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

bioLytical Laboratories

Status: Completed

Conditions: Syphilis Infection; Syphilis

Treatments: Device: iStatis Syphilis Ab Test

Study type: Interventional

Funder types: Industry

Identifiers

NCT06365606

CLS-015A

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,500 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,500 participants in 2 patient groups

Performance onsite

Experimental group

Description:

Capillary (fingerstick) blood samples collected from the participants will be tested with the iStatis Syphilis Ab Test in the hands of trained healthcare professionals at the point-of-care setting.

Treatment:

Device: iStatis Syphilis Ab Test

Performance in lab

Experimental group

Description:

Venous whole blood and plasma samples collected from the participants will be tested with the iStatis Syphilis Ab Test in the hands of trained healthcare professionals at the point-of-care setting. The results are compared with Abbott Architect Syphilis Tp (EDA) referent test, and in cases of positive results, further confirmatory testing (BD Macro-Vue Particle Agglutination (RPR) and Serodia Particle Agglutination (TPPA)) will be conducted.

Treatment:

Device: iStatis Syphilis Ab Test