Evaluation of the Diagnostic Sensitivity and Specificity of the Determine™ Syphilis Advanced Test.

A Prospective, Multi-centre Study to Evaluate the Diagnostic Sensitivity and Specificity of the Determine™ Syphilis Advanced Test.

This is a prospective, multi-centre study which will evaluate the diagnostic sensitivity and specificity of the Determine™ Syphilis Advanced test. The test is intended for professional use and the performance evaluation will be performed by professional healthcare and laboratory staff. The study will also have a retrospective study arm. The Determine™ Syphilis Advanced validation will be conducted in accordance with the World Health Organization's TSS-6 guidance on Syphilis rapid diagnostic tests, ISO 20916 (In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice), the study protocol, Good Clinical Practice and the respective local medical device laws.

Study Overview

• Status: Not yet recruiting
• Conditions: Syphilis Infection
• Intervention / Treatment: Diagnostic test: Diagnostic test: Determine™ Syphilis Advanced test

Detailed Description

Syphilis is a sexually transmitted infection (STI) caused by the spirochete Treponema pallidum subspecies. Globally, there were an estimated 7.1 million adults between 15 and 49 years of age who acquired syphilis in 2020. Syphilis is transmitted through sexual contact with infectious lesions, through blood transfusions and from mother-to-child during pregnancy; most infections are asymptomatic or unrecognized. Without treatment, the disease lasts for many years and is divided into stages: primary syphilis, secondary syphilis and latent syphilis. Mother-to-child transmission of syphilis (congenital syphilis) can adversely affect the foetus, but this can be averted by early detection and treatment of the mother during pregnancy.

Determine™ Syphilis Advanced is an in vitro, visually read, qualitative immunoassay for the detection of antibodies to Treponema pallidum, in human capillary and venous whole blood, plasma or serum.

The test is intended for professional use, and the performance evaluation will be performed by professional healthcare and laboratory staff. Results for all sample types (capillary and venous whole blood, plasma or serum) will be evaluated against reference test results. In addition, for a sub-cohort, the Determine™ Syphilis Advanced test will be compared with the commercially available Determine™ Syphilis TP and the SERODIA-TPPA tests. Study staff performing the testing using the Determine™ Syphilis Advanced will be blinded to the participants' syphilis infection status and all other study syphilis test results. The study will enrol prospective participants, and will also have a retrospective study group.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Simon Kordowich, PhD; Phone Number: +49 162-136-8985; Email: simon.kordowich@abbott.com
• Study Contact Backup: Name: Camilla Forssten, PhD; Phone Number: +44 7792 902 244; Email: camilla.forssten@abbott.com

Study Locations

• Uganda
  • Entebbe, Uganda
    • Uganda Virus Research Institute
    • Contact: Pontiano Kaleebu, Professor, MD PhD; Email: Pontiano.Kaleebu@mrcuganda.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 12 years of age or older.
• The participant has confirmed previous / current syphilis according to their medical history, or the participant has unknown or negative syphilis infection status.
• The participant agrees to provide written informed consent.
• The participant agrees to complete all aspects of the study.

Additional inclusion criteria for frozen samples:

• The ethics committee-required written informed consent for study testing, or required documentation for sample use from a commercial vendor, is available.
• Sufficient volume for testing is available and the sample quality is adequate (for example no significant sample hemolysis)
• The sample must have been collected in EDTA vacutainers or serum tubes, processed to plasma and the plasma frozen within 36 hours of blood collection.

Exclusion Criteria:

• Participant has already participated in this study on a previous occasion.
• Participant is deemed vulnerable and / or unfit for participation in the study by the Investigator.
• Participant is unwilling or unable to provide informed consent.
• Participant is currently enrolled in a study to evaluate an investigational new drug or vaccine.

Additional exclusion criteria for frozen samples

• The sample has undergone more than one freeze thaw cycle
• The sample has been kept at -20 °C (± 5 °C) longer than 12 months. If the sample has been kept longer than 12 months, the storage temperature must have been colder than -20 °C (± 5 °C).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diagnostic test: Determine™ Syphilis Advanced test; Diagnostic test: Testing using the Determine™ Syphilis Advanced test will be conducted by study staff members.	Diagnostic test: Diagnostic test: Determine™ Syphilis Advanced test; The Determine™ Syphilis Advanced test is intended as an aid in detecting antibodies to Treponema pallidum in individuals with current or past infection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine the diagnostic sensitivity and specificity of the Determine™ Syphilis Advanced test results using fingerstick capillary whole blood, venous whole blood, serum and venous plasma, when the test is performed by professional users.	The diagnostic sensitivity and specificity of the Determine™ Syphilis Advanced test will be evaluated versus laboratory reference testing.	4 months
To compare the performance of the Determine™ Syphilis Advanced test with two commercially available similar tests	The Determine™ Syphilis Advanced test will be compared with two commercially available tests. These tests are the TPPA test (SERODIA-TPPA, Fujirebio) and the Determine™ Syphilis TP (Abbott) test.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the usability through completion of a user experience questionnaire.	A user experience questionnaire will be completed by study healthcare staff. The users will evaluate the ease of use, and confidence in correct performance, of various test steps and result interpretation. The response options are ranked on a scale of 1-5. where option 1 stands for Very easy, or Very confident as applicable, and 5 stands for Very Difficult, or Very unsure as applicable.	4 months
To determine the stability of venous whole blood, serum and plasma samples for use with Determine™ Syphilis Advanced, after refrigeration .	Venous whole blood, serum and plasma will be stored at 2-8 degrees Celsius during 7 days before testing with Determine™ Syphilis Advanced.	4 months

Collaborators and Investigators

• Sponsor: Abbott Rapid Dx
• Investigators: Principal Investigator: Pontiano Kaleebu, Professor, MD PhD, MRC/UVRI and LSHTM Uganda Research Unit

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: August 29, 2024
• First Submitted That Met QC Criteria: September 2, 2024
• First Posted (Actual): September 4, 2024

Study Record Updates

• Last Update Posted (Actual): September 4, 2024
• Last Update Submitted That Met QC Criteria: September 2, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Communicable Diseases; Sexually Transmitted Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases, Bacterial; Spirochaetales Infections; Treponemal Infections; Urogenital Diseases; Genital Diseases; Syphilis
• Other Study ID Numbers: D10159847 (7D34VAL24-002)

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