SAN DIEGO, June 11, 2020 /PRNewswire/ -- Confirm BioSciences, a leading provider of comprehensive screening tools and solutions, today announced that a COVID-19 antibody test the company offers, manufactured by Healgen Scientific, performed exceptionally well in a recent serological test validation project conducted by National Institutes of Health (NIH), National Cancer Institute (NCI) and National Institute of Allergy and Infectious Disease (NIAID) researchers to guide antibody test development. The study findings indicate that the Healgen test's sensitivity and specificity make it suitable for use as a leading screening tool for COVID-19.
"Accurate serology tests play a key role in public health decision-making about returning to work and resuming normal activities safely," said Nikhil Nayak, Chief Operating Officer, Confirm BioSciences. "The ability to identify people who've recovered from COVID-19 and developed antibodies against possible reinfection can also help developers create effective treatments. We're pleased that a test we offer performed so well because Confirm BioSciences is committed to helping the medical community fight the pandemic."
The study evaluating the test's performance was conducted by NIH, NCI and NIAID researchers through a collaborative effort led by the Food and Drug Administration (FDA) and the Centers for Disease Control (CDC). The NCI released testing results for the Healgen test offered by Confirm BioSciences on May 28, 2020. The results of the EUA Authorized Serology Tests evaluated by the FDA can be found here.
Using the reverse transcription polymerase chain reaction (RT-PCR) lab technique as well as CDC Lab Developed ELISA to determine sensitivity and specificity, researchers rated Healgen at 97% sensitivity and 98% specificity with IgG and at 100% sensitivity and 100% specificity with IgM. The test was rated at 100% sensitivity and 98% specificity when IgG and IgM results were combined. In practical terms, these results indicate that the Healgen test is a leading screening tool for COVID-19 infection.
The research also shows the serology test can detect samples with a dilution titer as high as 1:6400, which means the Healgen test can detect extremely low concentrations of SARS-CoV-2 antibodies in samples. In addition, the research showed there is no cross-reactivity between the Healgen serology test and serum samples that are positive for HIV. That's important because it indicates that the test is highly specific for coronavirus, meaning it is effective at screening out false positives.
National, state and local governments rely on scientific data as they make decisions on social distancing and economic activity guidance issued to citizens and businesses. The availability of accurate, high-quality tests to determine how many people have contracted the virus and identify those who have developed antibodies is critically important in making science-based decisions and exploring new treatment options. A case study with more details is available at the Confirm BioSciences site at https://www.confirmbiosciences.com/covid-19-resources/nci-confirm-biosciences-covid-19-test-validation/.
About Confirm BioSciences
Confirm BioSciences is a leading provider of high-quality, comprehensive screening tools and solutions across the full spectrum of health and wellness. With core competencies in testing drugs of abuse and broader health metrics, Confirm is dedicated to providing its customers with meaningful, actionable information. The company's product portfolio ranges from instant and lab-based testing solutions for drugs of abuse, including HairConfirm® and DrugConfirm®, to HealthConfirm®, a line of testing solutions for health and wellness, with results delivered in insightful user-friendly reports. As an industry authority, Confirm educates and empowers its customers, and supports initiatives that create drug-free and healthy homes, workplaces and communities. The company is headquartered in San Diego, California. For additional information, visit https://www.confirmbiosciences.com.
SOURCE Confirm BioSciences