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Table 1 Characteristics of the included studies, 2011–18

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

Author (s), Year

Country

#Partici-pants

Age group, median

Study population characteristics

Histology profiles

Ratnam, 2011

Canada

1418

15–80, 30.6

Women referred to colposcopy and those routinely screened

Normal = 651, CIN1 = 366, CIN2 = 120, CIN2 + =401, CIN3 = 281

Waldstrom, 2011

Denmark

405

16–65, 32

Three years archived liquid-based samples, all with a diagnosis of LSIL

CIN2 + =67, CIN3 + =33

Fan, 2018

China

192

No data

Patients with abnormal cytology results and/or high-risk HPV infection

CIN1- = 41, CIN1 = 54, CIN2 = 28, CIn3 = 53, cancer = 16

Han,2018

China

197

No data

Women with abnormal cytological or HPV test results

CIN1- = 80, CIN1 = 16, CIN2/3 = 50, Caner = 51

Binnicker,2014

USA

350

No data

Residual specimens with a cytologic result of ≥ atypical squamous cells of undetermined significance (ASC-US)

CIN2 + =81, CIN3 + =41

Broccolo,2013

Italy

308

20–65

A retrospective study on cervical cytology specimens

Normal = 70, CIN1 = 159, CIN2 + =79

Waldstrom, 2012

Denmark

235

30–69, 42.2

Women with ASC-US cytology

Normal = 86, CIN1 = 35, CIN2 = 21, CIN3 = 26, Cancer = 1

Li,2017

China

318

No data

Women with ASCUS cytology attending routine outpatient primary cervical screening

Normal = 169, CIN1 = 74, CIn2 = 40, CIN3 = 16, cancer = 19

Benevolo,2011

Italy

464

17–78, 32

Hybrid Capture 2 (HC2)-positive patients, who underwent colposcopy

<CIN2 = 49, CIN2 + =49, SCC = 9

Wang, 2019

Korea

563

20–84, no

Liquid-based cytology samples

Normal = 51, CIN1 = 75, CIN2 = 16, CIN3 = 40, cancer = 38

Liu, 2014

China

335

No data

Women who underwent outpatient hospital-based gynecological screening

Normal = 30, CIN1 = 5, CIN2 = 1,CIn3 = 15, Cancer 41

Iftner, 2015

Germany

9451

30–60

Women undergoing routine cervical screening

<CIN2 = 513, CIN2 = 47, CIN3 + =43

Sorbye, 2011

Norway

520

25–69

Post-colposcopy follow-up of women with negative or low-grade biopsy

CIN2- = 396, CIN2 + = 124

Duvlis, 2015

Macedonian

413

19–78

Women that come for cervical cancer screening

Normal = 10, CIN1 = 22, CIN2 = 20, CIN3 = 9

Castro, 2013

Spain

165

18–75, 34.8

Women with endocervical samples harboring HPV 16 and/or 18 DNA

CIN2- = 93, CIN2 + = 72

Pierry, 2012

USA

246

19–75

Women in a higher risk urban screening population

Normal = 137, CIN1 = 64, CIN2 = 25, CIN3 = 20

Alaghehbandan, 2013

Canada

1360

15–80, 30.7

women with a history of abnormal cytology referred to colposcopy

Normal = 635, CIN1 = 345, CIN2 + =380, Cancer = 10

Clad, 2011

Germany

424

No data

Women referred to colposcopy due to an abnormal Pap smear

Normal = 108, CIN1 = 64, CIN2 = 89, CIN3 = 150, Cancer = 13

Varnai, 2018

Germany

66

21–66, 34.6

Office based screening population who were HPV-DNA positive for at least one of the following HR- HPV types: HPV 16, 18, 31, 33 and 45

Normal = 6, CIN2 = 5, CIN3 = 22

Coquillard, 2011

USA

2049

No data

Women both low and high risk

Normal = 1694, CIN1 = 78 CIN2 + =73

Shen, 2013

China

272

16–77, 37

Women with abnormal colposcopy

CIN1- = 80, CIN2 = 6, CIN3 + =25

Li, 2016

China

186

22–68

Patients underwent colposcopy

Normal = 32, CIN1 = 51, CIN2/3 = 71, cancer = 32

Liu, 2017

China

380

> 30

Women who were associated with high risk of cervical virus infection

Normal = 159, CIN1 = 68, CIN2 = 74, CIN3 = 68, cancer = 11

Benevolo, 2011

Italy

1610

18–83, 39.5

Retrospective analysis of women underwent an E6/E7 mRNA test on cervical samples

Normal = 74, CIN1 = 282, CIN2 = 120, CIN3 = 86, cancer = 24

Liu, 2018

Japan

171

22–76, 33

Women with pathologically-diagnosed CIN or cervical carcinoma

CIN1 = 16, CIN2 = 33, CIN3 = 83, SCC = 39

Persson, 2014

Sweden

219

23–60, 32

HR-HPV-positive women diagnosed with atypical squamous cells of undetermined significance (ASCUS) and low-grade squamous intraepithelial lesions (LSIL)

Normal = 56, CIN1 = 69, CIn2 = 37, CIN3+ 36

Sorbye, 2011

Norway

297

25–69

Women with ASC-US and LS

CIN1- = 53, CIN2 + =69

Andersson, 2011

Sweden

204

21–79, 32

Women who were undergoing gynecological screening or had been admitted to a referral center

Normal = 45, CIN1 = 33, CIn2 = 28, CIN3 = 31, Cancer 28

Oliveira, 2013

Portugal

554

18–73, 33

Women were referred for opportunistic screening and for evaluation of HPV associated lesions

Normal = 131, CIN1 = 128, CIn2 = 129, CIN3 = 146, Cancer = 14