Assessing laboratory performance in Trichinella ring trials.
Trichinosis (Trichinellosis) is a zoonotic disease acquired by eating raw or not adequately processed pork or wild game infected with the larvae of the roundworm genus Trichinella. According to European regulations, animals susceptible to Trichinella have to be examined for infestation. To evaluate the performance of laboratories in Germany, inter-laboratory comparisons known as "ring trials" were introduced by the Federal Institute for Risk Assessment in 2004. The current method of analysis makes use of tolerance zones based on the number of larvae in the sample, but does not permit one to determine if a given lab can detect an infested sample reliably, as required by the quality assurance recommendations of the International Commission on Trichinellosis (ICT). A new way of analysing the ring trial data is presented here, which is based on Bayesian hierarchical models. The model implements the ICT requirement by providing an estimate for the probability that a given lab would fail to detect a sample containing, say, five larvae. When applied to the 87 labs that participated in Germany's 2009 ring trials, it turns out this probability is greater than 10% for 21 of them, although only 10 of these in fact returned a false negative result. Such a new method is required to abide by the ICT requirements and make ring trials effective.
Clinical Trial Centre, Medical Faculty, University of Leipzig, Leipzig, Germany, David.Petroff@zks.uni-leipzig.de.
David
D
Petroff
Dirk
D
Hasenclever
Gregor
G
Makrutzki
Katharina
K
Riehn
Ernst
E
Lücker
D000818:Animals; D001499:Bayes Theorem; D003257:Consumer Product Safety; D005506:Food Contamination / Q000032:analysis*; D005513:Food Inspection; D016266:Food Parasitology; D005858:Germany; D017408:Guidelines as Topic; D007753:Laboratories / Q000592:standards*; D007814:Larva; D008460:Meat / Q000469:parasitology*; D015233:Models, Statistical; D011786:Quality Control; D013552:Swine; D014234:Trichinella / Q000302:isolation & purification*