Thin-layer technology: tempered enthusiasm.

Abstract

With the introduction of new technologies we often see a pattern of development. As a useful technology moves into the public sector there is often an episode of wild enthusiasm and uncritical acceptance, followed by a time of progressive disillusionment. However, with time and experience, a proper place for the method becomes established. Thin-layer technology is certainly an improvement and solves many of our preanalytical problems; however, it introduces some difficulties of its own. The rounding up of cells in liquid fixation makes cells of high-grade lesions smaller than they would be on a conventional preparation. The abnormal cells are often separated. For both of these reasons they may be overlooked. Furthermore, benign glandular cells can take on an ominous appearance. These differences in conventional and thin-layer morphology are proving to be a fruitful area for publication. Thin-layer technology cannot be all things to all situations, and this is especially true in body fluid and fine-needle cytomorphology. In our experience, while occasionally helpful, the thin-layer technique should not be the primary method for diagnosis in nongynecologic specimens. Time and effort would be better spent on trying to educate select clinicians on how to obtain better samples than to totally convert to thin-layer methodologies. Regarding FNA, the patient is best served when the pathologist is directly involved with the initial sample acquisition. Reimbursement is available for immediate sample interpretation, so funding should be available for staffing if an institution has the interest. For the record, we believe that liquid fixation and thin-layer methodology should not be the primary method for FNA, unless circumstances are absolutely prohibitive. An important problem with thin-layer technology lies with its added cost. Thin-layer interposes another series of steps into cytologic sample preparation. There is additional labor, additional time, another machine in the laboratory, and the significant cost of the reagents. In a situation where the price of a cytologic test is already close to margin, costs of the vial, filter, and preservative throw the test into unprofitability. Price structures have to be changed. Some institutions are waiting until there is more competition in the market and costs decrease. Alternatively, a lot of effort has been expended in trying to get government and other groups to accept the additional costs of the new test for gynecologic examinations, and many payers seem to be falling in line to accept the methodology, secondary to clinician and patient demand. Basic questions about ancillary technologies and gynecologic samples remain to be answered. Cytology is big business. Every year a significant segment of the population has a Pap smear performed. Hardly any other laboratory test can claim the volume of activity of the cervical smear. Any business that can hook into that market stands to prosper. Since the Pap smear has some well-publicized problems, the door is open for technology to nibble away at a few percentage points of false negativity. We are far from the first to ask if we can afford the incremental improvements of thin-layer and other ancillary technologies. There is a conundrum. Government, insurance companies, and our administrators are calling for us to hold back cost increases in medical care. Alternatively, these new technologies, patient demand for the perfect test, increased regulatory oversight, and legal challenges are increasing the cost of doing business. We do not know how to respond to the often-voiced fear that these ancillary technologies increase the cost of cytology services beyond some patients' ability to pay. In this confusion, we do know that we should use the best test to get the most accurate answer for our patients. In selected scenarios this may mean that we will have to accept the cost and follow thin-layer technology.