Syphilis Diagnostic Algorithm
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| WSLH Department: | CDD - Communicable Disease Division |
| WSLH Test Code: | SS02016 |
| Day(s) Performed: | Daily, Monday - Friday |
| Turn-around Time: | 1-4 days |
| Recommended Uses: | Screening test to aid in the diagnosis of syphilis infection. |
| Pre-approval: | N |
| Contraindications: | Not intended for use in screening blood or plasma donors. Patients with past infection will remain CMIA and TP-PA reactive for life even with successful treatment. This test is not recommended to evaluate for re-infection. Refer to Syphilis VDRL (Post-treatment) SS02019. |
| Additional Tests Performed: |
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. Reflex testing is automatic and will incur additional charges. |
| Preparation for Collection: | |
| Specimen Requirements: | 3 ml of serum (1 ml minimum) or 7-10 ml vacutainer, no additives |
| Collection Instructions: | Routine blood draw |
| Collection Kit/Container: |
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| Requisition Form: |
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| 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. |
| Rejection Criteria: | Specimens stored longer than 7 days at 2-8°C are unacceptable for testing. |
| Specimen Handling: | Specimens must be stored refrigerated (2-8°C) and transported with frozen cold packs. Freeze serum if testing will not be performed within 7 days of collection and ship with dry ice. |
| Packaging Requirements: | |
| Courier Information: | This test is not eligible for fee-exempt courier service. |
| Specimen Receiving Hours: | Monday-Friday 7:45 AM - 4:30 PM, Saturday 7:45 AM - 12:00 PM |
| 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 and TP-PA tests cannot distinguish between active and treated infection, and should not be used alone to determine response to therapy, relapse, current infection status, 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: |
| Methodology: | Chemiluminescent microparticle immunoassay (CMIA) |
| Includes: | CMIA: Qualitative immunoassay for IgG and IgM antibodies to Treponema pallidum VDRL: Quantitative microflocculation assay for the detection of nontreponemal (reagin) antibodies; titer on reactives TP-PA: Qualitative gelatin particle agglutination test for the detection of Treponema pallidum antibodies |
| Regulatory Compliance: |
| CPT Code: | 86780 |
| Price: | $22.00, Additional charges will incur based on algorithm |
| Fee Exempt Eligible: | Yes, with DHS approval only, 608-267-9003 |
| Billing and Revenue Office: | 1-800-862-1065 arbill@slh.wisc.edu |