are suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider, within the first five days of onset of symptoms \n
- Results are for the simultaneous identification of nucleocapsid antigens of SARS-CoV-2, influenza A and influenza B, but does not differentiate between SARS-CoV and SARS-CoV-2 viruses and is not intended to detect influenza C antigens \n
- 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 \n
- Positive results do not rule out bacterial infection or co-infection with other viruses \n
- Laboratories within the United States and its territories are required to report all SARS-CoV-2 results to the appropriate public health authorities \n
- Negative SARS-CoV-2 results should be treated as presumptive and confirmed with a molecular assay, if necessary, for patient management \n
- 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 \n
- 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 \n
- The Status COVID-19/Flu test is intended for use by medical professionals and laboratory personnel trained to perform the test \n
- Flocked nasopharyngeal swab for superior specimen collection and patient comfort \n
- COVID-19 - Sensitivity 93.9%, Specificity 100% \n
- Flu A - Sensitivity 91.4%, Specificity 95.7% \n
- Flu B - Sensitivity 87.6%, Specificity 95.9%
- Reading type:
- visual read
- Manufacturer #:
- 33225
- Application:
- rapid test kit
- Sample type:
- nasopharyngeal swab
- Time to results:
- 15 minute results
- Test format:
- test device
- Product dating:
- mckesson acceptable dating: we will ship >= 30 days
- Test method:
- lateral flow immunoassay
- Test name:
- covid-19 / flu a and b
- Contents 1:
- (25) test devices (25) extraction reagent capsules (25) sterile swabs positive control swab negative control swab package insert quick reference instruction
- Brand:
- Status
- UNSPSC:
- 41116144
- Mckesson #:
- 1186780
- Manufacturer:
- Lifesign, LLC
- Test type:
- antigen detection
- Number of tests:
- 25
