Abbott ARCHITECT Syphilis Testing
The number of U.S. cases of of primary and secondary syphilis increased 66.7% from 2011 to 2015. The Abbott™ ARCHITECT™ Syphilis Treponemal Test provides an automated method for detecting IgG and IgM antibodies to aid in the diagnosis of syphilis infection. Using the ARCHITECT treponemal tests, labs can increase the likelihood of detecting infections in the primary and latent stages, and will see a decreasing number of false positive results.
- ARCHITECT Syphilis Package Insert (G5-6810/R01)
- Syphilis, Centers for Disease Control and Prevention web page, https://www.cdc.gov/std/stats15/syphilis.htm. Accessed: 10 Feb 2017.
Intended Use and Important Safety Information
For In Vitro Diagnostic Use
Intended Use: The ARCHITECT Syphilis TP Assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of antibodies (IgG and IgM) directed against Treponema pallidum (TP) in human serum and plasma. The ARCHITECT Syphilis TP Assay is intended to be used as an initial diagnostic test or in conjunction with a nontreponemal laboratory test and clinical findings to aid in the diagnosis of syphilis infection.
The ARCHITECT Syphilis TP Assay is not intended for use in screening blood, plasma, or tissue donors since the effectiveness of the assay for this use has not been established.
Carefully follow the package insert instructions. The reliability of assay results cannot be guaranteed if there are any deviations from the package insert instructions.
United States Federal Law restricts this device to sale and distribution by or on the order of a physician, or to a clinical laboratory; and use is restricted to, by, or on the order of a physician.
Important Safety Information
- Chemical Hazards: This product contains sodium azide, which has been reported to form lead or copper azide on laboratory plumbing. These azides can explode upon percussion, such as hammering. To prevent formation of lead or copper azide, flush drains thoroughly with water after disposing of solutions containing sodium azide.
- Biohazards: This product contains human-sourced and/or potentially infectious components and must be handled in accordance with the OSHA Standard on Bloodborne Pathogens.