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

Jijgee Munkhdelger, Yeonim Choi, Dongsup Lee, Sunghyun Kim, Geehyuk Kim, Sangjung Park, Eunhee Choi, Hyunwoo Jin, Bo Young Jeon, Hyeyoung Lee, Kwang Hwa Park

Research output: Contribution to journalArticle

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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.

Original languageEnglish
Pages (from-to)422-427
Number of pages6
JournalDiagnostic Microbiology and Infectious Disease
Volume79
Issue number4
DOIs
Publication statusPublished - 2014 Jan 1

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Oligonucleotide Array Sequence Analysis
Cervix Uteri
Epithelial Cells
Messenger RNA
Cell Biology
Squamous Cell Carcinoma
DNA
Squamous Intraepithelial Lesions of the Cervix
Neoplasms
Sensitivity and Specificity
Population
Atypical Squamous Cells of the Cervix

All Science Journal Classification (ASJC) codes

  • Microbiology (medical)
  • Infectious Diseases

Cite this

Munkhdelger, Jijgee ; Choi, Yeonim ; Lee, Dongsup ; Kim, Sunghyun ; Kim, Geehyuk ; Park, Sangjung ; Choi, Eunhee ; Jin, Hyunwoo ; Jeon, Bo Young ; Lee, Hyeyoung ; Park, Kwang Hwa. / 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. In: Diagnostic Microbiology and Infectious Disease. 2014 ; Vol. 79, No. 4. pp. 422-427.
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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. / Munkhdelger, Jijgee; Choi, Yeonim; Lee, Dongsup; Kim, Sunghyun; Kim, Geehyuk; Park, Sangjung; Choi, Eunhee; Jin, Hyunwoo; Jeon, Bo Young; Lee, Hyeyoung; Park, Kwang Hwa.

In: Diagnostic Microbiology and Infectious Disease, Vol. 79, No. 4, 01.01.2014, p. 422-427.

Research output: Contribution to journalArticle

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AU - Lee, Dongsup

AU - Kim, Sunghyun

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AU - Park, Sangjung

AU - Choi, Eunhee

AU - Jin, Hyunwoo

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AU - Lee, Hyeyoung

AU - Park, Kwang Hwa

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N2 - 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.

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