Pre-Approval Required

No

Supplemental Information or Form

1. Pure, viable subculture
2. Completed submittal form with 2 patient identifiers (e.g. name and date of birth), collection date and source, a brief but complete patient history, cultural history and submitting laboratory’s findings
3. Documentation that indicates the role of this isolate in clinical disease
4. Form LAB 446

Performed on Specimens From

Nasopharynx or pharyngeal membrane, wound swab or aspiration

Acceptable Sample/Specimen Type for Testing

Confirmed or suspected Corynebacterium diphtheriae isolate

Minimum Volume Required

N/A

Storage & Preservation of Sample/Specimen Prior to Shipping

None

Transport

Tubed agar medium with a secured screw cap, labeled with patient’s name, date subcultured, and organism suspected

Sample/Specimen Labeling

None

Shipping Instructions which Include Specimen Handling Requirements

1. Grow isolate under appropriate conditions prior to shipping and verify purity
2. Ship at ambient temperature using appropriate DOT/IATA approved shipping procedures.

Test Methodology

As needed - Biochemical testing, Gene Sequencing by PCR, and/ or MALDI-TOF mass spectrometry, and subculture for referral to CDC if the isolate is confirmed as C. diphtheriae. Please note that referral to the CDC for diphtheria toxin testing will only be performed if the isolate is confirmed as C. diphtheriae

Turnaround Time

4 weeks

Interferences & Limitations

Mixed or nonviable culture

Additional Information

Please contact the MDL Bacterial Diseases Section (Reference Bacteriology Unit) for special consideration if any of the above criteria cannot be met.

MDL Points of Contact

Vaccine Preventable Pathogens & Molecular Bacteriology Unit: (510) 412-3700

Monday-Friday 8 AM to 5 PM PT

Email: MDL.Submissions@CDPH.ca.gov