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Triage BNP Test

For the Beckman Coulter AccessFamily of Immunoassay Systems.

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BNP results ≤100 pg/mL are representative of normalvalues in patients without CHF.

BNP results greater than 100 pg/mL are consideredabnormal and suggestive of patients with CHF.

BNP results ≥80 pg/mL measured in the first 72 hoursafter the onset of ACS symptoms are associatedwith an increased risk of death, myocardial infarction, and CHF.1

BNP results in HF patients indicate for every 100 pg/mLincrease in BNP concentration, there is a 35% increase in the relative risk of death.2

BNP concentrations in HF patients at the time of presentation >1,000 pg/mL indicates a significantlyhigher risk of all-cause, cardiac and pump-failuredeath. BNP concentrations >480 pg/mL indicate a significantly higher risk of cardiac-related readmissions.3,4

BNP concentrations in HF patients that do not decreasefrom hospital admission to discharge indicate anincreased risk of adverse events.5,6

Pre-discharge BNP results of 350-700 pg/mL indicate a hazard ratio of 5.1 for death or readmission for heart failure within 6 months.7

Pre-discharge BNP results >700 pg/mL indicate a hazard ratio of 15.2 for the same endpoint compared to patients with a pre-discharge BNPconcentration <350 pg/mL.7

BNP results >5000 pg/mL are considered very high values for BNP and exceed the upper limits of theBNP test.

The Triage BNP Test is intended for use with the Beckman Coulter Access Family of Immunoassay Systems for the in vitroquantitative measurement of B-type natriuretic peptide (BNP) in plasma specimens using EDTA as the anticoagulant.

The Triage BNP TestThe Triage BNP Test is a rapid, quantitative test forthe measurement of BNP. The test is used to:

Aid in the diagnosis of heart failureAssess heart failure disease severityRisk-stratify patients with acute coronary syndromesRisk-stratify patients with heart failure

Interpretation of ResultsThe Beckman Coulter Access Family of Immunoassay Systems calculates the test results automatically.

A number in pg/mL represents the amount of BNP present in the sample.


Clinical sensitivity and specificity.Triage BNP Test using a cut-off of 100 pg/mL for various age groups within each gender is described below:

The New York Heart Association (NYHA) developed afour-stage functional classification system for CHF thatis based on a subjective interpretation of the severity ofa patient’s clinical signs and symptoms.

An analysis of NYHA classification and BNP concentrations from the clinical study data indicate that there is a relationship between the severity of the clinical signs and symptoms of CHF and BNP concentration.

Performance Characteristics.Performance characteristics were determined using the Access immunoassay platform.

Analytical Sensitivity: 1 pg/mL (95% confidence)(The lowest detectable level of BNP distinguishable from zero).General Specificity: 98%, using threshold of 100 pg/mL in the non-CHF population age 55 and older 95% confidence limit of BNP concentration)Total imprecision: <7%

Assessment of the severity of CHF.

Males Females

95% 95% 95% 95% Confidence Confidence Confidence Confidence Age Sensitivity Interval Specificity Interval Sensitivity Interval Specificity Interval

<45 81.6% 70.8-92.5% 98.9% 97.4-100.0% 82.1% 68.0-96.3% 100.0% 100.0-100.0%

45-54 76.0% 67.5-84.6% 99.5% 98.5-100.0% 69.0% 57.1-80.9% 98.9% 97.5-100.0%

55-64 75.6% 68.2-82.9% 98.3% 97.7-98.9% 82.4 71.9-92.8% 96.4% 95.5-97.4%

65-74 79.3% 72.6-86% 98.9% 98.4-99.4% 97.9% 93.7-100.0% 95.0% 93.4-96.7%

75+ 82.4% 76.1-88.7% 95.8% 94.7-96.9% 91.9% 85.2-98.7% 75.7% 72.2-79.2%

NYHAFunctional I II III IVClass

95.4 221.5 459.1 1,006.3Median BNP(pg/mL

Population tested are patients with CHF.


Quidel | Rapid Diagnostics | quidel.com | 800.874.1517 | 858.552.1100

Ordering information

Materials Required Cat. # Description

Triage BNP Reagents 98200 100 determinations

(2 packs, 50 tests/pack)

Triage BNP QC Controls 98201 6 vials

(2.5 mL/vial, 2 vials each level)

Provided at approximately 80,

400 and 2,000 pg/mL

Triage BNP Calibrators 98202 6 vials

(6 x 1.5 mL)

S0–S5 1.5 mL/vial

Provided at zero, and

approximately 25, 100, 500,

2,500 and 5,000 pg/mL

Other materials required:Access Substrate, Access Wash Buffer II,One of the following Beckman Coulter immunoassay systems (Access, Access 2, Synchron LXi 725, UniCel DxC660i, UniCel DxC 680i, UniCel DxC 860i, UniCel DxC 880i, UniCel DxI 600, UniCel DxI 800 or UniCel DxC600i)

1 deLemos JA, Morrow DA, Bentley JH, Omland T, Sabatine MS, McCabe CH, Hall C, Cannon CP, Braunwald E. The prognostic value of B-type natriuretic pep-

tide in patients with acute coronary syndromes. New Engl. J. Med. 2001; 345: 1014-1021.

2 Doust, J.A., Pietrzak, E., Dobson, A., and Glasziou, P., How well does B-type natriuretic peptide predict death and cardiac events in patients with heart failure:

systematic review. BMJ 330:625-633, 2005.

3 Vrtovec, B., Delgado, R., Zewail, A., Thomas, C.D., Richartz, B.M., and Radovancevic, B., Prolonged QTc interval and high B-type natriuretic peptide levels to-

gether predict mortality in patients with advanced heart failure. Circulation 107:1764-1769, 2003.

4 Harrison, A., Morrison, L.K., Krishnaswamy, P., Kazanegra, R., Clopton, P., Dao, Q., Hlavin, P., and Maisel, A.S.., B-type natriuretic peptide predicts future car-

diac events in patients presenting to the emergency department with dyspnea. Ann. Emerg. Med. 39:131-138, 2002.

5 Cheng, V., Kazanegra, r., Garcia, A., Lenert, L., Krishnaswamy, P., Gardetto, N., Clopton, P., and Maisel, A., A rapid bedside test for B-type natriuretic peptide

predicts treatment outcomes in patients admitted for decompensated heart failure: a pilot study. J. Am. Coll. Cardiol. 37:386-391, 2001.

6 Bettencourt, P., Ferreira, S., Azevedo, A., and Ferreira, A.., Preliminary data on the potential usefulness of B-type natriuretic peptide levels in predicting out-

come after hospital discharge in patients with heart failure. Am. J. Med. 2002 113:215-219, 2002.

7 Logeart, D., Thabut, G., Jourdain, P., Chavelas, C., Beyne, P., Beauvais, F., Bouvier, E., and Solal, A.C., Predischarge B-type natriuretic peptide assay for identi-

fying patients at high risk of re-admission after decompensated heart failure. J. Am. Coll. Cardiol. 43:635-41, 2004.

© 2017 Quidel. All rights reserved.

Beckman Coulter, Access, UniCel, DxI, and SYNCHRON LX are trademarks of Beckman Coulter, Inc., and are registered in the USPTO.

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