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Eligible Submitters |
āTest is available to all pre-approved submitters within the state of California. It is preferred that submissions from clinical laboratories are routed through the corresponding county public health laboratories (PHL). For submissions from out-of-state, please refer to the APHL TB DST Reference Center websiteā. For any questions on service eligibility, please contact CDPHTBDST@cdph.ca.gov.ā
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āTāest Māāāeāthāāoāādāāāologāyāāā
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āWhole Genome Sequencing (WGS)-based genotyping of Mycobacterium tuberculosis complex (MTBC) cultures is performed for submission of raw WGS data to the National TB Surveillance system. The WGS-genotyping assay leverages Illumina next generation sequencing technology to sequence the entire genome of the microorganism. WGS data will be transferred to the Centers for Disease Control and Prevention (CDC) where it will be analyzed; CDC is responsible for sharing the genotyping analysis results with the pertinent public health jurisdiction. MDL will be contacting the submitter if the successful WGS cannot be obtained for the submitted culture.
āPlease contact the laboratory for more information on the method. ā
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Reflex Testing
Criteria |
Noneā
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Pāāāāre-āAāpproval Requiredā |
āPre-approval is not required except when requesting testing for the following: Duplicate submission, i.e., samples from the same patient collected within 3 months from prior collection date.āā
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Suppālemāental Information and Required Form(s)ā |
āUse
MDL Lab Web Portal for ordering the test, select Test Requisition āMycobacteriology-Drug Susceptibility Testing of MTBC (CA only)-444ā. Barcode submittal form (PDF) is currently not available for ordering WGS-DST assay. Please contact the laboratory if experiencing difficulties submitting the order.ā
āāPlease include submitterās test results on the submittal form.ā
āā
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Required Specimen Type(s)
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āāCulture on LJ (solid) or in BACTEC MGIT (liquid) media. Culture submitted on other types of media will be subcultured at MDL which will extend turnaround time. ā
Pure cultures with visible biomass are required.
āāSubmission of mixed or non-viable cultures, as well as primary specimens, is NOT acceptable for WGS-genotyping.
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Miniāāāmumāā Volume Required |
āāCulture in broth: 0.5 mL; 1.0 mL is preferred. Culture should have visible growth (recommended amount: equivalent to approximately 10ul of spun down biomass in a microcentrifuge tube).
Culture on solid media: visible growth (preferably equivalent to heaping 1 Āµl loopful of culture).
Cultures with insufficient amount of biomass would need to be incubated at MDL further, which will extend turnaround time.
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Specimen Stability
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āCultures:
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Room Temp (20Ā° - 25Ā°C): up to 12 weeks from subculture date.
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Refrigerated (2 ā 8Ā°C): up to 12 weeks from subculture date.
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Frozen (0Ā°C and below): subculture prior to submission.
āSubculture prior to submission if culture was not kept at appropriate temperature or if age exceeds 12 weeks and submit fresh culture once sufficient growth is obtained.ā
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āRejectionā Criteria
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- āāāSamples with insufficient or conflicting labelling
- Leaking samples
- Samples with insufficient quantities
- Samples that are too old
- Samples improperly stored or transported
- Specimen/sample types not meeting acceptance criteria
- Duplicate submission, i.e., samples from the same patient collected within 3 months from prior collection date, if no prior approval was receivedā
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Storage/Transport Conditions āāā
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āāCultures: Grow isolate under appropriate conditions. Isolates may be stored under refrigeration or at ambient temperature (2Ā° - 25Ā°C) prior to shipping.
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Transport Medium,ā
if applicable
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Not applicable
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Specimāen Labeling |
Two identifiers, including patient full name, and at least one other identifier (specimen accession number, date of birth, medical record number)
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Shipping Instructions and Specimen Handling Requirements
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āShip at temperature 2Ā° - 25Ā°C (do not freeze).
Follow the appropriate DOT/IATA approved shipping procedures. ā
Suspected or confirmed MTBC cultures should be shipped as a Category A Infectious Substance, Affecting Humans (UN2814āā).ā
Ensure that culture isolates are sent in media flask or tubes containing a screw-top cap that is additionally sealed with parafilm or tape for additional protection against leaking.
Ship to: California Departāment of Public Healthā
Microbial Diseases Laboratory ā
ATTN: TB Drug Susceptibility Testing Unit āā
850 Marina Bay Parkway, Specimen Receiving Room B106
Richmond, CA 94804ā
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Specimen Collection Instructions, if applicable
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Not applicable |
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Turnaround Time |
7-14 days
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Interferāences & Limitations |
āResults may be delayed or unattainable if mixed culture is submitted.
Submission of culture on the media types other than listed under sample requirements or submission of cultures with scant growth will delay testing and availability of the results.
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Reference Range |
Not applicable
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Additional Information |
āā An isolate from all patients with newly diagnosed culture-positive TB should be submitted for WGS genotyping.
Submitters should NOT submit isolates from the same patient to both MDL and the Michigan State PHL (National TB Genotyping Laboratory) to avoid duplication.
Isolates that are tested at MDL will be forwarded to the CDC if further characterization is needed or requested.
If TB WGS-based Drug Susceptibility Testing (DST) is needed, please indicate it as a requested test on the form 444; additional information is available under the
corresponding testā on the service menu.
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MDL āPoint of Contact |
For questions regarding submissions, please email
CDPHTBDST@cdph.ca.govāā or call the Mycobacterial, Mycotic, and Parasitic Diseases Section (MMPDS) at (510) 412-3929āā
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