Key result
Shewhart-CUSUM control charts successfully detected significant data trends and beyond control limit situations in 2 out of 42 ELISAs for FMDV type A.
The Shewhart-CUSUM control chart is a simple and reliable internal quality control method for detecting significant random and systematic variation in ELISA assays.
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May support Shewhart-CUSUM for ELISA QC in FMDV assays; hypothesis-generating and requires prospective validation before adoption.
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.
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Blacksell et al. (1994) studied Foot and mouth disease (n=42). Shewhart-CUSUM control charts was evaluated on Detection of significant random and systematic variation in assays. Shewhart-CUSUM control charts successfully detected significant data trends and beyond control limit situations in 2 out of 42 ELISAs for FMDV type A.
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