Hepatitis B, Hepatitis C, HIV Infections, Syphilis Infection
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTQuadQuik
Invitro diagnostic device
Sponsors
Ahsan Awan
Genlantis Diagnostics
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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.-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standard performance criteria | <1 day | Diagnostic Sensitivity, Diagnostic Specificity, Positive Predictive Value, Negative Predictive Value |
Countries
United States
Contacts
Primary ContactRobert H Zeiler, PhD
Backup ContactAhsan Awan, JD
Outcome results
None listed