Genlantis Diagnostics
To Demonstrate Clinical Performance of the TriQuik In Vitro Diagnostic Device
HIV Infections
Hepatitis C
Hepatitis B
Syphilis Infection
QuadQuik
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 Type : | Observational |
Estimated Enrollment : | 200 participants |
Official Title : | Multicenter Performance Study of QuadQuik In Vitro Diagnostic Device |
Actual Study Start Date : | April 1, 2023 |
Estimated Primary Completion Date : | April 1, 2023 |
Estimated Study Completion Date : | June 1, 2023 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Genlantis Diagnostics
San Diego, California, United States, 92121