Neisseria gonorrhoeae TMA !!! NOTE: The contents are valid only for: 06/05/2025 !!!

WSLH Department: CDD - Communicable Disease Division
WSLH Test Code: SC00122
Day(s) Performed:

Daily, Monday - Friday

Turn-around Time:

1-3 Days

Recommended Uses:

Screening of individuals at risk of STIs, including symptomatic individuals, contacts of STI patients, and individuals with multiple sex partners. (Contact the Laboratory or the Wisconsin Department of Public Health for current selective screening criteria and testing recommendations.)

Pre-approval:

N

Contraindications:

Non-culture tests like this are not recommended for medico-legal use (sexual abuse/assault) or for post-treatment assessment ("test of cure"). Swab specimens collected from sites other than those listed here or using swabs or kits other than those supplied for this assay will be rejected. Specimen (other than urine) received with no swab will be rejected. Female urine is recommended only if a pelvic exam will not be performed. The performance of this test has not been evaluated in specimens for patients less than 14 years of age and these specimens will not be tested.

Additional Tests Performed:
Preparation for Collection:

Patients should not urinate for at least one hour prior to urine collection.

Specimen Requirements:

Approved specimens: Clinician collected and patient collected vaginal swabs, clinician collected endocervical, throat or rectal swabs, and urine. Specimens from both symptomatic and asymptomatic patients are accepted.

Collection Instructions:

Follow instructions included with kit. Use only the collection materials supplied for this assay (with the exception of the primary urine collection device, not supplied.) 

Collection Kit/Container:
Requisition Form:
Required Information:

Clinical information regarding symptoms and onset must be provided. 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:

Specimens that have not been handled as described above will be rejected. Most common reasons for rejection include insufficient patient identifiers and extended time between collection and receipt in the lab.

Specimen Handling:

Prompt testing is highly recommended. 

Urogenital swabs must be stored and transported at 2-30°C for up to 60 days or frozen (-20 to -70°C) within 7 days and analyzed within 12 months of collection. 

Oral and rectal swabs must be stored and transported at 4-30°C or frozen (-20 to -70°C) and analyzed within 60 days of collection. 

Urine must be transferred to Aptima Urine Collection Kits within 24 hours and be within the fill lines on the tube. From there specimens should be stored and transported at 2-30°C and analyzed within 30 days or frozen (-20 to -70°C) within 7 days and analyzed within 12 months of collection.

Swab and urine specimens placed in collection kits may be transported to the laboratory at ambient temperatures. Use pressure-resistant bags as inner packaging for liquid (urine and swab) specimens. Avoid temperature extremes.

Packaging Requirements:

Category B Shipping 

Use pressure-resistant bags as inner packaging for liquid (urine and swab) specimens. 

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:

No Neisseria gonorrhoeae rRNA detected or Neisseria gonorrhoeae rRNA detected, Equivocal, and Invalid

Limitations:

Positive results in low prevalence populations should be interpreted carefully in conjunction with available clinical and risk information. Improper specimen collection and handling may compromise assay performance. A negative test does not exclude the possibility of infection. Identification of gonorrhoea does not rule out the possibility of additional causes of symptoms.

Therapeutic failure or success, and patient infectivity cannot be determined with the Aptima Combo 2 Assay since nucleic acid may persist in the absence of viable organisms.

Additional Tests Recommended:

Additional testing may be recommended in cases where false-positive or false-negative results could lead to adverse medical or psychological consequences. 

Chlamydia trachomatis TMA SC00128

HIV-1/HIV-2 Diagnostic Algorithm SS00095

Syphilis Diagnostic Algorithm SS02016

Trichomonas vaginalis TMA SC00201

Additional Comments:
Methodology:

Nucleic Acid Amplification Test (NAAT) using the Hologic Panther real-time probe based transcription mediated amplification (TMA) assay

Includes:

Amplification and qualitative detection of Neisseria gonorrhoeae nucleic acid from urogenital and extragenital sites. 

Regulatory Compliance:
CPT Code: 87591
Price: $39.00
Fee Exempt Eligible:

Yes, for those meeting DHS selective screening criteria only

Billing and Revenue Office:

1-800-862-1065 arbill@slh.wisc.edu

!!! NOTE: The contents are valid only for: 06/05/2025 !!!