Technical Evaluation of Brahms PCT Direct

Technical Evaluation of a Whole Blood Rapid Test Measuring Procalcitonin (BRAHMS PCT Direct)

Validation of the technical performance of the BRAHMS PTC direct point-of-care assay under routine conditions with native patient samples. The clinical validation is planned as a method comparison to a reference method (BRAHMS PCT sensitive KRYPTOR, Elecsys BRAHMS PCT). The study hypothesis is to show a highest correlation between the new product and the reference methods.

Study Overview

• Status: Completed
• Conditions: Infection

Detailed Description

Procalcitonin (PCT) is a highly sensitive and specific marker which can be detected in the blood stream in response to a bacterial infection. In contrast to conventional infection disease markers PCT permits the differential diagnosis between bacterial and viral infections. The marker is implemented on Intensive Care Units (ICU) and Emergency Departments (ED) worldwide since 1996. Until now various technologies all basing on the use of serum or plasma samples are available in the market.

BRAHMS GmbH (Clinical Diagnostics Division of Thermo Fisher Scientific) as manufacturer of the Procalcitonin assays has developed a new quantitative immunochromatographic whole blood point-of-care assay, the BRAHMS PCT direct. The test follows the principle of a sandwich assay with two anti-PCT antibodies, one immobilized on a nitrocellulose membrane and the tracer antibodies labeled with gold.

Validation of the technical performance of the product under routine conditions with native patient samples. The clinical validation is planned as a method comparison to a reference method (BRAHMS PCT sensitive KRYPTOR, Elecsys BRAHMS PCT). The internal pre-studies were performed with blood samples spiked with recombinant PCT and with native patient samples.

The primary objective of this study is to show a highest correlation between BRAHMS PCT direct with the PCT reference method for PCT- positive and negative samples.

The secondary object of this study is to show the advantage of BRAHMS PCT direct in time to result in comparison to the reference method.

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• France
  • Paris, France, 7565
    • Pitié Salpetrière. Groupement hospitalière universitaire Est
• Germany
  • Potsdam, Germany, 14467
    • Klinikum Ernst von Bergmann, gemeinnützige GmbH Akademisches Lehrkrankenhaus der Humboldt-Universität Berlin (Charité)
• Switzerland
  • Aargau
    • Aarau, Aargau, Switzerland, 5001
      • Kantonsspital Aarau Innere Medizin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

One cohort of 150-250 patients, possible infection at initial presentation in Kantonsspital Aarau.

Description

Inclusion Criteria:

• Age > 18 years
• possible infection at initial presentation
• informed consent

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between BRAHMS PCT direct and reference method.	Showing at least 90% correlation between BRAHMS PCT direct with the PCT reference method for PCT- positive and negative samples.	participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to result	The secondary object of this study is to show the advantage of BRAHMS PCT direct in time to result in comparison to the reference method.	participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Collaborators and Investigators

• Sponsor: Philipp Schuetz
• Collaborators: Thermo Fisher Scientific, Inc
• Investigators: Principal Investigator: Philipp Schuetz, PD, Dr.med., Kantonsspital Aarau

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: January 9, 2013
• First Submitted That Met QC Criteria: January 15, 2013
• First Posted (Estimate): January 18, 2013

Study Record Updates

• Last Update Posted (Estimate): December 12, 2014
• Last Update Submitted That Met QC Criteria: December 11, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Infection; Procalcitonin; Point-of-Care
• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: POC_1