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Epic Code LAB1230887 Gonococcus PCR

Important Note

Spectrum Health Regional Laboratory's Gonococcus testing is not validated for performance on pediatric patients under the age of 14 years old.  Testing for these patients must be collected in either an APTIMA Multi-Test Swab collection kit or the APTIMA Urine collection kit and will be sent out to a reference laboratory.  Please order a Reference Miscellaneous Test (#LAB848) and indicate complete test name when pediatric testing is necessary.

Test Name Alias

Gonococcus | GC | NG | STI

 

Interface Order Alias

1230887

Clinical Information

N. gonorrhoeae is the causative agent of gonococcal (GC) infections, the majority of which are uncomplicated lower genital tract infections and may be asymptomatic.  However, if left untreated in women, infections can ascend and cause PID which can manifest as endometriosis, salpingitis, pelvic peritonitis, and tubo-ovarian abscesses.  A smaller percentage of persons with gonococcal infections may develop disseminated Gonococcal Infection.

 

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

 

f a specimen has small numbers of GC cellular material, uneven distribution may occur which may affect the ability to detect small numbers of organisms in the collected material.  A cellular control is included in the assay to ensure an adequate sample has been obtained.  If negative results from the specimen do not fit with the clinical impression, a new specimen may be necessary.

Icons & Photos

SH/SHMG: Workday Order ITM-ITM-1190747

Non-SH: Supply form "STD Multi-Collection Kit"

Collection Instructions

Specimen Collection: Swab or Urine

 

Container(s): Alinity m Multi-Collect tube

 

Specimen Type: Female Genital Swab Alinity m Multi-Collect tube

 

  1. Specimens should be obtained with a swab using a speculum moistened with sterile warm water to facilitate collection.
  2. Lubricants other than water should not be used since they can be toxic to the organism.
  3. Discard disposable transfer pipette; it is not required for endocervical swab specimen collection
  4. Remove the sterile swab from the wrapper, taking care not to touch swab tip or lay it down on any surface
  5. Insert the white tip of the specimen collection swab into the endocervix canal.
  6. Gently rotate the swab for 15 – 30 seconds to ensure adequate sampling
  7. Withdraw the swab, carefully
  8. Handle the cap and tube carefully to avoid contamination, including the outside of the transport tube and cap. If necessary, change gloves.
  9. Unscrew the transport tube cap and immediately place the specimen collection swab into the transport tube so that the white tip is down.
  10. Carefully break the swab at the scored line on the shaft; use care to avoid splashing the contents
  11. Recap the transport tube. Ensure the cap seals tightly.
  12. Label the transport tube with sample ID, including date and time of collection.
  13. Transport to lab within 24 hours at room temperature or 14 days refrigerated.

 

Specimen Type: Male Genital Swab Alinity m Multi-Collect tube

 

  1. The patient must be instructed not to urinate at least 1 hour prior to sampling.
  2. Insert swab 2-4 cm into Urethra.
  3. Rotate swab for 3-5 seconds and withdraw swab.
  4. Insert swab into the Abbott multi-collect transport media. Snap off shaft of swab at the score line.
  5. Leave swab in tube. Cap tube and label specimen.
  6. Transport specimen within 24 hours at room temperature or 14 days refrigerated.

 

Specimen Type: Urine (First void)

 

Container(s): Sterile urine cup (with lid) or Alinity m multicollect sample kit

Preferred Volume to Collect: 30.0 mL
Minimum Volume to Collect: 10 mL if sterile cup is transported to lab; to fill line of Alinity m multicollect tube if transferred in office.

Aliquot: Yes - Transfer urine to Alinity m multicollect tube in office is preferred.

Collection Instructions:

  1. First void ("dirty") urine is included in this collection, this is collected before a UA specimen, if both are needed.
  2. Do not cleanse the genital area prior to specimen collection.
  3. Patient should not have urinated for at least one hour prior to sample collection.
  4. Follow directions above to obtain a first void urine specimen.
  5. Discard specimen collection swab, it is not required for urine specimen collection.
  6. Unscrew the transport tube cap, taking care not to spill the transport buffer within.
  7. Handle the cap and tube carefully to avoid contamination.
  8. Use the plastic transfer pipette to transfer urine from the collection cup into the transport tube until the liquid level in the tube falls within the clear fill window of the transport tube label or else a new specimen should be collected.
  9. Do not overfill. Slightly more than one full squeeze of the transfer pipette bulb may be required to transfer the necessary volume of urine specimen.
  10. Recap the transport tube carefully. Ensure the cap seals tightly.
  11. Label the transport tube with sample identification information, including date of collection. Take care not to obscure the fill window on the transport tube.

 

Transport Temperature:  Ambient (room temperature) or Refrigerated

 

NOTE:  Failure to collect a urine specimen, including the first part of the voiding, may decrease the sensitivity of this test. If the specimen cannot be delivered to the laboratory within a few hours after collection it should be stored and refrigerated until it can be delivered. Specimen must be received in laboratory for analysis within 24 hours of collection.
 

 

Specimen Type: Patient Self-Collect Swab

Self-collected vaginal swabs may be used as opposed to provider-collected swabs. Self-collected swabs are supported by current clinical guidelines as recent studies have shown their equivalence, if not superiority, in quality and their association with increased patient satisfaction.

NOTE: Self-collection must still take place in a healthcare setting and is not approved for at-home collection.

LINK: Self-Swab for Testing

LINK: References

 

 

Specimen Type: Oropharyngeal Swab 

 

1. Discard disposable transfer pipette; it is not required for oropharyngeal swab collection.

2. Remove the sterile swab from the wrapper, taking care not to touch swab tip or lay it down on any surface. 

3. The white tip of the swab should be rubbed against each tonsillar pillar and the posterior wall and rotated at least one time. Do NOT collect specimens from the tongue.

4. If pharyngeal exudate is present, this should also be sampled.

5. Withdraw the swab carefully. 

6. Handle the cap and tube carefully to avoid contamination, including the outside of the transport tube and cap. If necessary, change gloves.

7. Unscrew the transport tube cap and immediately place the specimen collection swab into the transport tube so that the white tip is down.

8. Carefully break the swab at the scored line on the shaft; use care to avoid splashing of contents.

9. Recap the transport tube carefully. Ensure the cap seals tightly or leakage may occur.

10. Label the transport tube with sample identification information, including date of collection using an adhesive label.

 

 

Specimen Type: Rectal Swab

 

1. Discard disposable transfer pipette; it is not required for oropharyngeal swab collection.

2. Remove the sterile swab from the wrapper, taking care not to touch swab tip or lay it down on any surface. 

3. The white tip of the swab should be inserted 1-2.5 cm into the anal canal and rotated at least one time. 

4. Withdraw the swab carefully. 

5. Handle the cap and tube carefully to avoid contamination, including the outside of the transport tube and cap. If necessary, change gloves. 

6. Unscrew the transport tube cap and immediately place the specimen collection swab into the transport tube so that the white tip is down. 

7. Carefully break the swab at the scored line on the shaft; use care to avoid splashing of contents. 

8. Recap the transport tube carefully. Ensure the cap seals tightly or leakage may occur.

9. Specimens discolored by stool or blood are acceptable.

10. Label the transport tube with sample identification information, including date of collection using an adhesive label.

Rejection Criteria

  • Leaky specimen
  • QNS
  • Urines in sterile cup not received into lab within 24 hours.

Specimen Stability

For Genital swabs:

  • Ambient: 14 days 2oC -30oC in Alinity m multi-collect  specimen container
  • Refrigerate: 14 days 2oC – 30oC in Alinity m multi-collect specimen container
  • Laboratory Retention: 7 days

 

For Urine:
If the urine is put directly in the Alinity m collection tube, the following applies:

  • Ambient: 14 days 2oC – 30oC in Alinity m multi-collect  specimen container
  • Refrigerate: 14 days 2oC – 30oC  in Alinity m multi-collect  specimen container
  • Laboratory Retention: 7 days

If only a urine cup is received

  • Refrigerate: 24 hours
  • Laboratory Retention: 24 hours

Test Frequency

Available Monday through Friday.

Usual TAT 2-5 days

Reference Range

Negative

Performing Department

Molecular Diagnostics

Performing Department Laboratory Location

Corewell Health Advanced Technology Laboratory (ATL), Grand Rapids, MI

Methodology

Polymerase chain reaction (PCR)

CPT

87591

CDM Code

3068759102

Epic Test ID

1230102555

LOINC

GONOCOCCUS MDI RESULT: N/A

GONOCOCCUS PCR GENITAL: 47387-6

GONOCOCCUS MDI RESULT: N/A

GONOCOCCUS PCR URINE: 21416-3

Mayo Access Code

Current unavailable

Reviewed Date

New Test - Currently Under Review