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Neutralizing Antibody Test

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Immunity Assessment Test

Semi-quantitative, surrogate viral neutralization test (sVNT) to measure COVID‑19 neutralizing antibody titers from blood collected using a convenient fingerstick kit or in-office phlebotomy draw.
 
  • 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

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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

Download MedRxiv Paper

Download DxTerity 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.

Test Objective B-cell depleting therapy Prednisone JAK inhibitors Antimetabolites Antimalarials TNF inhibitors Other 3 or No Medications N Fold Reduction in Titer (95% CI) P value 2 10 14 10 31 14 21 33 52.7 (18.3 - 152.0) 15.1 (4.9 - 46.3) 6.6 (2.9 - 15.3) 2.9 (1.5 - 5.6) 2.2 (0.96 - 5.0) 1.7 (0.92 - 3.2) 1.6 (0.92 - 2.8) 4.0E-10 9.0E-06 3.0E-05 0.0023 0.062 0.091 0.097

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:

  1. COVID-19 spike proteins are mixed with a blood sample.
  2.  If the sample contains NAbs, they will bind to the labeled segment.
  3. The mixture is then added to a test plate coated with ACE-2 targets, the receptor COVID-19 uses to enter human cells.
  4. If NAbs are present, they prevent COVID-19 from binding to human cells.
  5. 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.

1
 

Set up your account

Make future ordering easy by setting up your provider account today.

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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.

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Download Enrollment Form

Phone

By phone

Call DxTerity’s Customer Support team to establish your account.

Call us: +1-424-758-0100

 
2

Order collection kits

Once your account has been established, you or a member of your staff may begin ordering.

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Order online

Login to your account to place your order. Orders will be process within 24-48 hours.

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Order by email

Contact our Customer Support team by email to place your order

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Phone

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

 
3

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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.

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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.

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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.

 

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How can we help?

If you need assistance setting up or accessing your account please
email This email address is being protected from spambots. You need JavaScript enabled to view it. or call ​+1-424-758-0100.
For other inquiries, please contact us.

 

 

 

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