New blood test could speed up infection diagnosis
NCT ID NCT05305534
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study tested a new diagnostic device, the QIAstat-Dx panels, to see how well it identifies bacteria in blood samples from people with suspected bloodstream infections. Researchers compared the test results to standard methods using over 2000 samples. The goal is to provide faster and more accurate results to guide treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- QIAstat-Dx® BCID GN and GPF Plus AMR Panels (diagnostic device)
- What this could lead to
- If successful, this could provide a faster, more accurate way to identify bacteria causing bloodstream infections, helping doctors choose the right antibiotics sooner.
- What could go wrong
- This is a completed diagnostic accuracy study, not a treatment trial. The test may not be widely adopted or may have limitations in real-world settings.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
2,142 people
The number who actually took part.
- Started
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Dec 2023
- Finished
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Aug 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients suspected of bloodstream infection
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Positive (as identified through Gram stain) blood culture media specimens cultured within bottle types listed in IFU. * Residual and de-identified specimens. * Specimen from subject who has not previously been enrolled. * Fresh prospectively collected specimens tested within 24 hours of initial blood culture bottle positivity. * Frozen prospectively collected specimens frozen within 24 hours of initial blood culture bottle positivity. * Minimum 1.5 mL volume available * In stage 2 - Pure colony isolates of Bacilli, Actinobacteria, fungi (except Fusarium), Enterobacterales, Pseudomondales, Nesseriales, Pasteurellales, Bacterioidales, or Xanthomonadales. Exclusion Criteria: * Positive Blood Culture specimens inoculated with a sample type other than Blood (i.e. Paracentesis, or other body fluids) * Specimens collected off-label from the manufacturer's package insert (e.g., less than the minimum required blood volume was collected). * Frozen specimens which are unable to be cultured after thawing. * Specimen from subject previously enrolled
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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QIAGEN
Manchester, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.