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

C

Chembio Diagnostic Systems, Inc.

Status

Completed

Conditions

HIV Infections

Treatments

Device: In Vitro Diagnostic Device

Study type

Observational

Funder types

Industry

Identifiers

NCT01032902
CP-HIV01
IDE 14208

Details and patient eligibility

About

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.

Enrollment

2,808 patients

Sex

All

Ages

2+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

2,808 participants in 3 patient groups

Known HIV positive
Description:
Patients from HIV clinics with documented infections
Treatment:
Device: In Vitro Diagnostic Device
High Risk for Infection with HIV
Description:
Patients from defined HIV high-risk populations - i.e. intravenous drug users, or patients presenting with symptoms of sexually transmitted disease.
Treatment:
Device: In Vitro Diagnostic Device
Low-Risk for Infection with HIV
Description:
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…
Treatment:
Device: In Vitro Diagnostic Device

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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