Skip to main content
OpenTrials
Completed

NCT Number: NCT03595501

Analytical and Clinical Performance Testing Plan

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hematology Hematologic Test

Age range

3 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Columbia University

New York, 10032, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hematology Analyzer - OLO

Device

Complete blood counts from OLO will be determined from analysis of whole blood samples

Hematology Analyzer - Predicate

Device

Complete blood counts from Predicate will be determined from analysis of whole blood samples

Primary outcomes

  1. Reproducibility of CBC parameters provided by the OLO device

    Time frame: 3 months

    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

  2. Repeatability of CBC parameters provided by the OLO device

    Time frame: 3 months

    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. Sample Matrix Comparison

    Time frame: 3 months

    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

  4. Method Comparison

    Time frame: 3 months

    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).

  5. Reference Interval Range

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

Sight Diagnostics

Industry

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 23, 2018
Registry last updated
Mar 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.