Mycoplasma genitalium NAA

Single-analyte tests

• Mycoplasma genitalium , NAA, Swab 180076

  Swab · Fasting not stated · Turnaround 3 - 4 days

  Method and collection

  Method

  Nucleic acid amplification (NAA)

  Collection

  Vaginal swab: Collect vaginal fluid sample using the Aptima® swab 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. 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.

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• Mycoplasma genitalium , NAA, Swab With Reflex to Macrolide Resistance Testing 180092

  Swab · Fasting not stated · Turnaround 3 - 4 days

  Method and collection

  Method

  Nucleic acid amplification (NAA)

  Collection

  Vaginal swab: Collect vaginal fluid sample using the Aptima® swab 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. 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.

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• Self-Collection in Office or Patient Service Center, Mycoplasma genitalium , Vaginal Swab, NAA 180105

  Swab · Fasting not stated · Turnaround 3 - 4 days

  Method and collection

  Method

  Nucleic acid amplification (NAA)

  Collection

  Paitent 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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Panels that include this biomarker

• Chlamydia/Gonococcus/Mycoplasma genitalium , NAA, Swab 180082

  3 analytes · Swab · Fasting not stated · Turnaround 3 - 4 days

  Method and collection

  Method

  Nucleic acid amplification (NAA)

  Collection

  Vaginal swab: Collect vaginal fluid sample using the Aptima® swab 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. 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.

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• Chlamydia/Gonococcus/Mycoplasma genitalium (With Reflex to Macrolide Resistance), NAA, Swab 180120

  3 analytes · Swab · Fasting not stated · Turnaround 3 - 4 days

  Method and collection

  Method

  Nucleic acid amplification (NAA)

  Collection

  Vaginal swab: Collect vaginal fluid sample using the Aptima® Multitest swab 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. 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) provided in the Aptima® Unisex collection kit. 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 from the Aptima® Unisex Swab kit (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.

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• Genital Mycoplasma Profile, NAA, Swab 180089

  3 analytes · Swab · Fasting not stated · Turnaround 3 - 4 days

  Method and collection

  Method

  Nucleic acid amplification (NAA)

  Collection

  Vaginal swab: Collect vaginal fluid sample using the Gen-Probe® Aptima® swab 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. 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.

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• Chlamydia/Gonococcus/Trichomonas vaginalis/Mycoplasma genitalium , NAA, Swab 180073

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

  Method and collection

  Method

  Nucleic Acid Amplification

  Collection

  Clinician collected vaginal swab: Collect vaginal fluid sample using the Aptima® swab 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. 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.

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• Chlamydia/Gonococcus/Trichomonas vaginalis/Mycoplasma genitalium (With Reflex to Macrolide Resistance), NAA, Swab 180111

  4 analytes · Swab · Fasting not stated · Turnaround 3 - 4 days

  Method and collection

  Method

  Nucleic Acid Amplification (NAA)

  Collection

  Clinician collected vaginal swab: Collect vaginal fluid sample using the Aptima® swab 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. 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.

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Single-analyte tests

• Mycoplasma genitalium rRNA, NAAT with Reflex to Macrolide Resistance 18456

  Urine · Fasting not stated · Turnaround Set up: Mon-Sat

  Method and collection

  Method

  Transcription-Mediated Amplification (TMA)

  Collection

  Performance of the assay has not been evaluated in individuals less than 15 years of age. 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-mycoplasma-genitalium-assay Urine must be transferred to an Aptima urine transport tube in accordance with the instructions in the urine collection kit package insert. After collection, urine specimens in the primary collection container can be stored at 2° C to 30° C for up to 24 hours before urine is transferred to the transport tube. For females, a vaginal swab is the preferred specimen type due to higher clinical sensitivity for detecting M. genitalium than other specimen types; however, female urine or clinician collected endocervical swabs may be used as alternative specimens when vaginal swab specimens are not available. If female urine or clinician-collected endocervical swab specimens test negative, testing with a vaginal swab may be indicated, if M. genitalium infection is suspected.

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• Mycoplasma genitalium, rRNA, TMA 91475

  Urine · Fasting not stated · Turnaround Set up: Daily (All shifts); Report available: 3 days

  Method and collection

  Method

  Transcription-Mediated Amplification (TMA)

  Preparation

  Refer to the appropriate specimen collection kit package insert for specific collection instructions

  Collection

  ⁠⁠⁠⁠⁠⁠⁠Performance of the assay has not been evaluated in individuals less than 15 years of age. 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-mycoplasma-genitalium-assay Urine must be transferred to an Aptima urine transport tube in accordance with the instructions in the urine collection kit package insert. After collection, urine specimens in the primary collection container can be stored at 2° C to 30° C for up to 24 hours before urine is transferred to the transport tube. For females, a vaginal swab is the preferred specimen type due to higher clinical sensitivity for detecting M. genitalium than other specimen types; however, female urine or clinician collected endocervical swabs may be used as alternative specimens when vaginal swab specimens are not available. If female urine or clinician-collected endocervical swab specimens test negative, testing with a vaginal swab may be indicated, if M. genitalium infection is suspected.

  Reference notes

  Not Detected

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