COVID 19 antibody testing enables you to determine who has been exposed to the virus and developed antibodies against the virus.  Having this information is essential to knowing who may be more safely integrated into the workforce.

Why choose COVAXX

COVAXX is a division of United Biomedical, a well-established and highly respected US company. COVAXX ELISA antibody test is superior in terms of accuracy and other key metrics as compared to other tests and methodologies on the market.  The COVAXX test is:

  • Accurate — Virtually 100% specificity and sensitivity
  • Precise — can differentiate between SARS-CoV-2 vs. other coronaviruses circulating
  • Fast — results in 2 hours

Deploying the test kits

Test Name: UBI® SARS-CoV-2 ELISA

  • Blood or plasma samples would be collected and sent to a lab.
  • The test kits would be performed in the lab using an ELISA machine.
  • The lab must be capable of testing for infectious agents.
  • A list of basic lab materials and equipment required to use the test kits, as well as proper procedures are provided by COVAXX.
  • Results for 96 tests per tray can be obtained in two hours.

Further technical information regarding the test and testing procedures are available at www.covaxx.com

Test Accuracy

The UBI SARS-CoV-2 ELISA is very accurate, highly specific and sensitive.
Validation tests conducted in California, Taiwan and China have demonstrated that the UBI® SARS-CoV-2 ELISA is highly sensitive, specific, and accurate. 100% of the blood samples collected post seroconversion of infection from patients who tested positive to COVID-19 by other methods were found to be positive using the UBI® SARS-CoV-2 ELISA. We have also tested over 900 blood samples that were collected before the present COVID-19 outbreak and none of these samples tested positive using our test, which means that the COVAXX test has not produced even one false positive result.

Test Availability

The demand for this exceptionally accurate and reliable antibody test is outpacing supply in the US and abroad.  Our relationship with COVAXX will enable MLM to access certain supply for its international customers.  So, please contact MLM as soon as possible to discuss placing orders.

FDA GUIDANCE

The FDA has allowed us to begin use and marketing of our tests under new guidance issued March 16, 2020. We have filed for an Emergency Use Authorization, however, may begin distributing as we have independently validated and notified the FDA of such intent. We are required to inform you of the following information:

  • 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.
  • This test is not for the screening of donated blood

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