Diagnostic Accuracy of Urine Flow Cytometry in Excluding Bacteruria

Study Overview
=================
Brief Summary
-----------------
A more rapid test for bacteriuria is desired. This will exclude the patients not having bacteriuria, which will contribute to a more rapid and accurate diagnosis of infectious diseases. The aim of the study is to investigate the diagnostic accuracy of point-of-care urine flow cytometry on diagnosing and excluding bacteriuria

Detailed Description
-----------------
A prerequisite for the appropriate use of antibiotics is timely access to accurate diagnostic tests, since treatment of acute infections should be initiated within a few hours to avoid serious complications such as bacteremia, sepsis, organ failure, septic shock and death. The diagnosis of urinary tract infections including acute pyelonephritis (APN) is difficult due to often weak and non-specific symptoms and high incidence of asymptomatic bacteruria in especially elderly patients. The diagnosis is verified by significant bacteriuria in urine culture. Unfortunately, the time from urine sample to result from urine cultures is more than 24 hours days. Urine test strips are unreliable with low specificity and low predictive values. Therefore, a point-of-care (POC) test is desired, which can provide rapid results and quickly identify a bacteriuria. One such tool may be urine flow cytometry (UFC), which has shown promising diagnostic value for the exclusion of bacteriuria with a high negative predictive value. However, better documentation for its use as an ED diagnostic screening method is needed. The aim of the study is to investigate the diagnostic accuracy of POC-UFC on diagnosing and excluding bacteriuria? Our hypothesis is that by excluding patients not having bacteriuria, it will contribute to a more rapid and accurate diagnosis

Official Title
-----------------
Diagnostic Accuracy of Urine Flow Cytometry in Diagnosing and Excluding Bacteruria in the Emergency Department

Conditions
-----------------
Acute Infection

Intervention / Treatment
-----------------
* Diagnostic Test: urine flow cytometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspicion of acute infections assessed by the receiving physician at the emergency department Exclusion Criteria: If the attending physician considers that participation will delay a life-saving treatment or patient needs direct transfer to the intensive care unit. Admission within the last 14 days Verified COVID-19 disease within 14 days before admission Pregnant women Severe immunodeficiencies: Primary immunodeficiencies and secondary immunodeficiencies (HIV positive CD4 <200, Patients receiving immunosuppressive treatment (ATC L04A), Corticosteroid treatment (>20 mg/day prednisone or equivalent for >14 days within the last 30 days), Chemotherapy within 30 days)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Suspected infection<br>All patients admitted to the emergency department with suspected infections assessed by the receiving physician | Diagnostic Test: urine flow cytometry<br>* Diagnostic test of urine flow cytometry. A urine sample will be collected according to routine procedure by a study assistant. The sample will be divided into two aliquots; half for routine urine culturing, and half for Point-of-care Urine Flow cytometry (POC-UFC) analysis (UF-5000, Sysmex, Kobe, Japan). The analysis will be performed according to manufacturer's instruction and conducted by laboratory staff. Laboratory staff will be blinded to the participants diagnosis and outcome. The results of the POC-UFC analysis will not be visible to the treating physician.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacteriuria | The urine culture analysis combined with microbiologist assessment will be used as reference standard for bacteriuria. Diagnostic accuracy will be conducted, and Youden index analysis will be used to estimate the best cut-off | urine collected within 4 hours of arrival to emergency department and analysed within one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verified infectious diagnosis by expert panel | An expert panel will define the final diagnosis (including APN) based on all findings during admission. The expert panel consists of two independent consultants from the emergency department with significant experience in emergency medicine and acute infections. They will individually determine the type of infection the patient admitted actually had. The final diagnosis will be based on all available relevant information from the patient medical record including MRI of kidneys and HR-CT of lungs. A standardized template will be used. Disagreement will be discussed until a consensus is reached. | 2 months after discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bacteruria, urinary tract infections, diagnosis, Emergency department, Acute infections