Megna Antibody Test Kit

Megna Point of Care Antibody Test

Coronavirus (COVID-19) IgM/IgG Rapid Test Kit

100%

Sensitivity (PPA)

95%

Specificity (NPA)

15

Results In Minutes

Now authorized for use at the point-of-care setting (CLIA Waived) with fingerstick whole blood specimens!

Megna Health’s Rapid COVID-19 lgM/lgG Combo Test Kit is authorized for detection of lgG and IGM antibodies to SARS-CoV-2 in serum and acid citrate dextrose (ACD) plasma specimens. Easy to Use and Manufactured in U.S.  Megna Health’s Rapid COVID-19 lgM/lgG Combo Test Kit requires no special equipment to read test results.

Megna Health rapid test targets the nucleocapsid protein or N protein for the antibody detection of Covid-19.

Megna Health rapid test has been authorized by FDA under an EUA for use by authorized laboratories;

Megna Health rapid test has not been FDA cleared or approved;

Megna Health rapid test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens; and

Megna Health rapid test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

CPT: 86328, 86769

SKU # SV10

Product Name: Megna – Rapid COVID-19 IgM/IgG Combo Test Kit

SKU: SV10

Country of Manufacture: USA

Sample Type: Blood

Method of detection: Colloidal Gold

Sensitivity: 100%

Specificity: 95%

Run Time for Test Restults: 15 minutes

Mobile App: N/A

The Megna Antibody test is intended for use by trained laboratory personnel and healthcare professionals.

Shipping Dimensions:
Antibody box: 6.75 x 4.75 x 2.5 inch (25 tests per box)
Shipping Carton-24x20x20 inches
• Each Carton contains 2000 tests (80 boxes)
• Each Carton weighs @45lbs
Best way for a pallet to go is 10 Cartons
Pallet size is standard 48×40 and 65 inches tall.
• Each pallet has 20,000 tests
• Each pallet weighs about 450lbs
Storage Temp: Room temp
Shelf Life: Expiration date on pouch
EUA Status: Authorized
CE Status: CE Marked
Unit of Issue: 25 tests per box
Availability: Ready to ship

 

FAQ

How accurate is the test?

The sensitivity is 100% and the specificity is 95%.

Are these tests covered by insurance?

The CMS CPT code is 86318. The individual’s insurance should be consulted to determine reimbursement

Are these tests authorized under the FDA's EUA?

Yes, Megna was granted it’s original authorization under the EUA on July 22nd, 2020. An extension for POC, CLIA Waived Use was granted on April 22nd, 2021. 

I would like to order. Who do I contact?

Contact your WMG Sales Representative or call 404-383-4099. Most orders can be shipped within 48 hours.