Parathyroid hormone (parathormone, parathyrin) - PTH, intact (STAT "Short Turn Around Time")

Catalog Number: 04892470160

INTENDED USE

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.

RESULTS ARE DETERMINED VIA A CALIBRATION CURVE WHICH IS INSTRUMENT-SPECIFICALLY GENERATED BY 2-POINT CALIBRATION AND A MASTER CURVE PROVIDED VIA THE REAGENT BARCODE.

STORAGE AND STABILITY

Store at 2-8 °C.

CALIBRATION

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 %.

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 ( 411 AND 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).

EVERY REAGENT SET HAS A BARCODED LABEL CONTAINING SPECIFIC INFORMATION FOR CALIBRATION OF THE PARTICULAR REAGENT LOT. THE PREDEFINED MASTER CURVE IS ADAPTED TO THE ANALYZER USING THE RELEVANT CALSET.

CALIBRATION MUST BE PERFORMED ONCE PER REAGENT LOT USING FRESH REAGENT (I.E. NOT MORE THAN 24 HOURS SINCE THE REAGENT KIT WAS REGISTERED ON THE ANALYZER). RENEWED CALIBRATION IS RECOMMENDED AS FOLLOWS:

CONTROLS FOR THE VARIOUS CONCENTRATION RANGES SHOULD BE RUN INDIVIDUALLY AT LEAST ONCE EVERY 24 HOURS WHEN THE TEST IS IN USE, ONCE PER REAGENT KIT, AND FOLLOWING EACH CALIBRATION.

LIMITS AND RANGES

Measuring range

MEASURING RANGE

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).

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 LIMITS OF MEASUREMENT

Lower detection limit of the test

SPECIFIC PERFORMANCE DATA

Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.

PRECISION

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:

INTERMEDIATE PRECISION

INTERMEDIATE PRECISION

INTERMEDIATE PRECISION

METHOD COMPARISON

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):

ANALYTICAL SPECIFICITY

No cross-reactivities were found for: Osteocalcin, PTH fragment 1-37, PTH-related protein (1-86),

THE FUNCTIONAL SENSITIVITY IS THE LOWEST ANALYTE CONCENTRATION THAT CAN BE REPRODUCIBLY MEASURED WITH AN INTERMEDIATE PRECISION CV OF ≤ 20 %.

BABLOK W, PASSING H, BENDER R, ET AL. A GENERAL REGRESSION PROCEDURE FOR METHOD TRANSFORMATION. APPLICATION OF LINEAR REGRESSION PROCEDURES FOR METHOD COMPARISON STUDIES IN CLINICAL CHEMISTRY, PART III. J CLIN CHEM CLIN BIOCHEM 1988 NOV;26(11):783-790.