Scientific Principles Behind Our Test

The COVID-19 IgG/IgM Rapid Test Device identifies anti-SARS-CoV-2 IgG/IgM antibodies through visual interpretation of color development.

 

Anti-human IgG and anti-human IgM are used to identify specific antibodies in the human whole blood, serum, or plasma specimen. When specimen is added to the sample well, specific IgM and/or IgG antibodies, if present, will bind to the SARS-CoV-2 antigens conjugated to colored particles on the conjugate pad. As the specimen migrates along the strip by capillary action and interacts with reagents on the membrane, the complex will be captured by anti-human IgM and/or anti-human IgG antibodies immobilized on the test region(s). Excess colored particles are captured at the internal control region.

 

The presence of a red band(s) on the test region(s) indicates a positive result for the particular IgG and/or IgM antibodies, and its absence indicates a negative result. A red band at the control region (C) serves as a procedural control, indicating that membrane wicking is working.

Approvals & Validation Studies

On March 10, 2020, FaStep received the EC Declaration of Conformity. See the document here. ​

On July 6, 2020, the US Food and Drug Administration (FDA) issued an Emergency Use Authorization for the FaStep Antibody test kit. See the Letter of Authorization here

Frequently Asked Questions

What do the test results mean?


The COVID-19 IgG and IgM Rapid Test yields qualitative results for the presence or absence of antibodies that are produced in response to exposure from the corona virus. A healthcare provider should offer preliminary guidance to the patient based on the qualitative and presumptive results of the test, as well as taking into account symptomology of the patient and other certain factors that they feel important to reach any clinical decisions. The test is not intended to be the sole basis for diagnosis but rather an instrument that offers a clinically valid indication of the presence of the total antibodies that may be produced as a result of exposure to the corona virus. 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




Can this test be sold directly to consumers?


No. At this time, this test is registered for sale and usage only in compliance with moderate and high-complexity CLIA requirements. Please reference CMS and CLIA guidelines on what qualifies a provider to offer testing solutions in the office setting.




What do the kits include?


- Individually wrapped testing device with desiccant - Buffer (reagent) - Sterile lancet - Alcohol pad - Capillary pipette




How can I use this test in my practice or facility?


The test yields a qualitative result for the presence or absence of the antibodies that may have been produced by exposure to the corona virus. Immunity is an important feature of returning to life and the medical community is only beginning to understand the relationship between total SARS/COV-2 antibody production and immunity to COVID-19. Please check to our website as additional information is published by the CDC on this topic.




What is the cost of the tests, return policy and when will I receive them?


The tests are packed in cases of 20 and are only available by the case at this time. Each individual test is priced at $49.99. We will only allow purchasing on our website when the product is in stock. These tests are available on a first-come, first-served basis and are not refundable once delivered to your location. If there are any changes to our estimated shipping window, we will notify you directly by e-mail and we will offer you the opportunity to cancel your order based on any changes to the delivery window. Please contact us for bulk purchasing or a replacement for damaged or defective devices at info@preventcare.com.




How do these tests differ from what laboratories offer?


This test is not a molecular polymerase chain reaction (PCR) test that requires laboratory equipment or confirmation. Our antibody serology test is a lateral flow assay that is reasonably priced and readily available for licensed medical professionals yields immediate qualitative results without the need to send in the specimen for laboratory testing. Other laboratory tests offered on the currently offered on the market have extremely limited availability and long turn-around times.




Can other versions of corona virus cause a positive result?


This novel coronavirus (SARS-CoV-2) is new and reached global pandemic infection rates with concerning efficiency. Other corona viruses, however, are well-known and are a routine part of our lives. Please carefully evaluate the sensitivity and specificity metrics on the validated study here to understand the degree to which false positives can occur due to infections by other corona viruses.




Do commercial or federal payers reimburse for this test?


In mid April, CMS offered guidance that billing codes will be created for this test. The speed with which this happens, the relationship to the FDA governance on the topic of serology tests and the pace of adoption by both federal and commercial payers is unclear at this time. Please check back to our website for updates. For additional guidance or specific questions on the topics above, please reach us directly at info@preventcare.com.




Can false positives or false negatives occur?


Yes. The novel coronavirus (SARS-CoV-2) is new and reached global pandemic infection rates with concerning efficiency. Other corona viruses, however, are well-known and are a routine part of our lives. Please carefully evaluate the sensitivity and specificity metrics on the validation study here (hyperlink) to understand the degree to which false positives can occur due to infections by other corona viruses and false negatives can occur by testing too early after the onset of symptoms. Additionally, please note that the test measures total IgM and total IgG, so 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.





For additional guidance or specific questions on the topics above, please reach us directly at info@preventcare.com.

Address: 3725 Southeast Ocean Boulevard, Stuart, FL, USA

Phone Number: 844-954-2444

FDA Policy for COVID-19 Diagnostic Tests during the Public Health Emergency. Here is the policy.

 

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