Background: Nucleic acids isothermal amplification techniques are gaining a wide popularity as diagnostic tools due to their simple operation, rapid reaction and without using thermocycler machine, e.g. Aptima HPV E6&7 mRNA test (HOLOGIC). However, mRNA based test asks for strict specimens preservation which limits its use in low resource setting. Isomega HPV test kit (National Bio-Founder, China) is a new HPV DNA based on isothermal amplification technology that can detect 15 high risk HPVs with simultaneous genotyping of HPV16 and HPV18 in a single tube by real-time fluorescence. The test procedure is simple and less than 90 minutes for operation on low cost and simple equipment. Objectives: To evaluate the agreement of HPV detection between Isomega HPV test and cobas 4800 HPV test (Roche) and their performance for cervical cancer screening.
Methods: Isomega HPV test and cobas 4800 HPV test were performed on cervical specimens collected from 2,774 women aged from 30 to 64 in high risk areas of cervical cancer in China. The sensitivity and specificity in detection of CIN2+, and the agreement between Isomega HPV test and cobas 4800 HPV test were assessed.
Results: The positivity rate of HPV 16 and 18 and other HR-HPV were 3.64%, 1.19%, 13.95% for Isomega HPV test and 3.53%, 1.29%, 13.63% for cobas 4800, respectively. The agreement between two methods was 94.77% (Kappa=0.818) for HR-HPV types, 99.60% (Kappa=0.943) for HPV16, 99.78% (Kappa=0.868) for HPV18 and 93.62% (Kappa=0.744) for other high-risk types. The sensitivity and specificity were 87.76%, 82.86% for Isomega, and 89.80%, 85.06% for cobas 4800.
Conclusions: Isomega HPV test showed high accordance with cobas 4800 HPV test with good sensitivity and specificity, would be a cost-efficient, fast and reliable HPV assay for cervical cancer screening in low resource setting.