Analytical and Clinical Performance Testing Plan

Hematology Clinical Trial

Official title:

Analytical and Clinical Performance Testing Plan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03595501
• Other study ID #: PR00014
• Status: Completed
• Start date: June 20, 2018
• Est. completion date: August 25, 2019

Study information

• Verified date: March 2021
• Source: Sight Diagnostics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Comparison and precision studies will be conducted in up to 5 clinical sites in Israel and the US, and include:

• Precision

• Sample Matrix Comparison

• Method comparison study and flagging analysis

• Reference interval range

Recruitment information / eligibility

• Status: Completed
• Enrollment: 679
• Est. completion date: August 25, 2019
• Est. primary completion date: March 6, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Months and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Exclusion criteria post blood draw and pre sample scan - For whole blood samples:

• Visibly hemolyzed or clotted specimens

• Specimens with insufficient blood volume to complete the procedure

• Samples older than eight hours

Exclusion criteria post sample scan:

• 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

Related Conditions & MeSH terms

• Hematologic Test
• Hematology

Intervention

Device:
• Hematology Analyzer - OLO
Complete blood counts from OLO will be determined from analysis of whole blood samples
• Hematology Analyzer - Predicate
Complete blood counts from Predicate will be determined from analysis of whole blood samples

Locations

Country	Name	City	State
United States	Columbia University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Sight Diagnostics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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