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

December 15, 2009
April 27, 2012
January 2010
April 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01032902 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Evaluation of the Performance of Chembio Diagnostics Systems, Inc. DPP® HIV 1/2 Rapid Test
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

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

serum and plasma

Non-Probability Sample

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

HIV Infections
Device: In Vitro Diagnostic Device
For the detection of antibodies to HIV in serum, plasma, blood and oral fluid
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2808
April 2012
April 2012   (final data collection date for primary outcome measure)

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.
Both
2 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01032902
CP-HIV01, IDE 14208
Yes
Chembio Diagnostic Systems, Inc.
Chembio Diagnostic Systems, Inc.
Not Provided
Not Provided
Chembio Diagnostic Systems, Inc.
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP