Systemic inflammatory response, bacterial sepsis, and high-concentration CRP states that may lead to false negatives due to the 'hook effect'
Conditions
Interventions
Gold Standard:Beckman immunoturbidimetry as the gold standard for detection
Index test:Smartphone microfluidic system based on spatiotemporal deep learning
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.In this study, we will use serum samples collected from another clinical trial entitled “Risk Factors and Biomarkers of Clostridioides difficile Infection in Patients with Inflammatory Bowel Disease” (Ethics Approval No.: 2023-358). All samples have clear CRP values determined by a fully automated clinical analyzer. To cover the full measurement range, we will deliberately and directionally select approximately 40 samples each for the low-concentration group ( 100 mg/L).
Exclusion criteria
Exclusion criteria: 1.Visibly unacceptable specimens such as severe hemolysis, severe lipemia, and severe jaundice;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CRP concentration; | — |
Countries
China
Contacts
Public ContactDanfeng Dong
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed