Use of combined Shewhart-CUSUM control charts in internal quality control of enzyme-linked immunosorbent assays for the typing of foot and mouth disease virus antigen

Rev Sci Tech. 1994 Sep;13(3):687-99. doi: 10.20506/rst.13.3.785.

Abstract

An enzyme-linked immunosorbent assay (ELISA) for the typing of foot and mouth disease virus (FMDV) antigen was employed for the routine laboratory diagnosis of FMD at a regional veterinary laboratory in northern Thailand. An objective procedure was developed to monitor the test performance of the ELISA, using absolute test control limits in a Shewhart-CUSUM (cumulative sum) control chart method. The procedure detected significant data trends and 'beyond control limit' situations for each antigen typing system (types O, A and Asia 1), using an assay variable (gamma i). Retrospective analysis using Shewhart-CUSUM control charts of data from 42 ELISAs demonstrated that control limits were exceeded in two assays for FMDV type A. The Shewhart-CUSUM control chart is a simple and reliable internal quality control method for the detection of significant random and systematic variation in assays.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • Antigens, Viral / analysis*
  • Aphthovirus / classification*
  • Aphthovirus / immunology
  • Enzyme-Linked Immunosorbent Assay / standards
  • Enzyme-Linked Immunosorbent Assay / veterinary*
  • Linear Models
  • Quality Control
  • Serotyping / standards
  • Serotyping / veterinary

Substances

  • Antigens, Viral