proBNP II STAT

Catalog Number: 05390109160

SYSTEM INFORMATION

For cobas e 601 and cobas e 602 analyzers: Application Code Number 173

INTENDED USE

Immunoassay for the in vitro quantitative determination of N‑terminal pro‑Brain natriuretic peptide in human serum and plasma. This assay is used as an aid in the diagnosis of individuals suspected of having congestive heart failure. The test is further indicated for the risk stratification of patients with acute coronary syndrome and congestive heart failure. The test may also serve as an aid in the assessment of increased risk of cardiovascular events and mortality in patients at risk for heart failure who have stable coronary artery disease.

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 OR E‑BARCODE.

STORAGE AND STABILITY

Store at 2‑8 °C.

CALIBRATION

Traceability: This method has been standardized against the Elecsys proBNP assay (  03121640). This in turn was standardized against reference standards by weighing pure synthetic NT‑proBNP (1‑76) into an equine serum matrix.

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).

CALIBRATION INTERVAL MAY BE EXTENDED BASED ON ACCEPTABLE VERIFICATION OF CALIBRATION BY THE LABORATORY.

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

5.00‑35000 pg/mL or 0.600‑4130 pmol/L (defined by the Limit of Detection and the maximum of the master curve). Values below the Limit of Detection are reported as < 5.00 pg/mL (< 0.600 pmol/L). Values above the measuring range are reported as > 35000 pg/mL (> 4130 pmol/L) or up to 70000 pg/mL (8260 pmol/L) for 2‑fold diluted samples.

LOWER LIMITS OF MEASUREMENT

Limit of Detection and Limit of Quantitation

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

Precision was determined using Elecsys reagents, pooled human sera and controls in a protocol (EP5‑A2) of the CLSI (Clinical and Laboratory Standards Institute): 2 runs per day in duplicate each for 21 days (n = 84). The following results were obtained:

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 (EP5‑A2) of the CLSI (Clinical and Laboratory Standards Institute): 2 runs per day in duplicate each for 21 days (n = 84). The following results were obtained:

PRECISION WAS DETERMINED USING ELECSYS REAGENTS, POOLED HUMAN SERA AND CONTROLS IN A PROTOCOL (EP5‑A2) OF THE CLSI (CLINICAL AND LABORATORY STANDARDS INSTITUTE): 2 RUNS PER DAY IN DUPLICATE EACH FOR 21 DAYS (N = 84). THE FOLLOWING RESULTS WERE OBTAINED:

INTERMEDIATE PRECISION

METHOD COMPARISON

A comparison of the Elecsys proBNP II STAT assay, 05390109160 (y) with the Elecsys proBNP II assay, 04842464160 (x) using clinical samples gave the following correlations (pg/mL):

ANALYTICAL SPECIFICITY

The Elecsys proBNP II STAT assay does not show any significant cross reactions with the following substances, tested with NT‑proBNP concentrations of approximately 230 pg/mL and 2300 pg/mL (max. tested concentration):

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,