Product Overview
The RAMP® CK-MB Test is a quantitative immunochromatographic assay for measuring creatine kinase-MB (CK-MB) in EDTA whole blood. Measurement of CK-MB aids in the rapid diagnosis of acute myocardial infarction (AMI) when the result is evaluated together with the patient’s medical history, clinical examination, electrocardiogram and other findings. The test is intended to help prioritize patient management for individuals suspected of AMI.
The assay uses 75 µL of EDTA whole blood and provides a quantitative result in approximately 12 minutes on a compatible RAMP instrument. Each kit contains 25 single-use test cartridges, test tips and buffer vials, together with a calibrated transfer device and lot card.
Important: The RAMP CK-MB Test is for in vitro diagnostic use and prescription use. For U.S. customers, it must be operated in a laboratory setting when used with the RAMP 200. The test result must not be used by itself to diagnose a patient, classify the extent of myocardial necrosis or monitor reperfusion patients. Review the complete Instructions for Use before testing.
Approximately 12 Minutes
The compatible RAMP instrument analyzes the prepared cartridge and reports a quantitative result.
75 µL Whole-Blood Sample
The assay uses EDTA whole blood. Other specimen types and anticoagulants have not been evaluated.
Quantitative CK-MB Result
The assay’s measurement range is 0.32–80 ng/mL, as stated in the current IFU.
Key Features
- Quantitative immunochromatographic assay for CK-MB
- Uses 75 µL of EDTA whole blood
- Provides a result in approximately 12 minutes
- Measurement range of 0.32–80 ng/mL
- Lower limit of detection of 0.32 ng/mL
- Results below 0.32 ng/mL or above 80 ng/mL are reported according to the IFU
- Lot card stores the lot number, expiration date and standard-curve information
- No additional user calibration beyond loading the lot card for each new test-kit lot
- Built-in cartridge controls and instrument self-diagnostic functions
- Compatible with the RAMP Reader or the modular RAMP 200 configuration specified in the IFU
- Twenty-five single-use tests per kit
Product Specifications
| Jant Catalog Number | MDC1102 |
|---|---|
| Product | RAMP CK-MB Test |
| Method | Quantitative immunochromatographic fluorescent assay |
| Analyte | Creatine kinase-MB (CK-MB) |
| Clinical Use | Aids in the rapid diagnosis of acute myocardial infarction and is intended to help prioritize management of patients suspected of AMI; results must be interpreted with other clinical information |
| Specimen | EDTA whole blood only; plastic K2EDTA tubes are recommended |
| Sample Volume | 75 µL |
| Time to Result | Approximately 12 minutes |
| Measurement Range | 0.32–80 ng/mL |
| Lower Limit of Detection | 0.32 ng/mL |
| Reporting Limits | Results below 0.32 ng/mL are reported as <0.32 ng/mL; results above 80 ng/mL are reported as >80 ng/mL |
| Kit Contents | 25 cartridges and test tips, 25 buffer vials, one 75 µL transfer device, one lot card and one IFU |
| Storage | 2–8°C; do not freeze. The IFU permits storage at 15–25°C for up to 14 days. |
| Specimen Timing | Complete testing within 2 hours of collection or store EDTA whole blood for up to 2 days at 2–8°C, following the IFU |
| Compatible Instruments | RAMP Reader or RAMP 200 control unit with test module, as specified in the IFU |
| Regulatory / Use Status | For in vitro diagnostic use; prescription use; for use by qualified personnel |
RAMP CK-MB Testing Workflow
Prepare
Bring the kit components to room temperature and thoroughly mix the EDTA whole-blood specimen according to the IFU.
Mix and Apply
Use the supplied transfer device to mix 75 µL of specimen with the buffer and apply the prepared sample to the cartridge.
Insert and Read
Insert the cartridge into the compatible RAMP instrument. The system analyzes the test and reports the result in approximately 12 minutes.
This workflow is a summary and is not a substitute for the complete Instructions for Use. Qualified personnel must follow the current IFU and laboratory procedures.
Designed for the RAMP Platform
The RAMP 200 is a modular, automated platform that supports compatible cardiovascular assays. A control unit can be connected to as many as three dual-port test modules, allowing laboratories to run two, four or six tests simultaneously.
The CK-MB test kit contains the lot card needed to load lot-specific calibration information into the instrument. Test kits, controls and analyzer components are ordered separately unless specifically included in the quotation.
Explore Other RAMP Cardiac Tests
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Quantitative myoglobin testing in EDTA whole blood for use with a compatible RAMP instrument.
Important Test Information
- For in vitro diagnostic use, prescription use and use by qualified personnel.
- For U.S. customers, the RAMP CK-MB Test must be operated in a laboratory setting when used with the RAMP 200.
- Use only EDTA whole blood. Other specimen types and anticoagulants have not been evaluated.
- Follow the IFU for specimen timing, storage, preparation, testing and quality-control requirements.
- Patient history, clinical examination, ECG findings and other information must be assessed together with the test result.
- The result is not intended to classify the extent of myocardial necrosis or monitor reperfusion patients.
- Heterophilic antibodies and other unevaluated substances may interfere with immunoassay results.
- Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner.
Frequently Asked Questions
The assay quantitatively measures CK-MB in EDTA whole blood using a compatible RAMP instrument.
Measurement of CK-MB aids in the rapid diagnosis of acute myocardial infarction. The result must be interpreted together with the patient’s medical history, clinical examination, ECG and other findings.
The test requires 75 µL of EDTA whole blood. Plastic K2EDTA collection tubes are recommended. Other specimen types and anticoagulants have not been evaluated.
The compatible RAMP instrument reports the quantitative result in approximately 12 minutes after the prepared cartridge is inserted.
The measurement range stated in the current IFU is 0.32–80 ng/mL. Results below or above that range are reported according to the IFU.
The IFU specifies the RAMP Reader or the RAMP 200 control unit with a compatible test module. View the RAMP 200 system page for platform information and request a quote for the required configuration.
Each kit contains a lot card with the test-lot information and standard curve. No additional user calibration is required beyond loading the lot card for each new test-kit lot.
RAMP Cardiac Controls are available for supported cardiac assays. Laboratories should follow the assay IFU and applicable federal, state, local and accreditation requirements for quality-control testing.
One MDC1102 kit contains 25 individually pouched test cartridges and test tips, 25 buffer vials, one calibrated 75 µL transfer device, one lot card and one Instructions for Use document.
Ordering Information
To place an order or request information, call Jant Pharmacal at 800.676.5565
| Catalog Number | Description | Unit of Measurement |
|---|---|---|
| MDC1102 | RAMP CK-MB Test | 25 tests/kit |
A compatible RAMP instrument and applicable quality-control materials are required and ordered separately unless included in the quotation.