IB10 sphingotest® 3-in-1 Cardiac
IB10 sphingotest® 3-in-1 Cardiac is a rapid point-of-care (POC) immunoassay for the quantitative in vitro determination of Cardiac Troponin I (cTnI), Creatine kinase-MB (CK-MB) and Myoglobin, 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-IB51 | Troponin I, CK-MB, Myoglobin (package of 10 discs)
Clinical Significance
This panel of three cardiac markers enhances the reliability of earlier identification and risk stratification of patients presenting with chest pain compared to a single marker (1,2). Measurements of cardiac protein markers are essential for the accurate diagnosis of acute coronary syndrome in the absence of well-defined electrocardiographic ST-segment elevations (3,4).
Expected Values
From a population of 224 individuals, the IB10 sphingotest® 3-in-1 Cardiac was used to determine the concentration upper reference limits of cTnI, CK-MB and Myoglobin. This population included apparently healthy individuals.
| cTnI | 0.10 ng/mL (99th reference percentile) |
| CK-MB | 8.58 ng/mL (95th reference percentile) |
| Myoglobin | 99.84 ng/mL (95th reference percentile) |
Each laboratory should establish a reference range that represents the patient population that is to be evaluated at their facility.
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 Type | Lithium-Heparin whole blood and plasma samples |
| Time to Result | 20 minutes |
| Analyte Stability for IB10 Measurement | 48 hours for whole blood |
| Measuring Range: | |
| cTnI | 0.05 – 30 ng/mL |
| CK-MB | 2.0 - 60 ng/mL |
| Myoglobin | 30.0 - 500 ng/mL |
| Limit of Detection: | |
| cTnI | 0.05 ng/mL |
| CK-MB | 2.0 ng/mL |
| Myoglobin | 30.0 ng/mL |
| No High Dose Hook Effect: | |
| cTnI | up to 500 ng/mL |
| CK-MB | up to 200 ng/mL |
| Myoglobin | up to 4,000 ng/mL |
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IB10 sphingotest® 3-in-1 Cardiac is a rapid point-of-care (POC) immunoassay for the in vitro quantitative determination of Cardiac Troponin I, CK-MB and Myoglobin.
References
(1) 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.
(2) Newby LK et al. Bedside multimarker testing for risk stratification in chest pain units: The chest pain evaluation by creatine kinase-MB, myoglobin, and troponin I (CHECKMATE) study. Circulation. 2001 Apr 10;103(14):1832-7.
(3) 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.
(4) Thygesen K et al. Task Force for the Redefinition of Myocardial Infarction. Universal definition of myocardial infarction. J Am Coll Cardiol. 2007 Nov 27;50(22):2173-95.