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YourBio Health's COVID-19 Antibody Test Kit

Information For Healthcare Professionals

The scientific understanding of COVID-19 and the antibodies that develop from infection or vaccination is constantly evolving. The protection that antibodies provide is currently being studied and is not yet fully known.

As the guidance from government agencies and other public health bodies becomes available, we will ensure our website contains the latest recommendations on interpreting the results of COVID-19 antibody tests.

Our Medical Oversight

The YourBio Health medical team is led by Chief Medical Officer Dr. Hutan Ashrafian and Medical Advisor Dr. Stephen Hahn.

Dr. Ashrafian is a senior clinician-scientist and surgeon with extensive experience developing novel biomedical and technological methods to address a wide range of healthcare issues. He earned his degree in Medicine at University College London where he also received an honors degree in Immunology and Cell Pathology.

Dr. Hahn is a Physician Medical Executive with more than 20 years of experience in oncology medical practice, translational/clinical research, clinical operations, and executive leadership in an academic health care environment.

How do we ensure high quality diagnostic results?

The TAP II Blood Collection Device and the YourBio Blood Collection kit are both CE-marked.

The YourBio antibody test uses the Roche Elecsys® Anti-SARS-CoV-2 S assay to determine the level of S Protein antibodies to SARS-CoV-2 in your blood sample. The assay has been shown to have 98.8% sensitivity and 99.8% specificity. The assay has a CE Mark and is approved for use in the UK.

All our diagnostic testing is completed in UKAS-accredited labs in the UK.

Medical Diagnosis

www.medical-diagnosis.net

ISO 15189 UKAS Standard Accredited (Cert 8567)

Professional Affiliations

YourBio Health, Inc. is a member in good standing with the Association of British HealthTech Industries (ABHI), the UK’s leading industry association for health technology (HealthTech).

What are the possible results from this test and what recommendations do we provide?

The test results will show if antibodies are detected (POSITIVE) or not detected (NEGATIVE), along with an assessment of the level of antibodies in units per millilitre (U/mL).

Based on the documentation provided by Roche, the assay results are reported according to the following guidelines:

Result Interpretation

Below 0.8 U/mL
NEGATIVE for anti-SARS-CoV-2-S
0.8 U/ml or above
POSITIVE for anti-SARS-CoV-2-S

Tested NEGATIVE for anti-SARS-CoV-2-S

What does your result mean?

Results from this test should NOT be used to diagnose a current SARS-COV-2 infection or to inform you about the status of an infection.

A result of NEGATIVE means that antibodies to the SARS-COV-2 virus were not detected in your sample.

A NEGATIVE result does NOT necessarily mean:

  • You have NOT had any prior SARS-COV-2 infections
  • You do NOT have a current SARS-COV-2 infection

It can take one to three weeks after an infection to develop enough antibodies to be detectable in this test.

In the months after an infection, antibody levels may decrease below the detection level.

  • If you have been vaccinated:

A result of NEGATIVE suggests that your body has not produced enough antibodies to SARS-COV-2 to be detectable in your sample.

Testing for antibodies induced by vaccination should be performed at least two weeks after complete vaccination (all required doses).

  • If you have NOT been vaccinated:

A result of NEGATIVE suggests that your body has not produced enough antibodies to SARS-COV-2 to be detectable.

Recommendation

Follow all precautionary measures as if you were unvaccinated.

In order to protect yourself from exposure, follow all local safety precautions and recommendations. www.nhs.uk/conditions/coronavirus-covid-19

If you have been vaccinated AND you received a NEGATIVE result from this test, we recommend you discuss the results of this test with your general practitioner.

Your antibody levels may change over time. Consider checking your antibodies again in 3 months to monitor any changes.

As the scientific understanding of these antibodies and the protection they may provide continues to develop, visit www.yourbiohealth.com for updates.

Questions about the results of this test? Consult your general practitioner.

Tested POSITIVE for anti-SARS-CoV-2-S

What does your result mean?

Results from this test should NOT be used to diagnose a current SARS-COV-2 infection or to inform you about the status of an infection.

A result of POSITIVE means that antibodies to the SARS-COV-2 virus were detected in your sample.

Detecting the presence of antibodies does not necessarily mean you are immune to the SARS-COV-2 virus.

  • If you have been vaccinated:

A result of POSITIVE suggests that your body produced antibodies to SARS-COV-2 from the vaccine or a prior infection.

  • If you have NOT been vaccinated:

A result of POSITIVE suggests that your body produced antibodies to SARS-COV-2 from a prior infection or exposure, even if you did not have any symptoms.

Recommendation

In order to protect yourself from exposure, follow all local safety precautions and recommendations. www.nhs.uk/conditions/coronavirus-covid-19

Your antibody levels may change over time. Consider checking your antibodies again in 3 months to monitor any changes.

As the scientific understanding of these antibodies and the protection they may provide continues to develop, visit www.yourbiohealth.com for updates.

Questions about the results of this test? Consult your general practitioner.

COVID-19 Antibody Testing References

For additional information about COVID-19 antibody testing and pandemic management, please refer to government agencies for guidance. Here are a few links you may find helpful in making COVID-19 related decisions. Keep in mind that each organization is responsible for reviewing its own guidelines as new information is made available and that these sites are not part of YourBio Health. Make sure you are viewing the most recent guidelines from government agencies.