This is a qualitative Transcription-Mediated Amplification Test intended to aid in the diagnosis of gonococcal urogenital disease.

This assay has not been evaluated for patients under the age of 14.

This assay is not intended for the evaluation of suspected sexual abuse or for other medico-legal indications.

Patients should avoid urinating for at least one hour prior to sample collection.

For urine specimens:

• Direct patient to provide a first-catch urine (approximately 20-30 mL of initial urine stream) into a urine collection cup.
• Minimum volume = 2mL
• Maximum volume = 30mL (>30 mL may reduce the sensitivity of the test)
   

Swab

• Swab placed in an Aptima Specimen Transport Tube at 2-30°C.

• Transfer 2.0mL of urine from the primary collection container to the Aptima Urine Specimen Collection Kit within 24hrs and transport at 2-30°C.  Liquid level must be between fill lines on tube.

• Urine collected at the AWH campus may be transported to the laboratory in the primary collection container.

• Transport specimen in an Aptima Specimen Transfer Tube at 2-30°C.  

Swab

• Swabs not in an Aptima Specimen Collection Kit.
• White swab from the Aptima Unisex Swab kit.

• Urine outside of an Aptima Urine Specimen Transport Container >24hrs
• Urine outside of the indicated fill volume.

• Specimens other than ThinPrep or SurePath liquid based cytology.

Swab in Aptima Swab Specimen Transport Tube
Ambient 2 months
Refrigerated 2 months
Frozen 1 year

Urine in Aptima Urine Specimen Transport Tube
Ambient 1 month
Refrigerated 1 month
Frozen 1 year

Liquid Cytology Specimen in Aptima Transport Tube
Ambient 14 days
Refrigerated 1 month
Frozen 1 year

• Specimens intended for GC testing must be transferred to an Aptima Specimen Transfer tube within 30 days of collection when stored at 2ºC to 30ºC.
• Specimens must be transferred before cytology processing if using a processor other than the ThinPrep 2000/3000 system.
• Specimens transferred to an Aptima Specimen Transfer tube post analysis on the ThinPrep 2000/3000 System must adhere to the cytology processing procedure in the Aptima Specimen Transfer Kit package insert which involves bleaching and removing filters in between specimens.

Negative or Positive

This test is performed on Hologic's Panther system using Aptima Combo 2 Assay which replicates a specific region of the 16s rRNA from GC.

Careful consideration of a positive result is recommended when interpreting individuals in low prevalence populations.

A negative result does not preclude the presence of a GC infection because results are dependent upon adequate specimen collection, absence of inhibitors, and sufficient rRNA to be detected. A positive result obtained from a patient after theraputic treatment cannot be interpreted as indicating the presence of viable GC.

Culture is recommended as the standard for detection of Neisseria gonorrhoeae in suspected sexual abuse or medic-legal indications.

First catch urine from women might detect up to 10% fewer infections when compared with endocervical swab samples.

>30 mLs of urine collected may decrease the sensitivity of the assay.

This assay has not been evaluated for patients under the age of 14.

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