Syphilis Diagnostic Algorithm

WSLH Department: CDD - Communicable Disease Division
WSLH Test Code: SS02016
Availability: Daily, Monday - Friday
Turn-around Time: 1-4 days
Recommended Uses: Screening test to aid in the diagnosis of syphilis infection.
Contraindications: Not intended for use in screening blood or plasma donors.
Additional Tests Performed:
Patient Preparations: Routine blood draw.
Specimen Requirements: 3 ml of serum (1 ml minimum) or 7-10 ml vacutainer, no additives.
Specimen Handling & Transport: Specimens must be stored refrigerated (2-8C) and transported with frozen cool packs. Freeze serum if testing will not be performed within 7 days of collection and ship with dry ice.
Collection Kit/Container: Serology Specimens
Sterile Transfer Tube
Collection Instructions: Routine blood draw.
Unacceptable Conditions: Specimens stored longer than 7 days at 2-8 degrees C are unacceptable for testing.
Requisition Form: CDD Requisition Form B
Required Information: Laboratory regulations require the following minimum information to be provided on the requisition form for a specimen to be accepted for testing: Patient name or unique identifier; date and time of collection, patient date of birth and sex, specimen type/site of collection, test request(s), clinician name and UPIN, and address for reporting results. Please be certain that name/identifier on the form matches that on the specimen label.
Results Include: Non-reactive or Reactive (screening CMIA); Non-reactive or Reactive with a titer (VDRL); Non-reactive, Reactive, or Inconclusive (TP-PA) and final interpretation.
Limitations: The CMIA test cannot distinguish between active and treated infection, and therefore should not be used to determine response to therapy, relapse, or reinfection. Assay interference due to circulating antibodies against yaws, pinta, and bejel has not been evaluated. Cross-reactivity with these treponemal disease conditions is to be expected.
Additional Tests Recommended:
Additional Comments: CMIA reactive specimens are automatically tested with the Quantitative Syphilis VDRL assay. If the VDRL test is non-reactive, a second treponemal test (TP-PA) will automatically be performed.
Methodology: Chemiluminescent microparticle immunoassay (CMIA)
Includes: Qualitative immunoassay for IgG and IgM antibodies to Treponema pallidum. Quantitative Syphilis VDRL and Syphilis TP-PA antibody tests will be performed, if indicated, and additional charge(s) will be incurred.
CPT Code: 86780
Price: $21.00
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