ABSTRACT
Objective: To explore the clinical values of using flexible multi-analyte profiling (xMAP) technology for detection of high-risk human papillomavirus (HR-HPV). Methods: Six hundred and thirty eight cervical exfoliated cell samples were collected from women who lived in the region with high-incidence of cervical cancer in Shanxi province. The samples were tested with xMAP technology and Hybrid Capture 2 ® Assay (hc2). Pathological diagnosis was used as a hallmark to evaluate the detection results. HR-HPV infection rate and its genotyping distribution were analyzed and the coincidence of two methods above was assessed. Results: The sensitivity, specificity and accuracy of xMAP technology were 77.78%, 93.59% and 92.42%, respectively. The negative and positive predictive values were 98.13% and 49.30%, respectively. The prevalence rate of HR-HPV was 11.7%. HPV16 and 52 were the dominant types in non-neoplastic disease and cervical intraepithelial neoplasia (CIN) grade 1; HPV16 and 58 were the most common types in CIN2 samples; HPV16 was the most frequent type in CIN3 and cervical cancer. The lesion progress was positively related to the infection rate of HPV16, 52 or 58 (P<0.01). The Kappa value for agreement between xMAP technology and hc2 was 0.60. Conclusions: Compared with the hc2 test, the xMAP technology was highly specific, and the sensitivity is 77.78%. The agreement of these two methods is satisfactory. More improvements should be made to elevate the sensitivity of xMAP method and to increase the numbers of genotypes that can be detected.
ABSTRACT
<p><b>OBJECTIVE</b>To evaluate the clinical application value of flexible multi-analyte profiling (xMAP) technology in detecting high-risk human papillomavirus (HR-HPV).</p><p><b>METHODS</b>Totally 1 061 women, aged 21-65 years, were randomly enrolled into the study. Cervical exfoliated cells were used in xMAP technology and hybrid capture II (hc2). Pathological diagnosis was used as golden standard. Consistency of these two methods was assessed.</p><p><b>RESULTS</b>The sensitivity and specificity of xMAP technology were 80.31% and 85.83%, respectively. The positive and negative predictive values were 44.5% and 96.9%, respectively. The Kappa value for consistency between xMAP technology and hc2 was 0.58.</p><p><b>CONCLUSIONS</b>The specificity of xMAP technology is similar to hc2 test, but the sensitivity is inferior to hc2. However, these two methods show good consistency in the detection of HR-HPV.</p>