Collect

Endocervical - Use cobas PCR Media Dual Swab Sample Kit: With large cleaning swab, remove excess mucus and blood from the cervical os and surrounding mucosa and discard. Insert the flocked specimen collection swab into the endocervical canal and gently rotate the swab 5 times in one direction. Do not over-rotate. Carefully withdraw the swab avoiding any contact with the vaginal mucosa.  Immediately place swab into transport tube. Carefully break the swab shaft at the score line. Recap and Label tube with patient information/source/date/time.

Vaginal swab - Use cobas PCR Media Uni Swab Sample Kit: Hold the swab with the scoreline above your hand and insert the swab about 5 cm (2 inches) into the vaginal opening. Gently turn the swab for about 30 seconds while rubbing the swab against the walls of the vagina. Withdraw the swab carefully. Immediately place swab into transport tube. Carefully break the swab shaft at the score line. Recap and Label tube with patient information/source/date/time.

Rectal swab - Use cobas PCR Media Uni Swab Sample Kit. Hold the woven swab with the scoreline above your hand.Insert the swab about 3 to 5 cm (1-2 inches) into the anal canal. Gently turn the swab in a clockwise direction for about 5-10 seconds while rubbing the swab against the walls of the rectum. Withdraw the swab carefully. If the swab is grossly contaminated with feces, discard and repeat the collection. Insert the swab into the collection tube and break the swab shaft at the score line. Recap and Label tube with patient information/source/date/time.

Throat swab - Use cobas PCR Media Uni Swab Sample Kit:  Holding the specimen collection swab with the scoreline above your hand, instruct patient to tilt head backwards, open mouth and say "ah." Insert the swab into the mouth and collect the specimen from the bilateral posterior pharynx, both tonsils and the uvula. Withdraw the swab carefully. Immediately place swab into transport tube. Carefully break the swab shaft at the score line. Recap and Label tube with patient information/source/date/time.

Urine – Use cobas PCR Urine Sample Kit: Patient should NOT urinate for at least 1 hour prior to collection of specimen. Patient should collect the 10-50 ml of the initial urine stream in a sterile preservative-free collection cup. Immediately transfer urine into the cobas PCR media tube using the provided disposable pipette. The correct volume of urine has been added when the fluid level is between the two black lines on the tube label. Tightly recap the cobas PCR media tube, discard the transfer pipette and invert the tube 5 times to mix. The specimen is now ready for transport. Label tube with patient information/source/date/time.

Urethral male - Use cobas PCR Media Dual Swab Sample Kit: (Discard large woven cleaning swab - not needed) Insert the flocked specimen collection swab 2-4 cm into the urethra. Rotate for 2-3 seconds. Immediately place swab into transport tube. Carefully break the swab shaft at the score line. Recap and Label tube with patient information/source/date/time.

 

Unacceptable Conditions

Use only cobas PCR Collection kits. Unacceptable specimens include wooden swabs, eye swabs and swab specimens without a swab in transport media. Large white swab is for preparatory cleaning of the endocervix and is unacceptable for testing when the dual swab is used for endocervical samples.

Carbomer containing products should not be used during specimen collection as this may affect test performance.

 

Storage/Transport Temperature

Swabs in cobas PCR media at 2-30°C within 30 days of collection. Unpreserved Urine at 2-30°C within 24 hours of collection. Urine in cobas PCR media specimen transport tube at 2-30° within 30 days of collection.

Stability (from collection to initiation)

In cobas PCR transport media:
Ambient: 30 days
Refrigerated: 30 days

Unstabilized urine (not in Roche PCR media) 24 hours ambient or refrigerated

Performed

Microbiology.
Monday - Friday

Performed

Microbiology.
Monday - Friday

Methodology

Polymerase Chain Reaction (PCR)
 

Reported

Results within 1-3 days
 

Reference Interval

Negative for C. trachomatis / N. gonorrhoeae.
Positive for C. trachomatis / N. gonorrhoeae.

Interpretive Data

A negative result does not preclude the presence of a C. trachomatis or N. gonorrhoeae infection because results are dependent on adequate specimen collection, absence of inhibitors, and sufficient DNA to be detected. Test results may be affected by improper specimen collection, improper specimen storage, technical error, or specimen mix-up.  The positive predictive value of the test varies depending on the organism prevalence in the population, the gender of the patient and the specimen type tested.  According to CDC guidelines, positive screening tests should be considered presumptive evidence of infection.  Test results are reported as positive, negative or indeterminate. If an indeterminate result is reported then submit a new specimen if indicated or treat patient based on clinical judgment.

CPT Codes

87491, 87591

 

Test Build Information

OrderCode OrderName ResultCode ResultName Result Units LOINC CPT
STDSW CHLAM/GC AMP PROBE CLSW Chlamydia Amp Probe   21613-5 87491, 87591
STDSW CHLAM/GC AMP PROBE GCSW GC Amplified Probe   24111-7  
STDSW CHLAM/GC AMP PROBE SSOUR Source   31208-2  

AOE Information (Ask at Order Entry Questions)

Order Code Order Description AOE Code AOE Name Answer Answer code question type
STDSW CHLAM/GC AMP PROBE SSOUR Source  Urine URNE  List
STDSW CHLAM/GC AMP PROBE      Cervical CRVX   
STDSW CHLAM/GC AMP PROBE      Rectal RECM   
STDSW CHLAM/GC AMP PROBE      Throat THRT   
STDSW CHLAM/GC AMP PROBE      Urethral URTH   
STDSW CHLAM/GC AMP PROBE      Vaginal VAGN   

Additional Information

For additional information or questions, contact RPSInterfaceSupport@unmc.edu
 
Collection

Collect

Endocervical - Use cobas PCR Media Dual Swab Sample Kit: With large cleaning swab, remove excess mucus and blood from the cervical os and surrounding mucosa and discard. Insert the flocked specimen collection swab into the endocervical canal and gently rotate the swab 5 times in one direction. Do not over-rotate. Carefully withdraw the swab avoiding any contact with the vaginal mucosa.  Immediately place swab into transport tube. Carefully break the swab shaft at the score line. Recap and Label tube with patient information/source/date/time.

Vaginal swab - Use cobas PCR Media Uni Swab Sample Kit: Hold the swab with the scoreline above your hand and insert the swab about 5 cm (2 inches) into the vaginal opening. Gently turn the swab for about 30 seconds while rubbing the swab against the walls of the vagina. Withdraw the swab carefully. Immediately place swab into transport tube. Carefully break the swab shaft at the score line. Recap and Label tube with patient information/source/date/time.

Rectal swab - Use cobas PCR Media Uni Swab Sample Kit. Hold the woven swab with the scoreline above your hand.Insert the swab about 3 to 5 cm (1-2 inches) into the anal canal. Gently turn the swab in a clockwise direction for about 5-10 seconds while rubbing the swab against the walls of the rectum. Withdraw the swab carefully. If the swab is grossly contaminated with feces, discard and repeat the collection. Insert the swab into the collection tube and break the swab shaft at the score line. Recap and Label tube with patient information/source/date/time.

Throat swab - Use cobas PCR Media Uni Swab Sample Kit:  Holding the specimen collection swab with the scoreline above your hand, instruct patient to tilt head backwards, open mouth and say "ah." Insert the swab into the mouth and collect the specimen from the bilateral posterior pharynx, both tonsils and the uvula. Withdraw the swab carefully. Immediately place swab into transport tube. Carefully break the swab shaft at the score line. Recap and Label tube with patient information/source/date/time.

Urine – Use cobas PCR Urine Sample Kit: Patient should NOT urinate for at least 1 hour prior to collection of specimen. Patient should collect the 10-50 ml of the initial urine stream in a sterile preservative-free collection cup. Immediately transfer urine into the cobas PCR media tube using the provided disposable pipette. The correct volume of urine has been added when the fluid level is between the two black lines on the tube label. Tightly recap the cobas PCR media tube, discard the transfer pipette and invert the tube 5 times to mix. The specimen is now ready for transport. Label tube with patient information/source/date/time.

Urethral male - Use cobas PCR Media Dual Swab Sample Kit: (Discard large woven cleaning swab - not needed) Insert the flocked specimen collection swab 2-4 cm into the urethra. Rotate for 2-3 seconds. Immediately place swab into transport tube. Carefully break the swab shaft at the score line. Recap and Label tube with patient information/source/date/time.

 

Unacceptable Conditions

Use only cobas PCR Collection kits. Unacceptable specimens include wooden swabs, eye swabs and swab specimens without a swab in transport media. Large white swab is for preparatory cleaning of the endocervix and is unacceptable for testing when the dual swab is used for endocervical samples.

Carbomer containing products should not be used during specimen collection as this may affect test performance.

 

Storage/Transport Temperature

Swabs in cobas PCR media at 2-30°C within 30 days of collection. Unpreserved Urine at 2-30°C within 24 hours of collection. Urine in cobas PCR media specimen transport tube at 2-30° within 30 days of collection.

Stability (from collection to initiation)

In cobas PCR transport media:
Ambient: 30 days
Refrigerated: 30 days

Unstabilized urine (not in Roche PCR media) 24 hours ambient or refrigerated

Performed

Microbiology.
Monday - Friday
Ordering

Performed

Microbiology.
Monday - Friday

Methodology

Polymerase Chain Reaction (PCR)
 

Reported

Results within 1-3 days
 

Result Interpretation

Reference Interval

Negative for C. trachomatis / N. gonorrhoeae.
Positive for C. trachomatis / N. gonorrhoeae.

Interpretive Data

A negative result does not preclude the presence of a C. trachomatis or N. gonorrhoeae infection because results are dependent on adequate specimen collection, absence of inhibitors, and sufficient DNA to be detected. Test results may be affected by improper specimen collection, improper specimen storage, technical error, or specimen mix-up.  The positive predictive value of the test varies depending on the organism prevalence in the population, the gender of the patient and the specimen type tested.  According to CDC guidelines, positive screening tests should be considered presumptive evidence of infection.  Test results are reported as positive, negative or indeterminate. If an indeterminate result is reported then submit a new specimen if indicated or treat patient based on clinical judgment.
Administrative

CPT Codes

87491, 87591

 

RPS Interface Information

Test Build Information

OrderCode OrderName ResultCode ResultName Result Units LOINC CPT
STDSW CHLAM/GC AMP PROBE CLSW Chlamydia Amp Probe   21613-5 87491, 87591
STDSW CHLAM/GC AMP PROBE GCSW GC Amplified Probe   24111-7  
STDSW CHLAM/GC AMP PROBE SSOUR Source   31208-2  

AOE Information (Ask at Order Entry Questions)

Order Code Order Description AOE Code AOE Name Answer Answer code question type
STDSW CHLAM/GC AMP PROBE SSOUR Source  Urine URNE  List
STDSW CHLAM/GC AMP PROBE      Cervical CRVX   
STDSW CHLAM/GC AMP PROBE      Rectal RECM   
STDSW CHLAM/GC AMP PROBE      Throat THRT   
STDSW CHLAM/GC AMP PROBE      Urethral URTH   
STDSW CHLAM/GC AMP PROBE      Vaginal VAGN   

Additional Information

For additional information or questions, contact RPSInterfaceSupport@unmc.edu