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
  Purpose

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.


Condition Intervention
HIV Infections
Device: In Vitro Diagnostic Device

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Chembio Diagnostic Systems, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

serum and plasma


Enrollment: 2808
Study Start Date: January 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Known HIV positive
Patients from HIV clinics with documented infections
Device: In Vitro Diagnostic Device
For the detection of antibodies to HIV in serum, plasma, blood and oral fluid
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.
Device: In Vitro Diagnostic Device
For the detection of antibodies to HIV in serum, plasma, blood and oral fluid
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…
Device: In Vitro Diagnostic Device
For the detection of antibodies to HIV in serum, plasma, blood and oral fluid

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Point-of-care test sites including clinics and physician office settings

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01032902

Locations
United States, California
Univeristy of California, San Diego
La Jolla, California, United States, 92093
United States, Florida
Therafirst
Fort Lauderdale, Florida, United States, 33308
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201-1559
United States, Pennsylvania
St. Christopher's Hospital for Children/ Drexel University College of Medicine
Philadelphia, Pennsylvania, United States, 19102
United States, Texas
University of Texas HSC
Houston, Texas, United States, 77030
Sponsors and Collaborators
Chembio Diagnostic Systems, Inc.
  More Information

No publications provided

Responsible Party: Chembio Diagnostic Systems, Inc.
ClinicalTrials.gov Identifier: NCT01032902     History of Changes
Other Study ID Numbers: CP-HIV01, IDE 14208
Study First Received: December 15, 2009
Last Updated: April 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Chembio Diagnostic Systems, Inc.:
Human immunodeficiency virus
Rapid Test
HIV
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on April 16, 2014