LifeSign #33225 Rapid Test Kit Status™ Antigen Test COVID-19 / Flu A and B Nasopharyngeal Swab Sample 25 Tests TEST KIT, RAPID SARS COV-2/FLUA&B ANTIGEN (25TESTS/KT) D/S 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 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 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 COVID-19 - Sensitivity 93.9%, Specificity 100% Flu A - Sensitivity 91.4%, Specificity 95.7% Flu B - Sensitivity 87.6%, Specificity 95.9% Manufacturer # 33225 Brand Status™ Manufacturer LifeSign Country of Origin Unknown Application Rapid Test Kit Contents (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 Reading Type Visual Read Sample Type Nasopharyngeal Swab Sample Test Format Test Device Test Method Lateral Flow Immunoassay Test Name COVID-19 / Flu A and B Test Type Antigen Test Time To Results 15 Minute Results UNSPSC Code 41116144 Lifesign #33225 Status TM ------ lifeSign COVID-19/Flu A&B A Rapid Immunoassay for the Simultaneous Direct Detection and Differential Diagnosis of SARS-CoV-2, Influenza Type A and Type B Antigen from nasopharyngeal swab specimens 25/KIT Sensitivity and Specificity − COVID-19 - Sensitivity 93.9%, Specificity 100% − Flu A - Sensitivity 91.4%, Specificity 95.7% − Flu B - Sensitivity 87.6%, Specificity 95.9% • FDA Emergency Use Authorization (EUA) • Visually read in 15 minutes • Flocked nasopharyngeal swab for superior specimen collection and patient comfort Easy 3 Step Procedure e e T Tear the tab off the Extraction Reagent Capsule and dispense entire contents into the Extraction Well. Insert the specimen swab in the Swab Stand. · Rotate swab 3 times to mix the specimen. · Let stand 1 minute. · Rotate swab 3 times again and discard the swab. Raise the device upright and let stand 1-2 seconds. Gently tap the device to ensure the liquid flows into the hole. Lay the device back down. Set a timer for 1 S minutes. O Read test results at 15 minutes. NOTE: False positive or false negative results can occur if the test is not read between 15 and 20 minutes. • Refer to our website at www.lifesignmed.com for complete test procedure details, training video and package insert. • Status™ COVID-19/FLU A&B is an antigen test for use with nasopharyngeal swab specimens. • Status™ COVID-19/FLU A&B test has been granted emergency use authorization (EUA) by the FDA for use at the point-of-care setting. 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.
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