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

76474-110

: Germaine Laboratories

76474-110

: Germaine Laboratories

: 33225

Description:
Rapid Immunoassay
Cat. No.:
76474-110
Run time:
15 min

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%).

: 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.

: 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).

: 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).

: 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.