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 a 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 2: PreservCyt(ThinPrep)® and SurePath™ specimens
Effective October 17, 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 PreservCyt (Thinprep)® and SurePath™ specimens. There will be no changes to the collection devices for this phase of the transition. However, the following changes to methodologies are included.
Collection Device | PreservCyt (ThinPrep)® or SurePath™ | PreservCyt (ThinPrep)® or SurePath™ |
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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As part of the transition, test names will be edited to NAAT (nucleic acid amplification technology) which includes both polymerase chain reaction (PCR) and transcription mediated amplification (TMA) target amplification technologies. Order codes will remain the same for the tests affected in this phase. The following order codes will be affected by Phase 2 of the transition:
4123 | CT/NG, TMA, THINPREP | CT/NG, NAAT, THINPREP |
5403 | CHLAMYDIA, TMA, THINPREP | CHLAMYDIA, NAAT, THINPREP |
5402 | GONORRHEA, TMA, THINPREP | GONORRHEA, NAAT, THINPREP |
5404 | CT/NG, TMA, SUREPATH | CT/NG, NAAT, SUREPATH |
5401 | CHLAMYDIA, TMA, SUREPATH | CHLAMYDIA, NAAT, SUREPATH |
5400 | GONORRHEA, TMA, SUREPATH | GONORRHEA, NAAT, SUREPATH |
3912 | TRICHOMONAS, AMPLIFIED | TRICHOMONAS, NAAT |
8167 | PAP TEST,SUREPATH, IMAGED+HPV HR IF ASC + CT/NG, TMA + HSV I/II PCR | PAP TEST,SUREPATH, IMAGED+HPV HR IF ASC + CT/NG, NAAT + HSV I/II PCR |
8144 | PAP TEST, TP, IMAGED+HPV HR IF ASC/LSIL+CT/NG, TMA+HSV I/II+TRICH | PAP TEST, TP, IMAGED+HPV HR IF ASC/LSIL+CT/NG, NAAT+HSV I/II+TRICH |
Test Code | Previous Name | New Name |
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Collection Device Distribution
There will be no changes to the collection devices for this phase. PreservCyt (ThinPrep)® and SurePath® specimens should be collected per standard procedure.
FDA Approved Status
The performance characteristics for the Roche COBAS® CT/NG and TV test have been evaluated and approved by the FDA for PreservCyt (ThinPrep)®. CPL has verified these performance characteristics. The performance characteristics for the Roche COBAS® CT/NG and Roche COBAS® TV test have been evaluated by CPL for SurePath™. Specimen types and sources that have not been specifically evaluated and approved by the FDA will include the following disclaimer on each report:
“The performance of this assay has not been specifically approved by the FDA for the Surepath collection device. The performance characteristics for these devices have been validated by Clinical Pathology Laboratories, Inc. CPL is authorized under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high complexity testing.”
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.