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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Chembio Diagnostic Systems, Inc.

ClinicalTrials.gov Identifier:

NCT01032902

First received: December 15, 2009

Last updated: April 27, 2012

Last verified: April 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	December 15, 2009
Last Updated Date	April 27, 2012
Start Date ^ICMJE	January 2010
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 15, 2009)	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). [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01032902 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 15, 2009)	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. [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Evaluation of the Performance of Chembio Diagnostics Systems, Inc. DPP® HIV 1/2 Rapid Test
Official Title ^ICMJE	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
Brief 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples Without DNA Description: serum and plasma
Sampling Method	Non-Probability Sample
Study Population	Point-of-care test sites including clinics and physician office settings
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Device: In Vitro Diagnostic Device For the detection of antibodies to HIV in serum, plasma, blood and oral fluid
Study Group/Cohort (s)	Known HIV positive Patients from HIV clinics with documented infections Intervention: Device: In Vitro Diagnostic Device High Risk for Infection with HIV Patients from defined HIV high-risk populations - i.e. intravenous drug users, or patients presenting with symptoms of sexually transmitted disease. Intervention: Device: In Vitro Diagnostic Device Low-Risk for Infection with HIV Individuals not known to belong to any of the defined high-risk groups - i.e. "healthy patients" presenting for routine physicals or other unrelated non-life threatening illnesses, or individuals from a general low risk population such as students, employees of academic or other institutions, etc… Intervention: Device: In Vitro Diagnostic Device
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	2808
Completion Date	April 2012
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	2 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01032902
Other Study ID Numbers ^ICMJE	CP-HIV01, IDE 14208
Has Data Monitoring Committee	Yes
Responsible Party	Chembio Diagnostic Systems, Inc.
Study Sponsor ^ICMJE	Chembio Diagnostic Systems, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Chembio Diagnostic Systems, Inc.
Verification Date	April 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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