Automation and ISO 17025 Test Validation of a Toxoplasma GondiiAntibodies Enzyme-Linked Immunosorbent Assay

Autor: Wu, John T.Y., Wong, Lester S.Y., Chow, Eva Y.W., Bowlby, Evelyn E.
Zdroj: SLAS Technology: Translating Life Sciences Innovation; October 2003, Vol. 8 Issue: 5 p42-50, 9p
Abstrakt: The authors automated an enzyme-linked immunosorbent assay to detect porcine serum antibodies to Toxoplasma gondii. Two thousand swine sera can be assayed in two eight-hour shifts using a robotic workstation. The automated-ELISA programming is not complex and the test configuration is flexible. This high-throughput screening (HTS) a-ELISA can achieve a 10-fold increase (100→ 1000 tests) in test capacity over the manual method. The assay has been validated according to the requirements of the ISO/IEC 17025 standard. These include repeatability, reproducibility, and optimal threshold value studies. Other requirements are proficiency panel testing, analyst training, standard operation procedure, and equipment certifications.
Databáze: Supplemental Index