• The offered test kits are manufactured in an IS0-13485 Certified Facility. There is no higher degree of standard or accreditation.
• They have been validated on REAL Covid-19 patients.
• The test is accurate to 88.4% clinical Sensitivity and 98.04% Clinical Specificity.
• The tests return results in as little as 15 minutes and are simple and straightforward to use.
• My Doctors Choice™ offers COVID-19 Tests that have been submitted to the FDA for immediate EUA use by way of a 92 page abstract submited methodology and technology. The FDA has granted the right to market and distribute pursuant to EUA guidelines set forth by the FDA for the novel Coronavirus Pandemic.
• Don't trust test kits that are not authorized.
Doctors, Nurses, Pharmacists, Healthcare Organizations and First Responders. Anyone with an NPI number can purchase. With the reach of COVID•l9 reaching new heights every day, our medical professionals need a simple and accurate solution for testing.
Testing with the COVID-19 test is easy and resembles the tests diabetics use to test their blood sugar. Simply "prick a finger with the included lance, drip 2 drops of blood into the included testing cassette, drip 2 drops of testing solution into the cassette, and wait approximately 5 minutes for results. Interpreting results is a very straightforward process.
CPT® Code 86328 was established for antibody tests using a single step method immunoassay. It is reported that Medicare and Medicaid reimburses $51.00 for the test. The AMA recommends contacting individual payers for reimbursement guidelines.
The COVID-19 lgM/lgG Rapid Test has undergone significant accuracy testing and has seen strong Diagnostic Specificity.
The COVID-19 lgM/lgG Rapid Test was compared with clinical diagnosed positive samples using the Novel Coronavirus Diagnosis and Treatment Plan (Provisional 5th Edition).
The study was conducted by the Fifth Affiliated Hospital of Sun Yat-Sen University, 600 miles from the initial breakout All specimens were tested according to the user instruction of the test kit. The results obtained confirm 88.4% Clinical Sensitivity, and 98.04% Clinical Specificity. Similar results have been obtained in additional clinical tests.
This test detects lgG amd igM antibodies to
SARS-CoV-2 in human blood
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My Doctors Choice™ offers COVID-19 tests that is authorized to be distributed pursuant to FDA EUA guidance. Under the announced FDA policy, upon filing its submittal, My Doctors Choice™ is authorized to market and distribute SARS-CoV-2 IgM / IgG Rapid Test kits to any licensed healthcare practitioner in the United States for diagnostic use while it awaits a final decision on its FDA EUA application. While the policy does not apply to at-home testing, the policy does allow testing in laboratories or by healthcare workers at the point-of-care.The FDA has granted the right to market and distribute COVID-19 Tests pursuant to EUA guidelines set forth by the FDA for the novel Coronavirus Pandemic. This test has 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 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.