OraSure Technologies Diagnostics Direct Syphilis Health Check™

Description

Syphilis Health Check is a reliable, user-friendly rapid test for the detection of Treponema pallidum (syphilis) antibodies. It is FDA cleared and CLIA Waived for use with fingerstick whole blood and delivers results with laboratory accuracy in 10 minutes.

• Rapid: Provides results in 10 minutes enabling patients to learn their status in a single visit and allows Syphilis positive patients to be connected to care while a lab test is completed for confirmed diagnosis.
• Flexible: CLIA-waived for fingerstick whole blood and offers the ability to test in non-traditional testing environments, such as outreach programs and mobile testing clinics. Ideal for both clinical and non-clinical settings. Please note, this test is not intended for use in screening blood or plasma donors.
• Accurate: Highly accurate: 98.0% sensitivity, 97.2% specificity; reads for both IgM and IgG.
• Simple: Can be easily read in all settings; no need for a reader. Walk-away procedure allows providers to batch tests, enabling more people to get tested, reducing indirect costs and improving turnaround time.
• Accessible: Can be used with people ages 13 years and older.
• Proven Results: Studies have verified the accuracy at all stages of infection including latent, which provides the ability to detect infection in pregnant people for identification of potential congenital syphilis at every trimester.

Specifications

• Content And Storage: 4°C to 30°C
• CE Marker: No
• Clia Complexity: Waived
• Detectable Analytes: T. pallidum
• Sensitivity: 98%
• Type: Syphilis Rapid Test
• Disposable: Single-use
• Quantity: 20 tests
• Specificity: 97.20%
• Test Time: 10 minutes
• Form: Ready-to-Use (RTU)
• Operating Temperature Range: 15°C to 30°C