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) VacutainerTM SSTTMII 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 SSTTMII Advance, and BD PSTTMII).
Results: Compared with plain tubes, old SSTTMII 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 PSTTMII 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 SSTTMII 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 SSTTMII Advance specimen tubes. New BD SSTTMII Advance tubes and plain tubes give generally comparable results. BD PSTTMII tubes should not be used for steroid hormone measurements on the Bayer Advia Centaur® instrument.
