COVID-19 Rapid Antibody Testing
Cell Vault is now offering COVID-19 antibody testing, conducted by a medical professional, in the comfort and safety of your home. Appointments now available in the next 7 days.
As a cancer survivor, I need to be extra careful when observing social distancing and general interaction with other people. The nurse from Cell Vault couldn’t have been more professional and conscientious. She wore a glove and mask the entire visit, washed her hands twice, and even offered to wait in the hall while we waited for the results. I’m so impressed and thankful I was able to get tested from a company that clearly prioritizes my health.
How does the service work?
The COVID-19 IgM/IgG rapid antibody test is designed to detect antibodies that form in response to SARS-CoV-2, the virus that causes COVID-19.
- Physician order is generated for your test
- Appointment team reaches out within 24 hours to schedule your test with a trained medical professional
- Test is conducted in single use PPE, and can be done inside, or weather permitting, on a patio, terrace, or in a garage
- The test uses blood collected from a quick and painless finger stick
- Up to 5 family members (ages 4+) can be scheduled in one house call
- Insurance reimbursement documentation saved in your patient portal
Results are provided 15 minutes later
Test must be conducted by a trained medical professional. We will schedule for our staff to come to your home and administer the test.
Developed by W.H.P.M. / HemoSure and manufactured in the USA, the first validation study was submitted to the FDA in March 2020. The relative accuracy of the test was 97.9%
Relative accuracy is a reflection of “specificity” and “sensitivity”:
- Specificity refers to the detection of antibodies developed specifically in response to SARS-CoV-2, the virus that causes COVID-19 (and reflects potential for false positive results): 100% (0% false positives)
- Sensitivity refers to the test’s ability to detect antibodies (and reflects potential for false negative results): 94% (6% false negatives due to several samples read 4-6 days post infection)
SARS-COV-2 Antigen and IgG/IgM Antibody Test Results
An independent review was conducted by UCLA’s David Geffen School of Medicine to further validate these results. The study determined the relative accuracy to be 99.4%.
What are Antibodies?
Antibodies are proteins which the body produces days or weeks after fighting the infection, and indicate an immune response to the virus.
Two types of antibodies are detected in the test:
- IgM antibodies are the body’s first line of defense, and form as early as 3-7 days after infection
- IgG antibodies, or “neutralizing antibodies” are the immune system’s more specific, long-term response and form 7-30+ days after infection
Typically, there is an overlap between IgM and IgG antibodies, where IgM remains detectable for more than 35 days, depending on immune response.
Recent data from Mass General indicates that IgG antibodies remain in the system 12-24 months, but wane over time depending on the severity of infection and strength of immune response.
Both symptomatic and asymptomatic individuals can develop antibodies following an infection.
Key test features of this test are:
- Manufactured in the USA
- Positive/Negative Results in 15 minutes.
- Requires blood from a simple fingerstick.
- Increased screening with IgM and IgG antibody detection
- The FDA has made this test available for use under Emergency Use Authorization and is pending FDA Authorization (notification submitted March 2020)
The FDA has indicated these tests should not be used as the sole basis for diagnosis of COVID-19
Check CDC Coronavirus General webpage for updates and information on COVID-19: https://www.cdc.gov/coronavirus/2019-ncov/
What is the COVID-19 Rapid Antibody Test?
The COVID-19 Rapid Antibody Test is designed to detect antibodies that are produced by the body in response to the virus that causes COVID-19. COVID-19 antibodies are proteins which the body produces days or weeks after fighting the infection, and typically indicate an individual has developed an immune response after recovering from the virus, even if a person didn’t exhibit any symptoms of the COVID-19 disease.
How is the COVID-19 Rapid Antibody Test administered?
A fingerstick is used to collect a small amount of blood from your finger to be tested. The healthcare professional will then apply your blood on the Test, which will show results within 15 minutes.
What does it mean if the test is positive?
Your result may indicate that you have contracted COVID-19 and that you may need to quarantine to avoid spreading the virus to other individuals. A positive result may also indicate previous infection that is no longer active. There is also the small chance that this Test provided a false positive result, which could be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E, or such false positive could arise from other factors. The healthcare professional conducting the Test will explain the results to you once the Test is done.
What does it mean if the test is negative?
A negative Test result means the antibodies to the virus that causes COVID-19 were not detected in your sample. That could be due to the fact that you were either not infected with COVID-19, or if you are tested too early in your illness, that your body hasn’t had the opportunity to produce antibodies to the infection. A false negative could also arise from other facts involving the Test, the blood sample or the testing procedures. This false negative result means that you could possibly still have contracted COVID-19 even though the Test result is negative.
What is the different between PCR testing, antigen testing and antibody testing ?
Both PCR and antigen testing are intended to diagnose active COVID-19 infections, using saliva or a nasal swab. While an individual has an active infection, both PCR and antigen test will be positive. Once an individual has recovered, both the PCR and antigen test will be negative. Antibody tests do not detect active infection. Instead, they are designed to detect an immune response to a past exposure to COVID-19. Antibody tests conducted too early following an infection (<7 days) will read negative. Once an individual develops an immune response, the antibody test will read positive.
Is the test covered by insurance?
We do not accept insurance at the moment; however, we will provide supporting materials to help you file a claim, including the physician order and invoice with billing codes. We can not guarantee reimbursement.
Is this test FDA approved?
While the Test has been submitted for FDA review, it is not yet cleared or approved by the US FDA. In instances where there are no FDA-approved or cleared tests available, the FDA can make tests available under Emergency Use Authorization (EUA). The EUA for this rapid Test is supported by the Secretary of Health and Human Services.
In March 2020, the manufacturer of the Test submitted an Emergency Use Authorization (EUA) to the FDA. While this application is under review, please note the following information:
- 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 or immunity.
- 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.
How can I get more information about the test and my rights?
The most current information on COVID-19 is available on the CDC General webpage: https://www.cdc.gov/coronavirus/2019-ncov/
If you have more questions about the test, please ask your doctor or call your local health department.
Cell Vault can provide in-home testing for your employees. Please submit your information if you are interested in learning more.
Cell Vault is a T-cell biobank. We allow individuals to cryopreserve their healthy immune cells in case they can be used in a future fight with cancer. As part of our core business, we send medical professionals to our customers’ homes to collect their blood. As such, we’re able to leverage an existing network of 6,000+ phlebotomists around the country to deliver at-home point of care COVID-19 antibody testing.