Abstract

Objective To evaluate the clinical application of matrix assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) system on human papillomavirus (HPV) detection. Methods Total 509 out-patients were selected to detect infection rates for 14 HR-HPV subtypes by MALDI-TOF MS method. The predictive value of MALDI-TOF MS method for assessing cervical abnormality was compared with cytology results. The Hybrid Capture Ⅱ (HC2) method was used in 72 cases with pathological diagnosis results to compare the concordance of the detection results between MALDI-TOF MS method and HC2 method. Results The total HPV positive infection rate was 56.6% ( 288/509 ). Among the 14 HR-HPV subtypes 8 of them had an infection rate of more than 5% and they were HPV16 (60.1% ,173/288), HPVI8 ( 30.6%, 88/288 ), HPV39 ( 20.8%, 60/288 ), HPV45 ( 11.8%, 34/288 ), HPV52 ( 11.8% ,34/288 ), HPV31 ( 11.5%, 33/288 ), HPV35 ( 5.9%, 17/288 ), HPV58 ( 5.6%, 16/288 ) . Multi-HPV genotypa infection rate was 49.6% alone double infection was the most prevalent type. The HR-HPV infection rates were increased alone with the severity of cervical squamous intraepithelial lesions. Infection rate was significantly higher in disease group than the normal and inflammation group (χ2=25.40,P<0.05). The sensitivity, specificity, positive predictive value and negative predictive value were 87.5%, 45.5%, 75.3% and 98.2% respectively for detecting high grade cervical lesions. The concordance between HC2 method and MALDI-TOF MS method was 97.2%, and the latter had a higher sensitivity in cervical intraepithelial neoplasia (CIN) cases. Conclusion MALDI-TOF MS method for detection and genotyping of HPVs with its high-sensitivity, high-specificity and high-throughput exhibits good values in clinical applications, especially suitable for large-scale cervical screening and epidemiology investigation. Key words: Cervical intraepithelial neoplasia; Papillomaviridae; Genotype; Spectrometry; mass; matrix-assisted laser desorption-ionization

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