Neisseria gonorrhoeae (Gonorrhea)

Specimens are screened by a target amplification nucleic acid probe test that utilizes target capture for in vitro qualitative detection and differentiation of ribosomal Ribonucleic acid (RNA) (rRNA) from Chlamydia trachomatis and/or Neisseria gonorrhoeae

This test is only available to program approved sites.

Immunology

Target Amplification Nucleic Acid Probe

Urine Specimens: Use the Aptima Urine Specimen Collection kit. The patient should not have urinated for at least one hour prior to specimen collection. Direct the patient to provide a first catch urine (approximately 20 to 30 mL of the initial urine stream) into a urine collection cup which is free of any preservatives. Collection of larger volumes of urine may result in rRNA target dilution that may reduce test sensitivity. Female patients should not cleanse the labial area prior to providing the specimen. Remove the cap and transfer 2 mL of urine into the urine specimen transport tube using the disposable pipette provided. The correct volume of urine has been added when the fluid level is between the black fill lines on the urine transport tube label. Urine in primary collection container needs to be transferred within 24 hours. Recap the urine specimen transport tube tightly. This specimen is now referred to as the processed urine specimen.

Endocervical swab specimens: Use the Aptima Unisex Swab Collection kit. Remove excess mucus from the cervical os and surrounding mucosa using the cleaning swab (white shaft swab in the package). Discard this swab. Insert the specimen collection swab (blue shaft swab in the package) 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 swab specimen transport tube and immediately place the specimen collection swab into the transport tube. Carefully break the swab shaft at the score line; avoid splashing the contents. Recap the swab specimen transport tube tightly.

Male Urethral swab specimens: Use the Aptima Unisex Swab Collection kit. The patient should not have urinated for at least one hour prior to sample collection. Insert the specimen collection swab (blue shaft swab in the package) 2 to 4 cm into the urethra. Gently rotate the swab clockwise for 2 to 3 seconds in the urethra to ensure adequate sampling. Withdraw the swab carefully. Remove the cap from the swab specimen transport tube and immediately place the specimen collection swab into the specimen transport tube. Carefully break the swab shaft at the score line; avoid splashing the contents. Recap the swab specimen transport tube tightly.

Vaginal Specimens: Use the Aptima Multitest Swab Specimen Collection kit. Partially peel open the Aptima Multitest swab package. Remove the swab. Do not touch the soft tip or lay the swab down. If the soft tip is touched, the swab is laid down, or the swab is dropped, use a new Aptima Multitest Swab Specimen Collection kit. Hold the swab, placing your thumb and forefinger in the middle of the swab shaft covering the score line. Do not hold swab shaft below the score line. Carefully insert the swab into the vagina about 2 inches (5 cm) past the introitus and gently rotate the swab for 10 to 30 seconds. Make sure the swab touches the walls of the vagina so that moisture is absorbed by the swab. Withdraw the swab without touching the skin. While holding the swab in same hand, unscrew the cap from the tube. Do not spill the contents of the tube. If the contents of the tube are spilled, use a new Aptima Multitest Swab Specimen Collection kit. Immediately place the swab into the transport tube so that the score line is at the top of the tube. Carefully break the swab shaft against the side of the tube. Discard the top portion of the swab shaft. Tightly screw the cap onto the tube.

Rectal Specimens:: Use the Aptima Multitest Swab Specimen Collection kit. Partially peel open the Aptima Multitest swab package. Remove the swab. Do not touch the soft tip or lay the swab down. If the soft tip is touched, the swab laid down, or the swab is dropped, use a new Aptima Multitest Swab Collection kit. Hold the swab, placing your thumb and forefinger in the middle of the swab shaft covering the score line. Do not hold swab shaft below the score line. Carefully insert the swab into the rectum about 1-2 inches (3-5 cm) past the anal margin and gently rotate the swab for 5 to 10 seconds. Withdraw the swab without touching the skin. While holding the swab in hand, unscrew the cap from the tube. Do not spill the contents of the tube. If contents of the tube are spilled, use a new Aptima Multitest Swab Specimen Collection kit. Immediately place the swab into the transport tube so that the score line is at the top of the tube. Carefully break swab shaft at the top of the tube. Discard the top portion of the swab shaft. Tightly screw the cap onto the tube.

Pharyngeal Specimens: Use the Aptima Multitest Swab Specimen Collection kit. Partially peel open the Aptima Multitest swab package. Remove the swab. Do not touch the soft tip or lay the swab down. If the soft tip is touched, the swab is laid down, or the swab is dropped, use a new Aptima Multitest Swab Specimen Collection kit. Hold the swab, placing your thumb and forefinger in the middle of the swab shaft covering the score line. Do not hold the swab shaft below the score line. Carefully insert the swab into the throat ensuring contact with bilateral tonsils (if present) and the posterior pharyngeal wall. Withdraw the swab without touching the inside of the cheeks or tongue. While holding the swab in hand, unscrew the cap from the tube. Do not spill the contents of the tube. If the contents of the tube are spilled, use a new Aptima Multitest Swab Specimen Collection Kit. Immediately place the swab into the transport tube so that the score line is at the top of the tube. Carefully break swab shaft at the score line against the side of the tube. Discard the top portion of the swab shaft. Tightly screw the cap onto the tube.

Store extragenital (pharyngeal and rectal) specimens at 4–30°C (39–86°F) after collection

Store urogenital and urine specimens at 2-30°C (35.6-86°F) after collection

Specimens should be sent daily or next working day.

• Urine specimens must be received within 30 days after collection
• Swab specimens must be received within 60 days after collection

Transport in provided MSPHL shipping containers.

Urine
Endocervical Swabs
Male urethral swabs
Rectal swabs
Pharyngeal swabs
Vaginal swabs

Immunology Test Request Form
Instructions for completing the Test Request Form

Negative = rRNA not detected
Positive = rRNA detected
Indeterminate = Test is inconclusive, submit another specimen if patient has not been prophylactically treated
Test Cancelled/Unsatisfactory = Specimen not usable, submit another sample if patient has not been prophylactically treated

Expired Transport Media
No Swab in Collection Device (excluding urines) or 2 Swabs Present
Specimen is not labeled with the patient’s name or 2 unique identifiers
Quantity Not Sufficient
Improper Swab in Collection Device
Urine Collection Device Too Full (must fall between the two black indicator lines)
Improper Collection Device
Receipt of Swabs > 60 Days after Collection Date
Receipt of Urines > 30 Days after Collection Date
Sample transport conditions failed to meet acceptability criteria during accessioning

Patient on antibiotic therapy, 10% blood in swab specimens, 30% blood in urine specimens

1-2 days after receipt of specimen

N/A

87491

43305-2, Dual LOINC:  64017-7

Results should be used in conjunction with other clinical data available to the clinician.