Criterion | Inclusion | Exclusion |
---|---|---|
Population | Individuals with a cervix, 15 years of age and older, who have been sexually active, and who have no symptoms of cervical cancera Population subgroups: – By age group (15–19, 20–24, 25–29, 30–69, 70+) – HPV-vaccinated populations | Study population includes > 25% individuals with recent abnormal screening results |
Index screening test | – Primary high-risk HPV testing with HPV nucleic acid testsb alone – High-risk HPV testing with HPV nucleic acid tests, followed by some form of triage (e.g. cytology or HPV testing with partial genotyping for HPV 16 or 18, sequential partial genotyping for HPV 16 or 18 followed by cytology to further triage those positive for HPV 16 or 18). Subgroups: – Method of sample collection for high-risk HPV testing (i.e. self-collected (home vs. in clinic) vs. clinician-collected) – Type of assay (i.e. generic, partial genotyping, full genotyping) – HPV test threshold for a positive result (i.e. 1 pg/mL, 2 pg/mL) | HPV test using in situ hybridization, p16 immunostaining, or HPV viral load Earlier versions of commercial tests that have been replaced (e.g. Hybrid Capture 1) Urine for sample collection Point-of-care tests |
Comparator screening test | – Conventional or liquid-based cytology, with or without follow-up by high-risk HPV testing – High-risk HPV testing with HPV nucleic acid tests, followed by different forms of triage than in the index test – hrHPV testing with HPV nucleic acid tests, using a different method of sample collection (i.e. self-sampled (home vs. clinic) vs. clinician-sampled) | Visual inspection with acetic acid or visual inspection with Lugol’s iodine |
Reference standards | • Colposcopy with histologic examination of tissue specimens, when indicated. • Study protocol stipulates that reference standard is applied to: – All patients, or – All screening test-positive patients and a subset (e.g. random 10%) of screening test-negative patients | Reference standard only applied to screen-positive patients |
Outcomes and target conditions | Diagnostic test accuracy: Number and proportion of people positive and negative on each test (TP, FP, TN, FN), sensitivity and specificity to screen for high-grade cervical lesions (CIN 2, CIN 3, HSIL), and/or invasive cervical cancer (squamous cell carcinoma or adenocarcinoma) | Â |
Timing of reference standard | Reference standard test performed before any management based on the index test result | Â |
Setting | Studies from Very High Human Development Index countries | Â |
Study design | – Observational studies (e.g. prospective or retrospective cohorts, or cross-sectional studies) in which all participants receive both the index and comparator screening test, followed by verification of disease status using the reference standard in all patients or in all screening test-positive patients and a subset (e.g. random 10%) of screening test-negative patients – Randomized controlled trials where participants are randomized to different screening tests but all receive the same reference standard | Conference proceedings; government reports; systematic reviews; case reports; case-control studies; editorials |
Language | English or French | Â |
Publication date | 1995–present |  |