Technical Evaluation of Brahms PCT Direct

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01771029

Enrollment

150

Registered

2013-01-18

Start date

2013-02-28

Completion date

2014-09-30

Last updated

2014-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection

Keywords

Procalcitonin, Infection, Point-of-Care

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* none

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

France, Germany, Switzerland

Outcome results