Researchers have developed a new software, called ELISAtools to limit variability in commercial research biomarker testing kits
Variability in common among research biomarker tests like ELISA. Researchers have developed a new software program, called ELISAtools which provides a stable platform to compare data from assay kits and minimize variability over months or even years. The results were published online in PLOS One.
ELISA or Enzyme-Linked Immunosorbent Assay is a technique used to detect antibodies or infectious agents in a sample of blood or urine. Antibodies are proteins produced by the body in response to infection in order to identify and neutralise any foreign substances (antigen) such as viruses and bacteria.
ELISA tests are used globally across clinical, biomedical and basic research fields to measure biomarkers. Clinical ELISA test kits used in the hospital setting are regulated to ensure tight quality control boundaries for accuracy and consistency. However, the hundreds of commercially available research-use-only ELISA test kits are not regulated, which often leads to noticeable variability in results over time, between testing kits, and across different laboratories.
After implementing this software, the variability in test results dropped from over 60 percent, to under 9 percent, well within our quality control limits
The research team unexpectedly encountered high variability from one ELISA test kit during a project for the National Cancer Institute measuring thrombosis and inflammation biomarkers in the plasma of cancer subjects and healthy donors. The team realized that the data was changing significantly as they received different shipments of the kit from the manufacturer. After a detailed examination, researchers determined differences in the ELISA kit was causing the issue. Research data from over 400 patient samples could not be compared due to these differences in the ELISA kits. To solve this problem, the research team created the ELISAtools software program to reduce future variability in test results.
“After implementing this software, the variability in test results dropped from over 60 percent, to under 9 percent, well within our quality control limits,” said Deborah J. Stearns-Kurosawa, PhD, senior author of the study and associate professor of pathology and laboratory medicine at Boston University School of Medicine (BUSM). “We work on studies that go on for years, and this tool creates a constant, level playing field that we believe will improve accuracy and clinical utility of research.”
