FDA Emergency Use Authorized COVID-19 “Coronavirus” IgG/IgM Rapid Test Kit

(For Medical Professional Use Only)

FDA Emergency Use Authorized Coronavirus (COVID-19) Instant Test Kits

  • FDA Emergency Use Authorization (EUA)
  • Rapid results within 10 minutes
  • Small sample size
  • Sold in packs of 25
  • Shelf life of up to 24 months from manufacture date
  • Test to be performed in a CLIA moderate- or high-complexity setting *
  • Verification of use case prior to shipping is mandatory

This test has not been authorized by the FDA under an EUA for use by authorized laboratories.

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

This test is only authorized for the duration of the deleration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics 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.

* Please defer to your local regulations. To learn more, download the FDA Fact Sheet: Antibody Test Oversight and Use For COVID-19.

To request more information about our Rapid Coronavirus (Covid-19) test kit-such as the product insert or the CE documentation, please complete the form below.

Sold in counts of 25, minimum of 25 units for all orders.

COVID-19 IgG/IgM Rapid Test Cassette

The Novel Coronavirus testing kit 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:

Study 1: Healgen Clinical Agreement Validation
The clinical performance of the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) was evaluated by testing a total of 191 plasma (K2EDTA) clinical samples—90 positive samples and 101 negative samples) from individual patients exhibiting pneumonia, respiratory symptoms and fever etc. Testing was performed at two sites in China from January to mid-March 2020. COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) results for IgM and IgG detection were compared to the results of RT-PCR assays for SARS-CoV-2 from oropharyngeal swabs (Site #1) and sputum (Site #2). At Site #1, 61 retrospective specimens and 4 prospective specimens were included in the study. At Site #2, 95 retrospective specimens and 31 prospective specimens were included in the study. The time from RT-PCR result to collection of specimens (plasma) ranged from 15-45 days (Site #1) and 0-38 days (Site #2). The time from collection of specimens (plasma) from each individual to testing ranged from 12-23 days (Site #1) and 3-29 days (Site #2). Overall study results are shown in below (Table 1).


IgG:
Positive Percent agreement (PPA): 96.7% (87/90) (95%CI: 90.7%~98.9%) Negative Percent agreement (NPA): 98.0% (99/101) (95%CI: 93.1%~99.5%)
IgM:
Positive Percent agreement (PPA): 86.7% (78/90) (95%CI: 78.1%~92.2%) Negative Percent agreement (NPA): 99.0% (100/101) (95%CI: 94.6%~99.8%)
Overall (either IgG+ or IgM+):
Positive Percent agreement (PPA): 96.7% (87/90) (95%CI: 90.7%~98.9%) Negative Percent agreement (NPA): 97.0% (98/101) (95%CI: 91.6%~99.0%)

Study 2: Independent Clinical Agreement Validation
The test was validated against a panel of previously frozen samples consisting of 30 SARS-CoV-2 antibody-positive serum samples and 80 antibody-negative serum and plasma samples. Each of the 30 antibody-positive samples were confirmed with a nucleic acid amplification test (NAAT) and both IgM and IgG antibodies were confirmed to be present in all 30 samples. The presence of antibodies in the samples was confirmed by several orthogonal methods prior to testing with the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma). The presence of IgM and IgG antibodies specifically was confirmed by one or more comparator methods. Antibody-positive samples were selected at different antibody titers.
All antibody-negative samples were collected prior to 2020 and include: i) Seventy (70) samples selected without regard to clinical status, “Negatives” and ii) Ten (10) samples selected from banked serum from HIV+ patients, “HIV+”. Testing was performed by one operator using one lot of the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma). Confidence intervals for sensitivity and specificity were calculated per a score method described in CLSI EP12-A2 (2008).
For evaluation of cross-reactivity with HIV+, it was evaluated whether an increased false positive rate among antibody-negative samples with HIV was statistically higher than the false positive rate among antibody-negative samples without HIV (for this, a confidence interval for the difference in false positive rates was calculated per a score method described by Altman). The results and data analysis are shown in the tables below.


Product Facts:

  • 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 this Coronavirus test kit 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.
    4. Wait for the colored line(s) to appear. After 2 minutes, if the red color has not moved across the test window or if blood is still present in the specimen well (S), add 1 additional drop of the sample buffer to the buffer well (B).
    5. 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:
The colored line in the control line region (C) changes from blue to red. No line appears in the test line regions M or G. The result is negative.
IgM Positive:
The colored line in the control line region (C) changes from blue to red, and a colored line appears in test line region M. The test result indicates the presence of IgM anti-SARS-Cov-2 antibodies.
IgG Positive:
The colored line in the control line region (C) changes from blue to red, and a colored line appears in test line region G. The test result indicates the presence of IgG anti-SARS-CoV-2 antibodies
IgG and IgM Positive:
The colored line in the control line region (C) changes from blue to red, and two colored lines appear in test line regions M and G. The test results indicate the presence of IgM and IgG anti-SARS-CoV-2 antibodies.
Invalid:
Control line is partially red, and fails to completely change from blue to red. 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

Are these tests FDA approved?

These tests are authorized by the FDA for emergency use as of May 29, 2020. On March 16th, 2020 the FDA published a guideline to cover this that can be found on the FDA website.

Confirm BioSciences is Healgen Scientific’s Largest Distributor in North America.

Are these tests CLIA waived?

While FDA has indicated in their March 16th guideline that such tests may be appropriate for use in clinical laboratories and by healthcare workers at the point of care, the policies in the Policy for Diagnostic Tests for Coronavirus Disease-2019 do not provide a CLIA categorization and do not override any CLIA requirements.

Please contact your Local State or County Health Agency to ask for guidance on the CLIA status of the antibody tests that have not received a EUA authorization, yet indicated by FDA as an appropriate test to use by healthcare workers at the point of care setting.

You can also review these links that might be helpful:

  • Covered COVID-19 tests include all FDA-authorized COVID-19 diagnostic tests, COVID-19 diagnostic tests that developers request authorization for on an emergency basis, and COVID-19 diagnostic tests developed in and authorized by states.
  • CPT Codes for COVID 19 Tests

How do I collect the blood sample?

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

Who can buy these tests?

Medical providers such as hospitals, physician offices, urgent care, outreach clinics, and temporary patient care settings that have appropriately trained personnel or medical supply distribution companies that currently sell medical products to these settings.

Can I be reimbursed for these by insurance?

Please check these two links:

Does it test for both antibodies?

Yes, the test will detect both IGG and IGM. To find out more product information please go to our website and fill out a form so we can provide you more information please

Does it 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 tests?

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 forms online

Price of these tests?

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