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).
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 age||125 pg/mL|
|Patients 75 years of age and older||450 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.
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.
(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.