NCT05692505

Multicenter Performance Study of QuadQuik Invitro Diagnostic Device

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Genlantis Diagnostics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• HIV Infections
• Hepatitis C
• Hepatitis B
• Syphilis Infection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	QuadQuik	Invitro diagnostic device

Timeline

• Start date: 2023-04-01
• Primary completion: 2023-04-01
• Completion: 2023-06-01
• First posted: 2023-01-20
• Last updated: 2023-01-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study