RAMP 200 / RAMP Cardiovascular Tests at the Point-of-Care

Study Overview
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Brief Summary
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This clinical investigation is designed to demonstrate the performance characteristics of the RAMP® cardiac tests analyzed on the RAMP® 200 by non-laboratorial Operators at the point-of-care when compared to the results for the same samples analyzed on the RAMP® Reader.

Official Title
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Performance Evaluation of the RAMP® Cardiac Tests / RAMP® 200 in a Point-Of-Care Setting (C-POC)

Conditions
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Acute Coronary Syndrome, Myocardial Infarction, Heart Failure, Congestive Heart Failure

Intervention / Treatment
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* Device: RAMP 200
* Device: RAMP Reader


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Study Arms A - Troponin I (ACS/MI) Males or Females, 18 years of age or older, of any race Has had a routine test order of Troponin for suspected Acute Coronary Syndrome / Myocardial Infarction (ACS/MI) - as per institutional guidelines Willing to voluntarily agree to sign a consent form (if applicable) Study Arms B - Myoglobin (ACS/MI) Males or Females, 18 years of age or older, of any race Has had a routine test order of Troponin for suspected Acute Coronary Syndrome / Myocardial Infarction (ACS/MI) - as per institutional guidelines Myoglobin test result falls within the reportable range of the test as reported in the RAMP® Myoglobin IFU. Willing to voluntarily agree to sign a consent form (if applicable) Study Arms C - CK-MB (ACS/MI) Males or Females, 18 years of age or older, of any race Has had a routine test order of Troponin for suspected Acute Coronary Syndrome / Myocardial Infarction (ACS/MI) - as per institutional guidelines CK-MB test result falls within the reportable range of the test as reported in the RAMP® CK-MB IFU. Willing to voluntarily agree to sign a consent form (if applicable) Study Arm D - NT-proBNP (HF) Males or Females, 18 years of age or older, of any race Has had a routine test order of NT-proBNP or BNP for suspected Heart Failure (HF) - as per institutional guidelines Willing to voluntarily agree to sign a consent form (if applicable) Exclusion Criteria: Study Arms A, B, C - Troponin I, Myoglobin, CK-MB (ACS/MI) Healthy Subjects Pregnant or lactating Subjects not having a cardiac marker test ordered Blood sample collected >24 hours prior to screening Subjects without adequate volumes of surplus EDTA whole blood available for all required trial testing Non-compliance to the protocol or the inclusion criteria Study Arm D - NT-proBNP (HF) Healthy Subjects Pregnant or lactating Subjects not having a cardiac marker test ordered Blood sample collected >24 hours prior to screening Subjects without adequate volumes of surplus EDTA whole blood available for all required trial testing Non-compliance to the protocol or the inclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Troponin I<br>Subjects who have undergone a routine test order of Troponin for suspected Acute Coronary Syndrome / Myocardial Infarction (ACS/MI). Waste sample blood will then be tested on the RAMP 200 and the RAMP Reader for comparison. | Device: RAMP 200<br>* The RAMP® Reader is a general use fluorometer that analyzes results produced by immunoassays that use a fluorophore having an excitation wavelength at 560 nm and an emission wavelength of 610 nm. The RAMP® 200 is Response Biomedical's second generation reader. The RAMP® 200 is designed to process more tests with a smaller footprint.<br>Device: RAMP Reader<br>* The RAMP® Reader is a general use fluorometer that analyzes results produced by immunoassays that use a fluorophore having an excitation wavelength at 560 nm and an emission wavelength of 610 nm. The RAMP® Reader is Response Biomedical's first generation reader instrument. Designed for use at near-patient/bedside or locations such as: laboratories, hospitals, on-site Emergency Response and Emergency Rooms.<br>|
| Myoglobin<br>Subjects who have undergone a routine test order of Troponin for suspected Acute Coronary Syndrome / Myocardial Infarction (ACS/MI) and who have a RAMP Myoglobin test result that is within the test reportable range. Waste sample blood will then be tested on the RAMP 200 and the RAMP Reader for comparison. | Device: RAMP 200<br>* The RAMP® Reader is a general use fluorometer that analyzes results produced by immunoassays that use a fluorophore having an excitation wavelength at 560 nm and an emission wavelength of 610 nm. The RAMP® 200 is Response Biomedical's second generation reader. The RAMP® 200 is designed to process more tests with a smaller footprint.<br>Device: RAMP Reader<br>* The RAMP® Reader is a general use fluorometer that analyzes results produced by immunoassays that use a fluorophore having an excitation wavelength at 560 nm and an emission wavelength of 610 nm. The RAMP® Reader is Response Biomedical's first generation reader instrument. Designed for use at near-patient/bedside or locations such as: laboratories, hospitals, on-site Emergency Response and Emergency Rooms.<br>|
| CK-MB<br>Subjects who have undergone a routine test order of Troponin for suspected Acute Coronary Syndrome / Myocardial Infarction (ACS/MI) and who have a RAMP CK-MB test result that is within the test reportable range. Waste sample blood will then be tested on the RAMP 200 and the RAMP Reader for comparison. | Device: RAMP 200<br>* The RAMP® Reader is a general use fluorometer that analyzes results produced by immunoassays that use a fluorophore having an excitation wavelength at 560 nm and an emission wavelength of 610 nm. The RAMP® 200 is Response Biomedical's second generation reader. The RAMP® 200 is designed to process more tests with a smaller footprint.<br>Device: RAMP Reader<br>* The RAMP® Reader is a general use fluorometer that analyzes results produced by immunoassays that use a fluorophore having an excitation wavelength at 560 nm and an emission wavelength of 610 nm. The RAMP® Reader is Response Biomedical's first generation reader instrument. Designed for use at near-patient/bedside or locations such as: laboratories, hospitals, on-site Emergency Response and Emergency Rooms.<br>|
| NT-proBNP<br>Subjects who have undergone a routine test order of NT-proBNP or BNP for suspected Heart Failure (HF). Waste sample blood will then be tested on the RAMP 200 and the RAMP Reader for comparison. | Device: RAMP 200<br>* The RAMP® Reader is a general use fluorometer that analyzes results produced by immunoassays that use a fluorophore having an excitation wavelength at 560 nm and an emission wavelength of 610 nm. The RAMP® 200 is Response Biomedical's second generation reader. The RAMP® 200 is designed to process more tests with a smaller footprint.<br>Device: RAMP Reader<br>* The RAMP® Reader is a general use fluorometer that analyzes results produced by immunoassays that use a fluorophore having an excitation wavelength at 560 nm and an emission wavelength of 610 nm. The RAMP® Reader is Response Biomedical's first generation reader instrument. Designed for use at near-patient/bedside or locations such as: laboratories, hospitals, on-site Emergency Response and Emergency Rooms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Substantial Equivalence of the RAMP® Reader and the RAMP® 200 when running the RAMP® Cardiac tests. | The primary objective is to achieve substantial equivalence of the RAMP® cardiac tests on the RAMP® Reader and the RAMP® 200 in a point-of-care (POC) setting by evaluating the following analytical performance specifications: precision on the RAMP® 200, when used at maximum complexity, utilizing frozen control materials; precision on the RAMP® 200, when used at maximum complexity, utilizing whole blood specimens; and, performance via method comparison across the reportable ranges of the RAMP® cardiac tests. | method comparison - subjects will be followed for the duration of 1 blood draw, with a total study enrollment over 3 months. |