Technical Evaluation of Brahms PCT Direct

Completed

• Conditions: Infection

• Registration Number: NCT01771029
• Lead Sponsor: Philipp Schuetz

Brief Summary

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.

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 Timeline

• Study First Submitted: 2013-01-09
• Study First Submitted QC: 2013-01-15
• Study First Posted: 2013-01-18
• Study Start: 2013-02
• Primary Completion: 2014-06
• Study Completion: 2014-09
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-11
• Last Update Posted: 2014-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Time to result	participants will be followed for the duration of hospital stay, an expected average of 2 weeks	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.

Trial Locations

Locations (3)

Pitié Salpetrière. Groupement hospitalière universitaire Est; 🇫🇷 Paris, France

Kantonsspital Aarau Innere Medizin; 🇨🇭 Aarau, Aargau, Switzerland

Klinikum Ernst von Bergmann, gemeinnützige GmbH Akademisches Lehrkrankenhaus der Humboldt-Universität Berlin (Charité); 🇩🇪 Potsdam, Germany