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One of The only remaining FDA Emergency Use<br> Authorization (EUA) Approved IgG/IgM Rapid Test Kits.

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The Healgen Test Kit Possesses The Highest Accuracy Of All Tests When It Comes To The Onset Of Infection

In practical terms, these results indicate that the Healgen Test is THE leading screening tool for infection onset.

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Get 30% OFF When You
Order 1 Box

Get 43% OFF When You
Order 3+ Boxes

Get 53% OFF When You
Order 5+ Boxes

LIMITED TIME. 1 Box for $23.96 per test kit (25 kits/box MOQ)

Healgen IgG/IgM Rapid Cassette

Test Facts:
FDA EUA Authorized: 05/29/2020

* The FDA has only granted this test emergency use authorization in a CLIA moderate- or high-complexity setting. Please refer to your local regulations. To learn more, download the FDA Fact Sheet: Antibody Test Oversight.

 

  • This test has been authorized by FDA under an EUA for use by authorized laboratories;
  • This test has been authorized only for the presence of IgM and IgG antibodies.
  • This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
  • Please let us know if you require our CLIA laboratory to handle the reporting of the test results to local, state and federal agencies. 

The Healgen Test Kit Possesses The Highest Accuracy Based On The Onset Of Infection

IgG

97% sensitivity and 98% specificity.

IgM

100% sensitivity and 100% specificity.

IgG & IgM

100% sens & 98% spec IgG and IgM combined

Procedural Video

Included in each box:

25 kits

25 pipettes per box

1 large buffer per 25 kits

Package insert

WHOLESALE PRICE 

$23.96 Per Test Kit

25 Test Kits Minimum

$700.00/Box 

$599.00/Box

In practical terms, these results indicate that the Healgen Test is THE leading screening tool for infection onset.

As of today, we have in excess of 1 million test units available for sale. Same day shipping is available for orders placed before 2 pm PST.

Healgen Named "A Cut Above The Rest!"
by an independant test of 60 serological tests

A new study evaluated the accuracy of more than 60 coronavirus antibody tests.

Healgen IgG/IgM was Named as a cut above the Rest!

Business Insider July 23rd, 2020

A new, independent review published in the journal Diagnostics evaluated more than 60 serological (blood) antibody tests on the market. 

The researchers found that most antibody tests didn’t perform as well as their manufacturers claimed.

Scientists use two basic measures to determine the accuracy of an antibody test: sensitivity and specificity. 

The researchers also highlighted the 13 highest-performing antibody tests on the market. A few FDA-approved tests — from Beijing Wantai Biological Pharmacy, Healgen, and Abbott — made the cut.

However, the first FDA-approved antibody test, from the biotech company Cellex, did not. 

The rapid test from Healgen was one of the few tests with 100% sensitivity and 100% specificity — but those results were only for IgM antibodies.

The Healgen test for IgG antibodies had 96.7% sensitivity and 97.5% specificity.

Therefore, both of the company’s own submitted test results match the percentages listed on the FDA website.

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