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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-14

Study Completion Date

2024-07-11

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Syphilis Infection Syphilis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Caregivers

Participants and the healthcare providers are not aware of the syphilis status.

Study Groups

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Performance onsite

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.

Group Type EXPERIMENTAL

iStatis Syphilis Ab Test

Intervention Type DEVICE

Capillary (fingerstick) blood, venous whole blood and plasma samples prospectively collected from the participants will be tested on the iStatis Syphilis Ab Test.

Performance in lab

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.

Group Type EXPERIMENTAL

iStatis Syphilis Ab Test

Intervention Type DEVICE

Capillary (fingerstick) blood, venous whole blood and plasma samples prospectively collected from the participants will be tested on the iStatis Syphilis Ab Test.

Interventions

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iStatis Syphilis Ab Test

Capillary (fingerstick) blood, venous whole blood and plasma samples prospectively collected from the participants will be tested on the iStatis Syphilis Ab Test.

Intervention Type DEVICE

Eligibility Criteria

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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.