QIAstat-Dx® BCID Plus AMR Panels Clinical Performance Study

Launched by QIAGEN GAITHERSBURG, INC · Mar 22, 2022

Keywords

ClinConnect Summary

The QIAstat-Dx® BCID Plus AMR Panels Clinical Performance Study is a research trial aimed at evaluating how well two specific testing panels (the BCID Plus AMR GPF-Panel and the BCID Plus AMR GN-Panel) can identify different types of blood diseases compared to other testing methods. This study is currently looking for participants who have tested positive for blood infections, as determined by a Gram stain test. Eligible participants need to be over a certain age (not specified here), and they must have fresh or properly frozen blood samples collected within 24 hours of their initial positive test.

If you participate in this trial, you will be contributing to important research that could improve how blood infections are diagnosed. It's important to know that only certain types of blood samples will be accepted, and those who have been part of a similar study before will not be able to join. The goal of this research is to help doctors better understand and treat blood diseases, making it a valuable opportunity for anyone eligible.

Gender

ALL

Eligibility criteria

• 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