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COVID-19 Rapid Antibody Test

SKU: FS-2004
COVID-19 Rapid Antibody Tests help assess if you have antibodies to the virus that causes COVID-19 by utilizing lateral flow technology that is used for the qualitative, differential detection of both antibodies. In general, antibodies can be detected 1-3 weeks after infection.
Price: $375.00
COVID-19 Rapid Antibody Test
COVID-19 Rapid Antibody Test
Product Details

COVID-19 Rapid Antibody Test

COVID-19 Rapid Antibody Tests help assess if you have antibodies to the virus that causes COVID-19 by utilizing lateral flow technology that is used for the qualitative, differential detection of both anti-bodies. In general, antibodies can be detected 1-3 weeks after infection.

Includes 25 test kits, ONLY $15.00 per test.

COVID-19 Antibody Test Features:

  • Results in 15 minutes
  • NO laboratory equipment required
  • Easy-to-use
  • Test kits can be stored and used at room temperature
  • Reduces risk of spreading the virus to healthcare workers
  • Provides actionable information to all patients
  • Provides insightful return-to-work information
  • Detection Window (IgM): 3-5 days after incubation
  • Dual band results for simple interpretation
  • Multivariable analysis of immunoglobin IgG & IgM
  • Room temperature storage or refrigerated (2-30⁰C / 36-86⁰F)Procedural internal control included
  • Buffer included

COVID-19 Antibody Test Specifications:

  • Clinical Evaluation
    • Positive Percent Agreement (PPA): IgG 96.7%; IgM 86.7%; Overall 96.7%
    • Negative Percent Agreement (NPA): IgG 98.0%; IgM 99.0%; Overall 97.0%
  • Clinical Agreement with Characterized Samples
    • Sensitivity: IgG 96.7%; IgM 100%; Combined 100%​
    • Specificity: IgG 97.5%; IgM 100%; Combined 97.5%​
  • Specimen: Whole Blood, Serum, Plasma
  • Time to Results: 10 minutes
  • Shelf Life: 24 months from the date of manufacture
Included: 
  • Test Cassette
  • Pipette
  • Buffer solution
  • Instructions-for-Use (IFU)
  • Quick Reference Guide
1. Remove the test cassette from the sealed foil pouch and use it as soon as possible.
2. Lay device on flat surface and add specimen (see specific instructions for each
specimen type below):
a. For Serum or Plasma Specimen: With the plastic dropper provided, draw serum/plasma
specimen to exceed the specimen line, as shown in the diagram below. Hold the dropper
vertically and transfer drawn serum/plasma specimen into the sample well (S). Immediately add
2 drops (about 80 μL) of sample buffer to the buffer well (B) ensuring that buffer vial tip does
not touch the sample. Avoid air bubbles.
b. For Whole Blood Specimen: Hold the plastic dropper vertically and transfer 1 drop of whole
blood (about 10 μL) to the sample well (S) of the test device. Immediately add 2 drops (about
80 μL) of sample buffer to the buffer well (B) ensuring that buffer vial tip does not touch the
sample. Avoid air bubbles.
3. Wait for the control line (C) to change from blue to a red color. If, after 2 minutes,
the sample has not moved across the test window or if blood is still present in the
sample well (S), add 1 additional drop of sample buffer to the buffer well (B).
4. The results should be read in 10 minutes. Do not interpret the result after 15
minutes.
What is an antibody?
An antibody (also known as an immunoglobulin) is part of our body’s response to a foreignmolecule or pathogen (also known as an antigen) such as a virus or bacterium. The immuneresponse is valuable as it helps to fight off infection. Protective antibodies can in some cases provide long-term immunity so we do not become re-infected with the same viruses or bacteria. As such, antibodies are vital for our health. Yet, we don’t always develop antibodies—or the right or sufficient antibodies—to fight off all infectious diseases. For example, people infected with HIV or hepatitis C virus do not usually develop protective antibodies

What is antibody testing?
Antibody assays have the ability to detect past infections and indicate probable immunity.COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Device detects the presence of antibodies IgM and IgG, developed in response to the SARS-CoV-2 virus.
  • IgM antibodies: develop EARLY after SARS-CoV-2 virus exposure. 
  • IgG antibodies: develop LATER after SARS-CoV-2 virus exposure; indicates longer termimmunity.

Why would I want an antibody test? What is the potential benefit?
An antibody test tells you if you have been infected with the virus that causes COVID-19, even if you only developed mild symptoms or were asymptomatic. Knowing this answer is an important piece of information as we enter the next phase of the pandemic.

Does testing positive for antibodies benefit my community?
Antibody tests are playing a critical role in learning more about the virus and the fight againstCOVID-19. Antibody tests can provide public health officials with information on how many people in the community have been infected, which is important with COVID-19 as we have learned that some people do not have symptoms or have few symptoms. It can help public health officials learn more about how the virus spreads within communities and which groups of people were most susceptible to being infected, while also identifying which groups of people have recovered.
In addition, if you do test positive for antibodies, you may be a candidate to donate your plasma to be used for a patient treatment called convalescent plasma therapy that is being used by several leading healthcare institutions to help patients with COVID-19 who are sick or critically ill to recover. Studies have shown that plasma donations from patients who have overcome the virus can help patients who are still struggling with it currently.

Who should be tested using the COVID-19 antibody test?
IgG antibody testing should be performed to assess whether an individual (e.g., healthcare worker, student, general population, etc.) has been exposed to SARS-CoV-2 in the past. If a serology test delivers a positive result for the IgG antibody, that means the individual was previously exposed to SARS-CoV-2 and may indicate prior infection which may be resolved or is still resolving, and/or protection against re-infection ("protective immunity”)

How quickly do I get results?
Positive results will appear on the device within minutes. We recommend that negative results be confirmed 15 minutes after diluent is applied.

If I test positive for COVID-19 virus antibodies, does that mean that I have immunity to this virus and can no longer get the disease?
Developing antibodies to this virus tells you that your body has produced a defensive response, what is medically called an ‘immune response’ to fight off the virus. Research is underway to learn if the antibodies you developed will prevent you from becoming infected again as happens with antibodies that form after infection with other viruses like chickenpox or measles. However, because the COVID-19 virus is so new, we still don’t know if the antibodies you develop will lead to your having immunity, which would prevent you from becoming infected again. This is something the scientific community will actively be studying to provide recommendations going forward.

What is the role of serology in return to work/return to daily life decisions?
Our position at Flagship Health Group, LLC is that antibody testing is an important tool in assessing potential risk and fostering a safer environment for all of us and our communities. We look forward to additional research to clearly establish the role of all forms of testing in inferring immunity for COVID-19. Other respiratory illnesses have been shown to produce antibodies that can be confirmed through lab testing to confirm immune protection for a period of time. We encourage all individuals, regardless of their antibody response/test result, to continue to practice safety and health measures, such as social distancing, to further minimize risk.

What equipment is needed to generate test results?
The COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test is a self-contained device. No laboratory equipment is required to obtain results. Person(s) administering the test will need to provide their own alcohol swabs.

Has this been approved by the FDA?
The COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Device is one of thirteen assays to have received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) to detect antibodies against SARS-CoV-2. The validation study was done in collaboration between the FDA, National Institutes of Health, Centers for Disease Control and Prevention, and the Department of Health and Human Service's Biomedical Advanced Research and Development Authority.
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