Public Health and Environmental Laboratories

Harvest Order Choice: 40002

Synonyms: Hologic APTIMA Assay for Neisseria gonorrhoeae

Program: Automated Assays

Unit: STD

Useful For: Qualitative detection of ribosomal RNA (rRNA) from Neisseria gonorrheae (GC) to aid in the diagnosis of gonorrheal disease

Method: NAAT / TMA (transcription mediated amplification)

Charge: $7.00

Request Form: BACT-24

Container/ Tube: Hologic APTIMA Unisex Swab or Hologic APTIMA Urine transport tube supplied in the Hologic APTIA Collection Kits

Type: Female endocervical swab, male urethral swab, female and male urine, throat or rectal swab specimens, collected using Hologic APTIMA Specimen Collection Kits

Volume: Inoculated swab in 2.9 mL of transport media or 2 mL urine added to 2.0 mL of transport media

Collection Instructions:

Urethral:

• Patients should be instructed not to urinate for at least 1 hour prior to samplecollection.
• Insert the unisex collection swab (blue shafted swab in package with green printing) 2 to 4 cm into the urethra.
• Gently rotate swab clockwise for 2 to 3 seconds in urethra to ensure adequate sampling.
• Withdraw the swab carefully.
• Remove the cap from the Hologic APTIMA transport tube and immediately place specimen collection swab into the transport tube being careful not to spill the liquid transport media.
  Carefully break the swab against the side of the tube at the score line and discard the top portion of the shaft; use care to avoid splashing of the contents.
• Re-cap the swab specimen transport tube tightly.

Endo-Cervical:

• Remove excess mucus from the cervical os and surrounding mucosa using the white shafted cleaning swab provided in the Hologic APTIMA unisex collection kit (enclosed in package with red printing) and then discard the swab.
• Insert the unisex specimen collection swab (blue shafted swab in package with green printing) into the endocervical canal.
• Gently rotate the swab clockwise for 10 to 30 seconds in the endocervical canal to ensure adequate sampling.
• Withdraw the swab carefully; avoid any contact with the vaginal mucosa.
• Remove the cap from the Hologic APTIMA swab specimen transport tube and immediately place the specimen collection swab in to the transport tube being careful not to spill any of the liquid transport media from the tube.
• Carefully break the swab against the side of the tube at the score line and discard the top portion of the shaft; use care to avoid splashing of the contents.
• Re-cap the swab specimen transport tube tightly.

Urine:

• Patients should be instructed not to urinate for at least 1 hour prior to sample collection.
• Direct patient to provide a first-catch urine sample (approximately 20 to 30 ml of the initial urine stream) into a urine collection cup free of any preservatives. Collection of larger volumes of urine may result in specimen dilution that may reduce test sensitivity.
• Female patients should not cleanse the labial area prior to providing the specimen.
• Remove the cap from the Hologic APTIMA Urine transport tube, being careful not to spill any of the liquid transport media, and transfer 2 ml of urine into the transport tube using the disposable pipette provided in the collection kit. The correct volume of urine has been added when the fluid level is between the black fill lines on the urine transport
  tube label.
• Re-cap the urine specimen transport tube tightly. This is now known as the processedurine specimen.

Storage:
Swab specimens: must be transported to the laboratory in the swab specimen transport medium and tube from the appropriate collection kit; must be stored and transported to the laboratory at 2° to 30° C and tested within 60 days of collection Urine specimens: The urine specimens must be transferred into the specimen transport tube within 24 hours of collection, and must be transported to the laboratory in the Hologic APTIMA Urine specimen transport tube.  Specimens must be stored and transported to the laboratory at 2° to 30° C and tested within 30 days of collection.

Causes for Rejection: Expired specimen collection kit, no name or unique identifier on the specimen tube, specimen collection kit other than Hologic APTIMA collection kits, labeling discrepancies, improper specimen collection swabs, multiple specimen collection swabs, no specimen collection swab, leakage, breakage, improper level of transport media and/ or urine in specimen collection tube, cap on specimen tube other than the cap supplied with the kit. Outdated specimens (swab specimens collected more than 60 days prior to receipt at our
facility, or urine specimens collected more than 30 days prior to receipt at our facility) and not indicated as being frozen at the clinic during the delay in transport to our facility. (Also
Frozen swab or urine specimens collected more than 90 days prior to receipt at our facility).

Interpretation: Assay test results are automatically interpreted by the APTIMA Assay Software using the GC protocol.  A test result may be negative, equivocal, positive, or invalid as determined by total RLU (relative light units) in the detection step.  Test results should be interpreted in conjunction with the patient’s clinical presentation and other clinical data. Positive results in low-prevalence populations should be interpreted with careful consideration.

Reference Interval: Negative

Limitations: The APTIMA GC Assay provides qualitative results. Therefore, a correlation cannot be drawn between the magnitude of a positive assay signal and the number of organisms in a specimen; A negative result does not preclude a possible infection because results are dependent on adequate specimen collection. 
Results from the APTIMA GC Assay should be interpreted in conjunction with other laboratory and clinical data available to the clinician; Therapeutic failure or success cannot be determined with the APTIMA GC Assay since nucleic acid may persist following appropriate antimicrobial therapy; Reliable results are dependent on adequate specimen collection.
The APTIMA GC Assay is not intended for the evaluation of suspected sexual abuse or for other medico-legal indications. For those patients for whom a false positive result may have adverse psycho-social impact, CDC recommends re-testing by a method using an alternate technology.

Availability: N/A