Easy Check COVID‑19 IgM/IgGTM Antibody Test

Easy Check COVID‑19 IgM/IgGTM Antibody Test

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How It Works

From Blood to Result in 10 Minutes1

1 Deposit 10 ul of blood sample into the handheld testing device.
2 Add 1 drop of assay buffer.
3 Read the test results at 10 minutes.

1. Warning and Precautions:
This test to measure coronavirus antibodies has been authorized by FDA under an EUA for use by authorized laboratories that meet requirements to perform moderate or high complexity tests. This test has not been FDA cleared or approved. This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. 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. This product is intended for professional use and not for home use. Not for the screening of donated blood.

Why Easy Check

Setting the Gold Standard for SARS‑CoV‑2 Antibody Testing

Lab‑Accurate Results

One of the highest accuracy rates for SARS‑CoV‑2 antibody detection via
lateral flow technology²

 

96.6% Sensitivity

98.2% Specificity

98.1% Overall Accuracy

 

98.6% Overall Concordance with Roche's Elecsys® anti-SARS‑CoV‑2 antibody assay

In Just 10 Minutes

Rapid test for detection of seropositivity
of SARS-CoV-2 for whole blood, 
plasma, or serum samples

 

Requires only a small patient sample (10uL)

At Scale

Easy Check is manufactured in the U.S. and available to ship immediately

 

 

No ancillary equipment or training required

2. Chan, C., Shahul, S., Coleman, C., Tesic, V., Parker, K., Yeo, J. (2020). Evaluation of the Truvian Easy Check COVID-19 IgM/IgG Lateral Flow Device for Rapid Anti-SARS-CoV-2 Antibody Detection. American Journal of Clinical Pathology. https://doi.org/10.1093/ajcp/aqaa221

FAQs

We're Here to Help

General

What is the purpose of a COVID-19 antibody test?

The COVID-19 antibody test is used to help determine whether the patient was previously infected with SARS-CoV-2 – even if the patient had few or no symptoms. According to the CDC, antibody tests should not be used to diagnose a current COVID-19 infection, except in instances in which viral testing is delayed. However, antibody tests can be used by researchers and public health leaders to learn about how many people have been exposed or infected within a population.

What is the difference between molecular, antigen, and antibody tests?

According to the FDA, there are two main categories of SARS-CoV-2 tests available.

  1. Diagnostic tests indicate whether the patient has an ongoing COVID-19 viral infection. There are different types of diagnostic tests:

    a. Molecular tests  (also known as PCR, qPCR, or RT-PCR tests) detect viral genetic material. Typically, molecular tests are highly accurate and do not need to be repeated.

    b. Antigen tests  detect specific proteins from the virus. Since antigen tests have lower sensitivity than molecular tests, they are more likely to miss an active COVID- 19 infection. Negative antigen tests may need to be confirmed with a molecular test.

  2. Antibody tests  detect the presence of an immune response to the virus, which indicates previous viral exposure. Since antibodies can take several days or weeks to develop, an antibody test cannot be used to diagnose an ongoing COVID-19 infection. Truvian’s Easy Check COVID-19 IgM/IgG™ Antibody Test is an antibody test.

What are the different types of serology tests?

A serology test is a blood test that detects whether patients have been exposed to a specific pathogen. According to the Johns Hopkins Center for Health Security, there are four types of serology tests:

  1. Lateral flow assays  (also known as rapid diagnostic tests) are commonly used in point-of-care settings and show a qualitative readout of the presence of antibodies. The blood sample is flowed over a membrane that has the target antigen anchored. If the sample contains antibodies specific to the antigen, they form a complex that results in a colored band. Truvian’s Easy Check COVID-19 IgM/IgG™ Antibody Test is a lateral flow test.

  2. Enzyme-linked immunosorbent assays  (ELISAs) are performed in a lab. This type of test provides a readout of antigen-antibody interactions by “sandwiching” the patient's antibodies between the viral protein and reporter antibodies.

  3. Chemiluminescent immunoassays  (CLIA) are performed in a lab. This type of test shows whether a patient has antibodies by displaying a fluorescent signal when the patient’s antibodies interact with virus proteins.

  4. Neutralization tests  are performed in a lab. This type of test indicates whether the patient has active antibodies by measuring how much the patient’s antibodies prevent viral infection and replication.

Truvian Easy Check COVID-19 IgM/IgG™ Antibody Test

Is this test available to individuals?

Truvian’s Easy Check COVID-19 IgM/IgG™ Antibody Test is intended for professional use and not for home use.

What is the cost per test?

Truvian’s Easy Check COVID-19 IgM/IgG™ Antibody Test is an affordable device that is manufactured in the United States. For more information, please get in touch with us here.

Is the test qualitative or quantitative?

Truvian’s Easy Check COVID-19 IgM/IgG™ Antibody Test is a qualitative test that detects the presence of antibodies to SARS-CoV-2. It does not provide information on how many antibodies there may be.

Is this test accurate?

Truvian’s Easy Check COVID-19 IgM/IgG™ Antibody Test exceeds the current EUA requirements for COVID-19 antibody tests and has consistently demonstrated robust, reproducible, and accurate assay results in real-world situations.

Jerry Yeo, PhD, DABCC, FAACC, Professor of Pathology at the University of Chicago, published a landmark clinical study in The American Journal of Clinical Pathology that revealed one of the highest overall accuracy rates for SARS-CoV-2 antibody detection via lateral flow technology. During this independent analytical and clinical validation, Easy Check demonstrated excellent performance with a sensitivity of 96.6%, specificity of 98.2%, and overall accuracy of 98.1%. In addition, Easy Check was tested against Roche’s Elecsys® anti-SARS-CoV-2 antibody assay and showed an overall concordance of 98.6%.

What type of samples can be used?

Truvian’s Easy Check COVID-19 IgM/IgG™ Antibody Test requires only a small patient sample for an accurate antibody test (10 uL) and can be used with whole blood, serum, or plasma.

How long does the test take?

Truvian’s Easy Check COVID-19 IgM/IgG™ Antibody Test provides lab-accurate results in ten minutes.

How should a positive result be interpreted?

A positive antibody test may indicate that antibodies to SARS-CoV-2 were detected and the patient has potentially been exposed to COVID-19 at some point in the past. It is unknown how long antibodies to SARS-CoV-2 will remain present in the body after infection.

Patients with a positive IgM result may have been recently infected with SARS-CoV-2 and developed an antibody response to the virus. Patients with a positive IgG result may have previously contracted COVID-19 and developed an antibody response to the virus, but this does not exclude recently infected patients who are still contagious.

For the most up-to-date information, please refer to the CDC guidelines.

How should a negative result be interpreted?

According to the CDC, a negative antibody test may indicate that a patient may not have had COVID-19. However, the patient may have a current or recent infection, since it takes the body 1-3 weeks to produce antibodies. Patients should continue to take safety precautions to protect themselves and others around them.

For the most up-to-date information, please refer to the CDC guidelines.

How does this product close testing gaps?

Truvian’s Easy Check COVID-19 IgM/IgG™ Antibody Test empowers healthcare providers, payers, researchers, and leaders to provide accurate, quick, and low-cost antibody testing at scale to the patients and communities they serve. This ongoing and timely data plays a critical role in guiding public health policy and informing vaccine development.