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Brief study of the Becton Dickinson solid-phase component system for thyrotropin.

I assessed the Becton Dickinson (BD) ‘ ‘Fhyroid Stimulating Hormone MAb (‘ I) Solid Phase Component System” (Becton Dickinson U.K. Ltd., Oxford, England), performing this immunoradiometric assay exactly as described by the manufacturer. For liquid handling I used a Model 505 sampler (Tecan U.K. Ltd., Reading, England) and measured the radioactivity of the tubes with a Model 2104 gumme counter [Berthold Instruments (U.K.) Ltd., St. Albans, England]. For data reduction I used the spline curve-fit program provided within the counter. The detection limit of this assay (mean + 2 SD) was 0.0 15 milli-int. unitlL (n = 20), compared with the manufacturer’s claim of 0.03 milli-int. unitlL. All samples were analyzed in duplicate and the precision dose profile (1) was calculated. The CV was <5% between 0.1 and 125 milli-int. unitsfL. Compared with serum, heparinized plasma gave values 4% higher, EDTA-treated plasma 6% lower, and fluorideoxalate-anticoagulated plasma 13% lower. Severe hemolysis of 10 g/L resulted in a 10% increase in measured thyrotropin. Published performance criteria for thyrotropin assays (2, 3) agree that there should be no overlap between the variability around the detection limit and the variability around the lower limit of the euthyroid range. In this assay, the 2.6 SD limit of the zero is 0.025 milli-int. unit,IL, and the 2.6 SD limit of the 2.5 percentile is 0.323 milli-int. unitlL. Clearly there is a very good separation of the lower euthyroid limit from the detection limit. The 93% analytical recovery of exogenous thyrotropin (2nd International Reference Preparation 80/558) in specimens from a single distribution in the U.K. External Quality Assessment Scheme for thyroid-related hormones, as determined with this assay, compared favorably with the mean recovery for all laboratories. I find this assay to be robust and easily run in the Tecan 505. The spline curve-fit program with automatic smoothing factor calculation in the Berthold software produced good curve fits. The low detection limit (mean + 2.6 SD, 99.5%) of 0.025 milli-int. unitlL, the upper limit of approximately 125 miiiint. unitsfL, the good recovery, and the excellent precisiondose profile of this assay mean that it can be recommended for routine use. I thank Becton Dickinson U.K. Ltd for providing materials used in this study.