Evaluation of the Truvian Easy Check COVID-19 IgM/IgG™ Lateral Flow Device for Rapid Anti-SARS-CoV-2 Antibody Detection

Independent Evaluation of Easy Check COVID-19 IgM/IgGTM Performance

November 9, 2020

The SARS-CoV-2 pandemic has dramatically impacted the global community with over 33.5 million cases worldwide and greater than 1 million deaths.1 The scientific and medical community have taken a three-prong approach to attacking the greatest health threat of our generation. This approach includes improving fundamental knowledge of SARS-CoV-2 and COVID-19, advancing detection and diagnosis of COVID-19, and advancing treatment and prevention of COVID-19 (including vaccination).2

Serology tests are a type of test that look for antibodies in the blood. From rapid antibody tests that provide results in 10 minutes to lab-based antibody tests that can take 1-3 days, these serology tests span the range of approaches currently being pursued to control the SARS-CoV-2 pandemic. Serology tests can be used in combination with molecular (PCR) testing as an aid in diagnosing individuals with COVID-19.3-5 Additionally, serology tests have been used in numerous seroprevalence studies to understand the national and global impact of SARS-CoV-2.6-8 Because of its great utility in disease control and mitigation, it is important that serology tests are robust and accurate. Validation of a test should not end with the manufacturer but rather, it should include numerous independent evaluations in actual clinical laboratories to ensure robustness, reproducibility and accuracy of the assay results under real world situations. Dr. Chan from the Yeo laboratory at University of Chicago chose to perform an independent evaluation of the Easy Check because of its excellent performance as reported in IFU and independent studies by NCI. In this study, Yeo and colleagues performed a thorough analytical evaluation, concordance testing against a high performing lab-based system and tested for cross-reactivity/interferences.9

To learn more, read the American Journal of Clinical Pathology study here.

 

References:
1. World Health Organization. WHO Coronavirus Disease (COVID-19) Dashboard, <https://covid19.who.int/region/amro/country/us> (2020).
2. NIAID. NIAID strategic plan details COVID-19 research priorities, <https://www.niaid.nih.gov/sites/default/files/NIAID-COVID-19-Strategic-Plan-2020.pdf> (April 23, 2020).
3. Gudbjartsson, D. F. et al. Humoral Immune Response to SARS-CoV-2 in Iceland. N Engl J Med, doi:10.1056/NEJMoa2026116 (2020).
4. Mlcochova, P. et al. Combined Point-of-Care Nucleic Acid and Antibody Testing for SARS-CoV-2 following Emergence of D614G Spike Variant. Cell Rep Med 1, 100099, doi:10.1016/j.xcrm.2020.100099 (2020).
5. Miller, T. E. et al. Clinical sensitivity and interpretation of PCR and serological COVID-19 diagnostics for patients presenting to the hospital. FASEB J, doi:10.1096/fj.202001700RR (2020).
6. Havers, F. P. et al. Seroprevalence of Antibodies to SARS-CoV-2 in 10 Sites in the United States, March 23-May 12, 2020. JAMA Intern Med, doi:10.1001/jamainternmed.2020.4130 (2020).
7. Stringhini, S. et al. Seroprevalence of anti-SARS-CoV-2 IgG antibodies in Geneva, Switzerland (SEROCoV-POP): a population-based study. Lancet, doi:10.1016/S0140-6736(20)31304-0 (2020).
8. Pollán, M. et al. Prevalence of SARS-CoV-2 in Spain (ENE-COVID): a nationwide, population-based seroepidemiological study. The Lancet, doi:10.1016/s0140-6736(20)31483-5 (2020).
9. Chan, C. W., Sajid, S., Coleman, C., Tesic, V., Parker, K., Yeo, K.T.J. 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 doi:10.1093/AJCP/AQAA221 (2020).

 

Renee Higgins, PhD
Manager, Scientific Affairs

Renee Higgins, PhD, is a molecular biologist with a passion for diagnostics and making health and wellness accessible to everyone. As one of the founding employees at Truvian, she has also contributed to the growth of the company as a Scientist and Hematology Assay Development Manager. Dr. Higgins holds a PhD in Medicinal Chemistry and Molecular Pharmacology from Purdue University and completed her post-doc at the University of California, San Diego. Prior to her role at Truvian, she was a Scientist at Epic Sciences.