Status™ COVID-19/Flu A and B Rapid Test, Germaine Laboratories

Supplier: Germaine Laboratories

33225
76474-110KT 762.1 USD
76474-110
Status™ COVID-19/Flu A and B Rapid Test, Germaine Laboratories
Assays Immunological Assays

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-CoV2, 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.


  • Regulatory Status: FDA EUA Authorized for use in a POC setting
  • Determinations: nucleocapsid Antigen from SARS-CoV2, Influenza A and Influenza B
  • Storage requirements: 35 to 86° F
  • Test Time: 15 Minutes
  • Flocked nasopharyngeal swab for superior specimen collection and patient comfort
  • Made in the USA


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.


1 test + 1 specimen = 3 results.


CPT CODES: COVID-19: 87811QW, FLU A: 87804QW, FLU B: 87804QW-59.


Sensitivity and Specificity; Flu A (PPA 89.2%,NPA 99.4%); Flu B (PPA86.4%, NPA 99%); COVID-19 (PPA 94%, NPA 100%).


Certifications: 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.


Delivery information: Contents: Status COVID-19/Flu test devices, individually wrapped (25), Extraction Reagent in capsules (25), Sterile Swabs (25), Positive Control Swab (1), Negative Control Swab (1), Package Insert /Instructions for use (1), Quick Reference Instruction (1).


Packaging: Includes Status COVID-19/Flu test devices (25): The test strip in each device contains mouse monoclonal antibodies to nucleocapsid protein of influenza A, influenza B and SARS-CoV2. The device is individually pouched. Extraction Reagent in capsules (25): For use with swab specimens; 300 µl of Phosphate. Buffer with detergents and preservative. Sterile Swabs (25): For swab 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).


Caution: The Status™ COVID-19/Flu test is intended for use by medical professionals and laboratory personnel trained to perform the test. The Status™ COVID-19/Flu test is only for use under the Food and Drug Administration’s Emergency Use Authorization.

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