Neutralizing Antibody Test
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provider solutions
Immunity Assessment Test
- Assess patient COVID-19 neutralizing antibody status
- Easy to use fingerstick collection
- Test results available in about a week
Immunity Assessment Test
A simple way to assess patient risk for COVID-19 infection
Immunity Assessment Test
A simple way to assess patient risk for COVID-19 infection
A simple tool to measure COVID-19 neutralizing antibody levels
Antibodies are formed by the body following infection or vaccination, but only a subset of antibodies, known as neutralizing antibodies (NAbs), can bind to a virus and block it from entering a cell and causing an infection. Recent studies have shown that there is a strong correlation between neutralizing antibody titer and protection against symptomatic SARS-CoV-2 infection.1,2
DxTerity’s Immunity Assessment Test measures the amount of NAbs from 5 to 10 drops of blood collected with an easy-to-use, minimally-invasive, fingerstick kit. The test reports the NAb titers to help you understand the body’s response to vaccination or previous infection with the SARS-CoV-2 virus.
Download DxTerity Neutralizing Antibody White Paper
A better understanding of patient COVID-19 neutralizing antibody status
Following vaccination or infection, most individuals will generate high levels of COVID-19 neutralizing antibodies (NAbs). However, some people will not, underscoring the clinical utility of a simple, accurate and reliable test to measure levels of NAbs in patients.
Which individuals are at highest risk for not achieving the desired NAb levels following vaccination?
Individuals that may be influenced by factors like sex, obesity, autoimmune disease, genetics, age, nutrition, environmental and medications may be at risk for an impaired immune response.3 Those individuals being treated with immune suppressing drugs (Table 1) for common autoimmune diseases like rheumatoid arthritis (RA), multiple sclerosis (MS), Lupus, and Sjögren's are particularly at risk for low or no immune protection following COVID-19 vaccination.4,5
Post-vaccine Titer by Chronic Inflammatory Diseases Medication Group versus Immunocompetent Participants.
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Medication group1 N Fold Reduction in Titer (95% CI) P value2
Antibody levels following vaccination or COVID-19 infection also decrease naturally over time, which may expose individuals to potential reinfection.6 Understanding a patient’s unique neutralizing antibody levels can help them to make decisions to safeguard their health.
Surrogate Viral Neutralization Test (sVNT)
DxTerity’s Immunity Assessment Test utilizes the same trusted technology developed to measure COVID‑19 neutralizing antibody development and vaccine effectiveness during FDA SARS-CoV-2 clinical trials. The test has been validated to achieve a sensitivity (PPA) >95% and a specificity (NPA) >95%.
A brief overview of the testing process:
- COVID-19 spike proteins are mixed with a blood sample.
- If the sample contains NAbs, they will bind to the labeled segment.
- The mixture is then added to a test plate coated with ACE-2 targets, the receptor COVID-19 uses to enter human cells.
- If NAbs are present, they prevent COVID-19 from binding to human cells.
- Next, NAbs are amplified to measure their level.
Clinical references downloads:
MedRxiv: Predicting COVID-19 Vaccine Efficacy from Neutralizing Antibody Levels
Nature Biotechnology: Virus Neutralization test ACE2-spike protein
Ther Adv Neurol Disord: mRNA response in patients with MS
Clear and Easy to Interpret Test Results
Each sample is processed in DxTerity’s CLIA Licensed and CAP accredited clinical laboratory located in Los Angeles, CA. Test results can be downloaded and printed or downloaded onto a mobile device. The antibody levels or titer levels would be provided for each report. Discuss your results with your doctor as appropriate and decide what's best for your health.
DxTerity SARS-CoV-2 Immunity Assessment Test CPT Code
Competitive Viral Neutralization Test: CPT Code 86409
Download Sample COVID-19 NAb Test Report
Below are additional helpful resources for you.
Set up your account
Make future ordering easy by setting up your provider account today.
Online
Download and fill out the simple PDF form. Return it to DxTerity via email and our Customer Service team will set up your account.
Email us:
By phone
Call DxTerity’s Customer Support team to establish your account.
Call us: +1-424-758-0100
Order collection kits
Once your account has been established, you or a member of your staff may begin ordering.
Order online
Login to your account to place your order. Orders will be process within 24-48 hours.
Sign in
Order by email
Contact our Customer Support team by email to place your order
Email us:
Order by phone
Call our Customer Support team anytime to place your order, Monday - Friday, 9 a.m. - 5 p.m. PST.
Call us: +1-424-758-0100
Register your test
Log into your account. To register a test kit, type in the 7-character Device ID to register a DxTerity test kit. The 7-character Device ID must be entered correctly to process your test.
For EDTA tubes, contact our Customer Support team for instructions regarding test registration and shipping.
Collect and ship
specimen sample
Patient samples can be submitted for testing using DxTerity’s Serology Micro Collection Device or a standard EDTA whole blood (purple top) tube.
Once specimen samples are collected, ship the sample to our lab using the pre-paid return label included in your kit.
Get your results
Once your sample has been received at our lab, we will run your test and will report the results through your secure, HIPAA compliant portal account. You can expect results within 5-7 days.
Still have questions?
Here are some common questions we receive about our kits. For more information, please contact us.
FAQ’s
| Is this a one-time test? |
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While a patient can take this test one time to gain insight on their current antibody level to COVID-19, the CDC, FDA and vaccine manufactures have all acknowledged that it is not known how long protective antibodies to COVID-19 last. Taking DxTerity’s Immunity Assessment test multiple times throughout the year can give a better understanding of how NAb levels change following a booster shot or how NAb levels decrease over time. |
| Does the patient have to go to a patient service center to get blood drawn? |
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No, DxTerity’s Microcollection Device replaces phlebotomy and only requires 5 to 10 drops of blood via a minimally invasive fingerstick collection. |
| What are COVID-19 neutralizing antibodies? |
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Neutralizing antibodies are an important specific defense against COVID-19. Neutralizing antibodies not only bind to the COVID-19 virus, but they also bind in a manner that blocks infection. Only a small subset of the many antibodies that bind a virus are capable of neutralization. After a COVID-19 infection, it takes a couple of weeks for infected and vaccinated individuals to produce effective neutralizing antibodies, but these can persist for months or longer to guard against future infection. |
| How will the information be protected? |
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DxTerity is a California CLIA licensed, CAP accredited clinical laboratory that adheres to all state and federal laws regarding the protection of personal health information (PHI). All data provided to DxTerity is fully encrypted bidirectionally in transit and at rest. |
| What if the Immunity Assessment Test results suggest that no neutralizing antibodies were detected? |
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Antibodies take 1 – 3 weeks to fully develop to a measurable level in a person who has been infected with COVID-19 or post-vaccination. If the test did not detect neutralizing antibodies in the sample, it indicates that, at the time of testing, the patient did not have a measurable level in their blood. This could be because they have not had any exposure to COVID-19, have not been vaccinated, that not enough or too much time since vaccination or infection has passed, or their immune response could have been suboptimal due to a variety of risk factors. |
| Who can benefit from a Immunity Assessment Test? |
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The following individuals can benefit from a Immunity Assessment Test:
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How can we help?
If you need assistance setting up or accessing your account please
email
For other inquiries, please contact us.