As part of our comprehensive plan for Women’s Health testing, CPL will be transitioning Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV) testing to the Roche COBAS® 6800/8800 platform. The transition will take place in several phases based on specimen type:
- Phase 1: Urine specimens
- Phase 2: Liquid-based Pap specimens (Thinprep® and Surepath™)
- Phase 3: Swab specimens
The laboratory has validated the Roche platform and determined that:
- The Roche® and Hologic® methods are both FDA-approved nucleic-acid amplification technologies (NAAT).
- The Roche® method is qualitative real-time polymerase chain reaction (PCR).
- The Hologic® method is qualitative target capture and Transcription-Mediated Amplification assay (TMA).
- The Roche® and Hologic® methods are analytically equivalent according to CDC and CPL evaluations.
- The Roche® method confirms as a highly sensitive and specific assay.
- The stability and handling of fresh and transferred urine with both systems are equivalent so client impact is expected to be negligible.
CPL will make every effort to assure that this transition causes no disruption of service. We believe that this transition will improve the pre-analytical and analytical processes by increasing process uniformity and instrumentation redundancy.
Phase 1: Urine Specimens
Effective September 1, 2022, Clinical Pathology Laboratories will be transitioning from the Hologic Aptima® testing platform to the Roche COBAS® 6800 and 8800 for the detection of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV) for urine specimens. This transition phase will include the following changes to methodologies and collection devices.
Collection Device | Aptima® Urine (Yellow Aptima) | COBAS® PCR Urine Kit collection devices |
Testing Platform | Hologic Aptima® | Roche COBAS® 6800/8800 |
Methodology | Transcription-Mediated Amplification and Hybrid Capture | Real-time Polymerase Chain Reaction (PCR) |
Current | New |
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Order codes and test names will remain the same for the test affected in this phase. The following order codes will be affected by Phase 1 of the transition:
4335 | CT/NG, NAAT, URINE | 4445 | TRICHOMONAS, NAAT, MALE UR/SWAB |
5397 | GONORRHEA, NAAT, URINE | 3913 | TRICHOMONAS, NAAT, URINE |
5399 | CHLAMYDIA, NAAT, URINE | ||
Order Code | Name | Order Code | Name |
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Collection Device Distribution
Beginning in September distribution will begin transitioning from Aptima® Urine (Yellow Aptima) collection devices to COBAS® PCR Urine Kit collection devices. Clients will no longer be supplied with Aptima® Urine (Yellow Aptima) collection devices after current inventory is depleted, and orders for urine collection kits will be fulfilled with COBAS® PCR Urine Kits.
During the transition, Aptima® Urine (Yellow Aptima) collection devices will continue to be run on the Hologic® platform, and Roche COBAS® PCR Urine Kit collection devices will be run on the Roche COBAS® platform without delays to testing.
Please contact your local CPL facility for supplies. There will be no change in the ordering or distribution process.
FDA Approved Status
The performance characteristics for the Roche COBAS® CT/NG and TV test have been evaluated and approved by the FDA for COBAS® PCR Urine Kit in male and female patients. CPL has verified these performance characteristics.
CPT Code
The CPT codes for testing for Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis are unchanged.
Phased Approach
The transition will take place in several phases to accommodate the logistics of collection device distribution. Further communications will be published for the beginning and end of each transition phase. See the effective dates for the beginning of each phase in the chart below:
1 | Urine | 4335 | CT/NG, NAAT, URINE | 9/01/2022 |
1 | Urine | 5397 | GONORRHEA, NAAT, URINE | 9/01/2022 |
1 | Urine | 5399 | CHLAMYDIA, NAAT, URINE | 9/01/2022 |
1 | Swab | 4445 | TRICHOMONAS, NAAT, MALE UR/SWAB | 9/01/2022 |
1 | Urine | 3913 | TRICHOMONAS, NAAT, URINE | 9/01/2022 |
2 | ThinPrep® | 4123 | CT/NG, TMA, THINPREP | TBD* |
2 | ThinPrep® | 5402 | GONORRHEA, TMA, THINPREP | TBD* |
2 | ThinPrep® | 5403 | CHLAMYDIA, TMA, THINPREP | TBD* |
2 | ThinPrep® | 3912 | TRICHOMONAS, AMPLIFIED | TBD* |
2 | SurePath™ | 5404 | CT/NG, TMA, SUREPATH | TBD* |
2 | SurePath™ | 5400 | GONORRHEA, TMA, SUREPATH | TBD* |
2 | SurePath™ | 5401 | CHLAMYDIA, TMA, SUREPATH | TBD* |
2 | SurePath™ | 3912 | TRICHOMONAS, AMPLIFIED | TBD* |
3 | Swab | 3755 | C. TRACHOMATIS/N. GONORRHOEAE, RECTAL AND PHARYNGEAL | TBD* |
3 | Swab | 3770 | C. TRACHOMATIS/N. GONORRHOEAE, RECTAL/PHARYNGEAL | TBD* |
3 | Swab | 5249 | CT/NG, TMA, SIMPLESWAB | TBD* |
3 | Swab | 5398 | CHLAMYDIA, TMA, SIMPLESWAB | TBD* |
3 | Swab | 5396 | GONORRHEA, TMA, SIMPLESWAB | TBD* |
3 | Swab | 3911 | TRICHOMONAS, SWAB, AMP | TBD* |
3 | Swab | 3910 | TRICHOMONAS, SIMPLESWAB | TBD* |
Phase | Specimen Type | Order Code | Name | Effective Date |
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*TBD = To Be Determined
Please contact your Account Executive should you have any questions regarding these changes.
References
- COBAS® CT/NG Qualitative nucleic acid test for use on the COBAS® 6800/8800 Systems. Package Insert. Roche Diagnostics®. 07998007001-04EN.
- COBAS® TV/MG Qualitative nucleic acid test for use on the COBAS® 6800/8800 Systems. Package Insert. Roche Diagnostics®. 08308535001-03EN.
- https://www.cdc.gov/mmwr/preview/mmwrhtml/rr6302a1.htm