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Background: To ensure the accuracy of clinical human papillomavirus (HPV) testing, the nucleic acid extraction procedure should be thoroughly evaluated for each clinical sample type. Therefore, we evaluated whether the MagCore® Automated Nucleic Acid Extraction system (MagCore system) could improve HybriBio HPV test performance for cervical swab samples.
Methods: We compared the performance of HybriBio HPV genotyping and screening tests using samples prepared with the MagCore system and Cell Lysis Kit, which was provided by the HPV test manufacturer.
Results: The MagCore system extracted high quality DNA and outperformed the Cell Lysis Kit in the subsequent analysis. In terms of the HPV genotyping testing, use of the MagCore system-extracted DNA markedly increased the signal intensity compared to that of DNA extracted with the Cell Lysis Kit for low concentrations of HPV DNA. Thus, the analytical sensitivity of testing was increased approximately 10 times by using the MagCore system, and the reproducibility was also increased (97.1% vs. 88.2%). In terms of the HPV screening tests, use of the MagCore system improved the compatibility of the internal control and targets, reducing the risk of false or invalid results. The MagCore system also improved the amplification efficiency and quantification accuracy for HPV16 detection.
Conclusions: We demonstrated that the performance of HybriBio HPV genotyping and screening tests can be improved by using the MagCore system. This study not only provided an alternative, robust DNA extraction method for clinical users but also reemphasized the importance of establishing a reliable DNA extraction procedure for clinical HPV testing.
DOI: 10.7754/Clin.Lab.2017.170416
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