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Test Code GCDP Neisseria gonorrhoeae (GC) by Nucleic Acid Amplification (RT-PCR) Roche cobas 6800

Methodology

Nucleic Acid Amplification

Performing Laboratory

Munson Medical Center Laboratories

Specimen Requirements

 

Submit only 1 of the following specimens: 
Cervix/Endocervix (Females Only)
Collect specimen using cobas PCR Media Dual Swab Specimen Collection System Kit (contains 2 swabs: 1 large white, 1 small white) as follows:
1. Remove excess mucus from exocervix with medium cleaning swab (white swab) provided in cobas PCR Dual Swab Specimen Collection System Kit and discard.
2. Insert second medium swab (small white swab) into endocervix, and rotate swab for 10 to 30 seconds to ensure adequate sampling. (Swab received other than those provided with the kit is not acceptable.)

 

3. Withdraw swab.
4. Holding tube upright, verify that all medium is at bottom of transport tube. Unscrew cap of transport tube, fully insert swab into tube, and break swab shaft at the dark line. Discard the top portion of the swab. Screw cap on securely.
5. Label tube with patient’s name (first and last), patient's date of birth, specimen source, and date and time of collection.
6. Transport specimen between 2 and 30*C
7. Maintain sterility and forward promptly.
Note: 1. Specimen source is required.

2. Spermicidal agents and feminine powder sprays interfere with the assay and should not be used prior to collection.
3. When collecting both a Pap test and an endocervical swab, always collect the Pap specimen first. Then, use the small white swab to collect the Chlamydia trachomatis and Neisseria gonorrhoeae specimen. Do not use the large white swab.

 

Conjunctiva  Mayo send out test only
Collect specimen using APTIMA® Swab Specimen Collection System Kit (contains 2 swabs: 1 white, 1 blue) as follows:
1. Do not collect exudate.
2. Collect specimen using blue swab only from APTIMA® Swab Specimen Collection System Kit.
3. Pull down lower eyelid, and swab conjunctiva. Cells are required.
4. Solutions containing lidocaine will decrease the yield of infectious virus by 1 to 2 logs.
5. Holding tube upright, verify that all medium is at bottom of transport tube. Unscrew cap of transport tube, fully insert swab into tube, and break swab at score line (minimum volume: 0.5 mL of media). Screw cap on securely.
6. Label tube with patient’s name (first and last), patient's date of birth, specimen source, and date and time of collection.
7. Send specimen refrigerated.
8. Maintain sterility and forward promptly.
Note: Specimen source is required. The Roche Cobas 6800 is not validation for conjuctiva/eye sources. Mayo sendout only.

 

Oral/Pharyngeal
Collect specimen using the cobas PCR media Uni Swab Specimen Collection System Kit (contains 1 large white swab) as follows:
1. Collect swab from infected area of mouth or pharyngeal using a cobas PCR media Uni Swab Specimen Collection System Kit.
2. Return swab to the cobas PCR  tube breaking swab shaft at dark line. Discard the top portion of the swab.
3. Label tube with patient’s name (first and last), patient's date of birth, specimen source, and date and time of collection.
4. Send specimen at a temperature between 2 and 30*C
5. Maintain sterility and forward promptly.
Note: Specimen source is required.

 

Rectal
Collect specimen using cobas PCR Media Uni Swab Specimen Collection System Kit (contains1 large white) as follows:
1. Carefully insert large culture swab approximately 1 inch beyond anal sphincter.
2. Gently rotate swab to sample anal crypts.

3. Unscrew top of transport tube, fully insert swab in tube and break swab shaft at dark line. Discard the top portion of the swab. Cap tightly.
4. Label tube with patient’s name (first and last), patient's date of birth, specimen source, and date and time of collection.
5. Send specimen at a temperature between 2 and 30*C
6. Maintain sterility and forward promptly.
Note: Specimen source is required.

 

Urethra (Males Only)
Collect specimen using cobas PCR Media Dual Swab Specimen Collection System (kit contains 2 swabs: 1 large white, 1 small white) as follows:
1. Patient should not have urinated for at least 1 hour prior to specimen collection.
2. Insert small-tipped specimen swab (small whtie swab) 2 to 4 cm into urethra, and rotate swab for 2 to 3 seconds to ensure adequate sampling. The large white swab is not used for male urethral specimen collection. (Swab received other than those provided with the kit is not acceptable.)

3. Withdraw swab.
4. Holding tube upright, verify that all medium is at bottom of transport tube. Unscrew cap of transport tube, fully insert swab into tube, and break swab shaft at dark line. Discard top portion of swab. Screw cap on securely.
5. Label tube with patient’s name (first and last), patient's date of birth, specimen source, and date and time of collection.
6. Send specimen at a temperature between 2 and 30*C.
7. Maintain sterility and forward promptly.
Note: 1. Specimen source is required.

2. Spermicidal agents interfere with the assay and should not be used prior to collection.
 
Urine (Males and Females)
1. Patient should not have urinated for at least 1 hour prior to specimen collection.
2. Patient should collect first portion of a voided urine (first part of stream-not midstream) into a screw-capped, sterile, plastic, preservative-free specimen collection container. Instruct patient to collect only the first 10 to 50 mL of the urine stream to avoid dilutional effect.
3. Send 10-50 mL of urine in a cobas PCR media urine transport vial using the disposable pipette provided in the kit, filling until fluid level is between the 2 lines on the vial. Over or under filled transport vials will be rejected.
4. Label tube with patient’s name (first and last), patient's date of birth, specimen source, and date and time of collection.
5. Send specimen at a temperature between 2 and 30*C
6. Maintain sterility and forward promptly.
Note: 1. Specimen source is required.

2. The primary urine collection container (urine cup) is also acceptable if received in the laboratory within 24 hours of collection when stored and transported at refrigerate temperature.

Reference Values

Negative for Neisseria gonorrhoeae

Day(s) Test Set Up

Monday through Friday

Test Classification and CPT Coding

87591