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IB10 sphingotest® Shortness of Breath


IB10 sphingotest® Shortness of Breath (SOB) is a rapid point-of-care (POC) immunoassay for the in vitro quantitative determination of Cardiac Troponin I (cTnI), N-terminal pro-brain natriuretic peptide (NT-proBNP) and D-Dimer in human Lithium-Heparin whole blood and plasma.

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

Cat. No. IVR-IB53 | D-Dimer, NT-proBNP, Troponin I (package of 10 discs)

Clinical Significance

IB10 sphingotest® SOB is intended as an aid in the differential diagnosis and prognostic assessment of patients with symptoms of chest pain, typically accompanied by respiratory distress. Individually or in conjunction with each other, these markers: aid in the diagnosis of myocardial infarction (1,2), aid in the risk stratification of patients with acute coronary syndrome including prediction of the likelihood of developing heart failure (HF), aid in the diagnosis, assessment of severity and likelihood of survival in HF (3,4), and aid in determining the probability of rule-out of patients presenting with clinical symptoms of venous thromboembolism including pulmonary embolism and deep vein thrombosis (5).

Expected Values

Upper Reference Limit - cTnI

From a population of 224 individuals, IB10 sphingotest® Shortness of Breath was used to determine the concentration upper reference limit of cTnI. This population included apparently healthy individuals. The 99th percentile upper reference limit is 0.10 ng/mL.

Recommended Decision Threshold Values - NT-proBNP

From calibration based on the reference Roche Elecsys® proBNP assay as measured on both the Roche Elecsys® and the Ortho VITROS® Immunodiagnostic Systems, the recommended Decision Threshold Values for the IB10 sphingotest® Shortness of Breath (NT-proBNP) are:

Patients under 75 years of age125 pg/mL
Patients 75 years of age and older450 pg/mL


Upper Reference Limit - D-Dimer

From a population of 244 individuals, the IB10 sphingotest® Shortness of Breath was used to determine the concentration upper reference limit of D-Dimer. The 95th percentile upper reference limit, using lithium heparin as anti-coagulant, is 446.8 Fibrinogen Equivalent Units (FEU) ng/mL. It is commonly accepted that 1 D-DU is equal to 2 FEU.


 

Whole Blood vs. Plasma Comparison

All our assays correlate with r=0.9. For more detailed information please read the IFUs or connect with our sales representatives.

 


 

Key Features

Easy Handling
Sample TypeLithium-Heparin whole blood and plasma samples
Time to Result20 minutes
Analyte Stability for IB10 Measurement 24 hours for whole blood
Measuring Range:
cTnI0.05 – 30 ng/mL
NT-proBNP30 – 5,000 pg/mL
D-Dimer100 – 4,000 FEU ng/mL
Limit of Detection:
cTnI0.05 ng/mL
NT-proBNP30 pg/mL
D-Dimer100 FEU ng/mL
No High Dose Hook Effect:
cTnIup to 500 ng/mL
NT-proBNPup to 300,000 pg/mL
D-Dimerup to 40,000 FEU ng/mL

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IB10 sphingotest® Shortness of Breath is a rapid point-of-care (POC) immunoassay for the in vitro quantitative determination of Cardiac Troponin I, N-terminal pro-brain natriuretic peptide and D-Dimer.

Request a Quote


References

(1) Reichlin T et al. Utility of absolute and relative changes in cardiac troponin concentrations in the early diagnosis of acute myocardial infarction. Circulation. 2011 Jul 12;124(2):136-45.

(2) Fan J et al. Clinical Value of Combined Detection of CK-MB, MYO, cTnI and Plasma NT-proBNP in Diagnosis of Acute Myocardial Infarction. Clin Lab. 2017 Mar 1;63(3):427-433.

(3) Peacock et al. Cardiac troponin and outcome in acute heart failure. N Engl J Med. 2008 May 15;358(20):2117-26.

(4) Sakhuja et al. Amino-terminal pro-brain natriuretic peptide, brain natriuretic peptide, and troponin T for prediction of mortality in acute heart failure. Clin Chem. 2007 Mar;53(3):412-20.

(5) Kyrle et al. Deep vein thrombosis. Lancet. 2005 Mar 26-Apr 1;365(9465):1163-74.