Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06365606
Status:
COMPLETED
Last Update Posted:
2024-04-15
First Post:
2024-04-09
Brief Title:
Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis Syphilis Ab Test at the Point- Of-Care Sites
Sponsor:
bioLytical Laboratories
Organization:
bioLytical Laboratories
Study Overview
Official Title:
A Prospective Cross-Sectional Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis Syphilis Ab Test at the Point- Of-Care Sites
Status:
COMPLETED
Status Verified Date:
2024-08
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:
This study is a prospective cross-sectional study in which surgically non-invasive sample- taking is done only for the purpose of the study Capillary fingerstick whole blood and plasma ie obtained through venous EDTA whole blood collection and processing are collected by a healthcare professional The collected samples are tested in a routine testing environment ie healthcare providers at
Detailed Description:
A trained healthcare provide will collect 50μL of capillary whole blood and 11mL of EDTA venous whole blood VWB to be tested with the iStatis Syphilis Ab Test on site according to the Test Procedure described in the Instructions for Use IFU supplied with the reagents Same procedure must be followed using the extracted plasma sample to test 30μL of the plasma sample extracted and obtained through processing of the VWB on the iStatis Syphilis Ab Test An aliquot of the plasma sample will be transferred to the central laboratory to establish the reference test result using an enzyme immunoassay EIA Abbott Architect Syphilis Tp EDA In case of positive results in the EIA reference test of Abbott Architect Syphilis Tp EDA the sample will be sent for BD Macro-Vue Particle Agglutination RPR and Serodia Particle Agglutination TPPA testing
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