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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.
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,Â
plasma, or serum samples
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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
Evaluation of the Truvian Easy Check COVID-19 IgM/IgG™ Lateral Flow Device for Rapid Anti-SARS-CoV-2 Antibody Detection
Demystifying COVID-19 Antibody Testing
Truvian Receives FDA Emergency Use Authorization for Easy Check COVID-19 IgM/IgG™ Test
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
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.
According to the FDA, there are two main categories of SARS-CoV-2 tests available.
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.
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:
Truvian’s Easy Check COVID-19 IgM/IgG™ Antibody Test is intended for professional use and not for home use.
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.
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.
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%.
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.
Truvian’s Easy Check COVID-19 IgM/IgG™ Antibody Test provides lab-accurate results in ten minutes.
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.
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.
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.