Eligible
Submitters | Test is available to all pre-approved submitters within the state of California. Submissions from clinical laboratories should route through the corresponding county public health laboratories (PHL).
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Test Methodology
| Neisseria gonorrhoeae (GC) Antibiotic Susceptibility Testing (AST) for Azithromycin, Ceftriaxone, Cefixime, and Ciprofloxacin
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Reflex Testing
Criteria
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bioMérieux Etest Gradient Strip (“GC Etest”)
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Pre-Approval
Required
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Pre-Approval for isolates meeting one of following is
not required:
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N. gonorrhoeae isolates with decreased susceptibility to cefixime (MIC ≥0.25 µg/mL), ceftriaxone (MIC ≥0.125 µg/mL), or azithromycin (MIC >16.0 µg/mL).
- N. gonorrhoeae isolates from suspected treatment failures (Clinical Guidelines for Gonorrhea Treatment and Management of Suspected Treatment Failure PDF) and isolated from sites, including but not limited to urethra, endocervix/vagina, rectum, pharynx, blood, synovial fluid, and eye.
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N. gonorrhoeae isolates from disseminated gonococcal infections (DGI).
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N. gonorrhoeae isolates from ocular infections.
Pre-approval for other
N. gonorrhoeae isolates is required. Please contact STD program at stdcb_argc@cdph.ca.gov.
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Supplemental Information and Required Form(s)
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Use MDL Lab Web Portal for ordering the test, select Test Requisition form “Antimicrobial Susceptibility Testing– AST”.
Test Requested: Neisseria gonorrhoeae Antimicrobial Susceptibility Testing (AST)
For submitters who do not have access to the MDL LWP; please contact MDL.Submissions@CDPH.ca.gov for additional information.
Gradient Strip (GC Etest) Neisseria gonorrhoeae Antimicrobial Susceptibility Testing Services Frequently Asked Questions (FAQ)
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Required Specimen/ Sample Type(s)
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Pure, fresh culture of N. gonorrhoeae submitted on chocolate or modified Thayer Martin media supporting growth of
N. gonorrhoeae.
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Minimum Volume Required
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Not applicable
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Specimen Stability
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Prepare culture for transportation: First, obtain fresh culture by growing a pure
N. gonorrhoeae isolate at 35°C in 5% CO2 on suitable media for gonorrhea (such as chocolate agar or modified Thayer-Martin) for 24-48 hours, until obtain visible growth. Then, prepare and submit the culture fresh (24-72 hr) at time of shipping. Three options are recommended.
- To ship using an agar slant: Heavily inoculate a chocolate (or other suitable media for GC) slant with fresh growth. Incubate at 35°C with 5% CO2 until you see visible growth (18 – 24 hours is ideal). Then close cap tightly and ship at ambient temperature.
- To ship using an agar plate: Heavily inoculate a chocolate (or other suitable media for GC) plate with fresh growth. Incubate at 35°C with 5% CO2 until you see visible growth (18 – 24 hours is ideal). Then seal the plate lid tightly with parafilm and place the plate in zip lock biohazard bag and ship at ambient temperature.
- To ship using a frozen cryotube with TSB and 15% glycerol: Heavily inoculate a cryotube with fresh growth. Immediately place in a -60°C or lower freezer. Once the isolate is fully frozen, ship the isolate on dry ice.
Refer to ‘Specimen preparation for transport’ instructions in
Disseminated Gonococcal Infection (DGI) Guidance for Laboratories for details.
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Rejection Criteria
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- Isolate submissions with insufficient or conflicting labelling
- Broken or leaking samples
- Samples with insufficient quantities or growth
- Isolates that are too old or non-viable
- Specimen/sample types not meeting acceptance criteria (see FAQ), if no prior approval was received
- Mixed cultures
- Primary patient samples
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Storage/Transport Conditions
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Culture isolates may be shipped at ambient temperature or frozen in TSB with 15% glycerol on dry ice.
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Transport Medium,
if applicable
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Not applicable
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Specimen Labeling
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Testing subject to CLIA regulations. Minimum label requirement includes a patient’s first and last name and one other identifier (e.g. preferably submitter sample ID, or patient medical record number, or patient date of birth) on the specimen container and the test requisition.
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Shipping Instructions and Specimen Handling Requirements
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Ship isolates grown on media that supports
N. gonorrhoeae at ambient temperature or ship cultures frozen in TSB with 15% glycerol on dry ice.
The shipper is responsible for making sure that all samples and specimens are packaged and shipped according to current federal and state packaging and shipping regulations for Category A infectious substance and/or Category B diagnostic samples.
Ship to: California Department of Public Health
Microbial Diseases Laboratory
ATTN: Bacterial Diseases Section
850 Marina Bay Parkway, Specimen Receiving Room B106
Richmond, CA 94804
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Specimen Collection Instructions, if applicable
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Only pure, live cultures of
N. gonorrhoeae are acceptable for testing at MDL. Primary clinical specimens for culture isolation are not accepted by MDL at this time.
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Turnaround Time
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12 calendar days
Expedited testing may be available upon request.
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Interferences & Limitations
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Pure culture isolates must be viable for testing.
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Reference Range
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Not applicable
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Additional Information
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Gradient Strip (GC Etest) Neisseria gonorrhoeae Antimicrobial Susceptibility Testing Services Frequently Asked Questions (FAQ)
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MDL Point of Contact
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MDL- Reference Bacteriology Unit: (510) 412-3700
Email: MDLBDS@cdph.ca.gov
Monday-Friday 8 AM to 5 PM PT
Email: MDL.Submissions@CDPH.ca.gov
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