Analytical evaluation of the VITROS 5600 Integrated System in a pediatric setting and determination of pediatric reference intervals.

OBJECTIVES

To evaluate the VITROS 5600 Integrated System in a pediatric setting and to determine age- and gender-specific pediatric reference intervals for several common analytes.

DESIGN AND METHODS

The instrument was evaluated using QC material and patient samples. Reference intervals were determined using samples obtained from children attending select outpatient clinics.

RESULTS

Imprecision analysis for 25 analytes and serum indices, the turnaround time for a simulated workload, and MicroSensor performance were assessed in our pediatric laboratory. Pediatric reference intervals for 25 analytes were also determined according to the CLSI/IFCC C28-A3 guidelines using 770 samples and over 15,000 analyses.

CONCLUSION

The VITROS 5600 Integrated System is suitable for use in a pediatric setting. Age- and gender-partitioned pediatric reference intervals for 25 common analytes were also determined as a pilot to the ongoing CALIPER project. These reference intervals are valuable for all VITROS users as well as any laboratory assessing these analytes once they demonstrate the acceptability of transference to their laboratory.