Fast. Simple. Accurate. IB10 sphingotest® NT-proBNP is a rapid point-of-care (POC) immuno-assay for the in vitro quantitative determination of N-terminal pro-brain natriuretic peptide (NT-proBNP) in human whole blood or plas-ma using EDTA or Lithium- Heparin as the anticoagulant.

The test is designed for professional use only and may be used on sites where near patient testing is practiced.

• Quantitative Results

• Whole blood application

• Fast and fully automated – calibration via QR-code, no additional tests necessary

• Long-term storage at 2-8°C, 30 days stability at room temperature

• Measured on Nexus IB10 analyzer, a portable POC instrument

• Ideal for decentralized hospital facilities, acute care units and physicians practices

Clinical SignificanceNT-proBNP is a valuable diagnostic and prognostic Markers for cardio- vascular diseases, especially in patients with a New York Heart Association (NYHA) Class I-IV Congestive Heart Failure (CHF).1,2

The measurement of NT-proBNP is an important tool for aiding in the diagnosis and the assessment of the severity of patients with CHF.3,4

IB10 sphingotest® NT-proBNP

The assay for the in vitro quantitative determination of N-terminal pro-brain natriuretic peptide (NT-proBNP)

Easy Handling

SAMPLE TYPEEDTA or Lithium-Heparin

whole blood or plasma samples

TIME TO RESULT 20 minutes

MEASURING RANGE 30 - 5.000 pg/mL

LIMIT OF DETECTION 30 pg/mL

NO HIGH DOSE HOOK EFFECT up to 300.000 pg/mL

REPRODUCIBILITY

Sample Mean Level (pg/mL)

Total Precision CV (%)

1 130.07 13.8

2 1615.8 11.6

Products

Outstanding Precision

EXPECTED VALUES

Recommended Decision Threshold Values:

• Patients under 75 years of age: 125 pg/mL

• Patients 75 years of age and older: 450 pg/mL

Each laboratory should establish a reference range that represents the patient population that is to be evaluated.

Whole Blood vs. Plasma Comparison

Passing-Bablok regression analysis comparing the whole blood concentrations vs. the corresponding plasma concentrations from the same subject samples:

Slope 1.01 (95% C.I. = [0.97 – 1.06])y-Intercept 2.72 pg/mL

Method ComparisonCorrelation between IB10 sphingotest® NT-proBNP and Roche Elecsys® ProBNP II (cobas e411)

IB10

sphi

ngot

est®

NT-

proB

NP

[pg/

mL]

cobas e411 ProBNP II [pg/mL]

5000

4000

3000

2000

1000

00 1000 2000 3000 4000 5000

Passing-Bablok fit(y = -11.82 + 0.9682 x)95 % CI

If you have any questions please contact your local distributor

SphingoTec GmbH E-Mail: IB10@sphingotec.de

All IB10 sphingotest® test discs are CE-IVD marked

Nexus Dx, Inc., Ltd., 6759 Mesa Ridge Road, San Diego, CA 92121 USA/ Tel: 858-410-4600, FAX: 858-410-4700, www.nexus-dx.com

TheraGenesis GmbH Bahnhofstrasse 5 55276 Oppenheim, Germany Tel: +49 (0) 151 506 403 14 WE-EN-IB56-2Pager_02

CATALOG NUMBER DESCRIPTION

IVR-IB65 IB10 sphingotest® PCT Procalcitonin (package of 10 discs)

IVR-IB62 IB10 sphingotest® penKid® Proenkephalin (package of 10 discs)

IVR-IB58 IB10 sphingotest® DPP3 Dipeptidyl Peptidase 3 (package of 10 discs)

IVR-IB56 IB10 sphingotest® NT-proBNP NT-proBNP (package of 10 discs)

IVR-IB55 IB10 sphingotest® TSH TSH (package of 10 discs)

IVR-IB54 IB10 sphingotest® beta-hCG beta-hCG (package of 10 discs)

IVR-IB53 IB10 sphingotest® Shortness of Breath D-Dimer, NT-proBNP, Troponin I (package of 10 discs)

IVR-IB52 IB10 sphingotest® D-Dimer D-Dimer (package of 10 discs)

IVR-IB51 IB10 sphingotest® 3-in-1 Cardiac Troponin I, CKMB, Myoglobin (package of 10 discs)

IVR-IB50 IB10 sphingotest® Troponin-99 Troponin I (package of 10 discs)

References[1] Costello-Boerrigter LC, Burnett JC. The prognostic value of N-terminal proB-type natriuretic peptide. Nat Clin Pract Cardiovasc Med 2005;2:194-201.[2] Cowie MR, Jourdain P, Maisel A, et al. Clinical applications of B-type natriuretic peptide (BNP) testing. Eur Heart J 2003;24:1710-18.[3] 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.[4] 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.

© 2020 SphingoTec GmbH. Disclaimer: Products based on the Nexus IB10 technology (Nexus Dx, Inc., San Diego, CA, USA) described are CE-IVD-marked and hence certified and approved for use in the European Economic Area (EEA) only. Human diagnostic use of such products may be subject to local regulations. Please check for local availability and information on potential EEA-external approvals with the manufacturers. Caution - The information contained in this communication does not constitute nor imply an offer to sell or transfer any product based on the Nexus IB10 technology as in vitro diagnostic (IVD) product in the United States of America or Canada. No product based on the Nexus IB10 technology is currently available for sale as an IVD product in the United States of America or Canada. The analytical and clinical performance characteristics in compliance with U.S. FDA medical device regulations of any Nexus IB10 product, which may be sold at some future point in time in the U.S., have not yet been established. The IB10 sphingotest® PCT is a rapid point-of-care (POC) immunoassay for the in vitro quantitative determination of Procalcitonin (PCT) in the concentration range of 0.3 µg/L to 10.00 µg/L in EDTA whole blood and plasma. This assay is only intended for the diagnosis of sepsis, the assessment of the degree of severity, and monitoring of the change of sepsis severity. This assay is neither suitable nor intended for other applications and/or uses.