β-CrossLaps/serum (β-CTx in serum)

Catalog Number: 11972308160

INTENDED USE

Immunoassay for the in vitro quantitative determination of degradation products of type I collagen in human serum and plasma as an aid in assessing bone resorption. The test may be used as an aid in monitoring antiresorptive therapies (e.g. bisphosphonates, hormone replacement therapy - HRT) in postmenopausal women and individuals diagnosed with osteopenia.

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 reference standards precisely defined by weighing out synthetic peptide.

EVERY ELECSYS 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

0.010-6.00 ng/mL or 10-6000 pg/mL (defined by the lower detection limit and the maximum of the master curve). Values below the lower detection limit are reported as < 0.010 ng/mL (< 10 pg/mL). Values above the measuring range are reported as > 6.00 ng/mL (> 6000 pg/mL).

0.010-6.00 NG/ML OR 10-6000 PG/ML (DEFINED BY THE LOWER DETECTION LIMIT AND THE MAXIMUM OF THE MASTER CURVE). VALUES BELOW THE LOWER DETECTION LIMIT ARE REPORTED AS < 0.010 NG/ML (< 10 PG/ML). VALUES ABOVE THE MEASURING RANGE ARE REPORTED AS > 6.00 NG/ML (> 6000 PG/ML).

LOWER LIMITS OF MEASUREMENT

Lower detection limit of the test

NOT NECESSARY DUE TO THE BROAD MEASURING RANGE.

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, pooled human sera and controls in a protocol

INTERMEDIATE PRECISION

INTERMEDIATE PRECISION

METHOD COMPARISON

A comparison of the Elecsys β-CrossLaps/serum assay (y) - ng/mL - with the Serum CrossLaps™ One Step ELISA test from Osteometer (x) - pmol/L - using human serum is shown in the diagram below (linear regression):

ANALYTICAL SPECIFICITY

The monoclonal antibodies used in the Elecsys β-CrossLaps/serum assay recognize all fragments of type I collagen containing the β-8AA octapeptide twice. No cross-reactivity detectable with osteocalcin, PTH or bone ALP.

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