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DPP HIV-Syphilis System

PMA: BP180191
Proper Name: N/A
Tradename: DPP HIV-Syphilis System
Manufacturer: Chembio Diagnostic Systems, Inc.
Indication:

  • 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.

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