Evaluation of the Performance of Chembio Diagnostics Systems, Inc. DPP® HIV 1/2 Rapid Test

HIV Infections Clinical Trial

Official title:

Study to Establish the Ability of the Chembio Diagnostics Systems, Inc. DPP HIV 1/2 Rapid Test to Qualitatively Detect the Presence of Antibodies Against HIV-1 in Oral Fluid, Whole Blood (Capillary and Venous), Serum and Plasma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01032902
• Other study ID #: CP-HIV01
• Secondary ID: IDE 14208
• Status: Completed
• Phase: N/A
• First received: December 15, 2009
• Last updated: April 27, 2012
• Start date: January 2010
• Est. completion date: April 2012

Study information

• Verified date: April 2012
• Source: Chembio Diagnostic Systems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

This study has been designed to evaluate the performance of the Chembio Diagnostics Systems, Inc. DPP® HIV 1/2 rapid test. The device is intended to qualitatively detect the presence of antibodies against HIV-1/2 in oral fluid, whole blood (capillary and venous), serum or plasma. This study will assess the DPP® HIV 1/2 Screen assay's ability to detect HIV-1.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2808
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years and older

Eligibility

Inclusion Criteria:

• Must be at least 2 years of age (no upper age limit).

• Must be willing and able to receive post-test counseling, if applicable.

• Must sign (and be given) a copy of the written Informed Consent form and or Assent form (if applicable).

• Must be able to sustain fingersticks and venipuncture from the arm or hand only.

Exclusion Criteria:

• Am in a life threatening condition at the time of enrollment

• Have a suppressed immune systems (i.e. transplant patients, individuals diagnosed with non-HIV immunosuppressive illness, etc.).

• Have participated or are participating in a clinical trial for an HIV vaccine.

• Have previously participated in this clinical trial.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV Infections

Intervention

Device:
• In Vitro Diagnostic Device
For the detection of antibodies to HIV in serum, plasma, blood and oral fluid

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland
United States	Therafirst	Fort Lauderdale	Florida
United States	University of Texas HSC	Houston	Texas
United States	Univeristy of California, San Diego	La Jolla	California
United States	St. Christopher's Hospital for Children/ Drexel University College of Medicine	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Chembio Diagnostic Systems, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The device detects HIV-1 antibodies in a variety of sample matrices: capillary whole blood, venous whole blood (with EDTA or heparin anticoagulant), oral fluid, serum and plasma (with EDTA or heparin anticoagulant).		20 minutes	No
Secondary	The device provides a qualitative screen for the detection of antibodies to HIV-1 compared to an FDA approved HIV-1/2 EIA, with sensitivity and specificity equal to or greater than 98% at the lower 95% confidence interval boundary.		20 minutes	No