Multicenter Performance Study of TriQuik Invitro Diagnostic Device

A Multicenter Clinical Performance Study to Compare the Results Obtained From the TriQuik Invitro Diagnostic Device With Historical Medical Records From the Same Subject

This prospective and historical clinical study is designed to test the performance of the Genlantis TriQuik test kit (Cassette). The primary goal is to establish the sensitivity and specificity (i.e. how accurate the test is) when compared to the same patient's medical history.

Previous tests were performed on serum and whole blood specimens. A total of 607 serum specimens1 were collected for evaluation and comparison of the performance of the TriQuik Hepatitis B Surface Antigen (HBsAg) Test with a licensed commercial HBsAg EIA. 84 of 85 positive serum samples testing by the licensed commercial HBsAg EIA were reactive with TriQuik HBsAg Test and 520 of 522 negative samples testing by the licensed commercial HBsAg EIA were tested negative with TriQuik HBsAg Test.

Study Objective To demonstrate clinical performance of the TriQuik Invitro Diagnostic device.

Measurement Methodology Whole blood samples are collected by fingerstick. Samples should be tested immediately.

Using the supplied sample dropper, transfer specimen blood drop into the sample well. Wait 20-30 seconds. Add two drops of the supplied assay buffer (~90µL) to the same sample well 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 or HCV. 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.

50 with no documented medical history of HIV, HBV or HCV and are considered normal.

Male or female subjects, ages ≥18 years.

Inclusion Criteria:

• a documented medical history of HIV, HBV or HCV. 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 or HCV 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.

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