Diphtheria Toxin and Corynebacterium PCR !!! NOTE: The contents are valid only for: 10/09/2026 !!!
| WSLH Department: | CDD - Communicable Disease Division |
| WSLH Test Code: | MP00381 |
| Day(s) Performed: | Monday-Friday |
| Turn-around Time: | 1-3 business days |
| Recommended Uses: | Detection of the diphtheria toxin gene from Corynebacterium diphtheriae, Corynebacterium ulcerans, and Corynebacterium pseudotuberculosis isolates |
| Pre-approval: | No |
| Contraindications: | Testing is performed on clinical isolates. |
| Additional Tests Performed: |
Isolates that test positive for the toxin gene will be forwarded to CDC for confirmatory Elek testing. |
| Preparation for Collection: | |
| Specimen Requirements: | Isolate: C. diphtheriae, C. ulcerans, C pseudotuberculosis |
| Collection Instructions: | |
| 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 which is required to have a minimum of two identifiers. |
| Rejection Criteria: | Clinical specimens will not be tested. |
| Specimen Handling: | Isolates may be stored and transported at ambient temperatures. |
| Packaging Requirements: | |
| Courier Information: | Isolates submitted for public health surveillance or outbreak investigations are eligible for fee-exempt courier service. Use the Purple Mountain portal for specimen pick up (in Wisconsin) or use the VPD FedEx account if sending from out of state. |
| Specimen Receiving Hours: | Monday-Friday 6:00 AM - 4:30 PM, Saturday 6:30 AM - 12:30 PM |
| Results Include: | C. diphtheriae DNA detected/not detected, C. ulcerans/C. pseudotuberculosis DNA detected/not detected, Diphtheria toxin gene detected/not detected |
| Limitations: | Due to the relatedness of C. ulcerans and C. pseudotuberculosis, the gene targets are the same for these organisms and they will be reported as C. ulcerans/pseudotuberculosis. Some Corynebacterium isolates are known to be Non-Toxigenic Tox Bearing (NTTB); they have the toxin gene but do not actively produce toxin. This PCR test is unable to discriminate NTTB from tox-expressing Corynebacterium; therefore, if a tox-positive isolate is detected, the isolate will be forwarded to CDC for Elek toxin production testing. |
| Additional Tests Recommended: | Isolates that test positive for Diphtheria toxin gene will be forwarded for Elek test to confirm the presence of toxin. |
| Additional Comments: | |
| Methodology: | Real-time PCR |
| Includes: | Identification of C. diphtheriae and C. ulcerans/pseudotuberculosis. Identification of Diphtheriae toxin gene. |
| Regulatory Compliance: | |
| CPT Code: | 87798 |
| Price: | $225.00 |
| Fee Exempt Eligible: | Yes, if submitted for public health surveillance or outbreak investigations |
| Billing and Revenue Office: | 1-800-862-1065 arbill@slh.wisc.edu |