Megna Antigen Test Kit

Megna Antigen Test Kit

97%

Sensitivity (PPA)

100%

Specificity (NPA)

10

Results In Minutes

This test has not been reviewed by the FDA

CE Certified, available for sale in European Union
Made in the USA
Not available in the USA
FDA/EUA Authorization Pending
20 Complete Tests per Kit

 

The Megna Rapid COVID-19 Antigen Qualitative Test is a lateral flow colloidal gold immunoassay intended for rapid qualitative detection of nucleocapsid antigens from COVID-19 in human nasopharyngeal swab from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms. Results in 10 minutes, no equipment needed, individual buffers for each test. Just five simple steps is all it takes to quickly perform the Megna Health Rapid Antigen test for Coronavirus and receive highly sensitive (97%) and specific (100%).

The Megna Health Rapid Antigen test for Coronavirus offers the convenience of an easy to use mobile app for recording and sharing results. Unlike the rapid antigen tests by Quidel (Sophia) and BD (Veritor), the Megna Health Rapid Antigen test does not require purchasing a specialized reader device to produce results.

The Megna Health Rapid COVID-19 Antigen Qualitative Test is intended for use by trained healthcare and/or laboratory personnel in Point of Care (POC) settings. Negative results do not rule out SARS-CoV-2 infection, particularly those who have been in contact with the virus. Follow up testing with a molecular diagnostic test should be considered to rule out infection in these individuals.

​This rapid test is not for home-use or at-home specimen collection.

 

 

 

SKU# SV31

Product Name: Megna Rapid COVID-19 Antigen Qualitative Test
SKU:  SV31
Manufacturer: Megna Health, Inc
Country of Manufacture: USA
Incorporated: Owned and operated in the USA
Sample Type: Nasopharyngeal
Sensitivity: 97%
Specificity: 100%
Test Procedure: 5 steps
Test Run Time (minutes): 10 minutes
Mobile App: Yes

What’s in the box?

20  Test Cassettes

20  Nasal Swabs

20  Extraction Tubes

20   Bottles of Extraction Solution

1    Tube Rack

1    Package Insert

Package dimensions  (20 tests): 8.0 x 4.75 x 2.5 inches

Package Weight (20 tests):  0.56 lbs.

Carton Dimensions (1,600 tests):  24x20x20 inches

Carton Weight (1,600 tests):  45 lbs.

Pallet Dimensions (16,000 test 10 cartons): 48x40x60 inches

Pallet Weight (16,000 10 cartons): 450 lbs.

Swab Included: Nasal Swab

Storage Temp (In Celsius): 2C-30C

Shelf Life: 12 months from date manufactured, expiration dated on box

Internal Control Included: No

EUA Status: Submitted for authorization **Not Available for sale in the U.S.

CE Status: CE Certified

Availability:  Contact us for availability. RUO.

 

 



Additional Information

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