Chlamydia trachomatis

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Brief Description

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.

Laboratory Unit

Immunology

Methodology

Target Amplification Nucleic Acid Probe

Specimen Collection

Urine:  The patient should not have urinated for at least one hour prior to specimen collection. Using the disposable pipette provided in the kit, transfer 2 mL  of urine into the urine specimen transport tube within 24 hours of collection. Make sure urine level is between the two black fill lines.  Recap the tube tightly.  Specimen must be received within 30 days of collection.
Endocervical swabs:  Remove excess mucus from the cervical os using the cleaning swab (white shaft swab in the package).  Discard this swab.  Use the specimen collection swab (blue shaft swab in the package) to collect the specimen.  Rotate the swab for 10-30 seconds inside the endocervical canal.  Withdraw swab avoiding contact with the vaginal mucosa.  Immediately place the blue swab into the specimen transport tube.  Break the swab at the scoreline.   Recap the tube tightly.  Specimen must be received within 60 days of collection.
Male urethral swabs:  The patient should not have urinated for at least one hour prior to specimen collection. Use only the specimen collection swab (blue shaft swab) to collect specimen. Insert the blue swab 2-4 cm into the urethra.  Rotate for 2-3 seconds.  Withdraw swab and place into the specimen transport tube.  Break the swab at the scoreline. Recap the tube tightly.  Specimen must be received within 60 days of collection.
Vaginal swabs:  Use the specimen collection swab (orange shaft swab in the package) to collect the specimen.  Insert swab into opening of the vagina, about 2 inches.  Rotate swab for 10-30 seconds.  Withdraw swab without touching skin and place in vaginal collection device.  Break the swab at the scoreline.  Recap the tube tightly.  Specimen must be received within 60 days of collection.

Non-FDA cleared Specimens (verified in-house)
Rectal swabs:  Use the APTIMA Unisex Swab Specimen Collection Kit.  Discard the white shaft cleaning swab.  Insert the specimen collection swab (blue shaft) into the anal canal.  Rotate for 15–30 seconds.  Withdraw the swab carefully and place into the specimen transport tube.  Break the swab shaft at the score line.  Recap the tube tightly.  Specimen must be received with 60 days of collection.
Pharyngeal swabs:  Use the APTIMA Unisex Swab Specimen Collection Kit.  Discard the white shaft cleaning swab.  Instruct patient to tilt head backwards, open mouth, and say “ah”.  A tongue depressor may be used to facilitate seeing the pharynx.  Insert the specimen collection swab (blue shaft) without touching lips, teeth, tongue, or cheeks.  Gently and quickly, swab the tonsillar area side to side.  Withdraw the swab carefully and place into the specimen transport tube.  Break the swab shaft at the score line.  Recap the tube tightly.  Specimen must be received with 60 days of collection.

Storage/Transport

Store specimens at ambient room temperature or at refrigerator temperature (2-8°C) prior to shipment.

Specimens should be sent daily or next working day.

Transport in MSPHL shipping containers at room temperature (2-30°C).

Acceptable Specimen
Type(s)

Urine, female endocervical or male urethral swabs, rectal swabs, and pharyngeal swabs collected in APTIMA Combo 2 Assay transport media from patients 12 years old or older ordered through the MSPHL.  Vaginal swabs collected in APTIMA Combo 2 Assay transport media from patients 14 years old or older ordered through the MSPHL. The rectal and pharyngeal swabs are non-FDA cleared specimens.  A verification study was performed and determined to be acceptable for detecting Chlamydia trachomatis and Neisseria gonorrhoeae at the MSPHL.

Possible Results

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

Reference Range

Negative

Unacceptable Conditions

Expired Transport Media
No Swab in Collection Device (excluding urines) or 2 Swabs Present
No Name on Specimen
Name on Specimen Does Not Match Name on Request Form
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

Interfering Substances

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

Result Reported

1-2 days after receipt of specimen

Fees

N/A

CPT Codes

87491

LOINC/SNOMED Codes

43304-5, Dual LOINC:  45076-7

Additional Information

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