Status™ COVID-19/Flu A&B from Princeton BioMedica LifeSign, 25 Kits per Box

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A Rapid Immunoassay for the Simultaneous Direct Detection and Differential Diagnosis of SARS-CoV-2, Influenza Type A and Type B Antigen from anterior nasal and nasopharyngeal swab specimens

• COVID-19
  • Anterior nasal swab specimen − Sensitivity 93.8 %, Specificity 100%
  • Nasopharyngeal − Sensitivity 93.1 %, 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
• 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

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

Product Documentation

Status COVID-19 Flu 24 Month Expiration Letter

Status Flu A & B Annual Reactivity Testing Results Table

Status COVID-19 Flu Quick Reference Instructions / Procedure Card

Status LifeSign COVID-19 Flu Sell Sheet

Status COVID-19 Flu Princeton BioMeditech Patient Fact Sheet

Status COVID-19 Flu Princeton Princeton BioMeditech Healthcare Providers Fact Sheet