QIAstat-Dx® BCID Plus AMR Panels Clinical Performance Study
Research type
Research Study
Full title
Clinical performance evaluation study of the QIAstat-Dx® BCID GN and GPF Plus AMR Panels on positive blood culture and pure colony isolates from subjects with signs and symptoms of bloodstream infection.
IRAS ID
306927
Contact name
Sarah Johnson
Contact email
Sponsor organisation
QIAGEN
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 7 months, 31 days
Research summary
Bloodstream Infection (BSI) is defined as the invasion of the blood, a normally sterile site, with infectious pathogens demonstrated by the positivity of one or more positive blood cultures and associated with systemic signs of infection. All patients with BSI are at risk of developing sepsis, which can result in death. Identifying the pathogen responsible for a BSI and its antimicrobial resistance (AMR) can assist doctors in tailoring their treatment of the patient and increase chances of recovery.
This study will evaluate the clinical performance of the QIAstat-Dx BCID Plus AMR Panels on the QIAstat-Dx® Analyzer in the testing of positive blood cultures and pure colony isolates obtained from patients with signs and symptoms of BSI. This will be done by comparing the performance outcomes achieved by the devices with two comparator methods: standard microbiological techniques and PCR followed by bidirectional sequencing for AMR targets.
The QIAstat Dx® GPF-Panel is designed to detect 18 fungal and gram-positive bacterial targets, 11 AMR genes and one pan gram-negative target. The QIAstat Dx® GN-Panel which is designed to detect 13 gram-negative bacterial targets and 18 AMR genes. The panel(s) used will be decided based on the results of the gram stain performed as part of routine testing.
Blood culture samples will be procured prospectively but as residual from routine testing, from hospital inpatients displaying signs of BSI. Isolate (pure colony) samples will be obtained by sub-culturing the blood culture samples on agar plates. The samples will be pseudonymised and blinded at enrolment. Any findings from this study will not be received by subjects or their healthcare providers and will not be used to influence their treatment. For low prevalence targets, banked samples may be used in addition to contrived samples i.e. mock samples created using known isolates and healthy donor blood.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
22/WM/0089
Date of REC Opinion
26 Apr 2022
REC opinion
Unfavourable Opinion