SyphilisNCT06367621
Retrospective Study of iStatis Syphilis Ab Test (POC)
An observational study of Syphilis and Syphilis Infection, run by bioLytical Laboratories at 1 site in South Africa.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Syphilis, Syphilis Infection
- What is being tested?
- iStatis Syphilis Antibody Test
- Type of treatment
- Medical device
- How many people
- 1,500 participants
- Where
- 1 siteSouth Africa
- Study dates
- 15 Nov 2023to 11 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Retrospective cross-sectional study on left-over samples stored at -80°C from previous trials conducted by Epicentre Heath Research.
Who may be able to join
- Anti-Tp negative samples:
- -Stored at ≤ -80°C.
- 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.
Show all 13Show fewer
- 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.
- 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.
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Epicentre Health Research
Hillcrest, KwaZulu-Natal, 3650
About this study
Official title: 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.
Read the 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.
- Conditions
- Syphilis, Syphilis Infection
- Being tested
- iStatis Syphilis Antibody Test
- Keywords
- diagnostic kit, diagnostic devices, lateral flow device test, syphilis rapid test, syphilis point of care tests, iStatis Syphilis Antibody Test
- Medical subject headings
- Syphilis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iStatis Syphilis Antibody TestDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: iStatis Syphilis Antibody Test | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of the iStatis Syphilis Ab Test
To estimate the diagnostic specificity and diagnostic sensitivity of the iStatis Syphilis Antibody Test in detecting anti-Tp in plasma and serum
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start15 Nov 2023
- Primary completion15 Apr 2024
- Study completion11 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SyphilisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- bioLytical Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06367621
- Sponsor's protocol ID
- CLS-015C
- Status last verified
- Aug 2024
- First submitted
- 10 Apr 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Evaluation of Diagnostic Specificity and Sensitivity for iStatis Syphilis Ab Test at the Point-Of-Care Sites
- ClinicalTrials.gov ID
- NCT06367621
- Acronym / sponsor ID
- CLS-015C
- Conditions
- Syphilis, Syphilis Infection
- Keywords
- diagnostic kit, diagnostic devices, lateral flow device test, syphilis rapid test, syphilis point of care tests, iStatis Syphilis Antibody Test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- bioLytical LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 11 Jul 2024 (actual)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iStatis Syphilis Antibody Test diagnostic device | – | Device: iStatis Syphilis Antibody TestBio-banked plasma and serum samples available to Epicentre Health Research will be used for testing on iStatis Syphilis Antibody Test device. |
| 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 |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Retrospective cross-sectional study on left-over samples stored at -80°C from previous trials conducted by Epicentre Heath Research.
Key inclusion criteria (13 listed)
- Anti-Tp negative samples:
- -Stored at ≤ -80°C.
- Anti-Tp negative samples - pregnant women:
- Anti-Tp positive samples:
- Anti-Tp positive samples - pregnant women:
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iStatis Syphilis Antibody Test1500 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). | Device | iStatis Syphilis Antibody Test diagnostic device |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Syphilis and Syphilis Infection, run by bioLytical Laboratories at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of the iStatis Syphilis Ab Test (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.