Multicenter Performance Study of QuadQuik Invitro Diagnostic Device

Status Not yet recruiting

Clinical Trial Summary

To Demonstrate Clinical Performance of the TriQuik Invitro Diagnostic Device

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05692505
Study type	Observational
Source	Genlantis Diagnostics
Contact	Robert H Zeiler, PhD
Phone	7074779081
Email	rezeiler1970@gmail.com
Status	Not yet recruiting
Phase
Start date	April 1, 2023
Completion date	June 1, 2023

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