Catalog Number: 04892470160
For cobas e 411 analyzer: test number 840For cobas e 601 and cobas e 602 analyzers: Application Code Number 221
Immunoassay for the in vitro quantitative determination of intact parathyroid hormone in human serum and plasma for the differential diagnosis of hypercalcemia and hypocalcemia. This assay can be used intraoperatively.
Store at 2‑8 °C.
Traceability: This method has been standardized against Elecsys PTH ( 11972103). This in turn was standardized against a commercial PTH test (RIA). The recovery of the NIBSC 95/646 (WHO) standard was assessed by testing dilutions in human serum covering the measuring range (40‑4000 pg/mL) on 16 analyzers (cobas e 411 and cobas e 601 analyzers). The mean recovery was 100 % ± 4 %.
1.20‑5000 pg/mL or 0.127‑530 pmol/L (defined by the Lower Detection Limit and the maximum of the master curve). Values below the Lower Detection Limit are reported as < 1.20 pg/mL (< 0.127 pmol/L). Values above the measuring range are reported as > 5000 pg/mL (> 530 pmol/L).
Lower detection limit of the test
Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.
Precision was determined using Elecsys reagents and pooled human sera in a modified protocol (EP5‑A) of the CLSI (Clinical and Laboratory Standards Institute): 6 times daily for 10 days (n = 60). The following results were obtained:
A comparison of the Elecsys PTH STAT assay (y) with the Elecsys PTH assay (x) - performed on the Elecsys 2010 analyzer - using clinical samples gave the following correlations (pg/mL):
No cross-reactivities were found for: Osteocalcin, PTH fragment 1‑37, PTH‑related protein (1‑86), bone‑specific alkaline phosphatase, and β‑CrossLaps.