Gull Laboratories Receives FDA Clearance for EBV IgG ELISA Test

Strategic Insights -

Gull Laboratories, a leading provider of diagnostic test kits, has received FDA clearance to market a new test for assessing past infection with Epstein-Barr virus (EBV). The EBV IgG ELISA test measures antibody levels to the gp125 protein of EBV in patient serum, a valuable marker in the diagnosis of infectious mononucleosis. This new test is particularly useful when used in conjunction with other EBV tests, providing clinicians with a more accurate diagnosis. The test features Gull's Color-Controlled(TM) test format, allowing for easy adaptation to clinical testing in both large and small laboratories.

Key Takeaways:

  • Gull Laboratories has received FDA clearance to market a new test for assessing past infection with Epstein-Barr virus (EBV).
  • The EBV IgG ELISA test measures antibody levels to the gp125 protein of EBV in patient serum, making it a valuable marker in the diagnosis of infectious mononucleosis.
  • The test is particularly useful when used in conjunction with other EBV tests, providing clinicians with a more accurate diagnosis.
  • The EBV IgG ELISA test features Gull's Color-Controlled(TM) test format, allowing for easy adaptation to clinical testing in both large and small laboratories.
  • The test is a semi-quantitative test, providing more information for patient management than qualitative tests.
  • Gull Laboratories is a leading provider of diagnostic test kits, founded in 1974, and markets its products for use in hospitals and clinical laboratories around the world.
  • Ernest Sumsion, Interim President of Gull Laboratories, stated that kits for EBV testing are some of the company's best sellers, indicating a strong market demand for the new test.

Statistics:

  • Gull Laboratories was founded in 1974.
  • The company develops and markets high-quality diagnostic test kits.
  • The EBV IgG ELISA test provides a semi-quantitative measurement of antibody levels to the gp125 protein of EBV.
  • The test is a valuable marker in the diagnosis of infectious mononucleosis.
  • The test is particularly useful when used in conjunction with other EBV tests.

Sources:

  • Gull Laboratories, Inc., press release, Sept. 26, 1995.
  • PR Newswire, "Gull Laboratories, Inc. Receives FDA Clearance for EBV IgG ELISA Test".
  • Amex: GUL, Gull Laboratories, Inc. stock symbol.
  • NOTE TO EDITORS: Gull press releases are available at no charge through PR Newswire's Company News On-Call fax service and on PR Newswire's Web site.