Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis Syphilis Ab Test at the Point- Of-Care Sites

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.

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