Neisseria gonorrhoeae by Transcription Mediated Amplification (TMA)

CPT Code(s)

CPT 87591

Synonym(s)

Neisseria gonorrhoeae, NG

Performed

Molecular Diagnostics Laboratory

Clinical Indication and Relevance

The assay is useful to detect Neisseria gonorrhoeae from vaginal, penile meatal, rectal, throat (pharyngeal), endocervical, male urethral, and urine samples.

Methodology

The assay uses transcription mediated amplification (TMA) on the Hologic Panther system.

Minimum Specimen Requirements

Sample type:

Aptima Multitest Swab Specimen Collection Kit for vaginal, penile meatal, rectal, throat (pharyngeal) swabs
Aptima Unisex Swab Specimen Collection Kit for endocervical and male urethral swabs
Aptima Urine Specimen Collection Kit for male and female urine

Specimen Labeling

The specimen must be labeled with two identifiers at the time of collection. Examples of acceptable identifiers include but are not limited to: patient name, date of birth, hospital medical record number, accession number. A location (e.g., hospital room number) is not an acceptable identifier. Collection date and collector’s identifier are required.
A completed requisition form should be submitted with every sample and, at minimum, the following is required: ordering physician name, phone number, fax number, and patient’s name, identifying number of patient, patient sex, patient date of birth specimen type, collection date, tests requested, provisional diagnosis or clinical rationale for test, and billing information.

Transport:

Specimens can contain high levels of organisms. Specimens
must be shipped and transported in accordance with applicable local, national and international transportation regulations. Maintain proper storage conditions of 2-8°C during shipping to ensure integrity of the specimen.

Stability:

Swab specimens: After collection, transport and store the swab in the swab specimen transport tube at 2-30°C up to 60 days after collection.
Urine specimens: Transport to the lab at 2-30°C where it should be transferred to the Aptima urine specimen transport tube within 24 hours of collection.  Store Aptima urine specimen transport tube at 2-30°C and test within 30 days of collection.

Unacceptable Samples:

Improperly labeled or incorrect patient identification, specimen leaked,
incorrect media, specimen transport tube with no swab or two swabs, a cleaning swab or a swab not supplied by Hologic.  The Aptima Specimen Transfer Tube will not contain a swab.
For urine transport tubes, the liquid level must fall between the two black indicator lines on the tube label.
Specimen does not meet transport, storage or date of collection requirements.

Turnaround time

1-2 business days.