FDA Authorized Covid-19

Rapid Antibody Tests

Now Available!

 

CLIA Waived problem solved!  See Below

 

$500/box of 25 IgM/IgG tests

  • Results in 10 minutes
  • Easy to read
  • No Instrumentation
  • Professional use only - not for home testing

 

Healgen
We are excited to announce that we have partnered with a manufacturer of COVID-19 IgG/IgM Rapid Test Kits that are used for the qualitative, differential detection of both anti-SARS-CoV-2 IgM and IgG antibodies.
These COVID-19 kits have been recently authorized by the FDA under an Emergency Use Authorization (EUA).  Per the FDA, the intended use of the kits are to aid in identifying individuals with an adaptive immune response to SARS-CoV-2 (the virus that causes COVID-19) indicating recent or prior infection.
MOQ: 100 tests

Price: $20/test

For Professional Use Only

 

Point-of-Care Use

Our exclusive CLIA laboratory partner has created a proprietary, FDA approved system that allows us to sell these test kits to point-of-care facilities under a legal CLIA Umbrella.

This compliant umbrella facilitates reporting requirements of test results to government agencies and allows us to provide unparalleled customer service and the ability to sell to urgent care facilities, pharmacies, independent medical practices, selected third party administrators with medical professionals, hospitals, nursing homes, in house clinics for employers and self-insured organizations, patient service centers and more.  

Other distributors are only able to offer these test kits per the FDA test use classification which limits use to authorized laboratories that perform moderate or high complexity tests or pharmacies.

  • Our Rapid Test Kits are not only authorized for use by the FDA under an Emergency Use Authorization (EUA),
  • But validated by BOTH the World Health Organization (sensitivity & specificity)
  • And the NCI (National Cancer Institute).
  • Additionally, the kits have received the CE certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area.
  • We are in constant communications with the FDA, HHS, CDC and CLIA in order to assure we are adhering to all guidelines.  To us, it is very important to stay ahead of what is asked by the reporting agencies.

 

Order Here

Covid test flyer

 

 

Coronavirus Test Kits FAQs

Are they kits or do you need lab equipment to run the tests?

These are simple kits, no lab equipment needed except typical lancets, alcohol wipes, plastic pipettes for fingerstick blood sample.

Test Steps:

Is the kit approved by the FDA?

They are given FDA authorization under the EUA for the length of the emergency.  Once the emergency is declared done, the authorizations will be removed.

note from Dr. Earl - this means test results must be used in conjunction with clinical suspicion and other findings to confirm infection.

This is an IgM/IgG antibody test.  IgM antibodies may take days or weeks to develop after becoming infected with Coronavirus, thus may not be detected in very early stages.  IgG indicates longer term antibody response and may indicate previous infection.

This is as opposed to a nasal swab test you are sending to the lab which is detecting the virus itself.

You might think of it as you would for a rapid strep test - sometimes you still send an actual culture to the lab, or a urine for culture after your dipstick or in-office microscopy shows WBCs and bacteria.

https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/eua-authorized-serology-test-performance

Other Resources:

Healgen Scientific LLC Diagnostic COVID-19 IgG_IgM Rapid Test Cassette (WB_S_P) - Letter of Authorization

Fact Sheet for Health Care Providers

Fact Sheet for Recipients Use of Antibody Tests 04-28-2020

How Accurate are the tests?

Clinical Evaluation

    • Positive Percent Agreement (PPA): IgG 96.7%; IgM 86.7%; Overall 96.7%

    • Negative Percent Agreement (NPA): IgG 98.0%; IgM 99.0%; Overall 97.0%

Clinical Agreement with Characterized Samples

    • Sensitivity: IgG 96.7%; IgM 100%; Combined 100%​

    • Specificity: IgG 97.5%; IgM 100%; Combined 97.5%​

Is the test covered by insurance?

The billing code for non-CDC laboratory tests for SARS-CoV-2/COVID-19 is U0002. The patient's insurance company should be contacted to determine coverage and pricing.

Is it a CLIA Waived test?

Here is the FDA guidance from the March 16 2020 publication from FDA Rapid Test Kit Guidelines

Commercial Manufacturer Development and Distribution and Laboratory Development and Use of Serology Tests

Without an EUA
The policy described in this subsection applies to developers of serology tests that identify
antibodies (e.g., IgM, IgG) to SARS-CoV-2 from clinical specimens. This policy is limited to
such testing in laboratories or by healthcare workers at the point-of-care. This policy does not
apply to at home testing.

Considering that serology tests are less complex than molecular tests and are solely used to
identify antibodies to the virus, FDA does not intend to object to the development and
distribution by commercial manufacturers or development and use by laboratories of serology
tests to identify antibodies to SARS-CoV-2, where the test has been validated, notification is
provided to FDA, and information along the lines of the following is included in the test reports:

  • This test has not been reviewed by the FDA.
  • Negative results do not rule out SARS-CoV-2 infection, particularly in those who have
    been in contact with the virus. Follow-up testing with a molecular diagnostic should be
    considered to rule out infection in these individuals.
  • Results from antibody testing should not be used as the sole basis to diagnose or exclude
    SARS-CoV-2 infection or to inform infection status.
  • Positive results may be due to past or present infection with non-SARS-CoV-2
    coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

FDA recommends that developers planning to submit an EUA for serological testing as the sole
basis to diagnose or inform infection status, include information along the lines of the statements
above in their test reports until data is submitted and an EUA is authorized for additional uses.

However, here are some excerpts from recent FDA clarification from April 9, 2020

FDA Clarifies CLIA-waived Status for Point-of-Care SARS-CoV-2 Tests under Emergency Use Authorizations

The U.S. Food and Drug Administration (FDA) recently clarified that, when it grants an Emergency Use Authorization (EUA) for a point-of-care test, that test is deemed to be CLIA-waived. For the duration of the national emergency declaration for COVID-19, such tests can be performed in any patient care setting that operates under a CLIA Certificate of Waiver or Certificate of Compliance/Certificate of Accreditation.

In addition, FDA clarified that tests for SARS-CoV-2 that are offered prior to or without an EUA have not been reviewed by FDA, are not FDA authorized, and have not received a CLIA categorization. Thus, those tests are considered high complexity by default until they receive an EUA or other FDA approval that indicates they may be performed as moderate complexity or waived tests.

For more information, visit this FDA Web page, navigate to the section titled “General FAQs,” and view the first two questions and their corresponding answers.

 

FDA FAQs posted here-

Q: When FDA authorizes under an EUA a SARS-CoV-2 test for use at the point of care, does that mean it is CLIA waived?

A: Yes.  The settings in which an EUA-authorized test may be used are described in the Letter of Authorization.  As discussed in the Guidance for Industry and Other Stakeholders: Emergency Use Authorization of Medical Products and Related Authorities, when the FDA authorizes point of care tests (including SARS-CoV-2 point of care test systems) under an EUA, such tests are deemed to be CLIA waived tests.  Accordingly, for the duration of the emergency declaration, such tests can be performed in a patient care setting that is qualified to have the test performed there as a result of operating under a CLIA Certificate of Waiver or Certificate of Compliance.

We note that the term point of care in the EUAs may include settings such as hospitals, physician offices, urgent care, outreach clinics, and temporary patient care settings that have appropriately trained personnel to perform the test and are operating under a CLIA Certificate of Waiver or Certificate of Compliance. These terms generally do not apply to home specimen collection or at home testing unless otherwise specified.

A: Tests being offered prior to or without an EUA under the policies outlined in the FDA's Policy for Diagnostic Tests for Coronavirus Disease-2019 that have not yet been reviewed by the FDA, are not FDA authorized, and have not received a CLIA categorization.  While FDA has indicated 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.  Therefore, in accordance with CLIA, tests offered under these policies are considered high complexity by default until or unless they are authorized and deemed to be appropriate, through an EUA authorization or general FDA review processes, to be performed as moderate or waived complexity tests.

Laboratories using tests being marketed under the FDA's EUA policy should be mindful of CLIA requirements which are enforced by CMS and certain State authorities, and CMS guidance for laboratories during the COVID-19 public health emergency. Under CMS guidance, if a facility has the appropriate CLIA certificates and follows applicable CLIA regulations, state regulations and guidelines, the laboratory's CLIA certificate can be extended to cover testing in areas outside of the designated primary site or home base such as contiguous buildings, or any other designated temporary overflow location in its facility or temporary remote location, such as a parking lot. https://www.cms.gov/files/document/qso-20-21-clia.pdf-0

If you have a CLIA high complex lab designation, you may use the tests before the FDA EUA is issued.

If you are a CLIA waived lab, you will need to wait for the EUA in order to begin testing.

We will update this information as it comes in.

Is the rapid test done on a finger stick or a venous stick?

The rapid test can be done with a fingerstick whole blood sample.

How long does it take after exposure to detect disease?

3 - 5 days after symptoms appear or a week or more after exposure.  This is an antibody test and should be used along with clinical suspicion to arrive at a diagnosis.  If negative, it may be too soon to detect an antibody response and the test may need to be repeated or confirmed with PCR throat and nasal swab testing.