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Study flow diagram detailing the number of the initially retrieved articles and consequent exclusions
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Figure 1

Study flow diagram detailing the number of the initially retrieved articles and consequent exclusions

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Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies
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Figure 2

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies

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Methodological quality summary: review authors' judgements about each methodological quality item for each included study
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Figure 3

Methodological quality summary: review authors' judgements about each methodological quality item for each included study

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Summary ROC plot of 2 tests for detection of CIN 2+ (verified with histology): Conventional Cytology (ASCUS+) and HPV testing with hybrid capture 2 (1pg/mL). The black and red solid circles correspond to the summary estimates of sensitivity and specificity, and are shown with a 95% confidence region.
Figuras y tablas -
Figure 4

Summary ROC plot of 2 tests for detection of CIN 2+ (verified with histology): Conventional Cytology (ASCUS+) and HPV testing with hybrid capture 2 (1pg/mL). The black and red solid circles correspond to the summary estimates of sensitivity and specificity, and are shown with a 95% confidence region.

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Summary ROC plot of 2 tests for detection of CIN 3+ (verified with histology): Conventional Cytology (CC) (ASCUS+) and HPV testing with hybrid capture (HC) 2 (1pg/mL). The black and red solid circles correspond to the summary estimates of sensitivity and specificity, and are shown with a 95% confidence region.
Figuras y tablas -
Figure 5

Summary ROC plot of 2 tests for detection of CIN 3+ (verified with histology): Conventional Cytology (CC) (ASCUS+) and HPV testing with hybrid capture (HC) 2 (1pg/mL). The black and red solid circles correspond to the summary estimates of sensitivity and specificity, and are shown with a 95% confidence region.

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Summary ROC plot of 2 tests for detection of CIN 2+ (verified with histology): Conventional Cytology (CC) (LSIL+) and HPV testing with hybrid capture (HC) 2 (1pg/mL). The black and red solid circles correspond to the summary estimates of sensitivity and specificity, and are shown with a 95% confidence region.
Figuras y tablas -
Figure 6

Summary ROC plot of 2 tests for detection of CIN 2+ (verified with histology): Conventional Cytology (CC) (LSIL+) and HPV testing with hybrid capture (HC) 2 (1pg/mL). The black and red solid circles correspond to the summary estimates of sensitivity and specificity, and are shown with a 95% confidence region.

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Summary ROC plot of 2 tests for detection of CIN 3+ (verified with histology): Conventional Cytology (CC) (LSIL+) and HPV testing with hybrid capture (HC) (1pg/mL). The black and red solid circles correspond to the summary estimates of sensitivity and specificity, and are shown with a 95% confidence region.
Figuras y tablas -
Figure 7

Summary ROC plot of 2 tests for detection of CIN 3+ (verified with histology): Conventional Cytology (CC) (LSIL+) and HPV testing with hybrid capture (HC) (1pg/mL). The black and red solid circles correspond to the summary estimates of sensitivity and specificity, and are shown with a 95% confidence region.

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Summary ROC plot of 2 tests for detection of CIN 2+ (verified with histology): Liquid Based Cytology (LBC) (ASCUS+) and HPV testing with hybrid capture (HC) 2 (1pg/mL). The black and red solid circles correspond to the summary estimates of sensitivity and specificity, and are shown with a 95% confidence region.
Figuras y tablas -
Figure 8

Summary ROC plot of 2 tests for detection of CIN 2+ (verified with histology): Liquid Based Cytology (LBC) (ASCUS+) and HPV testing with hybrid capture (HC) 2 (1pg/mL). The black and red solid circles correspond to the summary estimates of sensitivity and specificity, and are shown with a 95% confidence region.

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Summary ROC plot of 2 tests for detection of CIN 3+ (verified with histology): Liquid Based Cytology (LBC) (ASCUS+) and HPV testing with hybrid capture (HC) 2 (1pg/mL). The black and red solid circles correspond to the summary estimates of sensitivity and specificity, and are shown with a 95% confidence region.
Figuras y tablas -
Figure 9

Summary ROC plot of 2 tests for detection of CIN 3+ (verified with histology): Liquid Based Cytology (LBC) (ASCUS+) and HPV testing with hybrid capture (HC) 2 (1pg/mL). The black and red solid circles correspond to the summary estimates of sensitivity and specificity, and are shown with a 95% confidence region.

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Summary ROC plot of 2 tests for detection of CIN 2+ (verified with histology): Liquid Based Cytology (LBC) (LSIL+) and HPV testing by hybrid capture (HC) 2 (1pg/mL). The black and red solid circles correspond to the summary estimates of sensitivity and specificity, and are shown with a 95% confidence region.
Figuras y tablas -
Figure 10

Summary ROC plot of 2 tests for detection of CIN 2+ (verified with histology): Liquid Based Cytology (LBC) (LSIL+) and HPV testing by hybrid capture (HC) 2 (1pg/mL). The black and red solid circles correspond to the summary estimates of sensitivity and specificity, and are shown with a 95% confidence region.

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CC (ASCUS+) for CIN2+.
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Test 1

CC (ASCUS+) for CIN2+.

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CC (ASCUS+) for CIN3+.
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Test 2

CC (ASCUS+) for CIN3+.

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CC (LSIL+) for CIN2+.
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Test 3

CC (LSIL+) for CIN2+.

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CC (LSIL+) for CIN3+.
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Test 4

CC (LSIL+) for CIN3+.

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LBC (ASCUS+) for CIN2+.
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Test 5

LBC (ASCUS+) for CIN2+.

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LBC (ASCUS+) for CIN3+.
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Test 6

LBC (ASCUS+) for CIN3+.

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LBC (LSIL+) for CIN2+.
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Test 7

LBC (LSIL+) for CIN2+.

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LBC (LSIL+) for CIN3+.
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Test 8

LBC (LSIL+) for CIN3+.

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HC2 (1pg/mL) for CIN2+.
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Test 9

HC2 (1pg/mL) for CIN2+.

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HC2 (1 pg/mL) for CIN3+.
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Test 10

HC2 (1 pg/mL) for CIN3+.

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HC2 (2 pg/mL) for CIN2+.
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Test 11

HC2 (2 pg/mL) for CIN2+.

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HC2 (2 pg/mL) for CIN3+.
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Test 12

HC2 (2 pg/mL) for CIN3+.

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PCR (13 hr types or more) for CIN2+.
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Test 13

PCR (13 hr types or more) for CIN2+.

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PCR (13 hr types or more) for CIN3+.
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Test 14

PCR (13 hr types or more) for CIN3+.

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PCR (10‐11 hr types) for CIN2+.
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Test 15

PCR (10‐11 hr types) for CIN2+.

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PCR (10‐11 hr types) for CIN3+.
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Test 16

PCR (10‐11 hr types) for CIN3+.

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Aptima for CIN2+.
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Test 17

Aptima for CIN2+.

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Aptima for CIN3+.
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Test 18

Aptima for CIN3+.

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PCR (4 hr types) for CIN2+.
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Test 19

PCR (4 hr types) for CIN2+.

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Care HPV test (0.5 pg/ml) for CIN2+.
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Test 20

Care HPV test (0.5 pg/ml) for CIN2+.

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Care HPV test (0.5 pg/ml) for CIN3+.
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Test 21

Care HPV test (0.5 pg/ml) for CIN3+.

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Cobas for CIN2+.
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Test 22

Cobas for CIN2+.

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Cobas for CIN3+.
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Test 23

Cobas for CIN3+.

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NASBA (5 types) for CIN2+.
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Test 24

NASBA (5 types) for CIN2+.

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NASBA (9 types) for CIN2+.
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Test 25

NASBA (9 types) for CIN2+.

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HC2+4 (1 pg/ml) for CIN2+.
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Test 26

HC2+4 (1 pg/ml) for CIN2+.

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HC2+4 (1 pg/ml) for CIN3+.
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Test 27

HC2+4 (1 pg/ml) for CIN3+.

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HC2 (1pg/mL) for CIN2+ no verification bias.
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Test 28

HC2 (1pg/mL) for CIN2+ no verification bias.

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CC or LBC (ASCUS+) for CIN2+ no verification bias.
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Test 29

CC or LBC (ASCUS+) for CIN2+ no verification bias.

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HC2 (1pg/mL) for CIN2+ women >30.
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Test 30

HC2 (1pg/mL) for CIN2+ women >30.

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self HPV test for CIN2+.
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Test 31

self HPV test for CIN2+.

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Summary of findings HPV (HC2, 1 pg/mL) vs Pap (LBC, ASCUS)

Human papillomavirus (HPV) compared to Papanicolaou (Pap) test for detection of cervical intraepithelial neoplasia (CIN 2+) in asymptomatic women

Patient or population: adult asymptomatic women

Settings: outpatient screening programmes

New Test: HPV, HC2 test Cut‐off value: 1 pg/mL

Comparison Test: Pap, liquid‐based cytology (LBC) test Cut‐off value: atypical squamous cells of undetermined significance (ASCUS)

Reference Test: a colposcopy exam with or without biopsy as clinically indicated

HPV

138,230 women
(25 studies)

Pooled sensitivity
(95% CI)

89.9%

(88.6 to 91.1%)

Pooled specificity
(95% CI)

89.9%

(89.7 to 90.0%)

Pap

82,003 women
(15 studies)

Pooled sensitivity
(95% CI)

72.9%

(70.7 to 75%)

Pooled specificity
(95% CI)

90.3%

(90.1 to 90.5%)

Test results

Number of results per 1000 women tested
(95% CI)

Quality of the evidence
(GRADE)

Comments

Prevalence of CIN 2+, 2%1

HPV

Pap

True positives (TP)

18

(18 to 18)

15

(14 to 15)

⊕⊕⊕⊝
moderate
due to inconsistency2,3

Women will be correctly classified and will receive further confirmatory testing or treatment

TP absolute difference

3 more

False negatives (FN)

2

(2 to 2)

5

(5 to 6)

Women will be falsely reassured that they do not have CIN 2+, and the potentially beneficial treatment may be missed or will be delayed

FN absolute difference

3 fewer

True negatives (TN)

881

(879 to 882)

885

(883 to 887)

⊕⊕⊕⊕
high3

Women will be correctly reassured that they do not have CIN 2+

TN absolute difference

4 fewer

False positives (FP)

99

(98 to 101)

95

(93 to 97)

Women will likely receive unnecessary further testing and possibly also unnecessary treatment; additionally further testing and unnecessary treatment may lead to adverse effects and use of resources without any health benefits

FP absolute difference

4 more

CI: Confidence interval; HPV human papillomavirus; Pap: Papanicolaou test, CIN: cervical intraepithelial neoplasia

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 Prevalence of 2% (20 women out of 1000) was assumed to be the average prevalence of cervical intraepithelial neoplasia 2+ in non HIV asymptomatic women.
2Serious inconsistency in sensitivity among studies with sensitivity ranging from 52%‐94% for Pap, and 61% to 100% for HPV.
3We did not downgrade for risk of bias, but the few limitations with studies were considered with inconsistency.

Figuras y tablas -
Summary of findings HPV (HC2, 1 pg/mL) vs Pap (LBC, ASCUS)
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Table 1. Pooled diagnostic accuracy of tests

Test

Disease threshold

studies

Pooled sensitivity (95% CI)

Pooled specificity (95% CI)

CC (ASCUS+)

CIN 2+

16

65.87% (54.94 to 75.33)

96.28% (94.72 to 97.39)

LBC (ASCUS+)

CIN 2+

15

75.51% (66.57 to 82.68)

91.85% (88.43 to 94.32)

CC (LSIL+)

CIN 2+

9

62.84% (46.79‐76.50)

97.73% (96.09‐98.70)

LBC (LSIL+)

CIN 2+

10

70.33% (59.73 to 79.11)

96.20% (94.57 to 97.36)

HC2 (1 pg/mL)

CIN 2+

25

92.60% (99.45 to 95.30)

89.30% (87.03 to 91.20)

PCR (> 12 types)

CIN 2+

6

95.13% (89.50 to 97.84)

91.89% (83.79 to 96.13)

APTIMA

CIN 2+

3

92.66% (31.77 to 99.71)

93.31% (47.30 to 99.54)

CC (ASCUS+)

CIN 3+

9

70.27% (57.87 to 80.30)

96.67% (94.56 to 98.00)

LBC (ASCUS+)

CIN 3+

13

75.97% (64.72 to 84.49)

91.19% (87.21 to 94.01)

CC (LSIL+)

CIN 3+

5

74.43% (67.81 to 80.10)

96.86% (94.87 to 98.10)

LBC (LSIL+)

CIN 3+

5

71.91% (51.68 to 86.00)

96.05% (93.53 to 97.60)

HC2 (1 pg/mL)

CIN 3+

19

96.50% (94.00 to 97.90)

89.20% (86.70 to 91.30)

PCR (> 12 types)

CIN 3+

4

93.57% (69.90 to 98.91)

86.49% (68.16 to 95.04)

APTIMA

CIN 3+

4

96.04% (72.91 to 99.54)

92.80% (86.15 to 96.39)

Tests with fewer than three studies are not included in the table.
Figuras y tablas -
Table 1. Pooled diagnostic accuracy of tests
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Table 2. Test comparisons

Comparison

Disease threshold

Relative sensitivity (95% CI)

Relative specificity (95% CI)

Studies

Analysis number

HC2 vs CC (ASCUS+)

CIN 2+

1.52 (1.24 to 1.86)

0.94 (0.92 to 0.96)

9

1

HC2 vs CC (ASCUS+)

CIN 3+

1.46 (1.12 to 1.91)

0.95 (0.93 to 0.9)

6

2

PCR (> 12 types) vs CC (ASCUS+)

CIN 2+

1.37 (0.58 to 3.21)

0.95 (0.76 to 1.19)

3

5

HC2 vs CC (LSIL+)

CIN 2+

1.28 (1.15 to 1.41)

0.91 (0.87 to 0.95)

6

7

HC2 vs CC (LSIL+)

CIN 3+

1.22 (1.12 to 1.32)

0.91 (0.87 to 0.95)

5

8

HC2 vs LBC (ASCUS+)

CIN 2+

1.18 (1.10 to 1.26)

0.96 (0.95 to 0.97)

10

11

HC2 vs LBC (ASCUS+)

CIN 3+

1.17 (1.05 to 1.30)

0.96 (0.95 to 0.98)

8

12

PCR (> 12 types) vs LBC (ASCUS+)

CIN 2+

1.53 (0.53 to 4.44)

0.90 (0.89 to 0.92)

3

15

PCR (> 12 types) vs LBC (ASCUS+)

CIN 3+

1.47 (0.64 to 3.35)

0.94 (0.8 to 1.09)

3

16

HC2 vs LBC (LSIL+)

CIN 2+

1.35 (1.19 to 1.53)

0.92 (0.89 to 0.95)

8

17

HC2 vs LBC (LSIL+)

CIN 3+

1.30 (0.86 to 1.96)

0.92 (0.8 to 1.00)

4

18

APTIMA vs LBC (ASCUS+)

CIN 3+

1.30 (0.49 to 3.41)

0.98 (0.93 to 1.04)

3

22

Comparisons with fewer than three studies are not included in the table
Figuras y tablas -
Table 2. Test comparisons
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Table 3. Variation in the accuracy of HC2 by covariates

Comparison

Studies

Disease threshold

Relative sensitivity (95% CI)

Relative specificity (95% CI)

Age > 30 vs any age

17 vs 20

CIN 2+

1.13 (1.03 to 1.25)

1.01 (0.98 to 1.04)

13 vs 14

CIN 3+

1.10 (1.02 to 1.19)

1.04 (1.00 to 1.08)

Increased vs low risk of

verification bias

17 vs 20

CIN 2+

1.05 (0.95 to 1.16)

1.00 (0.97 to 1.04)

12 vs 15

CIN 3+

1.09 (1.01 to 1.18)

1.00 (0.96 to 1.05)

High‐income vs

middle‐/low‐income countries

21 vs 16

CIN 2+

1.01 (0.91 to 1.12)

1.03 (1.00 to 1.07)

13 vs 14

CIN 3+

0.94 (0.87 to 1.02)

1.01 (0.96 to 1.05)

Assessed by bivariate random‐effects meta‐analysis including one covariate each time.
Figuras y tablas -
Table 3. Variation in the accuracy of HC2 by covariates
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Table Tests. Data tables by test

Test

No. of studies

No. of participants

1 CC (ASCUS+) for CIN2+ Show forest plot

16

61099

2 CC (ASCUS+) for CIN3+ Show forest plot

9

51857

3 CC (LSIL+) for CIN2+ Show forest plot

9

41494

4 CC (LSIL+) for CIN3+ Show forest plot

5

35648

5 LBC (ASCUS+) for CIN2+ Show forest plot

15

82003

6 LBC (ASCUS+) for CIN3+ Show forest plot

13

71919

7 LBC (LSIL+) for CIN2+ Show forest plot

10

33519

8 LBC (LSIL+) for CIN3+ Show forest plot

5

21166

9 HC2 (1pg/mL) for CIN2+ Show forest plot

25

138230

10 HC2 (1 pg/mL) for CIN3+ Show forest plot

19

120380

11 HC2 (2 pg/mL) for CIN2+ Show forest plot

2

26768

12 HC2 (2 pg/mL) for CIN3+ Show forest plot

2

26768

13 PCR (13 hr types or more) for CIN2+ Show forest plot

6

16343

14 PCR (13 hr types or more) for CIN3+ Show forest plot

4

14048

15 PCR (10‐11 hr types) for CIN2+ Show forest plot

2

3965

16 PCR (10‐11 hr types) for CIN3+ Show forest plot

1

2988

17 Aptima for CIN2+ Show forest plot

3

15895

18 Aptima for CIN3+ Show forest plot

4

17944

19 PCR (4 hr types) for CIN2+ Show forest plot

1

1985

20 Care HPV test (0.5 pg/ml) for CIN2+ Show forest plot

2

7044

21 Care HPV test (0.5 pg/ml) for CIN3+ Show forest plot

2

7046

22 Cobas for CIN2+ Show forest plot

2

11666

23 Cobas for CIN3+ Show forest plot

2

11666

24 NASBA (5 types) for CIN2+ Show forest plot

1

313

25 NASBA (9 types) for CIN2+ Show forest plot

1

313

26 HC2+4 (1 pg/ml) for CIN2+ Show forest plot

1

1352

27 HC2+4 (1 pg/ml) for CIN3+ Show forest plot

1

1352

28 HC2 (1pg/mL) for CIN2+ no verification bias Show forest plot

12

53013

29 CC or LBC (ASCUS+) for CIN2+ no verification bias Show forest plot

8

31341

30 HC2 (1pg/mL) for CIN2+ women >30 Show forest plot

13

69334

31 self HPV test for CIN2+ Show forest plot

4

23474
Figuras y tablas -
Table Tests. Data tables by test
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