HIV InfectionsNCT05692505
Multicenter Performance Study of QuadQuik Invitro Diagnostic Device
An observational study of HIV Infections and Hepatitis C, run by Genlantis Diagnostics at 1 site in United States.
Trial summary
To Demonstrate Clinical Performance of the TriQuik Invitro Diagnostic Device Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Hepatitis C, Hepatitis B
- What is being tested?
- QuadQuik
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2023to 1 Jun 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study patients are seen, recruited and consented from local clinics and physician offices.
Who may be able to join
- a documented medical history of HIV, HBV, HCV or syphilis. A combination of 2 or 3 conditions is acceptable.
- HbsAg patients need to have a HbsAg on file < 2 years. HIV and HCV patients only need one antibody test in their medical chart. no documented medical history of HIV, HBV, HCV or syphilis and are considered normal.
- Male or female subjects, ages ≥18 years. Signed informed consent provided by an authorized subject representative (based on local Institutional Review Board (IRB)/ethics panel requirements).-
Who cannot join
- Any other condition or prior therapy, which, in the opinion of the investigator, would make the subject unsuitable for this study.
- Participation in any phase of another clinical research study involving the evaluation of another investigational drug or device within 30 days before randomization.-
Trial locations and contacts
1 site in 1 country.
Ahsan Awan, JD contact
United States1 site
Genlantis Diagnostics
San Diego, California, 92121
Robert H. Zeiler, PhD
Ahsan Awan, JD
About this study
To Demonstrate Clinical Performance of the TriQuik Invitro Diagnostic Device
Read the detailed description
Measurement Methodology Whole blood samples are collected by fingerstick. Samples tested immediately.
Using the supplied sample dropper, transfer specimen blood drop into the two sample wells. Wait 20-30 seconds. Add two drops of the supplied assay buffer (~90µL) to the same sample wells Read result in 20 mins.
Primary end points will determine how accurate these tests are (p<=0.02) by analyzing for:
Diagnostic Sensitivity; TP / (TP + FN) The ability of the test to correctly identify those patients with the disease Diagnostic Specificity; TN / (TN + FP) The ability of the test to correctly identify those patients who are truly free of the specific disease Positive Predictive Value: TP / (TP+ FP) The probability that subjects with a positive test truly have the disease. Negative Predictive Value: TN / (FN + TN) The probability that subjects with a negative test truly don't have the disease.
An estimated 200 patients are to be enrolled as follows:
150 with a documented medical history of HIV, HBV, HCV or Syphilis. A combination of 2 or 3 conditions is acceptable.
HbsAg patients need to have a HbsAg on file < 2 years. HIV and HCV or Syphilis patients only need one antibody test in their medical chart.
50 with no documented medical history of HIV, HBV, HCV or Syphilis and are considered normal.
Male or female subjects, ages ≥18 years.
- Conditions
- HIV Infections, Hepatitis C, Hepatitis B, Syphilis Infection
- Being tested
- QuadQuik
- Medical subject headings
- HIV Infections, Hepatitis C, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuadQuikDiagnostic test
Invitro diagnostic device
| Study group | Role | What they receive |
|---|---|---|
| Positive test subjects | Subjects having previous positive tests verified by certified laboratory Receives: Diagnostic Test: QuadQuik | |
| Control subjects | Subjects having no previous positive tests verified by certified laboratory Receives: Diagnostic Test: QuadQuik |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard performance criteria
Diagnostic Sensitivity, Diagnostic Specificity, Positive Predictive Value, Negative Predictive Value
Measured: <1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start1 Apr 2023 (estimated)
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genlantis Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ahsan Awan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05692505
- Sponsor's protocol ID
- genl-qq-1
- Status last verified
- Jan 2023
- First submitted
- 11 Jan 2023
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Performance Study of QuadQuik Invitro Diagnostic Device
- ClinicalTrials.gov ID
- NCT05692505
- Acronym / sponsor ID
- genl-qq-1
- Conditions
- HIV Infections, Hepatitis C, Hepatitis B, Syphilis Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Genlantis DiagnosticsIndustry (pharma, biotech, devices)
- Collaborators
- Ahsan Awan
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 20 Jan 2023 (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.
To Demonstrate Clinical Performance of the TriQuik Invitro Diagnostic Device
Detailed description
Measurement Methodology Whole blood samples are collected by fingerstick. Samples tested immediately.
Using the supplied sample dropper, transfer specimen blood drop into the two sample wells. Wait 20-30 seconds. Add two drops of the supplied assay buffer (~90µL) to the same sample wells Read result in 20 mins.
Primary end points will determine how accurate these tests are (p<=0.02) by analyzing for:
Diagnostic Sensitivity; TP / (TP + FN) The ability of the test to correctly identify those patients with the disease Diagnostic Specificity; TN / (TN + FP) The ability of the test to correctly identify those patients who are truly free of the specific disease Positive Predictive Value: TP / (TP+ FP) The probability that subjects with a positive test truly have the disease. Negative Predictive Value: TN / (FN + TN) The probability that subjects with a negative test truly don't have the disease.
An estimated 200 patients are to be enrolled as follows:
150 with a documented medical history of HIV, HBV, HCV or Syphilis. A combination of 2 or 3 conditions is acceptable.
HbsAg patients need to have a HbsAg on file < 2 years. HIV and HCV or Syphilis patients only need one antibody test in their medical chart.
50 with no documented medical history of HIV, HBV, HCV or Syphilis and are considered normal.
Male or female subjects, ages ≥18 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive test subjects | – | Diagnostic Test: QuadQuikSubjects having previous positive tests verified by certified laboratory |
| Control subjects | – | Diagnostic Test: QuadQuikSubjects having no previous positive tests verified by certified laboratory |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study patients are seen, recruited and consented from local clinics and physician offices.
Key inclusion criteria (3 listed)
- a documented medical history of HIV, HBV, HCV or syphilis. A combination of 2 or 3 conditions is acceptable.
- HbsAg patients need to have a HbsAg on file < 2 years. HIV and HCV patients only need one antibody test in their medical chart. no documented medical history of HIV, HBV, HCV or syphilis and are considered normal.
- Male or female subjects, ages ≥18 years. Signed informed consent provided by an authorized subject representative (based on local Institutional Review Board (IRB)/ethics panel requirements).-
Key exclusion criteria (2 listed)
- Any other condition or prior therapy, which, in the opinion of the investigator, would make the subject unsuitable for this study.
- Participation in any phase of another clinical research study involving the evaluation of another investigational drug or device within 30 days before randomization.-
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 |
|---|---|---|
| QuadQuikInvitro diagnostic device | Diagnostic test | Control subjects, Positive test subjects |
Primary outcome
Standard performance criteria
Time frame: <1 day
Diagnostic Sensitivity, Diagnostic Specificity, Positive Predictive Value, Negative Predictive Value
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Individual participant dataSharing planned: Undecided
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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.
Ahsan Awan, JD contact
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 HIV Infections and Hepatitis C, run by Genlantis Diagnostics at 1 site in United States.
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 2 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: status not confirmed, as of the sponsor's last update on 20 Jan 2023. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert H Zeiler, PhD (7074779081, rezeiler1970@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standard performance criteria (time frame: <1 day). 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 20 Jan 2023.