Evaluation of the clinical performance of the Abbott RealTime High-Risk HPV for carcinogenic HPV detection

被引:19
作者
Halfon, Philippe [1 ,2 ]
Benmoura, Dominique [2 ,3 ]
Agostini, Aubert [3 ]
Khiri, Hacene [1 ]
Penaranda, Guillaume [1 ,4 ]
Martineau, Agnes [2 ]
Blanc, Bernard [2 ]
机构
[1] Lab Alphabio, F-13006 Marseille, France
[2] Hop Ambroise Pare, Marseille, France
[3] Hop Conception, Marseille, France
[4] CDL Pharma, Marseille, France
关键词
Abbott RealTime High-Risk HPV test; HPV; Digene Hybrid Capture II; Roche Linear Array; CERVICAL INTRAEPITHELIAL NEOPLASIA; HUMAN-PAPILLOMAVIRUS DNA; HYBRID CAPTURE; CANCER; WOMEN; CYTOLOGY; GENOTYPES; UTILITY; TESTS;
D O I
10.1016/j.jcv.2010.05.008
中图分类号
Q93 [微生物学];
学科分类号
071005 ; 100705 ;
摘要
Background: Abbott RealTime (RT) High-Risk (HR) HPV assay is a new qualitative real-time polymerase chain reaction (PCR) based assay for the detection of 14 HR HPV DNA. The assay can differentiate between the infection by HPV 16, HPV 18 and non-HPV 16/18 types through the distinct fluorescent labels on the type specific probes. Objectives: To evaluate the clinical performance of the Abbott RT HR HPV test, in comparison with biopsy, Hybrid Capture II (HCII), and Linear Array (LA), for detection of high-grade disease (CIN2+). Study design: The study population consisted of 143 women who were included in three referral gynecology clinics in Marseilles (France) between March 2007 and June 2008. The clinical performance of the RT HR HPV assay, performed on the fully automated m2000 system, was compared with HCII and LA. Results: HR HPV positivity rate was similar for all tests (Abbott RT HR HPV and HCII, 62%, and LA 63%). All tests had high sensitivities and negative predictive values for CIN2+ detection (>90%). The agreement between HCII and Abbott RT HR HPV, and between HCII and LA were 93% (k = 0.85) and 96% (k = 0.91) respectively. As expected, HPV16 or HPV18 positivity was greater in advanced grades of disease, especially in CIN2+ patients: 85% in CIN2+ vs. 33% in <CIN2 patients (p < .0001); 60% in CIN3+ vs. 47% in < CIN3 patients (p not significant). Conclusions: The clinical performance of the Abbott RT HR HPV assay is good and closely correlated with the two other assays. The automation and ability to identify type 16 and 18 make this a very attractive option for HPV testing in laboratories and potentially provides improved patient management. (C) 2010 Published by Elsevier B. V.
引用
收藏
页码:246 / 250
页数:5
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