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OraSure Diagnostics Direct Syphilis Health Check™ Rapid Test
$199.99
This item may require 5-7 business days to ship out from our facility.
Key Benefits:
- 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.
| Tests/Box | 20 |
| Type | Immunochromatographic assay |
| Time to results | 10 minutes |
| Sensitivity | 98% |
| Specificity | 97.2% |
| Detectable analytes | T. pallidum |
| Format | Cassette read procedure |
| Sample type |
Anterior nasal swab |
| External controls | Not Included |
| CLIA complexity | Waived |
| CPT code | 86780-QW |
| FDA authorization | 501(k) |