Amplicon ensures the Rapid Blood tests will yield accurate and reliable results that match the manufacturer's claims.
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.
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.
No special training: Medical professionals can easily perform
No equipment required: Visual test results
Easy to use COVID-19 tests give results within 10 minutes, allowing for accurate mass testing.
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.
Frequently tested but still maintaining social distancing guidelines.
Rapid IgM/IgG Tests are best used when combined with these symptoms:
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.
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.
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.
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.
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.
We are unable to offer product pickups from our office. All orders will be shipped.
No, it is not CLIA waived. There is no reimbursement.
We are unable to provide additional solution as each buffer solution is specific to the test it comes with.
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:
This policy is limited to such testing in laboratories or by healthcare workers at the point-of-care.
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.
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:
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?
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
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.
[Updated May 25, 2020]