Acute Coronary Syndrome, Congestive Heart Failure, Heart Failure, Myocardial Infarction
Conditions
Brief summary
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.
Interventions
DEVICERAMP 200
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.
DEVICERAMP Reader
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.
Sponsors
Response Biomedical Corp.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Study Arms A - Troponin I (ACS/MI) 1. Males or Females, 18 years of age or older, of any race 2. Has had a routine test order of Troponin for suspected Acute Coronary Syndrome / Myocardial Infarction (ACS/MI) - as per institutional guidelines 3. Willing to voluntarily agree to sign a consent form (if applicable) Study Arms B - Myoglobin (ACS/MI) 1. Males or Females, 18 years of age or older, of any race 2. Has had a routine test order of Troponin for suspected Acute Coronary Syndrome / Myocardial Infarction (ACS/MI) - as per institutional guidelines 3. Myoglobin test result falls within the reportable range of the test as reported in the RAMP® Myoglobin IFU. 4. Willing to voluntarily agree to sign a consent form (if applicable) Study Arms C - CK-MB (ACS/MI) 1. Males or Females, 18 years of age or older, of any race 2. Has had a routine test order of Troponin for suspected Acute Coronary Syndrome / Myocardial Infarction (ACS/MI) - as per institutional guidelines 3. CK-MB test result falls within the reportable range of the test as reported in the RAMP® CK-MB IFU. 4. Willing to voluntarily agree to sign a consent form (if applicable) Study Arm D - NT-proBNP (HF) 1. Males or Females, 18 years of age or older, of any race 2. Has had a routine test order of NT-proBNP or BNP for suspected Heart Failure (HF) - as per institutional guidelines 3. 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) 1. Healthy Subjects 2. Pregnant or lactating 3. Subjects not having a cardiac marker test ordered 4. Blood sample collected \>24 hours prior to screening 5. Subjects without adequate volumes of surplus EDTA whole blood available for all required trial testing 6. Non-compliance to the protocol or the inclusion criteria Study Arm D - NT-proBNP (HF) 1. Healthy Subjects 2. Pregnant or lactating 3. Subjects not having a cardiac marker test ordered 4. Blood sample collected \>24 hours prior to screening 5. Subjects without adequate volumes of surplus EDTA whole blood available for all required trial testing 6. Non-compliance to the protocol or the inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Substantial Equivalence of the RAMP® Reader and the RAMP® 200 when running 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. | 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. |
Countries
United States
Outcome results
None listed