Page 151 - Screening for Cervical Cancer: Systematic Evidence Review

Appendix C. Evidence Tables

Evidence Table 3B. Performance of HPV Testing for Triage (cont'd)

Quality
Patients & Methods Outcomes Measured Study Results & Limitations* Considerations
1007 women with Pap diagnosis Prevalence: Quality Score=9
abnormal Paps classified by Bethesda No CIN=269/1007=27% CIN 1 Ref. Std.: 2
referred for system w/HPV changes=477/1007=47% Blind: 2
colposcopy CIN II 124/1007=13% Verification: 2
HPV defined as CIN III/CIS=12% Consecutive: 0
negative consensus, Invasive carcinoma=4/1007=0.4% Spectrum: 1
16, 18, 31&33&35, Publication: 1
any high risk subtype, Se (High risk HPV, CIN II/III)=59% Industry: 1
all multiple high risk Sp (High risk HPV, CIN II/III)=59%
subtypes, and
unidentified type Se (High risk HPV, CIN I +)=51%
Sp (High risk HPV, CIN I +)=67%
Histology: No CIN/
CIN 1/HPV, CIN 2,
CIN 3/CIS, invasive
carcinoma

973 women ThinPrep® Pap Prevalence: Quality Score=11
undergoing routine diagnosis classified as Normal=783/973=80.4% Ref. Std.: 2
screening with ASCUS LSIL=125/973=12.8% Blind: 2
ASCUS Pap results HSIL=64/973=6.7% Verification: 2
and histologic HPV + for high risk Cancer=1/973=0.1% Consecutive: 2
diagnosis subtypes 16, 18, 31, Spectrum: 1
33, 35, 39, 45, 51, 52, Se (High risk HPV, Publication: 1
56, 58 LGSIL+)=76.3% Industry: 1
Sp (High risk HPV,
Histology: normal, LGSIL+)=69.5%
LSIL, HSIL, Cancer
Se (High risk HPV,
HGSIL+)=89.2%
Sp (High risk HPV,
HGSIL+)=64.1%

247 patients Primary outcome: Prevalence: Quality Score=7
attending a CIN I, II, II, invasive CIN I =18/247=7.3% Ref. Std.: 2
colposcopy clinic cancer ≥CIN II=40/247=16.2% Blind: 0
Verification: 2
Physician collected samples: Consecutive: 0
se (HPV, ≥CIN II+)=92.5% Spectrum: 1
sp (HPV, ≥CIN II+)=72.5% Publication: 1
Industry: 1
Patient collected samples:
se (HPV, ≥CIN II+)=92.5%
sp (HPV, ≥CIN II+)=61.8%

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