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Clinical Chemistry 44: 2139-2147, 1998;
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(Clinical Chemistry. 1998;44:2139-2147.)
© 1998 American Association for Clinical Chemistry, Inc.

Enzymes and Protein Markers

Analytical and clinical performance characteristics of Tandem-MP Ostase, a new immunoassay for serum bone alkaline phosphatase

Dennis L. Broyles1, Randall G. Nielsen1, Elizabeth M. Bussett1, W. Douglas Lu1, Isaac A. Mizrahi1, Patricia A. Nunnelly1, Tram A. Ngo1, Julia Noell1, Robert H. Christenson2,3, and Barry C. Kress1,a

1 Beckman Coulter, Inc., San Diego, CA 92196.
Departments of
2 Pathology and
3 Medical and Research Technology, University of Maryland School of Medicine, Baltimore, MD 21201.
a Address correspondence to this author at: Hybritech, Inc., P.O. Box 269006, San Diego, CA 92196-9006. Fax 619-549-9357; e-mail bckress{at}beckman.com.

The performance characteristics of the Tandem®-MP Ostase® assay, a new microplate immunoassay for bone-specific alkaline phosphatase (bone ALP; EC 3.1.3.1) in human sera, are described. Bone ALP is bound to streptavidin-coated microwells by a single biotinylated anti-bone ALP monoclonal antibody. Antigen is detected by the addition of p-nitrophenyl phosphate. The assay is performed at room temperature in <90 min. Imprecision was 2.3–6.1% with a detection limit of 0.6 µg/L. Method comparison of bone ALP measurements with the Tandem-MP Ostase assay and the mass-based Tandem-R Ostase assay (n = 285) indicated regression statistics of Tandem-MP Ostase = 1.03 Tandem-R Ostase + 0.22 µg/L, Sy||x = 4.0 µg/L, r = 0.97. Serum bone ALP values in apparently healthy men and in pre- and postmenopausal women were also similar between the two Ostase assay formats. Liver ALP reactivity determined using the slope and heat inactivation methods was similar in both Ostase assays. Liver ALP reactivity ranged from 3 µg/L (heat inactivation) to 6 µg/L (slope method) per 100 U/L of liver ALP activity, whereas bone ALP reactivity was 37 µg/L per 100 U/L of bone ALP activity, indicating a liver ALP relative reactivity of 8.1–16.2%. Similar results were obtained with the Alkphase-B bone ALP immunoassay. The Tandem-MP Ostase bone ALP assay demonstrated increased concentrations of serum bone ALP in conditions where bone metabolism is increased and showed a rapid, temporal decrease in serum bone ALP in Paget disease patients on bisphosphonate therapy. In conclusion, the Tandem-MP Ostase assay for serum bone ALP is a rapid, simple, robust nonisotopic alternative to the Tandem-R Ostase immunoradiometric assay that provides an accurate and sensitive assessment of bone turnover.




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