To establish the performance characteristics of the Samsung LABGEO IVD-A20 CHF Test in intended use settings, by comparing test results of the A20 CHF Test with results obtained from an FDA-cleared comparator assay.
Study Type
OBSERVATIONAL
Enrollment
191
University of Maryland
Baltimore, Maryland, United States
Minneapolis Medical Research Foundation
Minneapolis, Minnesota, United States
Manassas Clinical Research Center
Manassas, Virginia, United States
The proportion of clinically-confirmed CHF subjects for whom the Samsung LABGEO IVD-A20 CHF Test result was positive (clinical sensitivity).
Time frame: baseline
The proportion of non-CHF subjects for whom the LABGEO IVD A20 CHF Test result was negative (clinical specificity).
Time frame: baseline
Using a Passing-Bablok regression analysis, estimates of intercept and slope will be computed. Estimates of bias and corresponding 95% confidence interval for true bias at clinical decision threshold of 125mg/mL and 450 pg/mL will also be computed.
Method comparison will be assessed using a Passing-Bablok regression analysis to determine the relationship between the Samsung LABGEO IVD-A20 CHF Test measurement in plasma and the corresponding measurement in plasma obtained from the comparator assay.
Time frame: baseline
The proportion of subjects with a positive LABGEO IVD-A20 CHF Test result, for whom a clinical diagnosis of CHF was confirmed (positive predictive value).
Time frame: baseline
The proportion of subjects with a negative LABGEO IVD-A20 CHF Test result, for whom a clinical diagnosis of CHF was confirmed (negative predictive value).
Time frame: baseline
Computation of Receiver Operating Characteristic (ROC) curve and area under the curve (AUC) with 95% confidence interval for the true AUC.
This analysis will assess the ability of the Samsung LABGEO IVD-A20 CHF Test to discriminate between confirmed CHF subjects and non-CHF subjects.
Time frame: baseline
Variance components analysis will be conducted on data collected from each whole blood specimen undergoing point-of-care precision testing at study site. Estimates of within-run, between run, between day and total precision will be computed.
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The Samsung LABGEO IVD-A20 CHF Test result will be modeled as a function of testing days and runs, with replicates fully nested within runs, and runs fully nested within days.
Time frame: 10 days
Variance components analysis will be conducted on data collected from each plasma specimen undergoing point-of-care precision testing at study site. Estimates of within-run, between run, between day and total precision will be computed.
The Samsung LABGEO IVD-A20 CHF Test result will be modeled as a function of testing days and runs, with replicates fully nested within runs, and runs fully nested within days.
Time frame: 20 days
Mixed model regression analysis will be conducted on each specimen type (whole blood vs. plasma) and storage condition.
The natural logarithm of the Samsung LABGEO IVD-A20 CHF Test measurement will be modeled as a linear function of time (in hours) after baseline testing.A separate linear function will be fitted to data collected from each study specimen and the intercepts and slops from individual specimens will be modeled as random effects.
Time frame: 48 hours