New Pap Smear Tests Are Defective (a lab tech's report)

I am a laboratory  technician who screens pap smears, a cytotechnologist, cytotech for short, and I believe that fraud is taking place in this field as a result of falsely advertised and/or dysfunctional products approved by a scandal-ridden Food and Drug Administration.

Currently most pap smears are no longer smears, they are monolayered preparation.  The cellular material is dropped into a vial containing an alcohol solution. Some mucous and blood are dissolved and debris is removed. The sample is deposited on a slide in a single cellular monolayer. The great majority of cytotechs like it, including myself, as it is easier to read. Apparently the major reason it is in place is because of higher profitability.

The monolayer pap has an apparent dark side. It is advertised as being extraordinarily more accurate than a conventional pap smear. One corporation cites studies claiming accuracy increases of over 100-230 %.  A Dutch-Belgian study, published in 2009 in the Journal of the American Medical Association, found no increases. The U.S. Preventive Services Task Force concluded the same. An Australian study found an increase of 12 %. I think we may have seen an accuracy increase of 5-10 % at my laboratory. It appears that the manufacturer has major credibility issues with honesty in advertising.

The apparently deceptive advertising may be deliberate for the monolayer pap may have really been designed for an FDA approved, computerized microscope. One is advertised as being approximately 20-45 % more accurate than a cytotech alone.  Our lab did not see any accuracy increases. Studies in Australia, Ireland and USA concluded the same.  More dishonest advertising?  Apparently the device is highly profitable. It significantly increases the cost of the pap test.

After our lab procured the computerized microscope , we were alarmed by the tendency of the device to miss abnormal cellularity if present in large clusters. We also noticed that the device tended to zero in on air bubbles, chips in the glass, dirt, dark colored benign cells or just blank space. In many cases, abnormal cellularity seemed to be found by accident. The artificial intelligence of the device appears slipshod. Sometimes the device finds abnormal cells quite well, but this is an exception, in my experience. In my opinion, the device is not worth the money spent on it.

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