Randox Unveils SARS-CoV-2 Antibody Test to Determine Previous COVID-19 Infection in Just 1.5 Hours

Randox Laboratories (Crumlin, UK) has launched its new SARS-CoV-2 IgG test, utilizing patented Randox Biochip Technology to simultaneously detect IgG antibodies that are reactive to both of the leading COVID-19 diagnostic antigens - Spike Receptor Binding Domain (RBD) and Nucleocapsid protein (NP).

Maximum test sensitivity is ensured through simultaneous detection of both RBD-only and NP-only responders, making it superior to current commercially available COVID-19 IgG tests that are based on RBD or NP alone, from which false negative results can occur. The Randox SARS-CoV-2 IgG (RBD & NP) Array provides clinicians with an opportunity to discriminate vaccinated individuals from those naturally infected by COVID-19.

The Randox SARS-CoV-2 IgG (RBD & NP) Array has been developed for the Evidence Investigator, a semi-automated benchtop immunoassay analyzer delivering accurate results in just 1.5 hours. The new array has a specificity of 99.5% and sensitivity of 100% more than 14 days post PCR test with a sensitivity of 92.3% 0-14 days post PCR confirmation. The Randox SARS-CoV-2 antibody array will also include a calibrator and controls are available to order.

“When there is little or no access to molecular testing, serology tests provide a means to quickly triage suspected cases of COVID-19, enabling appropriate case management, and guiding public health measures, such as quarantine or self-isolation,” said Lynsey Adams, Randox Clinical Marketing Manager. “The new Randox SARS-CoV-2 IgG (RBD & NP) Array, provides a unique insight into disease severity, is an established method of indirect disease diagnosis, and facilitates epidemiological surveillance as the COVID-19 pandemic progresses.”