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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05692505
Other study ID # genl-qq-1
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 1, 2023
Est. completion date June 1, 2023

Study information

Verified date January 2023
Source Genlantis Diagnostics
Contact Robert H Zeiler, PhD
Phone 7074779081
Email rezeiler1970@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To Demonstrate Clinical Performance of the TriQuik Invitro Diagnostic Device


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date June 1, 2023
Est. primary completion date April 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.-

Study Design


Intervention

Diagnostic Test:
QuadQuik
Invitro diagnostic device

Locations

Country Name City State
United States Genlantis Diagnostics San Diego California

Sponsors (2)

Lead Sponsor Collaborator
Genlantis Diagnostics Ahsan Awan

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Standard performance criteria Diagnostic Sensitivity, Diagnostic Specificity, Positive Predictive Value, Negative Predictive Value <1 day
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