Gonococcus by NAA

Single-analyte tests

• Neisseria gonorrhoeae, NAA 188086

  Urine · Fasting not stated · Turnaround 2 - 3 days

  Method and collection

  Method

  Nucleic acid amplification (NAA)

  Collection

  Option 1: Gen-Probe® Aptima® Endocervical, Male Urethral, or Vaginal Swab Endocervical swab: 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. Insert the specimen collection swab (blue-shaft swab in the package with green printing) into the endocervical canal. Gently rotate the swab clockwise for 10 to 30 seconds in the endocervical canal to ensure adequate sampling. Withdraw the swab carefully; avoid contact with the vaginal mucosa. Remove the cap from the swab specimen transport tube and immediately place the specimen collection swab into the transport tube. Carefully break the swab shaft at the scoreline; use care to avoid splashing of the contents. Recap the swab specimen transport tube tightly. Male urethral swab: The patient should not have urinated for at least one hour prior to specimen collection. Insert the specimen collection swab (blue-shaft swab in the package with the green printing) 2 to 4 cm into the urethra. Gently rotate the swab clockwise for two to three seconds in the urethra to ensure adequate sampling. Withdraw the swab carefully. Remove the cap from the swab specimen transport tube and immediately place the specimen collection swab into the specimen transport tube. Carefully break the swab shaft at the scoreline; use care to avoid splashing of contents. Recap the swab specimen transport tube tightly. Vaginal swab: Care provider specimen: Collect vaginal fluid sample using the Gen-Probe® Aptima® vaginal swab kit by contacting the swab to the lower third of the vaginal wall and rotating the swab for 10 to 30 seconds to absorb fluid. Immediately place the swab into the transport tube and carefully break the swab shaft against the side of the tube. Tightly screw on the cap. Patient self-collection: Partially open the package of the Gen-Probe® Aptima® vaginal swab kit. Do not touch the soft tip or lay the swab down. If the soft tip is touched, the swab is laid down, or the swab is dropped, use a new Aptima® swab specimen collection kit. Remove the swab. Carefully insert the swab into the vagina about two inches past the introitus and gently rotate the swab for 10 to 30 seconds, making sure the swab touches the walls of the vagina so that moisture is absorbed by the swab. Withdraw the swab without touching the skin. Immediately place the swab into the transport tube and carefully break the swab shaft against the side of the tube. Tightly screw on the cap. Option 2: Urine Specimen: The patient should not have urinated for at least one hour prior to specimen collection. 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 specimen dilution that may reduce test sensitivity; lesser volumes may not adequately rinse organisms into the specimen. Female patients should not cleanse the labial area prior to providing the specimen. Add urine to the Aptima® Combo 2 urine collection device. The final volume must be between the two black lines on the device (about 2 mL). Option 3: Liquid-based Cytology Specimen ThinPrep® Vial − Broom or Brush/Spatula Broom-like collection technique: Obtain a sample from the cervix using a broom-like device by inserting the brush portion into the cervical os and then rotate the brush five times. Rinse the collection device in the PreservCyt® solution by pushing the brush into the bottom of the vial 10 times, forcing the bristles to bend apart to release the cervical material. As a final step, twirl the brush between the thumb and forefinger vigorously to further release cellular material. Discard the collection device. Tighten the cap on the ThinPrep® vial so that the torque line on the cap passes the torque line on the vial. Brush/spatula technique: Insert the brush into the endocervical canal until only the bottommost fibers are exposed. Slowly rotate the brush ¼ to ½ turn in one direction. Do not over-rotate the brush. Then, rotate the brush in the PreservCyt® solution 10 times while pushing against the wall of the ThinPrep® vial. Swirl the brush vigorously to release additional material. Discard the brush. Obtain an adequate sample from the ectocervix using a plastic spatula. Swirl vigorously in the ThinPrep® vial 10 times and discard the spatula. Tighten the cap on the ThinPrep® container so that the torque line on the cap passes the torque line on the vial.

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Panels that include this biomarker

• Chlamydia/Gonococcus , NAA 183194

  2 analytes · Urine · Fasting not stated · Turnaround 2 - 3 days

  Method and collection

  Method

  Nucleic acid amplification (NAA)

  Collection

  Option 1: Gen-Probe® Aptima® Endocervical, Male Urethral, or Vaginal Swab Endocervical swab: 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. Insert the specimen collection swab (blue-shaft swab in the package with green printing) into the endocervical canal. Gently rotate the swab clockwise for 10 to 30 seconds in the endocervical canal to ensure adequate sampling. Withdraw the swab carefully; avoid contact with the vaginal mucosa. Remove the cap from the swab specimen transport tube and immediately place the specimen collection swab into the transport tube. Carefully break the swab shaft at the scoreline; use care to avoid splashing of the contents. Recap the swab specimen transport tube tightly. Male urethral swab: The patient should not have urinated for at least one hour prior to specimen collection. Insert the specimen collection swab (blue-shaft swab in the package with the green printing) 2 to 4 cm into the urethra. Gently rotate the swab clockwise for two to three seconds in the urethra to ensure adequate sampling. Withdraw the swab carefully. Remove the cap from the swab specimen transport tube and immediately place the specimen collection swab into the specimen transport tube. Carefully break the swab shaft at the scoreline; use care to avoid splashing of contents. Recap the swab specimen transport tube tightly. Vaginal swab: Care provider specimen: Collect vaginal fluid sample using the Gen-Probe® Aptima® vaginal swab kit by contacting the swab to the lower third of the vaginal wall and rotating the swab for 10 to 30 seconds to absorb fluid. Immediately place the swab into the transport tube and carefully break the swab shaft against the side of the tube. Tightly screw on the cap. Patient self-collection: Partially open the package of the Gen-Probe® Aptima® vaginal swab kit. Do not touch the soft tip or lay the swab down. If the soft tip is touched, the swab is laid down, or the swab is dropped, use a new Aptima® swab specimen collection kit. Remove the swab. Carefully insert the swab into the vagina about two inches past the introitus and gently rotate the swab for 10 to 30 seconds, making sure the swab touches the walls of the vagina so that moisture is absorbed by the swab. Withdraw the swab without touching the skin. Immediately place the swab into the transport tube, and carefully break the swab shaft against the side of the tube. Tightly screw on the cap. Option 2: Urine Specimen: The patient should not have urinated for at least one hour prior to specimen collection. 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 specimen dilution that may reduce test sensitivity; lesser volumes may not adequately rinse organisms into the specimen. Female patients should not cleanse the labial area prior to providing the specimen. Add urine to the Aptima® Combo 2 urine collection device. The final volume must be between the two black lines on the device (about 2 mL). Option 3: Liquid-based Cytology Specimen ThinPrep® Vial − Broom or Brush/Spatula Broom-like collection technique: Obtain a sample from the cervix using a broom-like device by inserting the brush portion into the cervical os and then rotate the brush five times. Rinse the collection device in the PreservCyt® solution by pushing the brush into the bottom of the vial 10 times, forcing the bristles to bend apart to release the cervical material. As a final step, twirl the brush between the thumb and forefinger vigorously to further release cellular material. Discard the collection device. Tighten the cap on the ThinPrep® vial so that the torque line on the cap passes the torque line on the vial. Brush/spatula technique: Insert the brush into the endocervical canal until only the bottommost fibers are exposed. Slowly rotate the brush ¼ to ½ turn in one direction. Do not over-rotate the brush. Then, rotate the brush in the PreservCyt® solution 10 times while pushing against the wall of the ThinPrep® vial. Swirl the brush vigorously to release additional material. Discard the brush. Obtain an adequate sample from the ectocervix using a plastic spatula. Swirl vigorously in the ThinPrep® vial 10 times and discard the spatula. Tighten the cap on the ThinPrep® container so that the torque line on the cap passes the torque line on the vial.

  Reference notes

  No Chlamydia trachomatis or Neisseria gonorrhoeae detected

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• Chlamydia/Gonococcus , NAA With Confirmation 183616

  2 analytes · Urine · Fasting not stated · Turnaround 2 - 5 days

  Method and collection

  Method

  Nucleic acid amplification (NAA)

  Collection

  Option 1: Gen-Probe® Aptima® Endocervical, Male Urethral, or Vaginal Swab Endocervical swab: 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. Insert the specimen collection swab (blue-shaft swab in the package with green printing) into the endocervical canal. Gently rotate the swab clockwise for 10 to 30 seconds in the endocervical canal to ensure adequate sampling. Withdraw the swab carefully; avoid contact with the vaginal mucosa. Remove the cap from the swab specimen transport tube and immediately place the specimen collection swab into the transport tube. Carefully break the swab shaft at the scoreline; use care to avoid splashing of the contents. Recap the swab specimen transport tube tightly. Male urethral swab: The patient should not have urinated for at least one hour prior to specimen collection. Insert the specimen collection swab (blue-shaft swab in the package with the green printing) 2 to 4 cm into the urethra. Gently rotate the swab clockwise for two to three seconds in the urethra to ensure adequate sampling. Withdraw the swab carefully. Remove the cap from the swab specimen transport tube and immediately place the specimen collection swab into the specimen transport tube. Carefully break the swab shaft at the scoreline; use care to avoid splashing of contents. Recap the swab specimen transport tube tightly. Vaginal swab: Care provider specimen: Collect vaginal fluid sample using the Gen-Probe® Aptima® vaginal swab kit by contacting the swab to the lower third of the vaginal wall and rotating the swab for 10 to 30 seconds to absorb fluid. Immediately place the swab into the transport tube and carefully break the swab shaft against the side of the tube. Tightly screw on the cap. Patient self-collection: Partially open the package of the Gen-Probe® Aptima® vaginal swab kit. Do not touch the soft tip or lay the swab down. If the soft tip is touched, the swab is laid down, or the swab is dropped, use a new Aptima® swab specimen collection kit. Remove the swab. Carefully insert the swab into the vagina about two inches past the introitus and gently rotate the swab for 10 to 30 seconds, making sure the swab touches the walls of the vagina so that moisture is absorbed by the swab. Withdraw the swab without touching the skin. Immediately place the swab into the transport tube and carefully break the swab shaft against the side of the tube. Tightly screw on the cap. Option 2: Urine Specimen: The patient should not have urinated for at least one hour prior to specimen collection. 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 specimen dilution that may reduce test sensitivity; lesser volumes may not adequately rinse organisms into the specimen. Female patients should not cleanse the labial area prior to providing the specimen. Add urine to the Aptima® Combo 2 urine collection device. The final volume must be between the two black lines on the device (about 2 mL). Option 3: Liquid-based Cytology Specimen ThinPrep® Vial − Broom or Brush/Spatula Broom-like collection technique: Obtain a sample from the cervix using a broom-like device by inserting the brush portion into the cervical os and then rotate the brush five times. Rinse the collection device in the PreservCyt® solution by pushing the brush into the bottom of the vial 10 times, forcing the bristles to bend apart to release the cervical material. As a final step, twirl the brush between the thumb and forefinger vigorously to further release cellular material. Discard the collection device. Tighten the cap on the ThinPrep® vial so that the torque line on the cap passes the torque line on the vial. Brush/spatula technique: Insert the brush into the endocervical canal until only the bottommost fibers are exposed. Slowly rotate the brush ¼ to ½ turn in one direction. Do not over-rotate the brush. Then, rotate the brush in the PreservCyt® solution 10 times while pushing against the wall of the ThinPrep® vial. Swirl the brush vigorously to release additional material. Discard the brush. Obtain an adequate sample from the ectocervix using a plastic spatula. Swirl vigorously in the ThinPrep® vial 10 times and discard the spatula. Tighten the cap on the ThinPrep® container so that the torque line on the cap passes the torque line on the vial.

  Labcorp catalog page

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• Chlamydia/Gonococcus , NAA With Reflex to Trichomonas vaginalis , NAA 183198

  2 analytes · Urine · Fasting not stated · Turnaround 2 - 4 days

  Method and collection

  Method

  Nucleic acid amplification (NAA)

  Collection

  Vaginal swab collection: Care provider specimen: Collect vaginal fluid sample using the Gen-Probe® Aptima® Vaginal Swab Kit by contacting the swab to the lower third of the vaginal wall, rotating the swab for 10 to 30 seconds to absorb the fluid. Immediately place the swab into the transport tube and carefully break the swab shaft against the side of the tube. Tightly screw on the cap. Patient self-collection instructions: Partially open the package. Do not touch the soft tip or lay the swab down. If the soft tip is touched, the swab is laid down, or the swab is dropped, use a new Aptima® Vaginal Swab Specimen Collection Kit. Remove the swab. Carefully insert the swab into the vagina about 2" past the introitus and gently rotate the swab for 10 to 30 seconds, making sure the swab touches the walls of the vagina so that moisture is absorbed by the swab. Withdraw the swab without touching the skin. Immediately place the swab into the transport tube and carefully break the swab shaft against the side of the tube. Tightly screw on the cap. Endocervical swab: 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. Insert the specimen collection swab (blue-shaft swab in the package with green printing) into the endocervical canal. Gently rotate the swab clockwise for 10 to 30 seconds in the endocervical canal to ensure adequate sampling. Withdraw the swab carefully; avoid contact with the vaginal mucosa. Remove the cap from the swab specimen transport tube and immediately place the specimen collection swab into the transport tube. Carefully break the swab shaft at the scoreline using care to avoid splashing of the contents. Recap the swab specimen transport tube tightly. Male urethral swab: The patient should not have urinated for at least one hour prior to specimen collection. Insert the specimen collection swab (blue-shaft swab in the package with the green printing) 2 to 4 cm into the urethra. Gently rotate the swab clockwise for two to three seconds in the urethra to ensure adequate sampling. Withdraw the swab carefully. Remove the cap from the swab specimen transport tube and immediately place the specimen collection swab into the specimen transport tube. Carefully break the swab shaft at the scoreline using care to avoid splashing of contents. Recap the swab specimen transport tube tightly. Urine specimen: The patient should not have urinated for at least one hour prior to specimen collection. Direct patient to provide a first-catch urine (approximately 20 mL 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 specimen dilution that may reduce test sensitivity; lesser volumes may not adequately rinse organisms into the specimen. Female patients should not cleanse the labial area prior to providing the specimen. Add urine to the Aptima® COMBO 2 urine collection device. The final volume must be between the two black lines on the device (about 2 mL).

  Labcorp catalog page

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• PrEP Use Only: Chlamydia/Gonococcus , Urine or Urogenital Swab, NAA 188780

  2 analytes · Urine · Fasting not stated · Turnaround 2 - 3 days

  Method and collection

  Method

  Nucleic acid amplification (NAA)

  Collection

  Option 1: Aptima® Endocervical, Male Urethral, or Vaginal Swab Endocervical swab: 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. Insert the specimen collection swab (blue-shaft swab in the package with green printing) into the endocervical canal. Gently rotate the swab clockwise for 10 to 30 seconds in the endocervical canal to ensure adequate sampling. Withdraw the swab carefully; avoid contact with the vaginal mucosa. Remove the cap from the swab specimen transport tube and immediately place the specimen collection swab into the transport tube. Carefully break the swab shaft at the scoreline; use care to avoid splashing of the contents. Recap the swab specimen transport tube tightly. Male urethral swab: The patient should not have urinated for at least one hour prior to specimen collection. Insert the specimen collection swab (blue-shaft swab in the package with the green printing) 2 to 4 cm into the urethra. Gently rotate the swab clockwise for two to three seconds in the urethra to ensure adequate sampling. Withdraw the swab carefully. Remove the cap from the swab specimen transport tube and immediately place the specimen collection swab into the specimen transport tube. Carefully break the swab shaft at the scoreline; use care to avoid splashing of contents. Recap the swab specimen transport tube tightly. Vaginal swab: Care provider specimen: Collect vaginal fluid sample using the Gen-Probe® Aptima® vaginal swab kit by contacting the swab to the lower third of the vaginal wall and rotating the swab for 10 to 30 seconds to absorb fluid. Immediately place the swab into the transport tube and carefully break the swab shaft against the side of the tube. Tightly screw on the cap. Patient self-collection: Partially open the package of the Aptima® vaginal swab kit. Do not touch the soft tip or lay the swab down. If the soft tip is touched, the swab is laid down, or the swab is dropped, use a new Aptima® swab specimen collection kit. Remove the swab. Carefully insert the swab into the vagina about two inches past the introitus and gently rotate the swab for 10 to 30 seconds, making sure the swab touches the walls of the vagina so that moisture is absorbed by the swab. Withdraw the swab without touching the skin. Immediately place the swab into the transport tube, and carefully break the swab shaft against the side of the tube. Tightly screw on the cap. Option 2: Urine Specimen: The patient should not have urinated for at least one hour prior to specimen collection. 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 specimen dilution that may reduce test sensitivity; lesser volumes may not adequately rinse organisms into the specimen. Female patients should not cleanse the labial area prior to providing the specimen. Add urine to the Aptima® urine collection device. The final volume must be between the two black lines on the device (about 2 mL).

  Labcorp catalog page

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• Self-Collection in Office or Patient Service Center, Chlamydia trachomatis and Neisseria gonorrhoeae , Vaginal Swab, NAA 188013

  2 analytes · Swab · Fasting not stated · Turnaround 2 - 3 days

  Method and collection

  Method

  Nucleic acid amplification (NAA)

  Collection

  Patient Self-Collection: Partially open the package of the APTIMA® vaginal swab kit. Do not touch the soft tip or lay the swab down. If the soft tip is touched, the swab is laid down or the swab is dropped, use a new APTIMA® swab specimen collection kit. Remove the swab. Carefully insert the swab into the vagina about two inches past the introitus and gently rotate the swab for 10 to 30 seconds, making sure the swab touches the walls of the vagina so that moisture is absorbed by the swab. Withdraw the swab without touching the skin. Immediately place the swab into the transport tube, and carefully break the swab shaft against the side of the tube. Tightly screw on the cap.

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Single-analyte tests

• Neisseria gonorrhoeae RNA, TMA, Urogenital 11362

  Urine · Fasting not stated · Turnaround Set up: Mon-Fri (All shifts); Report available: 5 days

  Method and collection

  Method

  Transcription-Mediated Amplification (TMA)

  Preparation

  Urine: Patient should not have urinated within one hour prior to collection. Female patients should not cleanse the labial area prior to providing the specimen.

  Collection

  Vaginal Swab: Follow instructions in the Aptima® Multitest Collection Kit (orange label). Endocervical or Urethral Swab: Follow instructions in the Aptima® Unisex Swab Specimen Collection Kit (white label). In females, to ensure collection of cells infected with N. gonorrhoeae, columnar epithelial cells lining the endocervix should be obtained. Excess mucus should be removed prior to sampling. Urine: Direct patient to provide a first-catch urine (a maximum of 20-30 mL of the initial urine stream) into a urine collection cup free of any preservatives. 2 mL of urine specimen must be transferred into the Aptima® Specimen Transport Tube within 24 hours of collection and before being assayed. Use the tube provided in the urine specimen collection kit. The fluid (urine plus transport media) level in the urine transport tube must fall within the clear pane of the tube label. Labs performing cytology: Aliquot ThinPrep® PreservCyt® solution before performance of liquid-based cytology testing. ThinPrep® PreservCyt®: Transfer 1 mL ThinPrep® PreservCyt® solution into Aptima® Specimen Transfer Tube (green label) or Aptima® Multitest Collection Tube (orange label) or Unisex Swab Specimen Collection Kit (white label). SurePath™: SurePath™ fluid must be transferred to Aptima® tube within 4 days of collection. Transfer 0.5 mL SurePath™ solution into Aptima® Specimen Transfer Tube (green label) or Aptima® Multitest Collection Tube (orange label) or Unisex Swab Specimen Collection Kit (white label). For a complete list of assay limitations we recommend that you review the manufacturers package insert, https://www.hologic.com/package-inserts/diagnostic-products/aptima-combo-2-assay-ctng

  Reference notes

  Not detected

  Quest Diagnostics catalog page

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Panels that include this biomarker

• PrEP Chlamydia/Neisseria gonorrhoeae RNA, TMA, Urogenital 13701

  2 analytes · Urine · Fasting not stated

  Method and collection

  Method

  Transcription-Mediated Amplification (TMA)

  Preparation

  Urine: Patient should not have urinated within one hour prior to collection. Female patients should not cleanse the labial area prior to providing the specimen.

  Collection

  Vaginal swab: Follow instructions in the Aptima® Multitest Collection Kit (orange label). Endocervical or urethral swab: Follow instructions in the Aptima® Unisex Swab Specimen Collection Kit (white label). In females, to ensure collection of cells infected with N. gonorrhoeae/C. trachomatis, columnar epithelial cells lining the endocervix should be obtained. Excess mucus should be removed prior to sampling. Urine: Direct patient to provide a first-catch urine (a maximum of 20-30 mL of the initial urine stream) into a urine collection cup free of any preservatives. 2 mL of urine specimen must be transferred into the Aptima® Specimen Transport Tube within 24 hours of collection and before being assayed. Use the tube provided in the urine specimen collection kit. The fluid (urine plus transport media) level in the urine transport tube must fall within the clear pane of the tube label. ⁠⁠⁠⁠⁠⁠⁠For a complete list of assay limitations we recommend that you review the manufacturers package insert, https://www.hologic.com/package-inserts/diagnostic-products/aptima-combo-2-assay-ctng

  Quest Diagnostics catalog page

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