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

Last updated: August 9, 2024
Sponsor: bioLytical Laboratories
Overall Status: Completed

Phase

N/A

Condition

Sexually Transmitted Diseases (Stds)

Gynecological Infections

Rash

Treatment

iStatis Syphilis Ab Test

Clinical Study ID

NCT06365606
CLS-015A
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants/subjects (males, females, and pregnant women) getting tested forsyphilis for one or more of the following reasons: o at risk for syphilis ohaving signs and symptoms indicative for syphilis oRoutinetesting

  • Participants/subjects of 18 years or older and, who are able to give/sign theinformed consent.

Exclusion

Exclusion Criteria:

  • Participant younger than 18 years old

  • Participants unable to provide written informed consent

  • Participants currently undergoing treatment

Study Design

Total Participants: 1500
Treatment Group(s): 1
Primary Treatment: iStatis Syphilis Ab Test
Phase:
Study Start date:
March 14, 2024
Estimated Completion Date:
July 11, 2024

Study 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.

Connect with a study center

  • Epicentre Health Research

    Hillcrest, KwaZulu Natal 3650
    South Africa

    Site Not Available

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