A comparative review of laboratory-developed tests utilizing Invader HPV analyte-specific reagents for the detection of high-risk human papillomavirus.
BACKGROUND
Testing for human papillomavirus (HPV) has emerged as an important component of cervical cancer screening and disease management. Analytic performance (sensitivity, specificity, positive predictive value, negative predictive value, accuracy) and clinical relevance are important criteria by which any new test must be reviewed.


OBJECTIVE
This paper compares laboratory-developed tests, utilizing Invader analyte-specific reagents (ASRs) for the detection of oncogenic HPV DNA, to the Digene Hybrid Capture 2 test (HC2). In addition to accurately identifying the presence or absence of HPV, genotyping has emerged as an important consideration for risk stratification and patient management. This paper reviews all current relevant Invader HPV literature to explain how these results shape our current understanding of the topic.
Stillman
Michael J
MJ
Hologic, Inc., Marlborough, MA 01752, USA. michael.stillman@hologic.com
Day
Stephen P
SP
Schutzbank
Ted E
TE
D004279:DNA, Viral / Q000235:genetics* / Q000302:isolation & purification; D005260:Female; D005838:Genotype; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D027383:Papillomaviridae / Q000145:classification* / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000821:virology; D011237:Predictive Value of Tests; D012680:Sensitivity and Specificity; D014773:Virology / Q000379:methods*
D004279:DNA, Viral