OPERATING INSTRUCTIONS
5A.2
ThinPrep 2000 Processor Operator’s Manual
OPTIONAL INSTRUCTIONS FOR ANCILLARY TESTING
Testing for certain sexually transmitted diseases (STD) and for Human Papilloma Virus (HPV) in
conjunction with cytology may be performed using the residual specimen remaining in the Preserv-
Cyt sample vial after preparation of the ThinPrep Pap test slide. Such testing may also be enabled by
the removal of an aliquot of up to 4 mL (Aliquot Removal) from the PreservCyt sample vial before
preparing the ThinPrep Pap test slide.
Laboratory personnel must follow the specific instructions in this section to appropriately remove
the desired aliquot volume and prepare the PreservCyt sample vial for the ThinPrep Pap test. Adher-
ence to these instructions must be maintained to ensure there is no adverse effect on the ThinPrep
Pap test result.
Because cytology/HPV testing and STD testing address different clinical questions, Aliquot Removal
may not be suitable for all clinical situations. Physicians and other persons responsible for ordering
clinical tests should be familiar with the following:
• There is no evidence of degradation of cytology results by Aliquot Removal, however, this
cannot be ruled out for all specimens. As with any subsampling step in anatomic pathology,
chance misallocation of diagnostic cells may occur if they are very rare. If negative results
from the specimen do not fit with the clinical impression, a new specimen may be necessary.
• Aliquot Removal from low-cellularity specimens may leave insufficient material in the
PreservCyt sample vial for preparation of a satisfactory ThinPrep Pap test slide.
• Aliquot Removal may leave insufficient material in the PreservCyt sample vial for perfor-
mance of ancillary testing (e.g., reflexive HPV testing) using the residual specimen following
preparation of a ThinPrep Pap test slide.
• Co-collection of separate samples for the ThinPrep Pap test and STD testing may be consid-
ered in lieu of Aliquot Removal.
• When opting for concurrent cytologic and STD testing, providers should consider risk and
clinical history (e.g., disease prevalence, patient age, sexual history or pregnancy) as well as
specimen suitability (e.g., exudates or bleeding) that can impact diagnostic reliability.
Sexually Transmitted Diseases Treatment Guidelines 2002 (Centers for Disease Control and Preven-
tion, MMWR 2002: 51(No. RR-6)) provides clinical guidance for the management and treatment of
individual patients, including use of Pap testing.
It is essential that the instructions in Chapter 5B be followed if the Roche Diagnostics COBAS
AMPLICOR™ CT/NG test will be performed using the residual specimen after
a slide has been
prepared using the ThinPrep 2000 processor.
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