Clinical trial NCT05692505: Multicenter Performance Study of QuadQuik Invitro Diagnostic Device
Official title: Multicenter Performance Study of QuadQuik Invitro Diagnostic Device
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV Infections
Hepatitis C
Hepatitis B
Syphilis Infection
Lead sponsor: Genlantis Diagnostics
Sponsor class: INDUSTRY
Collaborators: name: Ahsan Awan
First posted: 2023-01-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study patients are seen, recruited and consented from local clinics and physician offices.

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.

Eligibility 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.-

Primary outcomes:
measure: Standard performance criteria
timeFrame: <1 day
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Genlantis Diagnostics
state: California
Study officials:
References: