Multicenter Performance Study of QuadQuik Invitro Diagnostic Device
Study Details
Study Description
Brief Summary
To Demonstrate Clinical Performance of the TriQuik Invitro Diagnostic Device
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Positive test subjects Subjects having previous positive tests verified by certified laboratory |
Diagnostic Test: QuadQuik
Invitro diagnostic device
|
| Control subjects Subjects having no previous positive tests verified by certified laboratory |
Diagnostic Test: QuadQuik
Invitro diagnostic device
|
Outcome Measures
Primary Outcome Measures
- Standard performance criteria [<1 day]
Diagnostic Sensitivity, Diagnostic Specificity, Positive Predictive Value, Negative Predictive Value
Eligibility Criteria
Criteria
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.-
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Genlantis Diagnostics | San Diego | California | United States | 92121 |
Sponsors and Collaborators
- Genlantis Diagnostics
- Ahsan Awan
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- genl-qq-1