An observational study in HIV Infections, Hepatitis C and Hepatitis B, sponsored by Genlantis Diagnostics. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-20.
Sponsored by Genlantis Diagnostics · Observational
To Demonstrate Clinical Performance of the TriQuik Invitro Diagnostic Device
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 200 is below the median of 240 across 2,136 observational studies indexed under Infections.
Browse Infections studies →Genlantis Diagnostics is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Study patients are seen, recruited and consented from local clinics and physician offices.
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).-
Exclusion Criteria:
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.-
Subjects having previous positive tests verified by certified laboratory
Diagnostic Test: QuadQuik
Subjects having no previous positive tests verified by certified laboratory
Diagnostic Test: QuadQuik
Invitro diagnostic device
Standard performance criteria
Diagnostic Sensitivity, Diagnostic Specificity, Positive Predictive Value, Negative Predictive Value
Time frame: <1 day
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Genlantis Diagnostics