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.
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.
Highly accurate: 98.0% sensitivity, 97.2% specificity; reads for both IgM and IgG.
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.
Can be used with people ages 13 years and older.
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.
*OraSure provides information regarding reimbursement (including, in some instances, potentially applicable CPT, HCPCS and/or analogous state or local codes or designations) for background purposes only. It does not constitute legal advice or a recommendation regarding clinical practice. Information provided is gathered from third-party sources and is subject to change without notice. The provider has the responsibility to determine medical necessity and to submit appropriate codes and charges for care provided. Any decision regarding specific coding is at the discretion of the healthcare professional, and provision of this information does not guarantee or facilitate reimbursement. OraSure makes no guarantee that the use of this information will prevent differences of opinion or disputes with Medicare or other payers as to the correct form of billing or the amount that will be paid to providers of service. Please contact your Medicare contractor, insurance provider, other payers, reimbursement specialists and/or legal counsel for interpretation of coding, coverage and payment policies or specific billing questions or concerns. Nothing herein is intended to promote or facilitate the purchase or use of products outside of their approved or cleared indications, and appropriate use of products should be based on the healthcare professional’s medical judgment.
