First clinical evaluation of MagRAPID
T
Thomas E. Davis
Primary Investigator
Enrolling By Invitation
18-100 years
All
Phase
N/A
150 participants needed
2 Locations
Brief description of study
The
aim of this study is to provide a first evaluation of the performance of
Momentum Bioscience’s MagRAPID test,
in a manual prototype format, when used with clinical samples. MagRAPID
is a hospital laboratory-based diagnostic test for the early detection and
characterisation of bacteria and fungi in blood.
Detailed description of study
The primary objectives of the study are to provide
preliminary data on the following aspects of MagRAPID performance:
1.
Its
sensitivity when detecting bloodstream infection from whole blood, compared to
traditional blood culture; and to clinical assessment of the likelihood of bloodstream
infection (BSI);
2.
Its
sensitivity and accuracy in describing detected organisms as Gram positive,
Gram negative or Candida: and if Gram
positive, whether Staphylococci, S. aureus,
Streptococci or Enterococci;
3.
To identify cut-off
values and thresholds for MagRAPID
reporting.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Bacteria, Yeast, fungi
-
Age: Between 18 Years - 100 Years
-
Gender: All
Inclusion Criteria:
- Adult patients that have had at least one (1) set of SOC blood cultures drawn
Exclusion Criteria:
-
Paediatrics
-
Unable to collect study blood sample
-
No SOC blood cultures taken
-
Patients estimated weight <110 lb at the time of study phlebotomy
Updated on
01 Aug 2024.
Study ID: 2001664921; MOMBIO-2019-001
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