Diagnostic performance of the E6/E7 mRNA-based Optimygene HR-HPV RT-qDx assay for cervical cancer screening

Wang, Hye-Young; Kim, Hyunil; Park, Kwang Hwa

doi:10.1016/j.ijid.2018.09.014

Cited by 7 publications

(4 citation statements)

References 30 publications

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“…On top of this, the reported AU-ROC curve by six of the articles [51,[58][59][60][61][62] varied from 63.8 to 90.9% which reflects the usefulness of the test in discriminating women having CIN2 + . In our review 8 studies [39,[51][52][53][54][55][56][57] reported the agreement between HPV-E6/E7 mRNA and HPV-DNA testing for the detection of cervical lesions at 77.6-92.5%. Compared to DNA-based tests (the most common one was Digene Hybrid Capture 2 HPV DNA test) which indicate only the presence or absence of the virus, detecting HPV E6/E7 mRNAs gives more insight into viral activity and by implication, clinical relevance (correlate better with the severity of the lesion).…”

Section: Discussionmentioning

confidence: 84%

HPV E6/E7 mRNA test for the detection of high grade cervical intraepithelial neoplasia (CIN2+): a systematic review

Derbie

Mekonnen

Woldeamanuel

et al. 2020

Infect Agents Cancer

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Background: Genital infection with certain types of Human papillomavirus (HPV) is a major cause of cervical cancer globally. For early detection of premalignant dysplasia, evidences are coming out on the usefulness of HPV E6/E7 mRNA test as a potential tool compared with cytology and HPV DNA testing. Taking into account shortage of compiled data on this field, the aim of this systematic review was to describe the latest diagnostic performance of HPV E6/E7 mRNA testing to detect high grade cervical lesions (CIN2+) where by histology was taken as a gold standard. Methods: Articles published in English were systematically searched using key words from PubMed/Medline and SCOPUS. In addition, Google Scholar and the Google database were searched manually for grey literature. Two reviewers independently assessed study eligibility, risk of bias and extracted the data. We performed a descriptive presentation of the performance of E6/E7 mRNA test (in terms of sensitivity, specificity, negative and positive predictive values) for the detection of CIN2 +. Results: Out of 231 applicable citations, we have included 29 articles that included a total of 23,576 study participants (age range, 15-84 years) who had different cervical pathologies. Among the participants who had cervical histology, the proportion of CIN2+ was between 10.6 and 90.6%. Using histology as a gold standard, 11 studies evaluated the PreTect HPV Proofer, 7 studies evaluated the APTIMA HPV assay (Gen-Probe) and 6 studies evaluated the Quantivirus® HPV assay. The diagnostic performance of these three most common mRNA testing tools to detect CIN2+ was; 1) PreTect Proofer; median sensitivity 83%, specificity 73%, PPV 70 and NPV 88.9%. 2) APTIMA assay; median sensitivity 91.4%, specificity 46.2%, PPV 34.3% and NPV 96.3%. 3) Quantivirus®: median sensitivity 86.1%, specificity 54.6%, PPV 54.3% and NPV was at 89.3%. Further, the area under the receiver operating characteristics (AU-ROC) curve varied between 63.8 and 90.9%. Conclusions: The reported diagnostic accuracy implies that HPV mRNA based tests possess diagnostic relevance to detect CIN2+ and could potentially be considered in areas where there is no histology facility. Further studies including its cost should be considered.

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Section: Discussionmentioning

confidence: 84%

HPV E6/E7 mRNA test for the detection of high grade cervical intraepithelial neoplasia (CIN2+): a systematic review

Derbie

Mekonnen

Woldeamanuel

et al. 2020

Infect Agents Cancer

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“… 29 30 Nowadays various studies are being done on the detection of HPV E6/E7 mRNA expression by different methods including both quantitative and qualitative. A study done by Wang et al 31 evaluated the performance of the Optimygene HR-HPV RT-qDx assay, which is an HPV E6/E7 mRNA-based assay, to detect 16 HR-HPV subtypes, concluded that the higher specificity and positive predictive value of this assay are valuable for predicting insignificant HPV DNA infections among patients with a borderline cytological diagnosis. Recently, a study done by Liu et al 32 on quantitative HPV E6/E7 mRNA assay using QuantiVirus HPV E6/E7 mRNA assay (Kodia, Henan, China) to compare the expression levels of HPV E6/E7 mRNA in HSIL and LSIL showed that the median E6/E7 mRNA copy number in HSIL (median, 14,684 copies/mL) was far higher than that in LSIL (median, 936.00 copies/mL) ( p < 0.001).…”

Section: Discussionmentioning

confidence: 99%

Evaluation of HPV E6/E7 mRNA Detection in Clinically Suspected Cases of Cervical Cancer with Abnormal Cytology: Time to Upgrade the Screening Protocols

et al. 2022

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Background Human papillomavirus (HPV) E6/E7 mRNA tests determine the oncogenic activity of the virus and represent a good clinical biomarker for predicting the risk of cervical cancer. So, the present study was conducted to know the role of HPV E6/E7 mRNA as a predictive biomarker for cervical carcinoma. Methodology The present study was conducted on 55 clinical samples of cervical scrapings and biopsy from the clinically suspected cases (based on signs and symptoms) of cervical cancer having abnormal PAP smear. The samples were processed in three steps—(1) HPV DNA detection, (2) HPV E6/E7 mRNA detection, and (3) histopathological analysis. Results Out of a total of 55 patients, 16 (29.09%) were positive for both HPV E6/E7 mRNA and HPV DNA and six were positive for only HPV DNA. So, a total of 22 (40%) patients were positive for HPV DNA. Out of these 22 samples, 10 (45.5%) were of HPV-16, six (27.3%) were of HPV-18, four (18.2%) were of HPV-31, and two (9.1%) were of HPV-45. Out of total 16 patients positive for HPV E6/E7 mRNA, 10 (62.5%) were of genotype 16 and six (37.5%) were of genotype 18. The patients who were found positive for HPV 31 and 45 genotypes did not have E6/E7 mRNA expression. On colposcopic-guided biopsy, among these 16 samples, eight (50%) were diagnosed with invasive squamous cell carcinoma, six (37.5%) with cervical intraepithelial neoplasia grade 3 (CIN3), and two (12.5%) with CIN2. Out of those six patients in whom only HPV DNA was positive, five had normal biopsy findings and one had CIN1. Conclusion The present study suggests that HPV E6/E7 mRNA detection could be more reliable than DNA testing for predicting the risk of progression of HPV-induced cervical lesions to cervical carcinoma and it can be used as a non-invasive tool for triage and patient follow-up.

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“…Constant overexpression of E6 and E7 leads to the development of cervical intraepithelial neoplasia (CIN) (8-10). Previous studies report that E6/E7 mRNA detection has a higher clinical speci city for detecting high-grade lesions compared to DNA-based tests but a lower sensitivity (11,12). Also, E6/E7 mRNA test results have a signi cant clinical predictive value and are more consistent with cytology and histology ndings compared to DNA-based tests (13).…”

Section: Introductionmentioning

confidence: 95%

HPV E6/E7 mRNA detection in women with abnormal histology in Qazvin province, Iran

Benvari

Aslanimehr

Samiee-Rad

et al. 2023

Preprint

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Objective: Human papillomavirus (HPV) infection, especially with type 16 or 18, is associated with cervical cancer. Two HPV proteins, E6 and E7, are essential factors in the carcinogenesis of HPV. The purpose of this study was to evaluate the presence of HPV 16/18 E6/E7 mRNA in women with abnormal histology in Qazvin province, Iran. Results: HPV 16/18 DNA and E6/E7 mRNA was observed in 60.6% and 42.4% of samples, respectively. The frequency of positive HPV 16/18 and E6/E7 results increased with the severity of the injury, but the latter correlates better with progressive lesions. Despite the non-different sensitivity, PPV, and NPV of these two tests, E6/E7 mRNA showed higher specificity for detecting high-grade lesions (52.30% vs 75.38, P = 0.006).

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Diagnostic performance of the E6/E7 mRNA-based Optimygene HR-HPV RT-qDx assay for cervical cancer screening

Cited by 7 publications

References 30 publications

HPV E6/E7 mRNA test for the detection of high grade cervical intraepithelial neoplasia (CIN2+): a systematic review

HPV E6/E7 mRNA test for the detection of high grade cervical intraepithelial neoplasia (CIN2+): a systematic review

Evaluation of HPV E6/E7 mRNA Detection in Clinically Suspected Cases of Cervical Cancer with Abnormal Cytology: Time to Upgrade the Screening Protocols

HPV E6/E7 mRNA detection in women with abnormal histology in Qazvin province, Iran

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