Clinical trial NCT01771029: Technical Evaluation of Brahms PCT Direct
Official title: Technical Evaluation of a Whole Blood Rapid Test Measuring Procalcitonin (BRAHMS PCT Direct)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection
Keywords: Procalcitonin
Infection
Point-of-Care
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Thermo Fisher Scientific, Inc
First posted: 2013-01-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: One cohort of 150-250 patients, possible infection at initial presentation in Kantonsspital Aarau.

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.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* possible infection at initial presentation
* informed consent

Exclusion Criteria:

* none

Primary outcomes:
measure: Correlation between BRAHMS PCT direct and reference method.
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary outcomes:
measure: Time to result
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Other outcomes:
Locations:
city: Paris
country: France
facility: Pitié Salpetrière. Groupement hospitalière universitaire Est
city: Potsdam
country: Germany
facility: Klinikum Ernst von Bergmann, gemeinnützige GmbH Akademisches Lehrkrankenhaus der Humboldt-Universität Berlin (Charité)
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau Innere Medizin
state: Aargau
Study officials:
affiliation: Kantonsspital Aarau
name: Philipp Schuetz, PD, Dr.med.
role: PRINCIPAL_INVESTIGATOR
References: