Long-term stability of a stabilized liquid quality-control serum.

To evaluate the long-term stability of a new liquid quality-control serum ("Decision", Beckman Instruments, Inc.) stabilized with ethylene glycol (330 mL/L), we analyzed it for 22 commonly measured analytes during storage at 2--8 degrees C for 24 days or -15 to -20 degrees C for 55 weeks. Three separate laboratories replicated the analyses, using various analytical methodologies. The data were subjected to linear regression analysis, regressing concentration on time. Analytes were considered unstable when the linear regression coefficient was unequal to zero with 95% or greater probability in all three laboratories. By this criterion all of the analytes were stable for at least 24 days when the control serum was stored at refrigerator temperature and for at least 55 weeks at freezer temperature. We conclude this material is a satisfactory substitute for existing lyophilized quality-control materials and offers certain advantages: stability, vial-to-vial uniformity, decreased waste, and eliminated reconstitution.