Multicenter Performance Study of QuadQuik Invitro Diagnostic Device

HIV Infections Clinical Trial

Official title:

Multicenter Performance Study of QuadQuik Invitro Diagnostic Device

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05692505
• Other study ID #: genl-qq-1
• Status: Not yet recruiting
• Start date: April 1, 2023
• Est. completion date: June 1, 2023

Study information

• Verified date: January 2023
• Source: Genlantis Diagnostics
• Contact: Robert H Zeiler, PhD
• Phone: 7074779081
• Email: rezeiler1970[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To Demonstrate Clinical Performance of the TriQuik Invitro Diagnostic Device

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: June 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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 patients only need one antibody test in their medical chart. no documented medical history of HIV, HBV, HCV or syphilis 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.-

Related Conditions & MeSH terms

• Communicable Diseases
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis C
• HIV Infections
• Infections
• Syphilis
• Syphilis Infection

Intervention

Diagnostic Test:
• QuadQuik
Invitro diagnostic device

Locations

Country	Name	City	State
United States	Genlantis Diagnostics	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Genlantis Diagnostics	Ahsan Awan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standard performance criteria	Diagnostic Sensitivity, Diagnostic Specificity, Positive Predictive Value, Negative Predictive Value	<1 day