Clinical Performance Evaluation of AI-Enabled Automated Gram Staining Device

Study Overview
=================
Brief Summary
-----------------
The investigators have developed an analysis AI for Gram staining. In this study, the investigators will compare the testing accuracy of automated Gram staining equipment with AI with the testing accuracy of laboratory technicians. Based on the results, the investigators will examine the possibility of clinical application of the automated Gram staining device.

Detailed Description
-----------------
Gram staining,whitch provides crucial information for selecting antibiotics in the diagnosis and treatment of infectious diseases, is often manually performed in many laboratories, and the microscopic findings are subjectively interpreted and reported based on the experience of laboratory technicians. Automating the entire process from staining to microscopic examination, as achieved by the AI-equipped automatic Gram staining device, can reduce the labor required for Gram staining. This automation enables even less experienced technicians to quickly report Gram staining results. The aim of this study is to evaluate the accuracy of the Auto microscopic examination of Gram-stained samples using anonymized processed slides created from clinical specimens. This evaluation will be compared with the accuracy of microscopic examinations performed by hospital laboratory technicians. If the accuracy of the machine is demonstrated, it can be registered as a medical device and proceed to the implementation stage in actual clinical settings. The implementation of this device in clinical laboratories is expected to reduce workload, expedite processes, and contribute to the optimization of antibiotic use based on Gram staining results.

Official Title
-----------------
Clinical Performance Evaluation of AI-Enabled Automated Gram Staining Device

Conditions
-----------------
Infection, Bacterial

Intervention / Treatment
-----------------
* Diagnostic Test: Automated Gram Staining Machine analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Patients in whom a Gram stain test was ordered Exclusion Criteria: No exclusion criteria
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Automated Gram Staining Machine analysis|Measure urine and sputum specimens using this device.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Outcome | The difference in accuracy rates between the Gram staining examination performed by laboratory technicians and the automated Gram staining device, including the approximate bacterial quantity based on Gram staining and morphology (categorized as -, 1+, 2+, 3+, 4+), presence of white blood cells, presence of phagocytic images, and, in the case of sputum, the Geckler classification. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Outcome | Impact of specimen type and identified bacterial species on testing accuracy. | Day 1 |