Test For COVID-19 Antibodies With Just A Drop of Whole Blood

Instant results in 5-10 minutes, similar to a blood sugar test.
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About

Amplicon's Role

Amplicon independently validates all COVID19 IgM/IG Rapid Tests offered. In business since 1996, Amplicon proactively performs investigational research to confirm the claims of all manufacturers. Doing our due diligence is a critical part of bringing the best performing tests to Medical Professionals.
Yield Accurate & Reliable Results

Amplicon ensures the Rapid Blood tests will yield accurate and reliable results that match the manufacturer's claims.

Logistics & Transport

Due to the unprecedented global pandemic, the supply chain is disrupted. Our team tracks, confirms and validates each order daily to ensure accurate delivery date information.

Fair Prices

It is important for us to offer low prices for the quantities needed. We believe frequent testing of all individuals is a critical component to understanding the spread of the virus.

Buyers Beware: There are tests on the market that do not work as claimed and sadly, some sellers are price gouging in this pandemic crisis. Amplicon helps alleviate these concerns.
Features

COVID-19 IgM/IgG Rapid Blood Test

The Rapid Blood Tests we offer detect antibodies to SARS-CoV-2 coronavirus (COVID-19) using a drop of whole blood. To conform to FDA criteria, only Medical Professionals can perform and interpret results
1

Simple & Easy to Operate

No special training: Medical professionals can easily perform

No equipment required: Visual test results

2

Results in ~5 to 10 minutes.

Easy to use COVID-19 tests give results within 10 minutes, allowing for accurate mass testing.

3

Detects Evidence of Infection

Rapid tests have the ability to detect both recent (IgM) and later-stage (IgG) antibodies to COVID-19 infection.

Rapid tests provide information on the stage of the infection.

Community Development

Employees

Service Workers

Construction Workers

Municipal Workers

Healthcare Workers

Frequently tested but still maintaining social distancing guidelines.

Products

Currently Available

FDA APPROVED
IgM/IgG

QuikPacII

100% Made in America.

Overall Test Specificity is 97.7%

FDA Listed

FDA APPROVED
IgM/IgG

Sienna

CE Certs & EUROPEAN standard 

FDA Listed

Made in Finland

FDA APPROVED
IgM/IgG

OrientGene

97.2% Concordance Rate

FDA Listed

Made in China

WHO Report Comparison of Cellex and OrientGene

Frequently Asked Questions

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.


Can anyone buy these tests?

Anyone who is authorized to make purchases for your company may place an order, but you must be affiliated with a Medical Professional in order to properly use the tests and interpret the results.

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.

What is Amplicon Distributors doing to validate these COVID-19 tests?

TBA

How accurate are these tests?

The tests we offer are confirmed to match the manufacturer's claims in regards to specificity, sensitivity, and concordance with the rtPCR tests. A diagnosis of current infection should only be made by a physician after all clinical and laboratory findings have been evaluated. 

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.

Can customers pick up products from our office?

We are unable to offer product pickups from our office. All orders will be shipped.

Is this test CLIA Waived, can we get reimbursed?

No, it is not CLIA waived. There is no reimbursement.

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.

Have the tests been approved by the FDA?

COVID-19 Rapid Blood Tests for use by laboratories and healthcare workers at the point-of-care, have 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) the following information 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.

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.

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]

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