Comparison of Bayer Advia Centaur® immunoassay results obtained on samples collected in four different Becton Dickinson Vacutainer® tubes

Abstract

Background: Medicines and Healthcare products Regulatory Agency's (MHRA's) Medical Device Alert MDA/2004/048 described bias in some endocrine test results obtained on a few immunoassay platforms, particularly the Bayer Advia Centaur® instrument, when using blood specimens collected into Becton Dickinson (BD) Vacutainer® SST™II Advance tubes. As users of BD tubes and the Advia Centaur® instrument, we addressed our concerns about the quality of the results that we had previously reported by undertaking an independent study. Method: We compared the results of 15 immunoassays performed on Bayer Advia Centaur® using blood specimens collected into four different BD Vacutainer® tubes (plain, old and newly released BD SST™ II Advance, and BD PST™II). Results: Compared with plain tubes, old SST™II Advance tube results showed no bias for testosterone, CA15-3, follicle-stimulating hormone and folate assays, but gave a positive bias for cortisol and a negative bias for vitamin-B12. Compared with plain tubes, BD PST™II tubes gave no significant bias for thyroid function tests, prolactin, parathyroid hormone, and CA125, but gave a negative bias for steroid assays, and a positive bias for gonadotrophins. The results obtained using new BD SST™II Advance tubes were generally comparable with those on plain tubes. Conclusions: Only for cortisol did our findings support the bias described by MHRA. Based on our results, apart from vitamin-B12 and possibly cortisol, there may have been no significant influence on clinical decisions as a result of using the old BD SST™II Advance specimen tubes. New BD SST™II Advance tubes and plain tubes give generally comparable results. BD PST™II tubes should not be used for steroid hormone measurements on the Bayer Advia Centaur® instrument. © 2006 The Association for Clinical Biochemistry.