Estimation of the stability of parathyroid hormone when stored at -80 degrees C for a long period.

BACKGROUND AND OBJECTIVES

Stability of parathyroid hormone (PTH) at -80 degrees C for long storage periods has never been studied. This can be of importance for the conclusions of studies where blood banks have been constituted. The study's aim was to evaluate stability of PTH when stored as serum or plasma EDTA samples at -80 degrees C.

DESIGN, SETTING, PARTICIPANTS & MEASUREMENTS: Samples were collected from 16 chronic hemodialysis patients using EDTA and gel-separator tubes. Plasma and serum were aliquoted; one aliquot was assayed with Elecsys and Liaison methods to determine the "baseline" values and another aliquot after 1, 3, 6, and 12 mo. The factors "method," "tubes," "subjects," and "time" were included in a mixed linear model to evaluate their effects on measured PTH values. The prediction interval methodology was used to assess where a future result could be obtained with a defined probability.

RESULTS

With the Liaison method, the maximum storage times with either dry or EDTA tubes were estimated to be 9 and 2 mo, respectively. With the Elecsys method, samples could be stored at least 2 yr with acceptable level of degradation.

CONCLUSION

PTH stability at -80 degrees C is not infinite. Maximum storage time and acceptance limits (30%) were defined, showing that with one method, samples should be stored for not more than 2 mo, whereas the other could be stored for up to 2 yr. With any PTH assay, the maximum storage time should be evaluated to ascertain that samples will keep their initial reactive profile after prolonged storage periods.