Run twice weekly

1-4 days

Indicated for use with symptomatic individuals, particularly those who have failed empiric therapy for other STIs and individuals with sex partners positive for Mycoplasma genitalium.

N

Non-culture tests like this are not recommended for medico-legal use (sexual abuse/assault) or for post-treatment assessment ("test of cure").

The performance of this test has not been evaluated in specimens for patients less than 15 years of age.

Clinician collected and patient collected vaginal swabs, clinician collected endocervical swabs, and urine. Urine must be transferred to Aptima Urine Collection Kits within 24 hours and be within the fill lines on the tube.

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.)

27 Yellow - Aptima Urine Collection Kit

29 Orange - Aptima Multitest Swab Collection Kit

29E White - Aptima Unisex Swab Collection kit

CDD Requisition Form A

CDD STI Requisition Form

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.

Swab specimens collected from sites other than those listed here will not be tested. Specimens collected using swabs or kits other than those supplied for this assay will be rejected. Specimens (other than urine) received with no swab will be rejected. Specimens from patients <15 years of age will be rejected.

Prompt shipment is highly recommended. 

Urogenital swabs should 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 90 days of collection.

Urine must be transferred to Aptima Urine Collection Kits within 24 hours and be within the fill lines on the tube. Urine should be stored and transported between 2-30°C and analyzed within 30 days or frozen (-20 to -70°C) within 7 days and analyzed within 90 days 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. To avoid temperature extremes, package in a cooler with a frozen cold pack.

Category B Shipping

Use pressure-resistant bags as inner packaging. To avoid temperature extremes, package in a cooler with a frozen ice pack.

This test is not eligible for fee-exempt courier service.

Monday-Friday 7:45 AM - 4:30 PM, Saturday 7:45 AM - 12:00 PM

No Mycoplasma genitalium rRNA detected or Mycoplasma genitalium rRNA detected, Equivocal, and Invalid

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 Mycoplasma genitalium does not rule out the possibility of additional causes of symptoms. Therapeutic failure or success, and patient infectivity cannot be determined with the Aptima Mycoplasma genitalium Assay since nucleic acid may persist in the absence of viable organisms.

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

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

Amplification and qualitative detection of Mycoplasma genitalium nucleic acid from urogenital sites.

FDA Approved

N

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