Test Code LAB0241000 Chlamydia trachomatis and Neisseria gonorrhoeae RNA Probe
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