Method and Sample Comparison Study Minicare BNP - COMP-BNP-CE03-AN2016

Heart Failure Clinical Trial

Official title:

Method and Sample Comparison Study of Minicare BNP at a Central Laboratory

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03112421
• Other study ID #: HHDx-07952
• Status: Completed
• Phase: N/A
• First received: April 3, 2017
• Last updated: September 7, 2017
• Start date: February 27, 2017
• Est. completion date: April 14, 2017

Study information

• Verified date: September 2017
• Source: Philips Handheld Diagnostics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Sample Comparison The objective of this study is to compare the Philips Minicare BNP test with the Centaur BNP test. BNP level measured in human blood samples (EDTA venous whole blood and/or EDTA plasma) will be assessed. Matrix Comparison To compare BNP measurements obtained using Minicare System for EDTA whole blood and EDTA plasma samples.Prior to the study start, a proficiency study will be performed on the Minicare BNP, Architect and I-STAT BNP assay to be sure that devices are performing according to expectations. Approximately 100 EDTA patient whole blood samples covering the entire measuring range of Minicare BNP from LOQ until end of measuring range (expected to be approximately 5000 ng/L) (Ref 7) will be tested (according to CLSI EP09A3 (Ref 5)) at a central laboratory using the Minicare BNP, Alere BNP, I-STAT BNP system. The outcome of the site routine assay (Centaur BNP systems) will be used to evaluate if the blood samples cover the entire distribution range of the assay. If necessary, up to 20% of the samples may be spiked so that the entire range of the assay is covered. The central laboratory will identify the blood tubes with a BNP request. Approximately 1000 μl EDTA whole blood will be available (left over material) for testing on the non-routine devices (i.e., Minicare BNP, Alere BNP, and I-STAT BNP). Testing for the Alere BNP, I-STAT BNP, and Centaur BNP systems will be performed according to the respective IFU's (Ref 1, 2, 3, 4). For the Minicare BNP system, test will be performed according to a DRAFT IFU or a similar document describing the sample treatment and handling for the Minicare BNP system. Alere BNP, I-STAT BNP and Minicare BNP samples should be tested within 6 hours after collection and Centaur BNP samples within 8h of collection. Although different stability claims for BNP, it is highly recommended to perform all measurements on all systems within 2 hours. For Alere BNP, I-STAT BNP, Centaur BNP analysis will be performed using a single blood sample for each patient. Alere BNP and I-STAT will use EDTA whole blood samples as sample type Centaur BNP will be tested on EDTA plasma samples. For the Minicare BNP, both EDTA whole blood and EDTA plasma will be tested for each patient. For the Minicare BNP system the whole blood samples will be tested using a pipette and the same sample will be tested using the SmearSafe Blood Dispenser (transfer device) to investigate a reliable use of such transfer device.

Only the routine Centaur BNP outcomes will be used as part of support for patient diagnosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 296
• Est. completion date: April 14, 2017
• Est. primary completion date: April 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Left over blood samples from eligible patients with BNP requests, available at the test site CENTRAL LABORATORY will be selected for this study.

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
Netherlands	Diagnostiek voor U	Eindhoven

Sponsors (1)

Lead Sponsor	Collaborator
Philips Handheld Diagnostics

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate the bias between the Philips Minicare BNP test with the Centaur BNP test of the measurement procedures.BNP level measured in human blood samples (EDTA venous whole blood and/or EDTA plasma) will be assessed.	To investigate the bias between the Philips Minicare BNP test with the Centaur BNP test using values spanning the common measuring interval of the measurement procedures.BNP level measured in human blood samples (EDTA venous whole blood and/or EDTA plasma) will be assessed.	May 2017
Primary	To compare BNP measurements obtained using Minicare System for EDTA whole blood and EDTA plasma samples.	To compare BNP measurements obtained using Minicare System for EDTA whole blood and EDTA plasma samples.	May 2017
Secondary	Percentage of agreement systems	To estimate the percent of agreement between the Minicare System and three commercially available BNP systems (i.e., Alere BNP, I-STAT BNP, and Centaur BNP tests) using a cut-off value of 100ng/L.	May 2017
Secondary	Percentage of agreement samples	To estimate the percent of agreement between EDTA whole blood and EDTA plasma samples for Minicare system using a BNP cut off value of 100ng/L	May 2017
Secondary	Evaluate performance of the SmearSafe Blood Dispenser (transfer device), for transferring whole blood from the blood tube directly to the Minicare BNP cartridge.	Evaluate performance of the SmearSafe Blood Dispenser (transfer device), for transferring whole blood from the blood tube directly to the Minicare BNP cartridge, so without use of pipette.	May 2017