FOR PROFESSIONAL USE ONLY | INFORMATION PAPER
We are working on importing tests that have been authorized under the Emergency Use Authorization by the FDA for professional use in testing individuals in a business or organization setting.
As of the date of this writing, no tests are APPROVED by the FDA for use in Covid screening.
The FDA has given limited AUTHORIZATION under their Emergency Use Authorization program, however, this authorization is restricted to use by professionals in a commercial setting and not for use by individuals in the management of their personal medical care.
These tests are packaged 100 individual kits per box and will sell for $ 19.99 each. These are finger-prick tests with a high-degree of accuracy but nothing is 100%. The tests are authorized for emergency use and should be administered under the supervision of a professional with some medical or health care training. It is a single finger-prick test and results are readable in 15 minutes.
Is this test FDA-approved or cleared?
No. This test is not yet approved or cleared by the United States FDA. When there are no FDA-approved or cleared tests available, and other criteria are met, the FDA can make tests available under an emergency access mechanism called an Emergency Use Authorization (EUA).
The EUA for this test is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics for the detection and/or diagnosis of the virus that causes COVID-19.
This EUA will remain in effect (meaning this test can be used) for the duration of the COVID-19 declaration, justifying emergency use of in vitro diagnostic tests (IVDs), unless it is terminated or revoked by FDA (after which the test may no longer be used).
THESE ARE NOT FOR FAMILY OR INDIVIDUAL TESTING.
If you are an individual seeking a COVID test for you or your family, contact your Doctor.
What’s Included?
Full instructions are provided, the actual test, a single-use, sterile lancet, alcohol prep pad and pipette for EACH test and a bottle of special buffer solution for each 10 tests. (2 drops of buffer use per test).
These tests are dual COVID-19 (Coronavirus) Antibody (Serology) Tests, marketed by the manufacturer as combination Covid-19 IgG / IgM tests.
This is a blood test. It is designed to detect antibodies (immunoglobulins, IgG and IgM) against the coronavirus that causes the disease called COVID-19. Antibodies are proteins produced by the immune system in response to an infection and are specific to that particular infection. They are found in the liquid part of blood specimens, which is called serum or plasma, depending on the presence of clotting factors.
When should these tests be used?
Having an antibody test is helpful if:
a health care provider believes the individual may have been exposed to the coronavirus which causes COVID19 based on current or previous signs and symptoms (e.g., fever, cough, difficulty breathing);
or for a person who lives in or has recently traveled to a place where transmission of COVID-19 is known to occur;
someone who has been in close contact with an individual suspected of or confirmed to have COVID-19; or persons believed or known to have recovered from COVID-19.
It is particularly suited for use in a wide screening program, that includes a number of other factors for screening (see cdc.gov) and when administered by a professional, in a business setting and when part of an overall health & safety program, ideally overseen by a medical professional or someone with medical training.
What does this screen for?
Antibody Test for IgG
This test detects IgG antibodies that develop in most patients within seven to 10 days after symptoms of COVID-19 begin. IgG antibodies are believed to remain in the blood after an infection has passed. These antibodies indicate that you may have had COVID-19 in the recent past and have possibly developed antibodies that may protect you from future infection. It is unknown at this point how much protection antibodies might provide an individual against reinfection.
Antibody Test for IgM
This test detects IgM antibodies. IgM is usually the first antibody produced by the immune system when a virus attacks. A positive IgM test indicates that a person may have been infected and that there may be an immune system response to the virus. When IgM is detected a person may still be infected, or they may have recently recovered from a COVID-19 infection.
ANY NEGATIVE OR POSITIVE TEST RESULT SHOULD BE CONSIDERED AN INDICATION AND SHOULD BE FOLLOWED-UP ON BY A LICENSED MEDICAL DOCTOR FOR GUIDANCE AND DISEASE PREVENTION CONSIDERATIONS.
RAPID TESTS ARE NOT MEANT TO BE USED TO TREAT, DIAGNOSE OR CURE ANY DISEASE.
NOT FOR PERSONAL OR INDIVIDUAL USE. For use in an industrial setting for screening purposes of a responsible party.
TESTS ARE NOT MEANT TO REPLACE YOUR INTERACTION WITH YOUR DOCTOR.
The CDC recommends if you test POSITIVE that you should practice self-quarantine and contact your Primary Care Physician.
AS ALWAYS -- any EMERGENCY circumstance needs emergency attention and you should call 9-1-1 in any emergency situation.
A signed certificate of compliance and agreement to our terms and conditions of sale will be a requirement of sale.
ORDER:
Tests are Available for Pre-Order in Quantities of 100 @ $ 19.99 each.
At this time, delivery estimates are approximately 6-10 days for delivery,
We use private courier, our own delivery teams, UPS, USPS and FedEx for delivery.
All transactions are subject to regulatory compliance, verification of intended use, and agreement to our standard terms and conditions of sale.
BACKGROUND
The Novel Coronavirus (also known as, Novel Corona Virus, COVID-19, and SARS-CoV-2 an infection widely believed to be the virus strain that causes “Corona Virus Disease 2019”) and has been identified to be a worldwide, pandemic, threat to humans. Hereinafter referred to collectively as “COVID-19”.
According to official statements COVID-19 is considered highly contagious. Specialists in the health fields propose that COVID-19 has a mortality rate even more than the flu. CDC statements are that COVID-19 can spread exponentially, with ease. It is believed that persons at particular risk are the eldery (persons over 65 years of age) and those with compromised immune systems, while people of all ages are at risk of catching COVID-19. Poor outcomes can occur for people of any age or condition, and science is learning more about these factors ongoing. The virus has many unknowns, including a person’s ability to have immunity following detection of antibodies in their blood, shedding of virus during various phases of infection (including the early phases for up to 14 days of reported contagion while a person is not necessarily exhibiting signs of disease), and more. These statements above have not been evaluated by the FDA or CDC. Readers are encouraged to contact their health professionals for up-to-date information and facts concerning COVID-19 before going out in public or allowing others into their homes. In addition, the following websites are found to contain the most reliable information presently available and readers are encouraged to review and research available information since much of it is subject to personal interpretation, changes frequently and may be updated without warning.
https://www.cdc.gov/coronavirus/2019-ncov/index.html
https://www.fda.gov/media/137005/download
TO ORDER:
Tests are sold in quantities of 100 and can be sent via Air or Ground to a US Based commercial address, in care of a commercial business.
Payment is via any major credit or debit card, or domestic ACH transfer with any US based checking account.
Purchases are NON-REFUNDABLE. Defective tests can be replaced at no cost within 30 days, subject to additional processing and transport cost.
As with any laboratory based screening, some false positives, false negatives and inconclusive/invalid results are to be expected.
We recommend ordering about 10% more than needed to ensure sufficient quantities.
Call 1-800-479-0776, 9:00 AM to 7:00 PM, Pacific, Monday through Friday.
Online ordering is being provisioned and when ready, will be accessible at:
WHAT’S INCLUDED:
Each Test Includes 1) Disposable Plastic 3ml Pipette, 1) Disposable, safe-use, one-time lancet, 1) Test Cartridge, Alcohol Prep Pads, Buffer Solution