Frequently Asked Questions

About Antibody Rapid Tests

What's the best way to use this test?

Rapid IgM/IgG Tests are best used when combined with these symptoms:

  • Loss of sense of smell or taste
  • Unusual shortness of breath
  • A "vibrating" sensation in their nerves/brain
  • Fever
  • Feeling of malaise or of getting sick
  • Gastrointestinal or stomach issues

Think about the entire story of the person getting tested! Use this test as part of the complete patient picture. Always consult with your doctor if you have doubts.

What type of technology are these COVID-19 tests?

The 2019 n Coronavirus IgM and IgG Test is a qualitative serology test for the detection of IgM and IgG antibodies to 2019-nCoronavirus in human serum, plasma or whole blood. The test provides a differential detection of anti-2019-nCov IgM and anti-2019-nCor-IgG antibodies and can be used for the presumptive distinction between a primary and secondary Coronavirus infection. This test is for in-vitro diagnostic use only. It's a Rapid Antibody Test.

How accurate are COVID-19 Rapid Blood Tests?

Each test is a bit different. For example, QuikPacII has an overall Test Specificity is 97.7%. OrientGene has a 97.2% Concordance Rate.

It is important to realize there are very low rates of false negative or false positive, but these can happen. Therefore these tests should be one critically important data point in the whole picture of the person being tested.

Can a business or organization be a customer/user of the Rapid Blood Tests even though they do not have any Medical Professional associated with it?

Yes! If a customer needs a Medical Professional, Amplicon can arrange to have one sent to the customer. Please email ross@amplicondist.com for assistance.

Antibody testing cheat sheet

Antibody: This Y-shaped molecule specifically attaches to foreign proteins to help destroy microbes and cells that are infected.
 

Antigen: This is a protein, or piece of a protein, that antibodies recognize as foreign. In an antibody test, this is what the antibodies stick to.

 

IgM antibody: Usually composed of five units, these antibodies arise early in infection to help guide the immune response and are included in some tests.

 

IgG antibody: Arising later in infection, these abundant antibodies typically work to fight reinfection. Most antibody tests measure these.

 

IgA antibody: Produced by mucus-containing tissues, like those in the respiratory tract, these antibodies are included in some tests.

 

Molecular test: This diagnostic test measures genetic material or protein biomarkers, rather than antibodies.

 

Neutralizing antibody: This type of antibody can bind to pathogens to prevent them from infecting cells. Few commercial antibody tests indicate whether a person’s antibodies are neutralizing.

 

Selectivity: This is a measure of how tightly antibodies bind to an antigen, and a predictor of the number of false negatives (antibodies missed) an antibody test will produce.

 

Specificity: This is a measure of how specific the antigen in the assay is for the antibodies it is trying to detect, and a predictor of the number of false positives (unrelated antibodies binding) an antibody test will produce.

How quickly do I get test results?

Positive results will appear on the device within minutes. We recommend that negative results be confirmed 10-15 minutes after diluent is applied. Tests are invalid after 15 minutes.

What equipment is needed to generate test results?

The Rapid Blood Tests are self-contained devices. No laboratory equipment is required to obtain results.

Do tests indicate exposure and immunity to COVID-19?

Scientists worldwide, and the FDA are trying to answer these question. While nothing is 100% certain, the presence of IgG or IgM antibodies has not been scientifically established to indicate immunity.

Purchasing

Who can purchase the COVID-19 Rapid Blood Tests?

You will need to be affiliated with a Medical Professional in order to properly utilize the tests and interpret the results. Any Medical Professional can perform this test.

Under Title 21, Volume 8, Section 810.2 of the Federal Regulations for the FDA use this definition:(g) Health professionals means practitioners, including physicians, nurses, pharmacists, dentists, respiratory therapists, physical therapists, technologists, or any other practitioners or allied health professionals that have a role in using a medical device for human use. (ie: If someone is trained to provide a flu shot, they can administer this test)

Can Amplicon provide one free sample of the Rapid Blood Tests?

The boxes are sold with 25 cassettes in each. Unfortunately, we cannot split them as there is only one Buffer bottle to share per kit of 25 tests.

Are serology tests CLIA Waived?

No, they are not CLIA waived. Laboratories authorized to use EUA-authorized tests are subject to various conditions that can be found in the EUA.

Each EUA also includes the settings in which the test is authorized. For ease of reference, the settings authorized in the EUAs are also noted in the EUA table on the EUA page. Tests that are noted with an "H" in the Authorized Settings are limited to use in laboratories certified under CLIA that meet requirements to perform high-complexity tests. Tests that are noted with an "H" and "M" in the Authorized Settings may be performed in laboratories certified under CLIA that meet requirements to perform high complexity and/or moderate complexity tests.

Can we provide any additional buffer solutions?

We are unable to provide additional solution as each buffer solution is specific to the test it comes with.

FDA Questions

What is a Medical Professional?

Title 21, Volume 8, Section 810.2 of the Federal Regulations for the FDA defines a medical professional as:

(g) Health professionals means practitioners, including physicians, nurses, pharmacists, dentists, respiratory therapists, physical therapists, technologists, or any other practitioners or allied health professionals that have a role in using a medical device for human use. 

As an example, if someone is trained to provide a flu shot, they can administer this test.

Are antibody tests FDA approved? Do they need to be?

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

COVID-19 Rapid Blood Tests for use by laboratories and healthcare workers at the point-of-care, has not been approved by the FDA. The FDA does not intend to object to the development and distribution of serology tests by commercial manufacturers or laboratories that identify antibodies to SARS-CoV-2 where 1) the test has been validated, 2) notification has been provided to the FDA, and 3) information along the lines of the following is included in the test report:

  • These test have 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 test 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.

This policy is limited to such testing in laboratories or by healthcare workers at the point-of-care.

What antibody tests are banned and should no longer be distributed for COVID-19?

The commercial manufacturers of serological tests have previously provided notification to FDA under the policy outlined in Section IV.D of the Policy for Coronavirus Disease-2019 Tests but have now been removed from that notification list.

https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-testing-sars-cov-2#nolonger

I am purchasing COVID-19 testing with a test kit listed on the notification lists for tests being offered under the policy in Section IV.C or IV.D in the Policy for Coronavirus Disease-2019 Tests. Should I notify FDA?

No. As stated in the Policy for Coronavirus Disease-2019 Tests, laboratories that are performing testing using the test kits of commercial manufacturers that have notified FDA as outlined in the guidance should not separately notify FDA.

Facilities performing COVID-19 testing must be certified under the Clinical Laboratory Improvement Amendments, or CLIA, which is administered by CMS. https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/

Test kits being offered prior to an EUA under the policies outlined in the FDA's Policy for Coronavirus Disease-2019 Tests have not yet been reviewed by the FDA, are not FDA authorized, and have not received a CLIA categorization. Unless and until an EUA is issued that authorizes additional testing environments for a specific test, under CLIA, use of that test is limited to laboratories certified to perform high complexity testing, and at the point-of-care when covered by the laboratory's CLIA certificate for high-complexity testing.

Laboratories offering such tests may be subject to additional requirements regarding establishment of performance specifications under the CLIA Regulations. Laboratories with questions about these requirements should contact CMS at LabExcellence@cms.hhs.gov.

(Updated 6/1)

I am purchasing COVID-19 testing with an EUA-authorized test kit. Should I notify FDA?

No. Notification is intended for tests being offered under certain policies in the FDA's Policy for Coronavirus Disease-2019 Tests. In those cases, FDA expects notification from laboratories intending to offer tests they have developed and commercial manufacturers intending to distribute test kits they have developed. FDA does not expect any notification or EUA request from laboratories that are performing testing using EUA-authorized test kits purchased from commercial manufacturers or their distributors. Facilities performing COVID-19 testing must be certified under the Clinical Laboratory Improvement Amendments, or CLIA, which is administered by CMS. https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/

Laboratories authorized to use EUA-authorized tests are subject to various conditions that can be found in the EUA.

Each EUA also includes the settings in which the test is authorized. For ease of reference, the settings authorized in the EUAs are also noted in the EUA table on the EUA page. Tests that are noted with an "H" in the Authorized Settings are limited to use in laboratories certified under CLIA that meet requirements to perform high-complexity tests. Tests that are noted with an "H" and "M" in the Authorized Settings may be performed in laboratories certified under CLIA that meet requirements to perform high complexity and/or moderate complexity tests. Tests that are noted with a "W" in the Authorized Settings are deemed to be CLIA-waived for use in patient care settings operating under a CLIA Certificate of Waiver. Tests noted with an "H," "M," and "W may be used in laboratories certified under CLIA that meet requirements to perform high complexity and/or moderate complexity tests and in patient care settings operating under a CLIA Certificate of Waiver.

(Updated 6/1)

Reimbursement

Are there new Current Procedural Terminology (CPT) codes for COVID-19 testing?

On April 10, 2020, the American Medical Association (AMA) CPT Committee announced two new CPT codes to report when patients receive blood tests that can detect antibodies for COVID-19. These two codes are:

  • 86328: Immunoassay for infectious agent antibody(ies), qualitative or semiquantitative, single step method (e.g., reagent strip); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19])
  • 86769: Antibody; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)(Coronavirus disease [COVID-19])

    Medicare has updated its billing systems to accept these new test codes.

    HCPCS code U0002 is still available for billing Medicare if your test does not fit any of the other existing code descriptors for COVID-19 testing. HCPCS code U0002  must have the modifier QW (example: U0002QW) to be recognized as a test that can be performed in a facility having a CLIA certificate of waiver. Note that MACs will not search their files to adjust claims already processed prior to implementation of CR 11765.

If your COVID-19 test can be done in a single step, the most appropriate code to use is 86328. Multi-step antibody testing for COVID-19 can be billed using 86769. What is the difference?

  • Single Step: CPT code 86328 was established for antibody tests using a single-step method immunoassay. This testing method typically includes a strip with all of the critical components for the assay and is appropriate for a point of care platform.
  • Multi Step: CPT code 86769 was established for COVID-19 antibody tests using a multiple step method. This testing method often involves several steps where a diluted sample is incubated in a sample plate.

Additional FAQ's on Medicare Fee-for-Service (FFS) Billing can be found here: https://www.cms.gov/files/document/03092020-covid-19-faqs-508.pdf

Payment Amounts

Local MACs are responsible for developing the payment amount for claims they receive for these newly created CPT codes in their respective jurisdictions until Medicare Updated: 5/15/2020 pg. 8 establishes national payment rates on the CLFS. Please see https://www.cms.gov/files/document/mac-covid-19-test-pricing.pdf or below for more information on current MAC payment rates. If there are questions or concerns about payments, laboratories should contact their MAC for additional information.

Medicare Administrative Contractor (MAC) COVID-19 Test Pricing Updated on May 19, 2020

[Updated May 25, 2020]