Proper Name: N/A
Tradename: DPP HIV-Syphilis System
Manufacturer: Chembio Diagnostic Systems, Inc.
- The DPP® HIV-Syphilis System is a single-use rapid, qualitative, multiplex, immunoassay for the detection of antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1/2), and/or Treponema pallidum bacteria (the causative agent of syphilis) in fingerstick whole blood, potassium-EDTA venous whole blood or potassium-EDTA plasma specimens.
- The test is intended to be used with the DPP Micro Reader.
- The test is intended for use by trained professionals in point of care and laboratory settings to aid in the diagnosis of HIV and syphilis infection.
- This test is suitable for use in multi-test algorithms designed for the statistical validation of rapid HIV test results and when multiple rapid HIV tests are available.
- The test is intended to be used as the first-tier assay in the reverse sequence syphilis screening algorithm to aid in the detection of infection with T. pallidum. A diagnosis of syphilis must be made in the context of treponemal and non-treponemal test results and in conjunction with clinical findings.
- This test is not intended for use as a confirmatory test in the “reverse sequence syphilis screening algorithm.”
- The results of DPP HIV-Syphilis test are read and interpreted only by DPP Micro Reader with dedicated software.
- The test is not intended for use in screening blood, blood products, or human cells or tissue or cellular and tissue-based products (HCT/Ps) for HIV and Syphilis.
- Indications For Use - DPP HIV-Syphilis System
- Package Insert - DPP HIV-Syphilis Reactive/Nonreactive Controls
- October 1, 2020 Approval Order - DPP HIV-Syphilis System
- Summary of Safety and Effectiveness - DPP HIV-Syphilis System