Human papillomavirus DNA testing is gaining wider acceptance, yet the major
ity of testing is still undertaken in the research setting using protocols
that are unsuitable for clinical diagnostic laboratories. Large-scale clini
cal human papillomavirus DNA testing is likely to be introduced as an adjun
ct to cervical cytology, so the cytology laboratory is an appropriate place
for it to be undertaken. This poses a challenge for any human papillomavir
us DNA test since it will be performed by technicians not specifically trai
ned in virology or molecular biology, and will need to produce consistently
reliable results in this setting. This is only realistically possible with
a standardized and quality-controlled, commercially produced human papillo
mavirus DNA test. There is currently only one such commercially available a
ssay, although there are a number of research-based tests that could logica
lly lead to additional commercial products. The technological basis of thes
e assays, together with available performance data, is reviewed in this cha
pter and the clinical utility of the tests is evaluated.