Multicenter Performance Study of QuadQuik Invitro Diagnostic Device

NCT05692505 | Unknown FDA Device

• 1 other identifier: genl-qq-1
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

To Demonstrate Clinical Performance of the TriQuik Invitro Diagnostic Device

Conditions

HIV Infections; Hepatitis C; Hepatitis B; Syphilis Infection

Outcome Measures

Primary Outcomes (1)

• Standard performance criteria

  Diagnostic Sensitivity, Diagnostic Specificity, Positive Predictive Value, Negative Predictive Value

  <1 day

Study Arms (2)

Positive test subjects

Subjects having previous positive tests verified by certified laboratory

Diagnostic Test: QuadQuik

Control subjects

Subjects having no previous positive tests verified by certified laboratory

Diagnostic Test: QuadQuik

Interventions

QuadQuik DIAGNOSTIC_TEST

Invitro diagnostic device

Control subjects; Positive test subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study patients are seen, recruited and consented from local clinics and physician offices.

You may qualify if:

• 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).-

You may not qualify if:

• 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.-

Sponsors & Collaborators

• Genlantis Diagnostics: lead
• Ahsan Awan: collaborator

Study Sites (1)

Genlantis Diagnostics

San Diego, California, 92121, United States

Location

MeSH Terms

Conditions

HIV Infections; Hepatitis C; Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hepatitis, Viral, Human; Flaviviridae Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Hepadnaviridae Infections; DNA Virus Infections

Central Study Contacts

Robert H Zeiler, PhD

CONTACT

7074779081; rezeiler1970@gmail.com

Ahsan Awan, JD

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: January 20, 2023
• Study Start: April 1, 2023
• Primary Completion: April 1, 2023
• Study Completion: June 1, 2023
• Last Updated: January 20, 2023

Record last verified: 2023-01

Locations

US (1)