The LifeSign Status COVID-19/Flu A&B Test Kit is a simple and efficient rapid lateral flow immunoassay test used by healthcare professionals for the detection and differentiation of Coronavirus (Sars-CoV-2) antigen, Influenza A and/or Influenza B on symptomatic patients. Approved for point-of-care testing, CLIA-waived, and has FDA Emergency Use Authorization (EUA), the specimen is collected directly through anterior nasal or nasopharyngeal swabbing, within the first five (5) days of symptoms onset on individuals who are suspected of respiratory viral infection consistent with COVID-19. Accurate and fast results will be shown on the test device in as fast as 15 minutes.

Reliable & Easy Testing: This Covid-19/Flu Kit comes with specimen sampling flocked swabs, extraction reagents, and test devices, and comes with simple steps of administration. The reagent is dispensed into the extraction well of the test device, and gathered nasal swab samples are directly dipped on it through a swab stand. The healthcare provider must rotate the swab 3 times to mix the specimen, let it stand for 1 minute, then rotate the sample 3 times again before discarding the sampling swab. Lastly, the test device must be raised upright (letting it stand for about 1-2 seconds), give it a gentle tap to allow the liquid to flow into the hole, before laying it back down and setting the timer for 15 minutes.

Quick & Accurate: Please take note that accurate results will be shown 15 minutes after testing, and should not exceed 20 minutes to avoid reading false positive or negative results. A solo colored horizontal mark on the "C" (control) area depicts that you have a negative result, while a positive result shows a colored mark on the "C" area and one on either the "A" (Influenza A), "B" (Influenza B), or CoV19 (COVID-19) areas. Invalid results show no lines on the "C" zone. This rapid test can identify infection in patients with the ff. Sensitivity and Specificity:

• COVID-19: Anterior Nasal - 93.8% Sensitivity, 100% Specificity; Nasopharyngeal - 93.1%, 100% Specificity
• Flu A: 91.4% Sensitivity, 95.7% Specificity
• Flu B: 87.6% Sensitivity, 95.9% Specificity
• HIghlights:
• Rapid detection & Differentiation between SARS-CoV-2, Influenza A or B
• Fast & Accurate Results within 15 minutes
• Easy to Use & Has Efficient Testing Procedure
• Authorized by the FDA under an EUA, pending FDA clearance / approval
• CLIA-Waived & Approved for Point-of-Care Testing
• 25 tests per kit

In the box:

• (25) Test Devices
• (25) Extraction Reagents in Capsule
• (25) Sterile Swabs
• (1) Positive Control Swab
• (1) Negative Control Swab
• (1) Package Insert/Instructions for Use
• (1) Quick Reference Instructions