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Test Code LAB0241000 Chlamydia trachomatis and Neisseria gonorrhoeae RNA Probe

Important Note

Specimens may contain extremely high levels of organisms. To avoid cross-contamination during specimen handling, please follow these recommendations:

1. Ensure specimen vials do not come in contact with other specimens

2. Individually bag each vial in a clean biohazard bag

3. Avoid touching the foil tops of the vials

4. Clean specimen processing areas at least once daily with disinfectant

Methodology

APTIMA Combo 2 Assay combines the technologies of target capture, Transcription-Mediated Amplification (TMA), and Dual Kinetic Assay (DKA) .

Performing Laboratory

CentraCare Laboratory Services

Specimen Requirements

The effects of tampon use, douching, and specimen collection variables have not been assessed for their impact on the detection of CT or GC.

 

Specimen source is required.

 

Submit only 1 of the following specimens:

 

Specimen Type: Endocervix

Container/Tube: Aptima Unisex Swab Specimen Collection Kit for Endocervical Specimens

Specimen Volume: Swab

Collection Instructions:

1. Remove excess mucus from the cervical os and surrounding mucosa using the cleaning swab (white shaft swab in the package with red printing).  Discard this swab.

NOTE: To remove excess mucus from the cervical os, a large-tipped swab (not provided) may be used.

2. Insert the specimen collection swab (blue shaft swab in the package with the green printing) into the endocervical canal.

 3. Gently rotate the swab clockwise for 10 to 30 seconds in the endocervical canal to ensure adequate sampling.

4. Withdraw the swab carefully; avoid any contact with the vaginal mucosa.

5. Remove the cap from the swab specimen  transport tube and immediately place the specimen collection swab into the transport tube.

6. Carefully break the swab shaft against the side of the tube at the scoreline and discard the top portion of the swab shaft; use care to avoid splashing of contents.

7. Re-cap the swab specimen transport tube tightly.

8. Label with patient's name (first and last), medical record number, date and actual time of collection, and type of specimen.

NOTE: Specimen stable for 60 days in APTIMA Collection Kit or if frozen within 7 days at -200 C to 700C testing up to 12 months.

 

Specimen Type: Urethra (males only)

Container/Tube: Aptima Unisex Swab Specimen Collection Kit for Male Urethtal Specimens

Specimen Volume: Swab

Collection Instructions:

1. The patient should not have urinated for at least 1 hour prior to sample collection.

2. Insert the specimen collection swab (blue shaft swab in the package with the green printing) 2 to 4 cm into the urethra.

3. Gently rotate the swab clockwise for 2 to 3 seconds in the urethra to ensure adequate sampling.

4. Withdraw the swab carefully.

5. Remove the cap from the swab specimen transport tube and immediately place the specimen collection  swab in the transport tube.

6. Carefully break the swab shaft against the side of the tube at the scoreline and discard the top portion of the swab shaft; use care to avoid splashing of contents.

7. Re-cap the swab specimen transport tube tightly.

8. Label with patient's name (first and last), medical record number, date and actual time of collection, and type of specimen.

NOTE: Specimen stable for 60 days in APTIMA Collection Kit or if frozen within 7 days at -200 C to 700C testing up to 12 months.

 

Specimen Type: Urine, first portion

Container/Tube:

Preferred: APTIMA Urine Specimen Collection Kit for Male and Female Urine Specimens

Acceptable: Sterile plastic container. 

NOTE: Stable for 30 days in APTIMA Urine Transport Tube. Only 24 hour stability if unpreserved specimen. If frozen within 7 days at -200 C to 700C testing up to 12 months.

Specimen Volume: 20 mL

Collection Instructions:

1. The patient should not have urinated for at least 1 hour prior to specimen collection.

2. Direct patient to provide a first-catch urine (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 rRNA target dilution thay may reduce test sensitivity. Female patients should not cleanse the labial area prior to providing the specimen.

3. Remove the cap and transfer 2 ml of the 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 specimen transport tube label.

4. Recap the urine specimen transport tube tightly.  This is now known as the processed urine specimen.

5. Label container with patient’s name (first and last), medical record number, date and actual time of collection, and type of specimen.

 

Specimen Type: Extragenital Throat Collection

Container/Tube: Aptima Multitest Swab Collection Kit

Specimen Volume:  Swab

Collection Instructions:

1. Insert the specimen collection swab provided in kit into mouth ensuring contact with bilateral tonsils and the back of throat, then withdraw the swab without touching inside of cheeks or tongue.

2. Remove the cap from the swab specimen transport tube and immediately place the specimen collection swab into the transport tube. 

3. Carefully break the swab shaft against the side of the tube at the scoreline and disgard the top portion of the swab shaft; use care to avoid splashing of contents.

4. Re-cap the swab specimen transport tube tightly.

5. Label with patient's name (first and last), medical record number, date and actual time of collection, and type of collection.

NOTE:   Specimen stable for 60 days in Aptima Collection Kit.

 

Specimen Type: Extragenital Rectal Collection

Container/Tube:  Aptima Multitest swab collection kit

Specimen Volume:  Swab

Collection Instructions:

1. Insert the specimen collection swab into rectum about 1-2 inches past the anal margin and gently rotate the swab clockwise for 5 to 10 seconds to ensure adequate sampling.

2. Withdraw the swab without touching the skin.

3. Remove the cap from the swab specimen transport tube and immediately place the specimen collection tube into the transport tube.

4. Carefully break the swab shaft against the side of the tube at the scoreline and disgard the top portion of the swab shaft, use care to avoid splashing of contents.

5. Re-cap the specimen transport tube tightly.

6. Label with patient's name (first and last) , medical record number, date and actual time of collection, and type of collection.

NOTE:   Specimen stable for 60 days in Aptima Collection Kit.

 

 

 

 

Specimen Type: Aptima Unisex Swab collection kit (Blue swab)

Miscellaneous sources (eye, throat, oral rectal)

Order :CGRNA(LAB0241153) for Mayo code MCTGC.  Chlamydiatrachomatis and Neisseria gonorrhaeae miscellaneous sites

Order:  MBAT for Mayo code CTRNA (Chlamydia on miscellaneous source)

Order: MBAT for Mayo code GCRNA (GC on miscellaneous source)

Order: MBAT for Mayo code MGRNA (Neisseria GC)

Specimen Transport Temperature

Ambient/Refrigerated

 

 

 

 

 

 

 

 

 

 

 

 

 

Reference Values

Negative

Day(s) Test Set Up

Monday through Friday

Test Classification and CPT Coding

87491-Chlamydia trachomatis
87591-Neisseria gonorrhoeae