Syphilis InfectionNCT06365606
Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis Syphilis Ab Test at the Point- Of-Care Sites
A study testing iStatis Syphilis Ab Test in people with Syphilis Infection and Syphilis, run by bioLytical Laboratories at 1 site in South Africa.
Trial summary
This study is a prospective cross-sectional study in which surgically non-invasive sample- taking is done only for the purpose of the study. Capillary (fingerstick) whole blood and plasma (i.e., obtained through venous EDTA whole blood collection and processing) are collected by a healthcare professional. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Syphilis Infection, Syphilis
- What is being tested?
- iStatis Syphilis Ab Test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteSouth Africa
- Study dates
- 14 Mar 2024to 11 Jul 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants/subjects (males, females, and pregnant women) getting tested for syphilis for one or more of the following reasons:
- o at risk for syphilis ohaving signs and symptoms indicative for syphilis oRoutine testing
- Participants/subjects of 18 years or older and, who are able to give/sign the informed consent.
Who cannot join
- Participant younger than 18 years old
- Participants unable to provide written informed consent
- Participants currently undergoing treatment
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Epicentre Health Research
Hillcrest, KwaZulu-Natal, 3650
About this study
Official title: A Prospective Cross-Sectional Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis Syphilis Ab Test at the Point- Of-Care Sites
This study is a prospective cross-sectional study in which surgically non-invasive sample- taking is done only for the purpose of the study. Capillary (fingerstick) whole blood and plasma (i.e., obtained through venous EDTA whole blood collection and processing) are collected by a healthcare professional. The collected samples are tested in a routine testing environment, i.e., healthcare providers at
Read the detailed description
A trained healthcare provide will collect 50μL of capillary whole blood and 11mL of EDTA venous whole blood (VWB) to be tested with the iStatis Syphilis Ab Test on site according to the 'Test Procedure' described in the Instructions for Use (IFU) supplied with the reagents. Same procedure must be followed using the extracted plasma sample to test 30μL of the plasma sample extracted and obtained through processing of the VWB on the iStatis Syphilis Ab Test. An aliquot of the plasma sample will be transferred to the central laboratory to establish the reference test result using an enzyme immunoassay (EIA) (Abbott Architect Syphilis Tp EDA). In case of positive results in the EIA reference test of (Abbott Architect Syphilis Tp EDA), the sample will be sent for BD Macro-Vue Particle Agglutination (RPR) and Serodia Particle Agglutination (TPPA) testing.
- Conditions
- Syphilis Infection, Syphilis
- Being tested
- iStatis Syphilis Ab Test
- Keywords
- syphilis rapid test, syphilis point of care tests, syphilis antibody test, iStatis Syphilis Ab Test, 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 Ab TestDevice
Capillary (fingerstick) blood, venous whole blood and plasma samples prospectively collected from the participants will be tested on the iStatis Syphilis Ab Test.
| Study group | Role | What they receive |
|---|---|---|
| Performance onsite | Experimental | Capillary (fingerstick) blood samples collected from the participants will be tested with the iStatis Syphilis Ab Test in the hands of trained healthcare professionals at the point-of-care setting. Receives: Device: iStatis Syphilis Ab Test |
| Performance in lab | Experimental | Venous whole blood and plasma samples collected from the participants will be tested with the iStatis Syphilis Ab Test in the hands of trained healthcare professionals at the point-of-care setting. The results are compared with Abbott Architect Syphilis Tp (EDA) referent test, and in cases of positive results, further confirmatory testing (BD Macro-Vue Particle Agglutination (RPR) and Serodia Particle Agglutination (TPPA)) will be conducted. Receives: Device: iStatis Syphilis Ab Test |
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 evaluate the diagnostic sensitivity and diagnostic specificity of the iStatis Syphilis Antibody Test at Point-Of-Care (POC).
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start14 Mar 2024
- Primary completion13 May 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 Syphilis InfectionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- 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
- NCT06365606
- Sponsor's protocol ID
- CLS-015A
- Status last verified
- Aug 2024
- First submitted
- 9 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
- A Prospective Cross-Sectional Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis Syphilis Ab Test at the Point- Of-Care Sites
- ClinicalTrials.gov ID
- NCT06365606
- Acronym / sponsor ID
- CLS-015A
- Conditions
- Syphilis Infection, Syphilis
- Keywords
- syphilis rapid test, syphilis point of care tests, syphilis antibody test, iStatis Syphilis Ab Test, iStatis Syphilis Antibody Test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- bioLytical LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- 13 May 2024 (actual)
- Study completion
- 11 Jul 2024 (actual)
- First posted
- 15 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.
This study is a prospective cross-sectional study in which surgically non-invasive sample- taking is done only for the purpose of the study. Capillary (fingerstick) whole blood and plasma (i.e., obtained through venous EDTA whole blood collection and processing) are collected by a healthcare professional. The collected samples are tested in a routine testing environment, i.e., healthcare providers at
Detailed description
A trained healthcare provide will collect 50μL of capillary whole blood and 11mL of EDTA venous whole blood (VWB) to be tested with the iStatis Syphilis Ab Test on site according to the 'Test Procedure' described in the Instructions for Use (IFU) supplied with the reagents. Same procedure must be followed using the extracted plasma sample to test 30μL of the plasma sample extracted and obtained through processing of the VWB on the iStatis Syphilis Ab Test. An aliquot of the plasma sample will be transferred to the central laboratory to establish the reference test result using an enzyme immunoassay (EIA) (Abbott Architect Syphilis Tp EDA). In case of positive results in the EIA reference test of (Abbott Architect Syphilis Tp EDA), the sample will be sent for BD Macro-Vue Particle Agglutination (RPR) and Serodia Particle Agglutination (TPPA) testing.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Performance onsite | Experimental | Device: iStatis Syphilis Ab TestCapillary (fingerstick) blood samples collected from the participants will be tested with the iStatis Syphilis Ab Test in the hands of trained healthcare professionals at the point-of-care setting. |
| Performance in lab | Experimental | Device: iStatis Syphilis Ab TestVenous whole blood and plasma samples collected from the participants will be tested with the iStatis Syphilis Ab Test in the hands of trained healthcare professionals at the point-of-care setting. The results are compared with Abbott Architect Syphilis Tp (EDA) referent test, and in cases of positive results, further confirmatory testing (BD Macro-Vue Particle Agglutination (RPR) and Serodia Particle Agglutination (TPPA)) will be conducted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants/subjects (males, females, and pregnant women) getting tested for syphilis for one or more of the following reasons:
- o at risk for syphilis ohaving signs and symptoms indicative for syphilis oRoutine testing
- Participants/subjects of 18 years or older and, who are able to give/sign the informed consent.
Key exclusion criteria (3 listed)
- Participant younger than 18 years old
- Participants unable to provide written informed consent
- Participants currently undergoing treatment
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 Ab TestCapillary (fingerstick) blood, venous whole blood and plasma samples prospectively collected from the participants will be tested on the iStatis Syphilis Ab Test. | Device | Performance in lab, Performance onsite |
Primary outcome
Sensitivity and specificity of the iStatis Syphilis Ab Test
Time frame: 15 weeks
To evaluate the diagnostic sensitivity and diagnostic specificity of the iStatis Syphilis Antibody Test at Point-Of-Care (POC).
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?
A study testing iStatis Syphilis Ab Test in people with Syphilis Infection and Syphilis, 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 3 inclusion and 3 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: 15 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.