• Results within 15 minutes 

  • Specificity: 100%

  • Sensitivity: 98.8%

  • No external reading device needed

  • Fingerstick whole blood (not venous blood draw)

  • High sensitivity to recent exposure to SARS-CoV-2

  • Overnight or 2Day shipping available

FDA EUA ISSUED COVID-19 RAPID TEST KIT

Our Covid-19 IgG/IgM test has been validated by the US Government

Available in the United States and US Territories (non US orders click here), this test is used to qualitatively detect IgG and IgM antibodies of coronavirus in human serum, human plasma,  venous whole blood or fingerstick blood. This device is FDA EUA issued to be used by Point of Care providers for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

 

UNDERSTANDING RAPID ANTIBODY TESTING

Please note that specifically to SARS-CoV-2, the virus that causes Covid-19, interpretation of the test as intended to indicate protective immunity is not an authorized intended use. When used at the POC, this test is only authorized to detect and differentiate IgM and IgG antibodies to SARS-CoV-2 in human fingerstick whole blood specimens. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity.  Even if an individual tests positive for IgG, that individual should still follow CDC guidelines of physical distancing requirements and other preventative measures such as wearing masks.

 

HOW TO USE COVID-19 IGG/IGM RAPID TEST FOR POINT OF CARE PROVIDERS

Simple and convenient to use, our kit includes everything needed to test for Covid-19 IgG and IgM.

What's Included in Each Box:

  • Test Cassette

  • Buffer Solution

  • Pipette

  • Alcohol Pad

  • Single-use Lancet

INTERNAL QUALITY CONTROL

Control Line will change colors to discern a valid test result

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ACCURATE AND AFFORDABLE

Our tests have been validated by the US Government

Our test has been validated to the following for fingerstick whole blood:

Positive Percent Agreement:

  • 0-7 days onset of symptoms IgM+ PPA: 100%

  • 8-14days onset of symptoms IgM+ IgG+ PPA: 83.3%

  • 15+ days onset of symptoms IgG: 100%

Negative Percent Agreement:

  • NPA/specificity rate for IgG/IgM: 100%

ADDITIONAL INFORMATION

  • FDA EUA issued antibody test kit for finger stick (not venous blood draw) for qualified point of care organizations

  • Minimum order of 1 box of 20 tests

  • Rapid results in 10-15 minutes with no external reading device

  • For use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection

  • Any reactive specimen must be confirmed with an RT-PCR

FREQUENTLY ASKED QUESTIONS

COVID Testing Questions? See below.

Can I purchase this for home-use?

Home use is not approved by the FDA at this time.  Medsential is working on an At-Home Use product that we will update members who sign up for our newsletter.

Who can purchase this test?

This test can be purchased by businesses or government organizations.  Call us for details.  Our team can help you understand if you qualify and even assist you in the qualification process.

How accurate is this test?

Our test has been validated to the following for finger stick whole blood:

Positive Percent Agreement:

0-7 days onset of symptoms IgM+ PPA: 100%

8-14days onset of symptoms IgM+ IgG+ PPA: 83.3%

15+ days onset of symptoms IgG: 100%

Negative Percent Agreement:

NPA/specificity rate for IgG/IgM: 100%

What happens when the result is invalid?

You will need to retest on a new test cassette if the Control Line doesn't turn from solid blue to solid red at the top of the Cassette, next to the "C".  The most common reason for this is using too little buffer solution or other procedures not followed properly.

Why are there three types of positive results?

Our test represents two different antibodies that the body creates in response to a Covid-19 infection. There are three positive results because one could be positive for IgM, IgG, or both IgM and IgG.

M: Is the IgM (immunoglobulin M) is the largest antibody and is the first antibody to appear in response to initial exposure to an antigen.  The IgM line in these tests are specifically designed to identify IgM antibodies in response to SARS-CoV-2, the virus associated with Covid-19.

G: Is the IgG (immunoglobulin G) is a type of antibody.  Representing approximately 75% of serum antibodies in humans, IgG is the most common type of antibody found in blood circulation [1].  IgG molecules are created and released by plasma B cells.  Each IgG has two antigen-binding sites.  The IgG line in these tests are designed to identify IgG antibodies in response to SARS-CoV-2, the virus associated with Covid-19.

How long before I can get my ordered tests?

Medsential uses FedEx 2Day as standard shipping.  FedEx Overnight service can be accommodated as well.  Just let your representative know when they call to finalize your order.

 
 
Medical Team

ORDER NOW

Order Verification

Order Form

Thank you for your order. Per FDA Regulations, a Medsential representative will be in contact shortly to finalize your order.

Medsential Covid-19 Rapid Test Kits are sold in boxes of 20 to qualified organizations per FDA guidelines. 

Please fill out this order form and a Medsential representative will call you within 24 hours to finalize your order.

Standard shipping is FedEx 2Day.  Overnight shipping can be accommodated. 

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MEDSENTIAL'S CE APPROVED COVID-19 RAPID TEST

COVID-19 CE APPROVED RAPID TEST 

 

In addition to our US FDA EUA issued test (for US rapid test, click here), we have a CE Approved rapid test for use in the following countries:

  • European Union

  • Australia

  • Brazil

  • South Africa

  • Dominican Republic

  • Italy

  • Chile

  • Peru

  • United Kingdom

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Having the Medsential Rapid Covid Test has made a huge impact on our department by helping to reinforce safety policies and increasing confidence in our department's efforts to provide a safe and healthy working environment. We have caught a few asymptomatic positives and some that never knew they had the virus.

HCESD#10 District Chief BR Luscomb

SIMPLE TO USE 

Medsential's CE Approved Test Kit is Simple to use with Fast Results

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CE APPROVED TEST'S ACCURACY

Global Clinical Trials of over 1500 patients:

Sensitivity: 96.79%

Specificity: 99.28%

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