Alberta Precision Laboratories

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Test Name/Synonym:

Chlamydia and Gonorrhea Screen - Nucleic Acid Amplification Test (CTGC NAAT, Chlamydia trachomatis, Neisseria gonorrhoeae) - Calgary Zone, South Zone

Pathogen:

Chlamydia trachomatis
Neisseria gonorrhoeae
CTGC NAAT
Gonorrhea
Cervicitis
Vaginitis
Pelvic Inflammatory Disease (PID)
Salpingitis
Urethritis
Proctitis
Pharyngitis
Conjunctivitis

Clinical Indications:

Preferred specimen source for females is a vaginal swab OR a cervical swab.
Preferred specimen source for males is a urine sample.

Test Includes:

Detection of Chlamydia trachomatis and Neisseria gonorrhoeae by nucleic acid amplification (NAAT)

Shipping and Handling Alert:

To prevent cross-contamination, it is extremely important to package specimens individually.

LABID (Connect Care):

LAB1376

Test Code:

CALGARY ZONE, SOUTH ZONE : M CHLAMGC
MEDITECH: CHGCROV1

Specimen Type:

Swab
Urine

Specimen Source:

Vagina
Cervix/Endocervical
Urethra
Throat
Rectal
Eye
Urine (first catch)

Primary Container:

APTIMA^®Multitest Swab Specimen Collection Kit (see below for valid specimen types)
APTIMA^® Unisex Swab Specimen Collection Kit (see below for valid specimen types)
Sterile Container (Urine)

Minimum Collection Volume:

Urine: 2 mL

Specimen Collection Requirements:

Swab Collection Kits for CT/GC NAAT	Cervix	Urethra	Vagina	Throat	Rectal	Eye
APTIMA^® Multitest Swab Specimen Collection Kit			✔	✔✱	✔✱	✔
APTIMA^® Unisex Swab Specimen Collection Kit	✔	✔		✔	✔	✔

✔ Valid collection kit for this site
✱Preferred collection kit for this site

Urine Collection Containers for CT/GC NAAT
Male or Female Collections	Male Collections only
90 mL sterile container with orange lid	30 mL sterile container with white lid

Note: Only one specimen is required to perform molecular testing for Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis. Refer to Trichomonas vaginalis for valid specimen sources.

Health Care Provider collection instructions for vaginal swab specimens using the Aptima^® Multitest Swab Collection Kit:

Insert swab (pink shaft) about 5 cm past introitus and rotate gently for 30 seconds.
Place swab into Aptima transport tube provided in collection kit. Snap off swab at score line so swab fits into closed tube.
Cap tube securely and label the tube with the patient full first and last name, date and time of collection, Provincial Health Number (PHN/ULI), or Government issued identification such as Federal, Military, RCMP, or Immigration.

Health Care Provider collection instructions for endocervical swab specimens using the Aptima^® Unisex Swab Collection Kit:

Remove excess mucus from the cervical os and surrounding mucosa using the cleaning swab (white shaft). Discard this swab.
Insert the specimen collection swab (blue shaft swab) into the endocervical canal. Gently rotate the swab clockwise for 10 to 30 seconds in the endocervical canal. Avoid touching vaginal wall when removing swab.
Place blue swab into Aptima transport tube. Snap off swab at score line so swab fits into closed tube.
Cap tube securely and label the tube with the patient full first and last name, date and time of collection, Provincial Health Number (PHN/ULI), or Government issued identification such as Federal, Military, RCMP, or Immigration.

Use of the incorrect swab for the source may result in reduced sensitivity of the test. Specimens will not be processed if swabs are placed in the incorrect transport tube.

Health Care Provider collection instructions for urethral swab specimens using the Aptima^® Unisex Swab Collection Kit:

Patient should not have urinated for at least 1 hour prior to collection.
With a rotating movement, insert swab (blue shaft) 2 to 4 cm into urethra..
Once inserted, rotate swab gently at least 1 full rotation using sufficient pressure to ensure swab comes into contact with all urethral surfaces. Allow swab to remain inserted for 2 to 3 seconds.
Place swab in the Aptima transport tube provided in collection kit. Snap off swab at score line so swab fits into closed tube.
Cap tube securely and label the tube with the patient full first and last name, date and time of collection, Provincial Health Number (PHN/ULI), or Government issued identification such as Federal, Military, RCMP, or Immigration.

Urine specimen collection instructions:

The patient should not have urinated for at least 1 hour prior to specimen collection.
The genital area must NOT be cleansed prior to urine collection.
Patient should collect first portion (up to 30 ml) of random voided urine (first part of stream) into a sterile, plastic, preservative-free container.
Minimum urine collection volume is 2 mL.
Ensure specimen collection containers are placed in a plastic resealable bag when providing the collection containers. For collection occurring at the laboratory or clinics instruct patient to place the specimen in the plastic resealable bag prior to placing the specimen in the washroom specimen cupboard or other designated area.
Also refer to patient instruction sheets:
Urine Sample Collection Instructions for Chlamydia trachomatis/Neisseria gonorrhoeae/Trichomonas vaginalis for Males MI6180
Urine Sample Collection Instructions for Chlamydia trachomatis/Neisseria gonorrhoeae/Trichomonas vaginalis for Females MI6070
Urine Sample Collection Instructions for Chlamydia trachomatis/Neisseria gonorrhoeae/Trichomonas vaginalis Testing and Midstream Urine (combined) MI6071 (use if the patient requires both a midstream collection for urinalysis and culture in addition to the initial stream collection for CT/GC/TV)

Test Resources:

Calgary Zone, South Zone: Microbiology Requisition (REQ9021MI)

Stability and Storage:

Swab in transport media is stable for 60 days at 2℃ -30℃ .

Urine in primary sterile collection container (i.e. orange top) must be transported to the lab at 2℃ -30℃ within 24 h from collection. Urine must be transferred into the APTIMA^® Urine Transport Tube for Male and Female Urine specimens within this time.

Once urine is in the transport urine transport tube, the specimens are stable for 30 days at 2℃ -30℃.

Processing:

Laboratory staff refer to procedure REG02-030 Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis Urine Specimen Collection Kit - APTIMA Assay.

Note:

If urine specimen received is < 2 mL, do NOT transfer the urine to Aptima Transport Tube. Apply Microbiology Problem Bench Label MI6075 to requisition indicating Urine was
< 2 mL, or clearly indicate on requisition that volume received was < 2 mL. This test will be cancelled by Microbiology as “Insufficient Specimen”
If urine specimen received is >30 mL, transfer only enough specimen for the liquid level in the transport tube to fall between the two black indicator lines on the tube label. If the liquid level is above this line, the specimen will be rejected. Apply Microbiology Problem Bench Label MI6075 indicating urine volume received was >30 mL, or clearly indicate on the requisition that volume received as >30 mL.
If urine specimen received is between 2-30 mL, transfer the entire volume to the transport tube. The liquid level MUST fall between the two black indicator lines or it will be rejected.

For collections in clinic, refer to APTIMA® Urine Specimen Collection Kit for Male and Female Urine Specimens (hologic.com)for instructions.

Transportation:

Routine

Method:

Aptima Combo 2 Assay (hologic.com)

Method and Interpretation of Results:

Nucleic amplification tests (NAATs) are molecular tests and are more sensitive than culture.

For those patients for whom a false positive result may have adverse psycho-social impact, re-testing is recommended.

For suspected sexual abuse cases, or other medico-legal indications refer to Canadian Guidelines on Sexually Transmitted Infections for investigation and testing guidelines: http://www.phac-aspc.gc.ca/std-mts/sti-its/cgsti-ldcits/index-eng.php

Routine Turn Around Time:

Turnaround time for negative result: 48 hours.

Testing Schedule:

Daily

Performing Site:

South Health Campus

Additional Test Information:

If culture for Neisseria gonorrhoeae is clinically indicated (eg. treatment failure), refer to: Neisseria gonorrhoeae Culture (Gonorrhea)

Last Updated On:

Wednesday, February 8, 2023

Date of Last Review:

Feb 3 2023 12:00AM

Registered Trademark Comments:

Aptima is a trademark of Hologic, Inc and/or its subsidiaries