Comparison |
| CLIA Classification |
FDA 510(k) Cleared | CLIA Waived for Whole Blood / CLIA Moderate Complexity for Plasma | CLIA Moderate Complexity | CLIA Moderate Complexity | CLIA Non-Waived |
| CLIA Classified |
CLIA Non-Waived | CLIA Waived Sample Dependent | CLIA Non-Waived | CLIA Non-Waived | CLIA Non-Waived |
| Contents 1 |
(25) Test Devices | (25) Test Devices, Reagent Code Chip Module, Printer Paper Roll, (25) Pipettes, Package Insert | (25) Test Devices, (25) Transfer Pipettes, Reagent Code Chip Module, Printer Paper Roll | Test Device, Transfer Pipette Reagent Code Chip, Printer Paper Roll | (25) Test Devices, Reagent Code Chip Module, Printer Paper Roll, (25) Pipettes, Package Insert |
| Country of Origin |
Canada | United States | United States | United States | United States |
| For Use With |
For Ramp® Automated Reader | For Triage® MeterPro® System | For Triage® MeterPro® System | For Alere Triage® MeterPro® System | For Triage® MeterPro® System |
| Product Dating |
McKesson Acceptable Dating: we will ship >= 60 days | McKesson Acceptable Dating: we will ship >= 60 days | McKesson Acceptable Dating: we will ship >= 30 days | McKesson Acceptable Dating: we will ship >= 60 days | McKesson Acceptable Dating: we will ship >= 60 days |
| Sample Type |
Whole Blood Sample | Whole Blood / Plasma Sample | Whole Blood / Plasma Sample | Whole Blood / Plasma Sample | Whole Blood / Plasma Sample |
| Technology |
Ramp® Technology | | | | |
| Test Format |
Cartridge Format | Cassette Format | Cassette Format | Cassette Format | Cassette Format |
| Test Kit Type |
Rapid | Standard | Rapid | Rapid | Standard |
| Test Method |
| Fluorescence Immunoassay (FIA) | | | Fluorescence Immunoassay (FIA) |
| Test Name |
Creatine Kinase MB | B-Type Natriuretic Peptide (BNP) | D-Dimer | Troponin I | Creatine Kinase MB / Myoglobin / Troponin I |
| Test Type |
Cardiac Marker | Cardiac Marker | Fluorescence Immunoassay (FIA) | Cardiac Marker | Cardiac Marker |
| Time to Results |
15 Minute Results | 20 Minute Results | 20 Minute Results | 20 Minute Results | 20 Minute Results |
| UNSPSC Code |
41116104 | 41116104 | 41116005 | 41116104 | 41116104 |
| Application |
Heart Health Test Kit | Heart Health Test Kit | Heart Health Test Kit | Heart Health Test Kit | Heart Health Test Kit |
| Number of Tests |
25 Tests | 25 Tests | 25 Tests | 25 Tests | 25 Tests |
| Purchase Program Type |
Standard Purchase | Standard Purchase | Standard Purchase | Standard Purchase | Standard Purchase |
| Reading Type |
Machine Read | Machine Read | Machine Read | Machine Read | Machine Read |
| Specialty |
Immunoassay | Immunoassay | Immunoassay | Immunoassay | Immunoassay |
| Storage Requirements |
Requires Refrigeration | Requires Refrigeration | Requires Refrigeration | Requires Refrigeration | Requires Refrigeration |
| Features and Benefits |
- The RAMP® CK-MB test is a fast, accurate and quantitative immunochromatographic test for the determination of CK-MB levels in human EDTA whole blood
- Measurement of CK-MB aids in the rapid diagnosis of acute myocardial infarction (AMI)
- Using a compact, easy-to-use, automated reader, the RAMP® Platform delivers objective, rapid test results with an average time to result of approximately 15 minutes
- Standardized test procedure for all cardiac assays
|
- The Triage BNP test measures BNP to aid in the diagnosis and assess the severity of congestive heart failure
- The test is also used for the risk stratification of patients with acute coronary syndromes and patients with heart failure
- Sensitivity 80.6%, specificity 98%
- Rapid results in approximately 15 minutes
- Results read by the Triage meterpro meter
- Sample Type: whole blood, plasma
- CLIA waived for whole blood
|
- Provides rapid, quantitative results in approximately 20 minutes
- The Alere Triage® D-Dimer Test is a rapid, quantitative immunoassay to aid in assessing and evaluating patients with suspected disseminated intravascular coagulation (DIC) and thromboembolic events including pulmonary embolism (PE) and deep vein thrombosis (DVT)
- Uses plasma or whole blood in EDTA
|
|
- For the quantitative determination of creatine kinase MB (CK-MB), myoglobin and troponin I in EDTA anticoagulated whole blood or plasma specimens
- The test is used as an aid in the diagnosis of myocardial infarction (injury)
- Tnl / CKMB / Myoglobin on one test device
|
