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Minimizing Lubricant-Compromised Results on ThinPrep Pap Tests – Evidence from Three Clinics
S86
Abstracts
Materials and Methods: A variety of commercially available carbomer‒ free lubricants were tested in two ways: filter occlusion by the lubricant in the absence of cells, and cell transfer in the presence of lubricant. For filter occlusion, increasing amounts of lubricant were spiked into ThinPrep vials. The vials were processed on a ThinPrep instrument, weighed before and after processing, and the weight of PreservCytÒ solution removed was analyzed. Similarly, cell transfer was evaluated by adding increasing amounts of lubricant to a constant volume of pooled gynecological specimen followed by ThinPrep processing. The resulting slides were stained with the ThinPrep Pap stain, and imaged with a ThinPrep Imaging System (Imager) specially customized to collect object count data. These data were then analyzed in relation to how much lubricant was added to the vials. Results: Summarized results of filter occlusion and cell transfer testing are presented in Figures 1 and 2 respectively. Discussion: Internal Hologic data has shown that lubricants containing carbomer, a thickening agent, consistently caused problems with filter occlusion and/or cell transfer with the ThinPrep System. The carbomer‒free lubricants tested in this study showed a range of filter occlusion and cell transfer results. Conclusion: Lubricants should be avoided when collecting cervical specimens for the ThinPrep Pap test. If lubricant must be used, it should be carbomer‒free, and ideally approved for use by Hologic.
occlusion properties of the lubricant and improves cell collection onto the slide. Materials and Methods: Cell pools prepared from residual gynecological specimens collected in PreservCyt solution were spiked with various carbomer-based lubricants at a final concentration of 100 mg of lubricant per sample: Aquagel (Parkerlabs, Inc.), Astroglide Physician’s Formula (BioFlim, Inc.), HR (HR Pharmaceuticals, Inc.), McKesson (McKesson), Medichoice (Owen and Minor), PDI (Professional Disposables International), Schein (Henry Schein), and SurGel (Ulmer Pharmaceutical). Samples were pelleted using the same centrifugation method used for remediating ThinPrep specimens contaminated with blood, but reprocessed with the buffered wash solution in place of CytoLytÒ solution containing 10% glacial acetic acid. Slides were prepared on a ThinPrep Processor, stained with the ThinPrep Stain solutions and cover-slipped before review. Results: Slides prepared from cell pools spiked with the lubricants showed an increase in cell coverage when the wash method was utilized and converted from unsatisfactory for evaluation to satisfactory. Some slides were completely devoid of cells without the treatment. Figure 1 shows an example of slides prepared from a gynecological cell pool spiked with lubricant, 10x magnification. The left image is no treatment. The right image is after reprocessing with the buffer solution. Conclusion: Use of the buffered wash solution shows potential as a remediation treatment for ThinPrep specimens that are contaminated with lubricant.
Figure 1
Figure 1
Filter Occlusion
194 Minimizing Lubricant-Compromised Results on ThinPrep Pap Tests e Evidence from Three Clinics Norman Soule, BS, HTL(ASCP)1, James Welch, MD1, Jason Dantic, BS1, Suzanne Werneke, BA, CT(ASCP)2 1 Cytocheck Laboratory, LLC., Parsons, Kansas; 2 Hologic Inc., Bedford, Massachusetts
Figure 2
Reduction in Cell Transfer
193 Use of a Unique Wash Solution to Remediate Lubricant Contamination from ThinPrep Specimens Erin Coffman, MS, Steven Hecht, BS, Paul MacLean, BS Hologic Inc., Bedford, Massachusetts Introduction: The ThinPrepÒ Pap test is an effective and widely used cervical cancer screening tool available to women. Since its implementation in 1996, invasive cervical cancers in the US have continued to decline. However, the use of lubricants, particularly ones with carbomer-based formulations, can interfere with the collection of the cervical specimen and cause an unsatisfactory ThinPrep Pap test result. Here, we present an experimental approach to remediating lubricant contamination of ThinPrep specimens by using a unique buffered wash solution that diminishes the
Introduction: ThinPrep Pap TestÒ (TPPT) adequacy may be compromised by lubricants which may partially polymerize in the alcoholic TPPT preservative solution. An “Unsatisfactory” determination will likely result in patient call back; or reprocessing may be attempted but with added, unreimbursed cost. Warm water is the recommended speculum lubricant e avoiding the issue altogether. However, provider preference or interest in optimal patient comfort may prompt use of a commercial lubricating jelly, with the choice largely driven by what is least expensive and readily available in the examination room. Products containing the thickening agent carbomer have particularly been associated with TPPT cases deemed “Unsatisfactory-due-to-lubricant” (UNSAT-L). The objective of this investigation was to determine the impact on UNSAT-L rates when clinicians who typically chose to use a lubricating jelly during cervical sampling had only carbomer-free product available in the examination rooms. Materials and Methods: A regional reference cytology laboratory reviewed UNSAT-L rates for their TPPT-submitting physicians groups. Three with significantly above-average rates were identified. Two agreed to replace all carbomer-containing lubricant within their practices with a TPPT manufacturer-approved, carbomer-free lubricant, Pap Test Lubricating Jelly
Abstracts (ACP, Rolling Meadows, IL). The third was already initiating a conversion to another recommended, non-carbomer lubricant, SurgilubeÒ (Savage LabsÒ, Melville, NY). UNSAT-L rates were compared collectively, per clinic, and by individual clinician for the 6-month periods before and after conversion. Results: A 93% reduction in “Unsatisfactory-due-to-lubricant” was seen with the combined physician’s groups. (Table 1) Individually, reductions for Clinics A, B, and C were 89.9%, 84.7% and 97.4% respectively. Both carbomer-free lubricating products showed similar performance. Conclusion: If a commercial lubricant is employed for ThinPrep Pap Test collection, specimen inadequacy due to lubricant can be markedly reduced by selection of a carbomer-free product.
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Table 1
Abstracts
Materials and Methods: A variety of commercially available carbomer‒ free lubricants were tested in two ways: filter occlusion by the lubricant in the absence of cells, and cell transfer in the presence of lubricant. For filter occlusion, increasing amounts of lubricant were spiked into ThinPrep vials. The vials were processed on a ThinPrep instrument, weighed before and after processing, and the weight of PreservCytÒ solution removed was analyzed. Similarly, cell transfer was evaluated by adding increasing amounts of lubricant to a constant volume of pooled gynecological specimen followed by ThinPrep processing. The resulting slides were stained with the ThinPrep Pap stain, and imaged with a ThinPrep Imaging System (Imager) specially customized to collect object count data. These data were then analyzed in relation to how much lubricant was added to the vials. Results: Summarized results of filter occlusion and cell transfer testing are presented in Figures 1 and 2 respectively. Discussion: Internal Hologic data has shown that lubricants containing carbomer, a thickening agent, consistently caused problems with filter occlusion and/or cell transfer with the ThinPrep System. The carbomer‒free lubricants tested in this study showed a range of filter occlusion and cell transfer results. Conclusion: Lubricants should be avoided when collecting cervical specimens for the ThinPrep Pap test. If lubricant must be used, it should be carbomer‒free, and ideally approved for use by Hologic.
occlusion properties of the lubricant and improves cell collection onto the slide. Materials and Methods: Cell pools prepared from residual gynecological specimens collected in PreservCyt solution were spiked with various carbomer-based lubricants at a final concentration of 100 mg of lubricant per sample: Aquagel (Parkerlabs, Inc.), Astroglide Physician’s Formula (BioFlim, Inc.), HR (HR Pharmaceuticals, Inc.), McKesson (McKesson), Medichoice (Owen and Minor), PDI (Professional Disposables International), Schein (Henry Schein), and SurGel (Ulmer Pharmaceutical). Samples were pelleted using the same centrifugation method used for remediating ThinPrep specimens contaminated with blood, but reprocessed with the buffered wash solution in place of CytoLytÒ solution containing 10% glacial acetic acid. Slides were prepared on a ThinPrep Processor, stained with the ThinPrep Stain solutions and cover-slipped before review. Results: Slides prepared from cell pools spiked with the lubricants showed an increase in cell coverage when the wash method was utilized and converted from unsatisfactory for evaluation to satisfactory. Some slides were completely devoid of cells without the treatment. Figure 1 shows an example of slides prepared from a gynecological cell pool spiked with lubricant, 10x magnification. The left image is no treatment. The right image is after reprocessing with the buffer solution. Conclusion: Use of the buffered wash solution shows potential as a remediation treatment for ThinPrep specimens that are contaminated with lubricant.
Figure 1
Figure 1
Filter Occlusion
194 Minimizing Lubricant-Compromised Results on ThinPrep Pap Tests e Evidence from Three Clinics Norman Soule, BS, HTL(ASCP)1, James Welch, MD1, Jason Dantic, BS1, Suzanne Werneke, BA, CT(ASCP)2 1 Cytocheck Laboratory, LLC., Parsons, Kansas; 2 Hologic Inc., Bedford, Massachusetts
Figure 2
Reduction in Cell Transfer
193 Use of a Unique Wash Solution to Remediate Lubricant Contamination from ThinPrep Specimens Erin Coffman, MS, Steven Hecht, BS, Paul MacLean, BS Hologic Inc., Bedford, Massachusetts Introduction: The ThinPrepÒ Pap test is an effective and widely used cervical cancer screening tool available to women. Since its implementation in 1996, invasive cervical cancers in the US have continued to decline. However, the use of lubricants, particularly ones with carbomer-based formulations, can interfere with the collection of the cervical specimen and cause an unsatisfactory ThinPrep Pap test result. Here, we present an experimental approach to remediating lubricant contamination of ThinPrep specimens by using a unique buffered wash solution that diminishes the
Introduction: ThinPrep Pap TestÒ (TPPT) adequacy may be compromised by lubricants which may partially polymerize in the alcoholic TPPT preservative solution. An “Unsatisfactory” determination will likely result in patient call back; or reprocessing may be attempted but with added, unreimbursed cost. Warm water is the recommended speculum lubricant e avoiding the issue altogether. However, provider preference or interest in optimal patient comfort may prompt use of a commercial lubricating jelly, with the choice largely driven by what is least expensive and readily available in the examination room. Products containing the thickening agent carbomer have particularly been associated with TPPT cases deemed “Unsatisfactory-due-to-lubricant” (UNSAT-L). The objective of this investigation was to determine the impact on UNSAT-L rates when clinicians who typically chose to use a lubricating jelly during cervical sampling had only carbomer-free product available in the examination rooms. Materials and Methods: A regional reference cytology laboratory reviewed UNSAT-L rates for their TPPT-submitting physicians groups. Three with significantly above-average rates were identified. Two agreed to replace all carbomer-containing lubricant within their practices with a TPPT manufacturer-approved, carbomer-free lubricant, Pap Test Lubricating Jelly
Abstracts (ACP, Rolling Meadows, IL). The third was already initiating a conversion to another recommended, non-carbomer lubricant, SurgilubeÒ (Savage LabsÒ, Melville, NY). UNSAT-L rates were compared collectively, per clinic, and by individual clinician for the 6-month periods before and after conversion. Results: A 93% reduction in “Unsatisfactory-due-to-lubricant” was seen with the combined physician’s groups. (Table 1) Individually, reductions for Clinics A, B, and C were 89.9%, 84.7% and 97.4% respectively. Both carbomer-free lubricating products showed similar performance. Conclusion: If a commercial lubricant is employed for ThinPrep Pap Test collection, specimen inadequacy due to lubricant can be markedly reduced by selection of a carbomer-free product.
S87
Table 1