About 90% of cervical cancer is caused by the infection with special subtypes of Human Papilloma Virus (HPV).1 High-risk HPV tests were recently approved by the U.S. Food and Drug Administration (FDA) as a primary screening tool for cervical cancer risk in woman aged 25-65 years without a simultaneous Pap smear. Molecular test systems are required to detect high- but also low-risk HPV subtypes with high specificity and sensitivity in a time and cost effective manner. MALDI-TOF Mass Spectrometry System (MassARRAY®, Agena Bioscience, Inc.) has the potential to meet these requirements.
The HPV MassARRAY® panel detects 19 specific oncogenic HPV genotypes in one single multiplex reaction. We analyzed 10 liquid based cytology samples and compared the results with the RT-PCR based COBAS and the hybridization based HPV LCD-array system.
All high risk HPV subtypes detected by the COBAS system or the HPV LCD-array were also identified by MassARRAY®. Whereas the COBAS system detected a maximal number of 3 HPV types (16, 18 and twelve other genotypes without subtyping), the MassARRAY® and the HPV LCD-array could discern further HPV subtypes in several patients.
We conclude that the MassARRAY® HPV assay represents a highly specific, sensitive, reliable and cost-efficient method for the detection of HPV subtypes in liquid samples (and FFPE samples 2) in a high throughput setting.
[1 Palmroth J, et al. Occurrence of vaccine and non-vaccine human papillomavirus types in adolescent Finnish females 4 years post-vaccination. Int J Cancer 2012; 131:2832-2838]
[2 Kriegsmann M, et al. Detection of HPV subtypes by mass spectrometry in FFPE tissue specimens: a reliable tool for routine diagnostics. J Clin Pathol 2017; 70:417-423]