This page is for Non-U.S. Companies. If you are a U.S. Medical Facility, please click here to learn about COVID-19 Tests for Medical Use Only.

COVID-19 “Coronavirus” IgG/IgM Rapid Test Cassette

Coronavirus (COVID-19) Test Kits (For Sale in EU and Internationally)

  • Results in 10 minutes
  • Small sample sizes
  • Accurate analysis
  • Sold in packs of 25
  • Made in USA inventory available
  • Shelf life of up to 24 months from manufacture date
  • CE marking (conforms with health standards for products sold within the European Economic Area)
  • Interested in IgG and IgM Controls? Inquire here for availability

To purchase or request more information, such as clinical trial info, the product insert, and CE documentation, please complete the form below.

Sold in counts of 100. International orders above 10,000 units will be given priority due to extremely high demand. Thank you for your understanding.

COVID-19 Test Info Request: International

COVID-19 IgG/IgM Rapid Test Cassette

The test manufactured by Healgen Scientific LLC is conducted by using whole blood/serum/plasma and placing it in the center well of the cassette and then adding two drops of the buffer to the buffer well labeled “B.” Results should appear within 10 minutes and are invalid after 15 minutes. For more information, watch our video.

Clinical Evaluation Results:

The clinical evaluation was carried out during February 2020 across 10 hospitals and reported on March 12, 2020. Further clinical evaluations are ongoing and any further information needed can be granted at request.

The results from the Healgen Scientific LLC  tests show that the testing reagent and reference reagent have equivalent effectiveness in detecting COVID-19 when tested in the same clinical specimens. Compared with the reference reagent, the positive agreement was 93.87% (95%CI:90.24%~96.46%), the negative agreement was 99.10% (95%CI:97.70%~99.75%) and total agreement was 97.19% (95%CI:95.65%~98.26%). The kappa value of the consistency analysis was 0.94 (95%CI:95.65%~98.26%). The results of the clinical evaluation show that the two reagents (methods) have a high degree of consistency and equivalent sensitivity and specificity in detecting COVID-19.

Product Facts:

    • Approved for sale in EU and Internationally
    • Made in USA inventory available
    • Following the incubation period, IgM may appear in blood within 3-5 days. IgG will appear as soon as 1-2 weeks.
    • Sample: Test can work with whole blood, plasma and serum samples.
    • Storage: The kit can be stored at room temperature or refrigerated (2-30°C).
    • Shelf Life: Up to 24 months from manufacture date
    • More information, such as the product insert, clinical trial results, and CE documentation is available at request
    • Healthcare Provider Fact Sheet
    • Recipient Fact Sheet

More detailed results of ongoing clinical evaluations and test stability report for these Corona test kits are available upon request.

COVID-19 IgG/IgM Rapid Test Cassette Instructions for Use

    1. Remove the test cassette from the sealed foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
    2. Place the test device on a clean and level surface.
    3. (For Whole Blood Specimen): Hold the 5 μL mini plastic dropper vertically and transfer 1 drop of whole blood (about 10 μL) to the specimen well(S) of the test device, then add 2 drops (about 80 μL) of sample buffer to the buffer well (B) immediately. Avoid air bubbles.

(For Serum or Plasma Specimens): With a 5 μL mini plastic dropper provided, draw serum/plasma specimen to exceed the specimen line as showed in the following image and then transfer drawn serum/plasma specimen into the sample well (S). Then add 2 drops (about 80 μL) of sample buffer to the buffer well (B) immediately. Avoid air bubbles.

  1. Wait for the colored line(s) to appear. The result should be read in 10 minutes. Positive results may be visible as soon as 2 minutes. Do not interpret the result after 15 minutes.

Interpretation of Results:

Negative: If only the C band is present, the absence of any burgundy color in the both T bands (IgG and IgM) indicates that no anti-COVID-19 antibodies are detected in the specimen. The result is negative.

IgM Positive: In addition to the presence of C band, if only IgM band is developed, the test indicates for the presence of IgM anti-COVID-19 in the specimen. The result is IgM anti-COVID-19 positive.

IgG Positive: In addition to the presence of C band, if only IgG band is developed, the test indicates for the presence of IgG anti-COVID-19 in the specimen. The result is IgG anti-COVID-19 positive.

IgG and IgM Positive: In addition to the presence of C band, both IgG and IgM bands are developed, the test indicates for the presence of both IgG and IgM anti-COVID-19 in the specimen. The result is IgG and IgM anti-COVID-19 positive.

Invalid: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

Frequently Asked Questions

How do I collect the blood sample for the COVID-19 IgG/IgM Rapid Test Cassette?

Please review the product insert regarding what type of blood sample will be appropriate to use in your test.

Can we ship these COVID-19 IgG/IgM Rapid Test Cassettes to XYZ country?

It depends on where you are located. Please fill out the form at the top of this page and a Sales Rep will get in touch with you.

Does COVID-19 IgG/IgM Rapid Test Cassette test for both antibodies?

Yes, the test will detect both IgG and IgM. To find out more product information please fill out a form so we can provide you more information.

Does the COVID-19 IgG/IgM Rapid Test Cassette show if there was a recent infection?

Please check the Letter to Health Care Providers on the FDA website regarding use of serological tests.

What if someone tests positive?

Please check the Letter to Health Care Providers on the FDA website regarding use of serological tests.

What is the accuracy of these COVID-19 IgG/IgM Rapid Test Cassettes?

Please check the insert of the test you are using for the clinical data provided. If you would like, you can request the full clinical study from your account rep or using the form at the top of this page to reach an account rep.

Price of these COVID-19 IgG/IgM Rapid Test Cassettes?

Please fill out the form to request information regarding price, minimum quantity and payment terms applicable to the test you are looking for.