[Study on the feasibility of human papilloma virus subtypes detection by automatic nucleic acid extraction workstation].

Objective: To verify the feasibility of human papilloma virus(HPV) subtypes detection by AUTRAX automatic nucleic acid extraction workstation.

Methods: A total of 183 HPV test samples (2 562 types) were collected during August 2014 in Peking Union Medical College Hospital. Nucleic acid determination kit of high-risk HPV types (16, 18, 35, 39, 58, 31, 33, 68, 56, 45, 59, 51, 52) and 6 , 11 type (real-time PCR) were applied for detection. Each sample was divided into two parts. One part was treated with manual extraction, which entailed manually preparing PCR reaction system and added the sample to the PCR plate. Another was treated with the AUTRAX automatic nucleic acid extraction workstation, which automatically prepared the reaction system and added to the PCR board. These two parts proceeded to the real-time PCR detection. The result of manual extraction was set as the golden standard and the Kappa consistency analysis was conducted. Meanwhile, precision and pollution prevention of the AUTRAX were verified.

Results: The sensitivity of AUTRAX automatic nucleic acids extraction workstation was 97.12% (101/104). The specificity was 99.51% (2 446/2 458). The accuracy was 99.42% (2 547/2 562). The result of Kappa consistency analysis showed that the two parts were the same (Kappa=0.926). Coefficient of variation (CV) of each HPV types was less than 5%.No pollution phenomenon was found.

Conclusion: AUTRAX automatic nucleic acids extraction workstation can be used for the HPV subtypes detection in clinical settings.