An interventional study of Diagnostic test: Determine™ Syphilis Advanced test in Syphilis Infection, sponsored by Abbott Rapid Dx. Not yet recruiting at 1 site in Uganda. Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-04.
Sponsored by Abbott Rapid Dx (part of Abbott) · Not applicable, Interventional, and Diagnostic
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.
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.
126 studies on the registry are indexed under Syphilis; 34 are open to participants now.
This study's planned enrollment of 400 is above the median of 354 across 85 interventional studies indexed under Syphilis.
Browse Syphilis studies →Abbott Rapid Dx is the lead sponsor of 12 studies on the registry; 6 are open to participants now.
First submitted after Abbott Rapid Dx became part of Abbott.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Additional inclusion criteria for frozen samples:
Exclusion Criteria:
Additional exclusion criteria for frozen samples
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: 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.
Time frame: 4 months
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.
Time frame: 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.
Time frame: 4 months
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2024; primary completion for Dec 2024, 3 months later.
Of 25 interventional studies with no phase under Syphilis, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 42. This study's planned 3 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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