Product Overview
The Respiratory Test Kit Status COVID-19 / Flu A and B 25 Tests CLIA Waived is part of ARG Medical's medical supply catalog, manufactured by LIFESIGN LLC.
ARG Medical is a Service-Disabled Veteran-Owned Small Business (SDVOSB) supplying hospitals, VA facilities, and government agencies. Bulk and government pricing available.
Features
- 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
- Product ships from McKesson with minimum 30 days dating
- 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
- 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
- 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 bacterial infection or co-infection with other viruses
- Laboratories within the United States and its territories are required to report all SARS-CoV-2 results to the appropriate public health authorities
- Negative SARS-CoV-2 results should be treated as presumptive and confirmed with a molecular assay, if necessary, for patient management
- 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
- 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
- The Status™ COVID-19/Flu test is intended for use by medical professionals and laboratory personnel trained to perform the test
- Flocked nasopharyngeal swab for superior specimen collection and patient comfort
Specifications
| Application | Respiratory Test Kit |
| Contents 1 | (25) Test Devices, (25) Extraction Reagent Capsules, (25) Sterile Swabs, Positive Control Swab, Negative Control Swab, Package Insert, Quick Reference Instruction |
| Number of Tests | 25 Tests |
| Product Dating | McKesson Acceptable Dating: we will ship >= 30 days |
| Purchase Program Type | Standard Purchase |
| Reading Type | Visual Read |
| Sample Type | Nasopharyngeal Swab Sample |
| Specialty | Immunoassay |
| Test Format | Test Device Format |
| Test Kit Type | Rapid |
| Test Method | Lateral Flow Immunoassay |
| Test Name | COVID-19 / Flu A and B |
| Test Type | Antigen Detection |
| Time to Results | 15 Minute Results |
Supplied by the kit (KT).
