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Epic Code LAB1230560 APTIMA Mycoplasma Genitalium (MGen), NAAT, Swab, Urine

Important Note

Please review complete specimen collection information for each specimen type, making note of the important notes within the specimen requirements.

This assay is not approved for patients under the age of 15, so testing will not be performed on patients in this age group.

Test Name Alias

M-Gen | Mgen

Interface Order Alias

1230560

Clinical Information

The Mycoplasma genitalium assay uses the APTIMA target nucleic acid amplification test (NAAT) for the qualitative detection of ribosomal RNA (rRNA) from Mycoplasma genitalium to aid in the diagnosis of M. genitalium urogenital infections in male and female patients.

Icons & Photos

 

 

Collection Instructions

Submit only ONE of the following specimens:

 

Specimen Type: Vaginal specimens

Container/Tube: APTIMA Multitest (Vaginal) Swab

Collection Instructions:

  1. Partially peel open the swab package.  Do not touch the soft tip or lay the swab down.
  2. Hold the swab so that the thumb and forefinger are positioned in the middle of the shaft covering the score line.  Do not hold the swab shaft below the score line.
  3. Carefully insert the swab into the vagina about 2 inches past the introitus and gently rotate the swab for 10 to 30 seconds.  Make sure the swab touches the walls of the vagina so that moisture is absorbed by the swab.  Withdraw the swab without touching the skin.
  4. While holding the swab in the same hand, unscrew the cap from the tube.  Do not spill the contents of the tube.  Do not touch the top of the cap.
  5. Immediately place the swab in the transport tube so that the score line is at the top of the tube.
  6. Carefully break the swab shaft at the score line against the side of the tube.
  7. Discard the top portion of the swab shaft.
  8. Tightly screw the cap onto the tube, being careful not to touch the top of the cap.
  9. Record the patient’s name and date of birth on the vial.

Important Note: Collect the specimen using only the APTIMA Multitest (Vaginal) Swab Collection Kit when requesting APTIMA Mycoplasma genitalium NAAT testing.  Other swabs are not acceptable for use with this assay when testing a vaginal specimen.

Important Note: 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 endocervical swabs may be used as alternative specimens when vaginal swab specimens are not available. If female urine or endocervical swab specimens test negative, testing with a vaginal swab may be indicated, if M. genitalium infection is suspected.

Transport Temperature: After collection, the multitest (vaginal) swab is transported and stored at room temperature or refrigerated until tested.

Reject due to:

  • Improper collection of the specimen may result in invalid results.  If the lab receives a swab specimen transport tube with no swab, two swabs, a cleaning swab, or a swab not supplied by Hologic the specimen must be rejected.
  • If specimens are bagged together and a specimen leaks, all specimens in the bag will be cancelled and a request for recollection will be made.
  • Improper labeling of specimen - Spectrum Health Laboratory requires 2 patient identifiers (Name and Date of Birth or SH MRN)

Laboratory Retention: Swab specimens will be stored at room temperature for 14 days from collection.

 

Specimen Type: Endocervical specimens

Container/Tube: APTIMA Unisex Swab for Endocervical Specimens

Collection Instructions:

  1. Peel open the swab package.  Do not touch the soft tips or lay the swabs down.
  2. Remove excess mucus from the cervical os and surrounding mucosa using the cleaning swab with the white shaft.  Discard this swab.
  3. Carefully insert the specimen collection swab (with the blue shaft) into the endocervical canal.  Gently rotate the swab for 10 to 30 seconds in the endocervical canal to ensure adequate sampling.
  4. Withdraw the swab carefully; avoid any contact with the vaginal mucosa.
  5. While holding the swab in the same hand, unscrew the cap from the tube.  Do not spill the contents of the tube.  Do not touch the top of the cap.
  6. Immediately place the swab in the transport tube so that the score line is at the top of the tube.
  7. Carefully break the swab shaft at the score line against the side of the tube.
  8. Discard the top portion of the swab shaft.
  9. Tightly screw the cap onto the tube, being careful not to touch the top of the cap.
  10. Record the patient’s name and date of birth on the vial.

Important Note: Collect the specimen using only the APTIMA Unisex Swab Collection Kit for Endocervical Specimens when requesting APTIMA Mycoplasma genitalium NAAT testing.  Other swabs are not acceptable for use with this assay when testing an endocervical specimen.

Transport Temperature: After collection, the endocervical swab is transported and stored at room temperature or refrigerated until tested.

Reject due to:

  • Improper collection of the specimen may result in invalid results.  If the lab receives a swab specimen transport tube with no swab, two swabs, a cleaning swab, or a swab not supplied by Hologic the specimen must be rejected.
  • If specimens are bagged together and a specimen leaks, all specimens in the bag will be cancelled and a request for recollection will be made.
  • Improper labeling of specimen - Spectrum Health Laboratory requires 2 patient identifiers (Name and Date of Birth or SH MRN)

Laboratory Retention: Swab specimens will be stored at room temperature for 14 days from collection.

 

Specimen Type: Male urethral specimens

Container/Tube: APTIMA Unisex Swab for Male Urethral Specimens

Collection Instructions:

  1. The patient should not have urinated for at least 1 hour prior to sample collection.
  2. Peel open the swab package.  Do not touch the soft tips or lay the swabs down.
  3. Carefully insert the specimen collection swab (with the blue shaft) 2 to 4 cm into the urethra.  Gently rotate the swab clockwise for 2 to 3 seconds in the urethra to ensure adequate sampling.
  4. Withdraw the swab carefully.
  5. While holding the swab in the same hand, unscrew the cap from the tube.  Do not spill the contents of the tube.  Do not touch the top of the cap.
  6. Immediately place the swab in the transport tube so that the score line is at the top of the tube.
  7. Carefully break the swab shaft at the score line against the side of the tube.
  8. Discard the top portion of the swab shaft.
  9. Tightly screw the cap onto the tube, being careful not to touch the top of the cap.
  10. Record the patient’s name and date of birth on the vial.

Important Note: Collect the specimen using only the APTIMA Unisex Swab Collection Kit for Male Urethral Specimens when requesting APTIMA Mycoplasma genitalium NAAT testing.  Other swabs are not acceptable for use with this assay when testing male urethral specimens.

Transport Temperature: After collection, the urethral swab is transported and stored at room temperature or refrigerated until tested.

Reject due to:

  • Improper collection of the specimen may result in invalid results.  If the lab receives a swab specimen transport tube with no swab, two swabs, a cleaning swab, or a swab not supplied by Hologic the specimen must be rejected.
  • If specimens are bagged together and a specimen leaks, all specimens in the bag will be cancelled and a request for recollection will be made.
  • Improper labeling of specimen - Spectrum Health Laboratory requires 2 patient identifiers (Name and Date of Birth or SH MRN)

Laboratory Retention: Swab specimens will be stored at room temperature for 14 days from collection.

 

Specimen Type: Urine

Container/Tube: Sterile urine cup

Preferred Volume to Collect: 20 to 30 mL

Minimum Volume to Collect: 4 mL

Collection Instructions:

  1. The patient should not have urinated for at least 1 hour prior to specimen collection.
  2. The patient should be directed to provide a first-catch urine (approximately 20 to 30 mL of the initial urine stream) into a sterile urine cup free of any preservatives.  Female patients should not clean the labial area prior to providing the specimen.
  3. Record the patient’s name and date of birth on the cup.

Transport Temperature: Urine specimens in the sterile urine cup must be transported to the laboratory stored at room temperature or refrigerated within 24 hours of collection.

Reject due to:

  • Improper collection of the specimen may result in invalid results.
  • If specimens are bagged together and a specimen leaks, all specimens in the bag will be canceled and a request for recollection will be made.
  • Invalid specimen types
  • Improper labeling of specimen - Spectrum Health Laboratory requires 2 patient identifiers (Name and Date of Birth or SH MRN)

Laboratory Retention: Urine specimens in the sterile urine cup will be stored at room temperature or refrigerated for 24 hours from collection.

 

Specimen Type: Urine

Container/Tube: APTIMA Urine Transport Tube

Preferred Volume to Collect: 20 to 30 mL collected in a sterile urine collection cup          

Minimum Volume to Collect: 4 mL collected in a sterile urine collection cup

Collection Instructions:

  1. The patient should not have urinated for at least 1 hour prior to specimen collection.
  2. The patient should be directed to provide a first-catch urine (approximately 20 to 30 mL of the initial urine stream) into a sterile urine cup free of any preservatives.  Female patients should not clean the labial area prior to providing the specimen.
  3. Remove the cap of the APTIMA urine specimen transport tube.
  4. Transfer 2 mL of urine from the collection cup to the urine specimen transport tube using the disposable pipette provided.  The correct volume of urine has been added when the fluid level is between the black fill lines on the urine specimen transport tube label.
  5. Re-cap the urine specimen transport tube tightly.
  6. Record the patient’s name and date of birth on the vial.

Transport Temperature: Urine specimens transferred to the APTIMA Urine Transport Tube within 24 hours of urine collection are transported and stored at room temperature or refrigerated until tested.

Reject due to:

  • After 2 mL of urine has been added to the APTIMA urine transport tube, the liquid level MUST fall between the two black indicator lines on the tube label. Otherwise, the specimen will be rejected.
  • Improper collection of the specimen may result in invalid results.
  • If specimens are bagged together and a specimen leaks, all specimens in the bag will be canceled and a request for recollection will be made.
  • Invalid specimen types
  • Improper labeling of specimen - Spectrum Health Laboratory requires 2 patient identifiers (Name and Date of Birth or SH MRN)

Laboratory Retention: Urine specimens transferred to the APTIMA Urine Transport Tube are stored at room temperature for 14 days from collection.

Important Note: Urine specimens should be submitted using only a sterile urine cup or the APTIMA Urine Transport Tube when requesting APTIMA Mycoplasma genitalium NAAT testing.  Other urine collection tubes are not acceptable for use with this assay.

 

Special Instructions

Important Note: This assay is not approved for patients under the age of 14, so testing will not be performed on patients in this age group.

APTIMA multitest (vaginal) swabs, APTIMA endocervical unisex swabs, APTIMA male urethral unisex swabs and male and female urine specimens are approved for testing.  Other specimen types are not acceptable.

Best practice to avoid specimen contamination: Do not touch top of cap, make sure all caps are secured, individually bag specimens and change gloves if they become contaminated.

A negative test result does not preclude the presence of a Mycoplasma genitalium infection because results are dependent on adequate specimen collection, absence of inhibitors, and sufficient rRNA to be detected.

Results for Mycoplasma genitalium will be reported as Positive or Negative (presumed negative for Mycoplasma genitalium rRNA). For specimens receiving a result of Invalid, a new specimen should be collected.

Test Frequency

Available at least once per week; usual turn-around time is less than 7 days.

Reference Range

Negative

Performing Department

MOLECULAR DIAGNOSTICS

Performing Department Laboratory Location

Advanced Technology Laboratory (ATL), Grand Rapids, MI

Methodology

The APTIMA Nucleic Acid Amplification Test (NAAT) utilizes target capture, Transcription-Mediated Amplification (TMA) and Dual Kinetic Assay (DKA) technologies for the detection of ribosomal RNA (rRNA) from Mycoplasma genitalium

CPT

87798

CDM Code

80106007

Epic Test ID

1230102182

LOINC

23300-7

Beaker LOINC

MYCOPLASMA NAAT APTIMA: 23300-7

Mayo Access Code

SHO1230560

Reviewed Date

8/23/2021

Beaker Names

Beaker Procedure Name: APTIMA MYCOPLASMA GENITALIUM NAAT
Beaker Display Name: APTIMA Mycoplasma Genitalium NAAT
BEAKER TEST NAME: APTIMA MYCOPLASMA GENITALIUM NAAT
BEAKER TEST REPORT NAME: Aptima Mycoplasma Genitalium NAAT

Beaker Synonyms

No synonym on file

Beaker Collection and Specimen Handling

BEAKER COLLECTION: +A

Beaker Location, Container and Temperature

BW CYTOLOGY: URINE CUP R (Preferred)-Ambient
BW CYTOLOGY: Aptima Multitest (Acceptable)-Ambient
BW CYTOLOGY: UNISEX APTIMA (Acceptable)-Ambient
LC MOLECULAR DIAGNOSTICS: URINE CUP R (Preferred)-Ambient
LC MOLECULAR DIAGNOSTICS: Aptima Multitest (Acceptable)-Ambient
LC MOLECULAR DIAGNOSTICS: UNISEX APTIMA (Acceptable)-Ambient