Effective April 22, 2024, Clinical Pathology Laboratories will consolidate Herpes Simplex Virus (HSV) Nucleic Acid Amplification Testing (NAAT) under order code 3915. Order code 6068 and 6069 will be discontinued.
| 3915 | HSV 1 AND 2 BY PCR | HSV 1 AND 2 BY NAAT |
| 6068 | HERPES SIMPLEX VIRUS, TMA | N/A (discontinued) |
| 6069 | HERPES SIMPLEX VIRUS, TMA | N/A (discontinued) |
| Order Code | Previous Name | New Name |
|---|
Clinical Pathology Laboratories has validated the Roche cobas® HSV 1 and 2 assay for use on the cobas® 4800 platform. CPL has found Roche cobas® HSV 1 and 2 to be clinically equivalent to the currently in use Hologic Aptima® HSV 1 and 2 and referral PCR HSV 1 and 2 tests.
Specimens are no longer acceptable frozen. Specimens may be transported at room temperature or refrigerated. Specimen types will be tested using the methodology as follows:
| Viral Transport Swab | 3 Days Room Temperature 2 Weeks Refrigerated |
Polymerase Chain Reaction (PCR) | Roche cobas® 4800 |
| Roche® Dual Swab | 2 Weeks Room Temperature 2 Weeks Refrigerated |
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| ESwab® | 3 Days Room Temperature 2 Weeks Refrigerated |
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| ThinPrep® | 2 Weeks Room Temperature 2 Weeks Refrigerated |
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| SurePathTM | 2 Weeks Room Temperature 2 Weeks Refrigerated |
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| Aptima® Multitest Swab | 2 Weeks Room Temperature 2 Weeks Refrigerated |
Transcription Mediated Amplification (TMA) | Hologic Panther® |
| Specimen Type | Stability | Methodology | Platform |
|---|
Each report will include a message indicating the method used. Specimens tested on Roche cobas® HSV 1 and 2 assay will include a Laboratory Developed Test message. It is FDA-modified for use with Viral Transport Swab, Roche® Dual Swab, ESwab®, ThinPrep®, and SurePathTM
Note:
Please avoid using any products including lubricants, creams, gels, and hygiene products containing CARBOMERS prior to collection of NAAT specimens. For the lists of acceptable and unacceptable lubricants, please review the following link: www.cpllabs.com/lubricants-for-pap-and-sti.
References:
Cobas® HSV 1 and 2 Test. Instructions for Use. 0897939001-01EN Rev. 1.0.
Aptima® Herpes Simplex Viruses 1 & 2 Assay. Instructions for Use. AW-15636 Rev. 001.