title: Comparison of the performance of the NucliSENS EasyQ HPV E6/E7 mRNA assay and HPV DNA chip for testing squamous cell lesions of the uterine cervix.
abstract: This study aims to evaluate the clinical performance of the NucliSENS EasyQ assay and compare it with HPV DNA genotyping for the detection of high-grade squamous intraepithelial lesions (HSIL) and cancer in a Korean population. In 188 total thin prep samples, the remaining fluid after cytology slide preparation was tested with Goodgene HPV DNA chips and the NucliSENS EasyQ HPV E6/E7 messenger RNA (mRNA) assay. The sensitivity and specificity of each test were calculated with HSIL and squamous cell carcinoma (SCC) as the disease endpoint. Out of the 188 samples, 139 (74%) were positive for DNA of 14 HPV types, while 57 (30%) cases were positive for E6/E7 mRNA. The DNA test was positive in cytology cases of SCC, HSIL, and atypical squamous cell. The mRNA test yielded results of 75%, 74%, 60%, 56%, and 29% positivity in abnormal cytology cases of SCC, HSIL, atypical squamous cells - cannot exclude HSIL, atypical squamous cells of undetermined significance, and low-grade squamous intraepithelial lesion, respectively. In normal cytology cases, the positivity rates were 9% and 53% for the mRNA and DNA tests, respectively. For detection of HSIL and SCC, the sensitivity of the mRNA test was 74.36% and that of the DNA test was 100%, while the specificities of the tests were 85% and 40.83%, respectively. These findings suggest that the HPV E6/E7 mRNA assay can overcome the shortcoming of low specificity of DNA assays for clinical detection of high-grade cervical lesions and malignancies.
authors.affiliation: Department of Pathology, Wonju College of Medicine, Yonsei University, Wonju, Republic of Korea.
authors.forename: Jijgee
authors.initials: J
authors.lastname: Munkhdelger
authors.affiliation: Department of Biomedical Laboratory Science, College of Health Sciences, Yonsei University, Wonju, Republic of Korea; Department of Biomedical Laboratory Science, Songho College, Hoengseoung, Republic of Korea.
authors.forename: Yeonim
authors.initials: Y
authors.lastname: Choi
authors.affiliation: Department of Pathology, Wonju College of Medicine, Yonsei University, Wonju, Republic of Korea; Department of Clinical Laboratory Science, Hyejeon College, Hongseong, Republic of Korea.
authors.forename: Dongsup
authors.initials: D
authors.lastname: Lee
authors.affiliation: Department of Biomedical Laboratory Science, College of Health Sciences, Yonsei University, Wonju, Republic of Korea; Institute for Life Science and Biotechnology, Yonsei University, Seoul, Republic of Korea.
authors.forename: Sunghyun
authors.initials: S
authors.lastname: Kim
authors.affiliation: Department of Biomedical Laboratory Science, College of Health Sciences, Yonsei University, Wonju, Republic of Korea.
authors.forename: Geehyuk
authors.initials: G
authors.lastname: Kim
authors.affiliation: Department of Biomedical Laboratory Science, College of Health Sciences, Yonsei University, Wonju, Republic of Korea; Department of Clinical Laboratory Science, College of Medical Science, Daegu Haany University, Daegu, Republic of Korea.
authors.forename: Sangjung
authors.initials: S
authors.lastname: Park
authors.affiliation: Institute for Lifestyle Medicine, Wonju College of Medicine, Yonsei University, Wonju, Republic of Korea.
authors.forename: Eunhee
authors.initials: E
authors.lastname: Choi
authors.affiliation: Department of Clinical Laboratory Sciences, College of Health Science, Catholic University of Pusan, Pusan, Republic of Korea.
authors.forename: Hyunwoo
authors.initials: H
authors.lastname: Jin
authors.affiliation: Department of Biomedical Laboratory Science, College of Health Sciences, Yonsei University, Wonju, Republic of Korea.
authors.forename: Bo-Young
authors.initials: BY
authors.lastname: Jeon
authors.affiliation: Department of Biomedical Laboratory Science, College of Health Sciences, Yonsei University, Wonju, Republic of Korea. Electronic address: hyelee@yonsei.ac.kr.
authors.forename: Hyeyoung
authors.initials: H
authors.lastname: Lee
authors.affiliation: Department of Pathology, Wonju College of Medicine, Yonsei University, Wonju, Republic of Korea. Electronic address: abba@yonsei.ac.kr.
authors.forename: Kwang Hwa
authors.initials: KH
authors.lastname: Park
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D052685:Alphapapillomavirus / Q000235:genetics*; D004279:DNA, Viral; D005260:Female; D005838:Genotype; D061809:Human Papillomavirus DNA Tests / Q000379:methods* / Q000592:standards; D006801:Humans; D008875:Middle Aged; D009856:Oncogene Proteins, Viral / Q000235:genetics*; D030361:Papillomavirus Infections / Q000150:complications*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D065310:Squamous Intraepithelial Lesions of the Cervix / Q000175:diagnosis* / Q000821:virology*; D002578:Uterine Cervical Dysplasia / Q000473:pathology / Q000821:virology; D055815:Young Adult
chemical_list: D004279:DNA, Viral; D009856:Oncogene Proteins, Viral
keywords: HPV DNA chips; HPV E6/E7 mRNA assay; High-grade cervical lesions; Human papillomavirus