Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06584214
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-29
Brief Title:
Evaluation of the Diagnostic Sensitivity and Specificity of the Determine Syphilis Advanced Test
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Multi-centre Study to Evaluate the Diagnostic Sensitivity and Specificity of the Determine Syphilis Advanced Test
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective multi-centre study which will evaluate the diagnostic sensitivity and specificity of the Determine Syphilis Advanced test The test is intended for professional use and the performance evaluation will be performed by professional healthcare and laboratory staff The study will also have a retrospective study arm The Determine Syphilis Advanced validation will be conducted in accordance with the World Health Organization39s TSS-6 guidance on Syphilis rapid diagnostic tests ISO 20916 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice the study protocol Good Clinical Practice and the respective local medical device laws
Detailed Description:
Syphilis is a sexually transmitted infection STI caused by the spirochete Treponema pallidum subspecies Globally there were an estimated 71 million adults between 15 and 49 years of age who acquired syphilis in 2020 Syphilis is transmitted through sexual contact with infectious lesions through blood transfusions and from mother-to-child during pregnancy most infections are asymptomatic or unrecognized Without treatment the disease lasts for many years and is divided into stages primary syphilis secondary syphilis and latent syphilis Mother-to-child transmission of syphilis congenital syphilis can adversely affect the foetus but this can be averted by early detection and treatment of the mother during pregnancy
Determine Syphilis Advanced is an in vitro visually read qualitative immunoassay for the detection of antibodies to Treponema pallidum in human capillary and venous whole blood plasma or serum
The test is intended for professional use and the performance evaluation will be performed by professional healthcare and laboratory staff Results for all sample types capillary and venous whole blood plasma or serum will be evaluated against reference test results In addition for a sub-cohort the Determine Syphilis Advanced test will be compared with the commercially available Determine Syphilis TP and the SERODIA-TPPA tests Study staff performing the testing using the Determine Syphilis Advanced will be blinded to the participants syphilis infection status and all other study syphilis test results The study will enrol prospective participants and will also have a retrospective study group
Determine Syphilis Advanced is an in vitro visually read qualitative immunoassay for the detection of antibodies to Treponema pallidum in human capillary and venous whole blood plasma or serum
The test is intended for professional use and the performance evaluation will be performed by professional healthcare and laboratory staff Results for all sample types capillary and venous whole blood plasma or serum will be evaluated against reference test results In addition for a sub-cohort the Determine Syphilis Advanced test will be compared with the commercially available Determine Syphilis TP and the SERODIA-TPPA tests Study staff performing the testing using the Determine Syphilis Advanced will be blinded to the participants syphilis infection status and all other study syphilis test results The study will enrol prospective participants and will also have a retrospective study group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None