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.
To Demonstrate Clinical Performance of the TriQuik Invitro Diagnostic Device