Evaluating the Accuracy of Antigen Test Kits (ATK) Compared to Real-time Polymerase Chain Reaction (RT-PCR) Confirmation during COVID-19 Outbreaks in Special Areas: A Study on Diagnostic Accuracy During an Outbreak Investigatio

Completed

• Conditions: Accuracy index of ATK in special area during outbreak investigation, how to judgement and management; covid-19 testing; accuracy; diagnostic test kits

• Registration Number: TCTR20231005002
• Lead Sponsor: Si Sa Ket Hospital

Brief Summary

sensitivity 83.4% (95% CI 80.3, 86.2%) specificity 100% (95% CI 82.4, 100%) Positive Predictive Value 100% (95% CI 99, 100%) Negative Predictive Value 15.3% (95% CI 9.48, 22.9%)

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-10-22
• Study Start: 2023-10-05
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 940

Inclusion Criteria

The patient was tested using both the ATK and PCR methods.

Exclusion Criteria

The patient who lost the result either one

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
positive suddenly after test ATK

Secondary Outcome Measures

Name	Time	Method
positive 3 day after test PCR