Catalog Number: 05390109160
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.
The electrochemiluminescence immunoassay “ECLIA” is intended for use on the cobas e 601 and cobas e 602 immunoassay analyzers.
|unopened at 2-8 °C||up to the stated expiration date|
|after opening at 2-8 °C||12 weeks|
|on the analyzers||8 weeks|
Store at 2-8 °C.
Do not freeze.
Store the Elecsys reagent kit upright in order to ensure complete availability of the microparticles during automatic mixing prior to use.
Traceability: This method has been standardized against the 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 frequency: 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:
after 12 weeks when using the same reagent lot
after 7 days (when using the same reagent kit on the analyzer)
as required: e.g. quality control findings outside the defined limits
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 (8277 pmol/L) for 2-fold diluted samples.
Lower limits of measurement
Limit of Detection (LoD) and Limit of Quantitation (LoQ)
Limit of Detection = 5.00 pg/mL (0.600 pmol/L)
Limit of Quantitation = 50.0 pg/mL (5.90 pmol/L)
The Limit of Detection was determined in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP17-A requirements.
The Limit of Detection is determined based on the Limit of Blank and the standard deviation of low concentration samples. The Limit of Detection corresponds to the lowest analyte concentration which can be detected (value above the Limit of Blank with a probability of 95 %).
The Limit of Quantitation (functional sensitivity) is the lowest analyte concentration that can be reproducibly measured with an intermediate precision CV of £ 20 %.
Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.
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 duplication each for 21 days (n = 84). The following results were obtained:
b) HS = human serum
c) PC = PreciControl
|cobas e 601 and cobas e 602 analyzer|
|PCc)Cardiac II 1||130||15.3||3.09||0.400||2.40||3.20||0.400||2.50|
|PC Cardiac II 2||4942||583||108||12.7||2.20||126||15.0||2.60|
A comparison of the Elecsys proBNP II STAT assay (y) with the Elecsys proBNP II assay (x) using clinical samples gave the following correlations (pg/mL):
Number of samples measured: 120
The sample concentrations were between approximately 5 and 35000 pg/mL.
|Passing/Bablok19||Linear regression||Deming regression|
|y = 0.992x - 2.14||y = 0.986x + 14.0||y = 0.988x + 8.83|
|t = 0.987||r = 0.998||r = 1.00|
The Elecsys proBNP II STAT assay does not show any significant cross reactions with the following substances, tested with NT-proBNP concentrations of approx. 230 pg/mL and 2300 pg/mL (max. tested concentration):
Adrenomedullin (1.0 ng/mL), aldosterone (0.6 ng/mL), angiotensin I (0.6 ng/mL), angiotensin II (0.6 ng/mL), angiotensin III (1.0 ng/mL), ANP28 (3.1 µg/mL), Arg-vasopressin (1.0 ng/mL), BNP32 (3.5 µg/mL), CNP22 (2.2 µg/mL), endothelin (20 pg/mL), NT-proANP1-30 (preproANP26-55) (3.5 µg/mL), NT-proANP31-67 (preproANP56-92) (1.0 ng/mL), NT-proANP79-98 (preproANP104-123) (1.0 ng/mL), renin (50 ng/mL), urodilatin (3.5 µg/mL).