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

NCT06584214 | Not Yet Recruiting

• 1 other identifier: D10159847 (7D34VAL24-002)
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Syphilis Infection

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• To evaluate the usability through completion of a user experience questionnaire.

  4 months

• To determine the stability of venous whole blood, serum and plasma samples for use with Determine™ Syphilis Advanced, after refrigeration .

  4 months

Study Arms (1)

Diagnostic test: Determine™ Syphilis Advanced test

EXPERIMENTAL

Diagnostic test: Testing using the Determine™ Syphilis Advanced test will be conducted by study staff members.

Diagnostic Test: Diagnostic test: Determine™ Syphilis Advanced test

Interventions

Diagnostic test: Determine™ Syphilis Advanced test DIAGNOSTIC_TEST

The Determine™ Syphilis Advanced test is intended as an aid in detecting antibodies to Treponema pallidum in individuals with current or past infection.

Diagnostic test: Determine™ Syphilis Advanced test

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Abbott Rapid Dx: lead

Study Sites (1)

Uganda Virus Research Institute

Entebbe, Uganda

Location

Study Officials

• Pontiano Kaleebu, Professor, MD PhD

  MRC/UVRI and LSHTM Uganda Research Unit

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Camilla Forssten, PhD

CONTACT

+44 7792 902 244; camilla.forssten@abbott.com

Simon Kordowich, PhD

CONTACT

+49 162-136-8985; simon.kordowich@abbott.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Study staff performing the testing using the Determine™ Syphilis Advanced and Determine™ Syphilis TP testing will be blinded to the participants' syphilis infection status.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: September 4, 2024
• Study Start: September 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 4, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)