For the Quantitative Determination of NT-proBNP in EDTA and Lithium Heparin Human Whole Blood and Plasma

IB10 sphingotest® NT-proBNP For In Vitro Diagnostic Use INTENDED USE The IB10 sphingotest® NT-proBNP is a rapid test for the in vitro quantitative determination of N-terminal pro-brain natriuretic peptide (NT-proBNP) in human whole blood or plasma using EDTA or lithium heparin as the anticoagulant. The NT-proBNP Test is intended for use in conjunction with the Nexus IB10 Analyzer and provides quantitative results in 20 minutes. This Test is designed for professional use only and may be used in hospital central laboratories and in alternate care settings such as emergency departments, critical...

• For in vitro diagnostic use only. • Carefully follow the Instructions for Use. • Prior to testing controls or patient samples, ensure that the Analyzer software is updated to the latest version. Refer to the Nexus IB10 manual for specific instructions. • Wear disposable gloves while handling samples. • Handle samples with care. Samples and used Test discs should be treated as if potentially infectious and should be discarded as biohazardous materials according to local regulations. • Thoroughly wash hands following handling. • The result obtained from the IB10 sphingotest® NT-proBNP does not...

RUNNING QC WITH EXTERNAL CONTROLS The manufacturer recommends the use of commercially available NT-proBNP Controls (please refer to section Materials/Equipment Required But Not Provided). Ensure that the NT-proBNP controls are handled and prepared according to the corresponding Instructions for Use (IFU). 1. Remove an unopened pouch from refrigeration and place it at room temperature (19 to 25 °C/66 to 77 °F) for at least 15 minutes prior to testing. 2. Open the pouch and remove the Test disc. 3. Place the Test disc on a level surface. 4. On the Nexus IB10 Analyzer press New Analysis. 5. The...

INTERPRETATION OF RESULTS The range of NT-proBNP concentration reported by the Nexus IB10 Analyzer is 30 pg/mL to 5,000 pg/mL. Results below or above this range will be shown as “< 30 pg/mL” or “> 5,000 pg/mL,” respectively. • Recommended Decision Threshold Values: • Patients under 75 years of age: 125 pg/mL • Patients 75 years of age and older: 450 pg/mL • NT-proBNP results less than or equal to the decision threshold values are considered normal values, representative of patients without CHF. • Results greater than the recommended decision threshold values are considered abnormal and are suggestive...

The following drugs were tested for potential interference in the IB10 sphingotest® NT-proBNP (Table 1). The list of drugs encompasses common prescription and over-the-counter medications, as well as those often prescribed in a cardiac patient population. The drugs were tested at concentrations as recommended in the CLSI Approved Guideline EP7-A2 'Interference Testing in Clinical Chemistry, '13 or at least three times the highest concentration reported following a therapeutic dose. No significant interference with the IB10 sphingotest® NT-proBNP was observed for the drugs listed in the table...

HOOK EFFECT No high dose Hook Effect was observed for NT-proBNP concentrations up to 300,000 pg/mL. The precision of IB10 sphingotest® NT-proBNP was determined using samples where recombinant NT-proBNP was added to normal human plasma at three concentrations (Table 3). The within-run and total precision was performed in two runs per day, in replicates of 5 per run at each concentration level for a 20 day period for a total number of repetitions of 200 at each concentration level. The within-run and total coefficients of variation (CVs) were computed according to CLSI guideline EP05-A3.14 WHOLE...

9. Cowie MR, Jourdain P, Maisel A, et al. Clinical applications of B-type natriuretic peptide (BNP) testing. Eur Heart J 2003;24:1710-18. 10. Mair J, Hammerer-Lercher A, Puschendorf B. The Impact of cardiac natriuretic peptide determination on the diagnosis and management of heart failure. Clin Chem Lab Med 2001;39:571-88. 11. McDonagh TA, Holmer S, Raymond I, et al. NT-proBNP and the diagnosis of heart failure: a pooled analysis of three European epidemiological studies. Eur J Heart Fail 2004;6:269-73. 12. Pierson-Perry J, Vaks JE, Durham AP, et al. Evaluation of detection capability for clinical...

Fur die quantitative Bestimmung von NT-proBNP in EDTA und Lithiumheparin von humanem Vollblut und Plasma

IB10 sphingotest® NT-proBNP Zum Gebrauch als In-vitro-Diagnostikum VERWENDUNGSZWECK Der IB10 sphingotest® NT-proBNP ist ein Schnelltest für die quantitative In-vitro-Bestimmung von N-terminalem pro-brain natriuretischem Peptid (NT-proBNP) in humanem Vollblut oder Plasma mithilfe von EDTA oder Lithiumheparin als Antikoagulans. Der NT-proBNP-Test ist für den Gebrauch zusammen mit dem Nexus IB10 Analysegerät vorgesehen und liefert innerhalb von 20 Minuten quantitative Ergebnisse. Der Test ist ausschließlich für den professionellen Gebrauch vorgesehen und kann im Zentrallabor von Krankenhäusern und...

ERFORDERLICHE, JEDOCH NICHT BEREITGESTELLTE MATERIALIEN/GERATE 1. Nexus IB10 Analysegerat - Modell Nr. BCA-IB10. 2. Handelsubliche NT-proBNP-Kontrollen zur externen Qualitatskontrolle (QC). Wenden Sie sich an den Handler in Ihrem Bereich, um empfohlene externe QC-Materialien oder damit verbundene technische Hilfe zu erhalten. 3. Kalibrierte, wiederverwendbare feste oder variable Volumenpipetten, die auBerst prazise und genau 500 pl Vollblut oder Plasma abgeben konnen. 4. Einweg-Pipettenspitzen zur Aufnahme und Abgabe von 500 pl Vollblut oder Plasma. • Gebrauchsanweisung genau beachten. • Stellen...

VERFAHREN Nexus IB10 Analysegerät Lesen Sie die Gebrauchsanweisung des Nexus IB10 Analysegeräts Hinweise zu Installation, Einrichtung und die vollständige Gebrauchsanweisung finden Sie im Benutzerhandbuch des Nexus IB10 Analysegeräts. Der Bediener muss die Gebrauchsanweisung vor Gebrauch lesen, um sich mit dem korrekten Betrieb und den Qualitätskontrollverfahren vertraut zu machen. DURCHFÜHRUNG VON SYSTEMPRÜFUNG UND DISKKALIBRIERUNG Bei jedem Einschalten des Nexus IB10 Analysegeräts wird automatisch ein Selbsttest durchgeführt. Der QR-Code auf jeder Testdisk enthält Informationen für die Diskkalibrierung,...