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FAQ is designed for healthcare professionals.

Consumers interested in the Palm Harbor Test Kit Bundle should please call our Tampa area pharmacy @ 727-787-2273

FAQ:

– Individually wrapped testing device with desiccant

– Buffer (reagent)

– Sterile lancet

– Alcohol pad

– Capillary pipette

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.

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.

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@fasteptestkits.com.

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.

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.

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.

No. At this time, the FDA has only authorized Corona Virus COVID-19 Antibody Detection Test Kits to be purchased and administered by a licensed healthcare professional. Please fill out this form and use our lookup feature to locate your doctor. We will initiate the communication on your behalf.

Approvals & Validation Studies

Leading Physician Testimonial

“Antibody testing is a critical feature to understanding population prevalence and immunity characteristics in our fight against COVID-19. The FaStep device, one of a select few authorized by the FDA, is an integral component to the testing protocols designed by many prominent hospitals and physician groups around the country.”

Dr. David M. Soria, MD, FAAEM

Director of Emergency Medicine 
Wellington Regional Medical Center
President, TruePartners Emergency Physicians
Board Certified – American Board of Emergency Medicine
Medical Director of Global Games NBA

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.

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