Description
Regulatory Status: CLIA Waived for Oral Fluid Whole Blood
Contents: (20) Test Cassettes, (20) Disposable plastic fixed volume pipettes, (1) 5mL Diluent Bottle, Package Insert
Determinations: Terponemal Antibody (Syphilis)
Storage Requirements: 2° – 27° C (35°-80° F)
Processing Time: 20 Minutes
Orasure Syphilis Test
Syphilis Health Check is a rapid qualitative screening test for detection of human antibodies to TP in serum, plasma or
whole blood. The method employs a unique combination of anti-human immunoglobulins gold conjugate and highly purified TP recombinant proteins to specifically detect anti-TP antibodies.
As the samples flow through the absorbent device, the anti-human immunoglobulins/protein A dye conjugate binds to the
human immunoglobulins forming an antigen-antibody complex. This complex binds to the recombinant protein in the
positive reaction zone and produces a pink-rose colored band. In the absence of anti TP antibodies, there is no line in the
positive reaction zone. The reaction mixture continues flowing through the absorbent device past the reaction and control
zones. Unbound conjugate binds to the reagents in the control zone producing a pink-rose color band, demonstrating that the reagents are functioning correctly.
- 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.
Catalog Numbers
- 1001-0698 – Tests
- 1001-0699 – Controls
Reimbursement Information
- CPT Code: 86780QW *
