Multicenter Performance Study of QuadQuik Invitro Diagnostic Device

Genlantis Diagnostics

Status

Not yet enrolling

Conditions

Syphilis Infection

Hepatitis C

Hepatitis B

HIV Infections

Treatments

Diagnostic Test: QuadQuik

Study type

Observational

Funder types

Industry

Other

Identifiers

NCT05692505

genl-qq-1

Details and patient eligibility

About

To Demonstrate Clinical Performance of the TriQuik Invitro Diagnostic Device

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.-