A Prospective Cross-Sectional Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis Syphilis Ab Test at the Point- Of-Care Sites
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Syphilis Infection
- Sponsor
- bioLytical Laboratories
- Enrollment
- 1500
- Locations
- 1
- Primary Endpoint
- Sensitivity and specificity of the iStatis Syphilis Ab Test
- Status
- Completed
- Last Updated
- last year
Overview
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 (i.e., 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, i.e., 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants/subjects (males, females, and pregnant women) getting tested for syphilis for one or more of the following reasons:
- •o at risk for syphilis ohaving signs and symptoms indicative for syphilis oRoutine testing
- •Participants/subjects of 18 years or older and, who are able to give/sign the informed consent.
Exclusion Criteria
- •Participant younger than 18 years old
- •Participants unable to provide written informed consent
- •Participants currently undergoing treatment
Outcomes
Primary Outcomes
Sensitivity and specificity of the iStatis Syphilis Ab Test
Time Frame: 15 weeks
To evaluate the diagnostic sensitivity and diagnostic specificity of the iStatis Syphilis Antibody Test at Point-Of-Care (POC).