Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06284187
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2024-02-19
Brief Title:
Diagnosis Test of Real-time Polymerase Chain Reaction RT-PCR for Pulmonary Tuberculosis
Sponsor:
Khon Kaen Hospital
Organization:
Khon Kaen Hospital
Study Overview
Official Title:
Diagnosis Test of Real-time Polymerase Chain Reaction RT-PCR for Pulmonary Tuberculosis
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
BACKGROUND Pulmonary tuberculosis remains the leading cause of morbidity and mortality in Thailand The microbiological detection of TB is important because of early and correct diagnosis drug resistance testing and ensures that the effective treatment can be achieved and in a timely manner Mycobacterial culture is the gold standard diagnostic test Currently a real-time polymerase chain reaction RT-PCR assay such as Allplex MTBMDRe Detection Seegene is commonly used
OBJECTIVE To evaluate the diagnosis value of the real-time multiplex PCR by using Allplex MTBMDRe Detection kit to detect MTB from sputum specimens with a gold standard TB culture
OBJECTIVE To evaluate the diagnosis value of the real-time multiplex PCR by using Allplex MTBMDRe Detection kit to detect MTB from sputum specimens with a gold standard TB culture
Detailed Description:
A retrospective study design of adult patients gt 15 years with suspected pulmonary M tuberculosis infection was conducted from January 2023 until October 2023 at Khon Kaen Hospital Sample size was 101 cases Sensitivity specificity accuracy negative predictive value NPV and positive predictive value PPV of Allplex MTBMDRe Detection each with its respective 95 confidence interval 95 CI were analysed with compared to MTB culture as the gold standard
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None