Retrospective Study of iStatis Syphilis Ab Test (POC)

April 12, 2024 updated by: bioLytical Laboratories

Retrospective Evaluation of Diagnostic Specificity and Sensitivity for iStatis Syphilis Ab Test at the Point-Of-Care Sites

The purpose of this retrospective clinical trial is to establish the clinical performance of the iStatis Syphilis AbTest. The data will be used to demonstrate the product is safe and effective for its intended use. The data obtained will be used in the application for CE certification under In Vitro Diagnostic Medical Device Regulation (IVDR) and World Health Organization (WHO) prequalification.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The objectives of this study are to establish the diagnostic sensitivity and diagnostic specificity of the iStatis Syphilis Ab Test. Left-over samples stored at -80ᵒC from the previous trials conducted by Epicentre will be used for this study. The samples are tested in a routine testing environment. Serum samples were tested for evidence of syphilis infection using a non-treponemal Rapid Plasma Reagin (RPR) assay. All reactive samples were further tested quantitatively.

Study Type

Observational

Enrollment (Actual)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
    • KwaZulu Natal
      • Hillcrest, KwaZulu Natal, South Africa, 3650
        • Epicentre Health Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Retrospective cross-sectional study on left-over samples stored at -80°C from previous trials conducted by Epicentre Heath Research.

Description

Inclusion Criteria:

  1. Anti-Tp negative samples:

    -Stored at ≤ -80°C.

  2. Anti-Tp negative samples - pregnant women:

    • Samples from pregnant women, 1st and multipara
    • Samples found negative or false reactive for anti-Tp assay with the reference method.
    • Stored at ≤ -80°C.

  3. Anti-Tp positive samples:

    • Samples screened with Abbott Architect Syphilis Tp and confirmed positive with BD Macro-Vue Particle Agglutination (RPR) and Serodia Particle Agglutination (TPPA).
    • Stored at ≤ -80°C.

  4. Anti-Tp positive samples - pregnant women:

    • Samples from pregnant women
    • Samples screened with Abbott Architect Syphilis Tp and confirmed positive with BD Macro-Vue Particle Agglutination (RPR) and Serodia Particle Agglutination (TPPA).
    • Stored at ≤ -80°C.

Exclusion Criteria:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
iStatis Syphilis Antibody Test diagnostic device
Bio-banked plasma and serum samples available to Epicentre Health Research will be used for testing on iStatis Syphilis Antibody Test device.
Device: iStatis Syphilis Antibody Test
1500 stored samples (plasma/serum) will be tested in a routine testing environment using the iStatis Syphilis Antibody Test diagnostic device. Results of tests will not be used for patient management decisions (observaltional).
Reference test
Either serum or plasma samples were tested with Abbott Architect Syphilis Tp (EDA) and MD Macro-Vue Particle Agglutination (RPR)/Serodia Particle Agglutination (TPPA) where applicable

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity of the iStatis Syphilis Ab Test
Time Frame: 8 weeks
To estimate the diagnostic specificity and diagnostic sensitivity of the iStatis Syphilis Antibody Test in detecting anti-Tp in plasma and serum
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

bioLytical Laboratories

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2023

Primary Completion (Estimated)

April 15, 2024

Study Completion (Estimated)

April 15, 2024

Study Registration Dates

First Submitted

April 10, 2024

First Submitted That Met QC Criteria

April 12, 2024

First Posted (Actual)

April 16, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLS-015C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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