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Background: This study was performed to evaluate the surface plasmon resonance-based (SPR) test with the W2600 System of GP Medical Technologies as a screening method for human papillomavirus (HPV) genotyping in China.
Methods: Between November 2012 and December 2013, the SPR test, hybrid capture II (HC2) test, and direct DNA sequencing assay were performed on 424 patients aged 22 - 65 years who attended the outpatient clinic at the Department of Obstetrics and Gynecology of West China Second University Hospital with diagnoses of chronic cervicitis or abnormal vaginal bleeding. Cervical specimens were collected from the cervical epithelia. Cytological and histological studies were also performed.
Results: A total of 424 patient specimens were screened. The positive, negative, and overall concordance between the SPR test and HC2 test was 93.48%, 89.16%, and 90.57%, respectively. The concordance between the SPR test and the direct DNA sequencing assay was 97.41%. Against the results of the direct DNA sequencing assay, the SPR test demonstrated a sensitivity of 96.86% and a specificity of 97.74%.
Conclusions: The SPR test is reliable, sensitive, and specific for HPV genotyping. Compared to the hybrid-capture assay, the SPR test may work on more than one specimen at a time and is a low-cost, rapid, and easy-to-use method with the potential for automation. The SPR test may be widely employed in China and other countries for HPV genotyping.
DOI: 10.7754/Clin.Lab.2016.151233
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