Analytical and Clinical Performance Testing Plan
1 other identifier
observational
679
1 country
1
Brief Summary
Clinical and analytical tests will be performed based on risk assessment and system specifications to verify that the performance of the investigational device is in accordance with its specifications.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2018
CompletedStudy Start
First participant enrolled
June 20, 2018
CompletedFirst Posted
Study publicly available on registry
July 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 6, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 25, 2019
CompletedMarch 4, 2021
March 1, 2021
9 months
May 28, 2018
March 3, 2021
Conditions
Outcome Measures
Primary Outcomes (5)
Reproducibility of CBC parameters provided by the OLO device
Reproducibility studies will be conducted using 3 levels of commercial control materials (low, normal and high) to measure all CBC reported parameters. Control material will be run on two instruments at each site. Standard deviation (SD) and coefficient of variation (CV) will be calculated for each measurand for: (1) Between lots/sites; (2) Between instruments; (3) Between days; (4)Between operators/runs; (5) within-run and (6) total variability
3 months
Repeatability of CBC parameters provided by the OLO device
Performance of the OLO device will be measured through repeatability of 20 replicates for 11 residual samples on each site. Samples collected for this study will include 4 within lab reference range, 3 around lower medical decision levels for HGB, PLT and WBC, and 4 around the upper range for RBC, HGB, WBC and PLT to cover all pathological levels and medical decision points. Standard deviation (SD) and coefficient of variation (CV) will be computed for each measurand per sample by site.
3 months
Sample Matrix Comparison
Paird capillary and venous whole blood samples will be collected. The samples will be analyzed in duplicate on the Sight OLO device. Analysis will include Passing-Bablok Regression analysis per parameter (Bland Altman plots, slope, intercept, with 95% confidence intervals, correlation coefficient, and % bias), between: The average of venous whole blood samples scans and average of capillary whole blood sample scans from the same individual on the Sight OLO device
3 months
Method Comparison
Evaluate the performance of the OLO device in comparison to values achieved with the predicate. Analysis will include Regression parameters (slope, intercept with 95% CI) between measurement of Sight OLO and measurement on predicate (Correlation coefficient, Bland Altman plots and overall % bias between predicate and Sight OLO device including % bias at medical decision points).
3 months
Reference Interval Range
Establish adult venous and fingerprick reference intervals for the OLO device. The non-parametric method will be used to calculate the lower and upper limits of the reference range.
3 months
Study Arms (2)
Hematology Analyzer - OLO
The investigational device is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening capillary or venous whole blood samples.
Hematology Analyzer - Predicate
The predicate device is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical and reference laboratories.
Interventions
Complete blood counts from OLO will be determined from analysis of whole blood samples
Complete blood counts from Predicate will be determined from analysis of whole blood samples
Eligibility Criteria
Adult and pediatric patients with normal (healthy) or abnormal blood counts (known clinical condition)
You may qualify if:
- For Residual Samples:
- Specimen obtained by venipuncture or finger prick and collected into tubes normally used by the site
- Patient is at least 3 months of age
- Samples within 8 hours from phlebotomy
- For Prospectively collected samples:
- Subject is at least 22 years of age
- Non-diseased individuals or, for specific studies, individuals with blood count ranges to cover indicated medical decision points and ranges
- Samples within 8 hours from phlebotomy
You may not qualify if:
- Visibly hemolyzed or clotted specimens
- Specimens with insufficient blood volume to complete the procedure
- Samples older than eight hours
- Instrument failure or sample rejected by the instrument due to system error or sample mishandling
- The daily quality control sample measurements indicate that the assay run is outside the specifications for the instrument
- Operator related error documented in the study records
- Failure to adhere to study specifics or protocols
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Columbia University
New York, New York, 10032, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Dr. Eldad Hod, Dr
Colombia University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2018
First Posted
July 23, 2018
Study Start
June 20, 2018
Primary Completion
March 6, 2019
Study Completion
August 25, 2019
Last Updated
March 4, 2021
Record last verified: 2021-03