Patient Preparation

Endocervical Swab: Remove excess mucus from the cervical os and surrounding mucosa using the cleaning swab (white shaft) included in the collection kit and then discard the swab. Insert the collection swab (blue shaft) in the endocervical canal and rotate clockwise 10-30 seconds. Withdraw the swab, avoiding contact with the vaginal mucosa. Place the swab into the transport tube/collection container, break the shaft at the score line, and recap tightly.

Male Urethral Swab: Patient should not have urinated for at least 1 hour prior to collection. Insert the collection swab (blue shaft) 2-4 cm into the urethra and rotate clockwise 2-3 seconds. Withdraw the swab and place it into the transport tube/collection container, break the shaft at the score line, and recap tightly.

Urine Specimen: Patient should not have urinated for at least 1 hour prior to specimen collection. Female patients should not have cleaned the labia area prior to collection. Collect the first 20-30 mL of voided urine specimen (i.e. the first part of the stream, NOT midstream) in a sterile, plastic, preservative-free specimen collection cup. Transfer 2 mL of urine into the Aptima urine specimen transport tube/collection container using the provided disposable pipette. Fill the tube to the level between the two central black fill lines.

Vaginal Swab: Holding the swab shaft above the score line, carefully insert the swab into the vagina about 2 inches (5 centimeters) past the introitus and rotate for 10-30 seconds, making sure the swab touches the vaginal walls so that the swab absorbs the moisture. Remove the swab without touching the skin, place in the transport tube/collection device, break the shaft at the score line, and recap tightly.

Rectal Swab: Holding the swab shaft above the score line, carefully insert the swab into the rectum past the anal margin about 1-2 inches (3-5 centimeters) and rotate for 5-10 seconds. Remove the swab without touching the skin, place in the transport tube/collection device, break the shaft at the score line, and recap tightly.

Throat Swab: Holding the swab shaft above the score line, swab the throat including the bilateral tonsils and posterior pharyngeal wall. Avoid the inside of the cheeks and tongue. Place the swab in the transport/collection device, break the shaft at the score line, and recap tightly.

Eye Swab: Holding the swab shaft above the score line, carefully swab the eye. Place the swab in the transport/collection device, break the shaft at the score line, and recap tightly. Eye swab specimens must be received by the laboratory with a paper blue requisition form. These specimens will be sent out to an outside reference laboratory for testing. Turnaround times may be affected for this specimen type.
 

Collect

Acceptable specimen types: endocervical swab, urethral swab, urine, rectal swab, throat swab, vaginal swab, or eye swab from individuals ≥14 years of age; cervical/endocervical specimens collected in ThinPrep Pap Test vials from individuals ≥21 years of age. For specimens collected with appropriate collection devices from patients <14 years of age, contact the pathology resident (EPIC chat, WC Lab Microbiology Consult Resident or page 13564).

Containers:
For male and female swabs (urethra or endocervical), use Aptima Unisex Swab Specimen Collection kit. Hologic catalog number 301041 (Lawson number 313057)

For male and female urine specimens, collect specimens in plastic, preservative-free, sterile containers and transfer 2 mL to the Aptima Urine Specimen Collection Kit. Hologic catalog number 301040 (Lawson number 313056)

For rectal, throat, vaginal, and eye swabs, collect specimens in Aptima MultiTest Swab Specimen Collection kit. Hologic catalog number PRD-03546 (Lawson number 535999).

Cervical/endocervical specimens should be collected in ThinPrep Pap Test vials containing PreservCyt Solution with broom-type or cytobrush/spatula collection devices according to the manufacturer's instructions. Hologic catalog number 70096-001 (Lawson number 167977).

If the primary collection container is submitted, the specimen must be received in the laboratory and transferred into the transport tube/collection device within 24 hours of collection.

Unacceptable Conditions

Any specimen type that is not considered acceptable (see “Collect”).
Specimen not received in proper Aptima transport container.
Swab specimens without a swab in the transport container.
Incorrect white shaft swab in Aptima transport container.
Insufficient or excessive volume - the volume of urine must be within the 2 black fill lines on the Aptima Urine transport container (2 mL). Overfilled or underfilled tubes will be rejected.
Orders on any specimens collected in ThinPrep vials from patients <21 years of age will be rejected and cancelled.
This assay is not intended for the evaluation of suspected sexual abuse or for other medico-legal indications. 
 

Storage/Transport Temperature

Transport at 2-30°C for endocervical swab specimens, urethral swab specimens, vaginal swab specimens, eye swab specimens, and urine specimens.

Transport at 4-30°C or minus 20°C to minus 70°C for throat swab specimens and rectal swab specimens.

Stability (from collection to initiation)

2-30°C within 60 days of collection for endocervical swab specimens, urethral swab specimens,  vaginal swab specimens, and eye swab specimens.

2-30°C within 30 days of collection for urine specimens.

Frozen at minus 20°C to minus 70°C for up to 12 months after collection for endocervical swab specimens, urethral swab specimens, vaginal swab specimens, and eye swab specimens.

Frozen at minus 20°C to minus 70°C for up to 116 days after collection for urine specimens.

4-30°C or minus 20°C to minus 70°C within 60 days of collection for throat swab specimens and rectal swab specimens.

 

Performed

Monday-Friday

Container

For male and female swabs (urethra or endocervical), use Aptima Unisex Swab Specimen Collection kit. Hologic catalog number 301041 (Lawson number 313057).

For male and female urine specimens, collect specimens in plastic, preservative-free, sterile containers and transfer 2 mL to the Aptima Urine Specimen Collection Kit. Hologic catalog number 301040 (Lawson number 313056).

For rectal, throat, vaginal, and eye swabs, collect specimens in Aptima MultiTest Swab Specimen Collection kit. Hologic catalog number PRD-03546 (Lawson number 535999).

Cervical/endocervical specimens should be collected in ThinPrep Pap Test vials containing PreservCyt Solution with broom-type or cytobrush/spatula collection devices according to the manufacturer's instructions. Hologic catalog number 70096-001 (Lawson number 167977).

If the primary collection container is submitted, the specimen must be received in the laboratory and transferred into the transport tube/collection device within 24 hours of collection.
 

Collect

Acceptable specimen types: endocervical swab, urethral swab, urine, rectal swab, throat swab, vaginal swab, or eye swab from individuals ≥14 years of age; cervical/endocervical specimens collected in ThinPrep Pap Test vials from individuals ≥21 years of age. For specimens collected with appropriate collection devices from patients <14 years of age, contact the pathology resident (EPIC chat, WC Lab Microbiology Consult Resident or page 13564).

Containers:
For male and female swabs (urethra or endocervical), use Aptima Unisex Swab Specimen Collection kit. Hologic catalog number 301041 (Lawson number 313057)

For male and female urine specimens, collect specimens in plastic, preservative-free, sterile containers and transfer 2 mL to the Aptima Urine Specimen Collection Kit. Hologic catalog number 301040 (Lawson number 313056)

For rectal, throat, vaginal, and eye swabs, collect specimens in Aptima MultiTest Swab Specimen Collection kit. Hologic catalog number PRD-03546 (Lawson number 535999).

Cervical/endocervical specimens should be collected in ThinPrep Pap Test vials containing PreservCyt Solution with broom-type or cytobrush/spatula collection devices according to the manufacturer's instructions. Hologic catalog number 70096-001 (Lawson number 167977).

If the primary collection container is submitted, the specimen must be received in the laboratory and transferred into the transport tube/collection device within 24 hours of collection.

Container

For male and female swabs (urethra or endocervical), use Aptima Unisex Swab Specimen Collection kit. Hologic catalog number 301041 (Lawson number 313057).

For male and female urine specimens, collect specimens in plastic, preservative-free, sterile containers and transfer 2 mL to the Aptima Urine Specimen Collection Kit. Hologic catalog number 301040 (Lawson number 313056).

For rectal, throat, vaginal, and eye swabs, collect specimens in Aptima MultiTest Swab Specimen Collection kit. Hologic catalog number PRD-03546 (Lawson number 535999).

Cervical/endocervical specimens should be collected in ThinPrep Pap Test vials containing PreservCyt Solution with broom-type or cytobrush/spatula collection devices according to the manufacturer's instructions. Hologic catalog number 70096-001 (Lawson number 167977).

If the primary collection container is submitted, the specimen must be received in the laboratory and transferred into the transport tube/collection device within 24 hours of collection.
 

Ordering Recommendations

Epic Test Name: Chlamydia/GC Amplification.
EPIC Lab Number: 170908830

Performed

Monday-Friday

Methodology

Detection of Chlamydia trachomatis and Neisseria gonorrhoeae by Transcription Mediated Amplification. This test is performed using the APTIMA Combo 2 Assay, which is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis and/or Neisseria gonorrhoeae.
 

Synonyms

  • Neisseria gonorrhoeae molecular
  • Chlamydia trachomatis molecular

Turn Around Time

Turn Around Time: 1-2 days
 

Reference Interval

CT Amplification Negative
GC Amplification Negative
 

Interpretive Data

The Hologic Aptima Combo 2 Assay for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae (CT/GC) is FDA approved for testing of vaginal, rectal, or throat specimens collected using the Aptima Multitest Swab Specimen Collection Kit (for individuals ≥14 years of age); endocervical or male urethral specimens collected using the Aptima Unisex Swab Specimen Collection Kit (for individuals ≥14 years of age); urine (male and female) collected using the Aptima Urine Collection Kit for Males and Females (for individuals ≥14 years of age); and cervical or  cervical/endocervical specimens collected in ThinPrep PreservCyt Solution (for individuals ≥21 years of age).

The clinical performance characteristics of this assay for rectal or throat specimens collected with the Aptima Unisex Swab Specimen Collection Kit have not been established. The technical performance of this assay for rectal or throat specimens received in the Aptima Unisex Swab Specimen Collection Kit, is expected to be identical to that of endocervical or male urethral specimens.  When requested, tests on rectal or throat specimen types collected in the Aptima Unisex Swab Specimen Collection Kit are performed as Laboratory Developed Tests, not approved by the FDA. The significance of results for these specimens must be interpreted considering the specific clinical situation by practitioners experienced in management of these conditions. If results are inconsistent with clinical impression, please submit a new specimen.
 

CPT Codes

87491, 87591
 

Performing Lab

Microbiology (Molecular Microbiology) ST-739 Phone: (212) 746-2400
Requests: orderable in Epic. Additional forms: Microbiology #44402 (Blue); Private Amb: Lab Req (non-OB/GYN) Form #50553
 
Collection

Patient Preparation

Endocervical Swab: Remove excess mucus from the cervical os and surrounding mucosa using the cleaning swab (white shaft) included in the collection kit and then discard the swab. Insert the collection swab (blue shaft) in the endocervical canal and rotate clockwise 10-30 seconds. Withdraw the swab, avoiding contact with the vaginal mucosa. Place the swab into the transport tube/collection container, break the shaft at the score line, and recap tightly.

Male Urethral Swab: Patient should not have urinated for at least 1 hour prior to collection. Insert the collection swab (blue shaft) 2-4 cm into the urethra and rotate clockwise 2-3 seconds. Withdraw the swab and place it into the transport tube/collection container, break the shaft at the score line, and recap tightly.

Urine Specimen: Patient should not have urinated for at least 1 hour prior to specimen collection. Female patients should not have cleaned the labia area prior to collection. Collect the first 20-30 mL of voided urine specimen (i.e. the first part of the stream, NOT midstream) in a sterile, plastic, preservative-free specimen collection cup. Transfer 2 mL of urine into the Aptima urine specimen transport tube/collection container using the provided disposable pipette. Fill the tube to the level between the two central black fill lines.

Vaginal Swab: Holding the swab shaft above the score line, carefully insert the swab into the vagina about 2 inches (5 centimeters) past the introitus and rotate for 10-30 seconds, making sure the swab touches the vaginal walls so that the swab absorbs the moisture. Remove the swab without touching the skin, place in the transport tube/collection device, break the shaft at the score line, and recap tightly.

Rectal Swab: Holding the swab shaft above the score line, carefully insert the swab into the rectum past the anal margin about 1-2 inches (3-5 centimeters) and rotate for 5-10 seconds. Remove the swab without touching the skin, place in the transport tube/collection device, break the shaft at the score line, and recap tightly.

Throat Swab: Holding the swab shaft above the score line, swab the throat including the bilateral tonsils and posterior pharyngeal wall. Avoid the inside of the cheeks and tongue. Place the swab in the transport/collection device, break the shaft at the score line, and recap tightly.

Eye Swab: Holding the swab shaft above the score line, carefully swab the eye. Place the swab in the transport/collection device, break the shaft at the score line, and recap tightly. Eye swab specimens must be received by the laboratory with a paper blue requisition form. These specimens will be sent out to an outside reference laboratory for testing. Turnaround times may be affected for this specimen type.
 

Collect

Acceptable specimen types: endocervical swab, urethral swab, urine, rectal swab, throat swab, vaginal swab, or eye swab from individuals ≥14 years of age; cervical/endocervical specimens collected in ThinPrep Pap Test vials from individuals ≥21 years of age. For specimens collected with appropriate collection devices from patients <14 years of age, contact the pathology resident (EPIC chat, WC Lab Microbiology Consult Resident or page 13564).

Containers:
For male and female swabs (urethra or endocervical), use Aptima Unisex Swab Specimen Collection kit. Hologic catalog number 301041 (Lawson number 313057)

For male and female urine specimens, collect specimens in plastic, preservative-free, sterile containers and transfer 2 mL to the Aptima Urine Specimen Collection Kit. Hologic catalog number 301040 (Lawson number 313056)

For rectal, throat, vaginal, and eye swabs, collect specimens in Aptima MultiTest Swab Specimen Collection kit. Hologic catalog number PRD-03546 (Lawson number 535999).

Cervical/endocervical specimens should be collected in ThinPrep Pap Test vials containing PreservCyt Solution with broom-type or cytobrush/spatula collection devices according to the manufacturer's instructions. Hologic catalog number 70096-001 (Lawson number 167977).

If the primary collection container is submitted, the specimen must be received in the laboratory and transferred into the transport tube/collection device within 24 hours of collection.

Unacceptable Conditions

Any specimen type that is not considered acceptable (see “Collect”).
Specimen not received in proper Aptima transport container.
Swab specimens without a swab in the transport container.
Incorrect white shaft swab in Aptima transport container.
Insufficient or excessive volume - the volume of urine must be within the 2 black fill lines on the Aptima Urine transport container (2 mL). Overfilled or underfilled tubes will be rejected.
Orders on any specimens collected in ThinPrep vials from patients <21 years of age will be rejected and cancelled.
This assay is not intended for the evaluation of suspected sexual abuse or for other medico-legal indications. 
 

Storage/Transport Temperature

Transport at 2-30°C for endocervical swab specimens, urethral swab specimens, vaginal swab specimens, eye swab specimens, and urine specimens.

Transport at 4-30°C or minus 20°C to minus 70°C for throat swab specimens and rectal swab specimens.

Stability (from collection to initiation)

2-30°C within 60 days of collection for endocervical swab specimens, urethral swab specimens,  vaginal swab specimens, and eye swab specimens.

2-30°C within 30 days of collection for urine specimens.

Frozen at minus 20°C to minus 70°C for up to 12 months after collection for endocervical swab specimens, urethral swab specimens, vaginal swab specimens, and eye swab specimens.

Frozen at minus 20°C to minus 70°C for up to 116 days after collection for urine specimens.

4-30°C or minus 20°C to minus 70°C within 60 days of collection for throat swab specimens and rectal swab specimens.

 

Performed

Monday-Friday

Container

For male and female swabs (urethra or endocervical), use Aptima Unisex Swab Specimen Collection kit. Hologic catalog number 301041 (Lawson number 313057).

For male and female urine specimens, collect specimens in plastic, preservative-free, sterile containers and transfer 2 mL to the Aptima Urine Specimen Collection Kit. Hologic catalog number 301040 (Lawson number 313056).

For rectal, throat, vaginal, and eye swabs, collect specimens in Aptima MultiTest Swab Specimen Collection kit. Hologic catalog number PRD-03546 (Lawson number 535999).

Cervical/endocervical specimens should be collected in ThinPrep Pap Test vials containing PreservCyt Solution with broom-type or cytobrush/spatula collection devices according to the manufacturer's instructions. Hologic catalog number 70096-001 (Lawson number 167977).

If the primary collection container is submitted, the specimen must be received in the laboratory and transferred into the transport tube/collection device within 24 hours of collection.
 
Container

Collect

Acceptable specimen types: endocervical swab, urethral swab, urine, rectal swab, throat swab, vaginal swab, or eye swab from individuals ≥14 years of age; cervical/endocervical specimens collected in ThinPrep Pap Test vials from individuals ≥21 years of age. For specimens collected with appropriate collection devices from patients <14 years of age, contact the pathology resident (EPIC chat, WC Lab Microbiology Consult Resident or page 13564).

Containers:
For male and female swabs (urethra or endocervical), use Aptima Unisex Swab Specimen Collection kit. Hologic catalog number 301041 (Lawson number 313057)

For male and female urine specimens, collect specimens in plastic, preservative-free, sterile containers and transfer 2 mL to the Aptima Urine Specimen Collection Kit. Hologic catalog number 301040 (Lawson number 313056)

For rectal, throat, vaginal, and eye swabs, collect specimens in Aptima MultiTest Swab Specimen Collection kit. Hologic catalog number PRD-03546 (Lawson number 535999).

Cervical/endocervical specimens should be collected in ThinPrep Pap Test vials containing PreservCyt Solution with broom-type or cytobrush/spatula collection devices according to the manufacturer's instructions. Hologic catalog number 70096-001 (Lawson number 167977).

If the primary collection container is submitted, the specimen must be received in the laboratory and transferred into the transport tube/collection device within 24 hours of collection.

Container

For male and female swabs (urethra or endocervical), use Aptima Unisex Swab Specimen Collection kit. Hologic catalog number 301041 (Lawson number 313057).

For male and female urine specimens, collect specimens in plastic, preservative-free, sterile containers and transfer 2 mL to the Aptima Urine Specimen Collection Kit. Hologic catalog number 301040 (Lawson number 313056).

For rectal, throat, vaginal, and eye swabs, collect specimens in Aptima MultiTest Swab Specimen Collection kit. Hologic catalog number PRD-03546 (Lawson number 535999).

Cervical/endocervical specimens should be collected in ThinPrep Pap Test vials containing PreservCyt Solution with broom-type or cytobrush/spatula collection devices according to the manufacturer's instructions. Hologic catalog number 70096-001 (Lawson number 167977).

If the primary collection container is submitted, the specimen must be received in the laboratory and transferred into the transport tube/collection device within 24 hours of collection.
 
Ordering

Ordering Recommendations

Epic Test Name: Chlamydia/GC Amplification.
EPIC Lab Number: 170908830

Performed

Monday-Friday

Methodology

Detection of Chlamydia trachomatis and Neisseria gonorrhoeae by Transcription Mediated Amplification. This test is performed using the APTIMA Combo 2 Assay, which is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis and/or Neisseria gonorrhoeae.
 

Synonyms

  • Neisseria gonorrhoeae molecular
  • Chlamydia trachomatis molecular

Turn Around Time

Turn Around Time: 1-2 days
 
Result Interpretation

Reference Interval

CT Amplification Negative
GC Amplification Negative
 

Interpretive Data

The Hologic Aptima Combo 2 Assay for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae (CT/GC) is FDA approved for testing of vaginal, rectal, or throat specimens collected using the Aptima Multitest Swab Specimen Collection Kit (for individuals ≥14 years of age); endocervical or male urethral specimens collected using the Aptima Unisex Swab Specimen Collection Kit (for individuals ≥14 years of age); urine (male and female) collected using the Aptima Urine Collection Kit for Males and Females (for individuals ≥14 years of age); and cervical or  cervical/endocervical specimens collected in ThinPrep PreservCyt Solution (for individuals ≥21 years of age).

The clinical performance characteristics of this assay for rectal or throat specimens collected with the Aptima Unisex Swab Specimen Collection Kit have not been established. The technical performance of this assay for rectal or throat specimens received in the Aptima Unisex Swab Specimen Collection Kit, is expected to be identical to that of endocervical or male urethral specimens.  When requested, tests on rectal or throat specimen types collected in the Aptima Unisex Swab Specimen Collection Kit are performed as Laboratory Developed Tests, not approved by the FDA. The significance of results for these specimens must be interpreted considering the specific clinical situation by practitioners experienced in management of these conditions. If results are inconsistent with clinical impression, please submit a new specimen.
 

Administrative

CPT Codes

87491, 87591
 

Performing Lab

Microbiology (Molecular Microbiology) ST-739 Phone: (212) 746-2400
Requests: orderable in Epic. Additional forms: Microbiology #44402 (Blue); Private Amb: Lab Req (non-OB/GYN) Form #50553
 

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