Continuous monitoring of bovine spongiform encephalopathy rapid test performance by weak positive tissue controls and quality control charts

Seuberlich, Torsten; Hofmann, M.A.; Juillerat, Valérie; Boujon, P.; Zurbriggen, Andreas; Doherr, Marcus G. (2009). Continuous monitoring of bovine spongiform encephalopathy rapid test performance by weak positive tissue controls and quality control charts. Veterinary microbiology, 134(3-4), pp. 218-26. Amsterdam: Elsevier 10.1016/j.vetmic.2008.08.010

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Bovine spongiform encephalopathy (BSE) rapid tests and routine BSE-testing laboratories underlie strict regulations for approval. Due to the lack of BSE-positive control samples, however, full assay validation at the level of individual test runs and continuous monitoring of test performance on-site is difficult. Most rapid tests use synthetic prion protein peptides, but it is not known to which extend they reflect the assay performance on field samples, and whether they are sufficient to indicate on-site assay quality problems. To address this question we compared the test scores of the provided kit peptide controls to those of standardized weak BSE-positive tissue samples in individual test runs as well as continuously over time by quality control charts in two widely used BSE rapid tests. Our results reveal only a weak correlation between the weak positive tissue control and the peptide control scores. We identified kit-lot related shifts in the assay performances that were not reflected by the peptide control scores. Vice versa, not all shifts indicated by the peptide control scores indeed reflected a shift in the assay performance. In conclusion these data highlight that the use of the kit peptide controls for continuous quality control purposes may result in unjustified rejection or acceptance of test runs. However, standardized weak positive tissue controls in combination with Shewhart-CUSUM control charts appear to be reliable in continuously monitoring assay performance on-site to identify undesired deviations.

Item Type:	Journal Article (Original Article)
Division/Institute:	05 Veterinary Medicine > Department of Clinical Veterinary Medicine (DKV) > DVK - Clinical Research [discontinued] 05 Veterinary Medicine > Department of Clinical Research and Veterinary Public Health (DCR-VPH) > Experimental Clinical Research 05 Veterinary Medicine > Department of Clinical Research and Veterinary Public Health (DCR-VPH)
UniBE Contributor:	Seuberlich, Torsten, Juillerat, Valérie, Zurbriggen, Andreas (A), Doherr, Marcus
ISSN:	0378-1135
Publisher:	Elsevier
Language:	English
Submitter:	Factscience Import
Date Deposited:	04 Oct 2013 15:25
Last Modified:	29 Mar 2023 23:33
Publisher DOI:	10.1016/j.vetmic.2008.08.010
Web of Science ID:	000263755400003
URI:	https://boris.unibe.ch/id/eprint/38251 (FactScience: 220770)