Abstract
Approximately 70% of cervical cancers are caused by HPV types 16/18 and thus the implementation of vaccination programmes with vaccines against HPV types 16/18 will have a major impact on the incidence of cervical cancer worldwide. However, this reduction will not be seen until several decades after full implementation of such vaccination programmes since the vaccines must be given to young adolescents before exposure to the virus and women who are already sexually active are not likely to be protected. Both GSK and Merck insist that even vaccinated women must continue to participate in regular cervical screening by the most sensitive method available since the vaccine can only give protection against up to 70% of cervical cancers. It is unlikely that the current vaccines will be modified to include additional high risk HPV types in the foreseeable future. While HPV testing is highly sensitive, it is not recommended for women under 30 years of age nor for vaccinated women. Additionally, HPV testing has poor specificity. The Digene Hybrid Capture 2 test is licensed for use only in conjunction with a cytology test, not as a stand-alone test, and the high risk panel has recognised cross reactivity with low risk HPV types. None of the other HPV test methods currently commercially available are FDA approved and all must be internally validated before use. This makes comparison of test results between laboratories difficult. The most sensitive and specific screening test currently available for women of all ages is the Cytyc ThinPrep System consisting of the ThinPrep Pap Test (TPPT) and the ThinPrep Imaging System (Imager). The TPPT was the first LBC system approved by the US FDA in 1996 and there are about 4,000 processors in use worldwide. The Imager was FDA approved in 2003 and over 350 systems are in routine use, mainly in the US. 40% of TPPT in the US are processed on Imager. There is clear evidence in peer reviewed literature that the Imager increases laboratory productivity by 100% and growing evidence that Imager detects more high grade SIL than the conventional smear or manual evaluation of TPPT. This aspect is particularly important since the number of cytological abnormalities will decrease as vaccination programmes are implemented. Cytotechnologists will see fewer and fewer abnormal smears and their skills will be put at risk. By doubling throughput, Imager will allow cytotechnologists to maintain their skills.