Germaine™ Laboratories Status™ Covid-19/Flu A & B Rapid Test

Description

A rapid, lateral flow immunoassay intended for the in-vitro simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV- 2, Influenza A, and Influenza B directly from nasopharyngeal swab specimens. The Status COVID-19/Flu Test is only for use under FDA EUA.

• 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
• 25 individually pouched test devices
• 1 test + 1 specimen = 3 Results
• Results in 15 minutes
• Made in USA

Includes

• Extraction Reagent Capsules (25): 300 μL of phosphate buffer with detergents and preservative, for use with swab specimens
• Sterile Swabs (25): For specimen collection
• Positive Control Swab (1): Influenza A, B, and SARS-CoV-2 Antigen (Non-infective
  recombinant nucleocapsid protein)
• Negative Control Swab (1): Inactivated Group B Streptococcus Antigen (Non-infective)
• Package Insert/Instructions for Use (1)
• Quick Reference Instruction (1)

Specifications

• Certifications/Compliance: FDA EUA Approved
• Content And Storage: 2° to 30°C (35° to 86°F)
• Control Sets: Includes Positive/Negative Control Swabs
• CE Marker: Yes
• Detectable Analytes: SARS-CoV-2, Influenza A/B Nucleic Acids
• Sample Type: Nucleocapsid Antigen from SARS-CoV2, Influenza A, and Influenza B
• Sensitivity: COVID-19: 93.9%, Flu A: 91.4%, Flu B: 87.6%
• Disposable: Single-use
• Includes: Rapid Test Devices (25), Sterile Swabs (25), Positive Control Swab (1), Negative Control Swab (1), Package Insert/Instructions for Use (1), Quick Reference Instruction (1)
• Quantity: 25 Tests
• Specificity: COVID-19: 100%, Flu A: 95.7%, Flu B: 95.9%
• Sterility: Non-sterile
• Test Time: 15 min.

The Status COVID-19/Flu test is only for use under FDA EUA. 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.