Commercial name | Approved indication(s)* | Assay target¶ | DNA or RNA |
Alinity m HR HPVΔ | Primary testing Co-testing Reflex testing | Group results of 11 high-risk HPV subtypes ([31, 33, 52, 58] and [35, 39, 51, 56, 58, 59, 66, 68]) and specifically reports on the presence or absence of HPV 16, 18, and 45 | DNA |
Aptima HPVΔ Aptima HPV 16 and 18/45Δ | Co-testing Reflex testing | Pooled detection of 14 high-risk HPV subtypes (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) Specifically reports on the presence or absence of HPV 16 and 18/45 | RNA |
careHPV◊ | Primary testing | Pooled detection of 14 high-risk HPV subtypes (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) | DNA |
Cervista HPV HRΔ Cervista HPV 16/18Δ | Co-testing Reflex testing | Pooled detection of 14 high-risk HPV subtypes (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) Specifically reports on the presence or absence of HPV 16 and 18 | DNA |
Cobas HPVΔ◊§ | Primary testing Co-testing Reflex testing Self-collection | Pooled detection of 12 high-risk HPV subtypes (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) and specifically reports on the presence or absence of HPV 16 and 18 | DNA |
digene Hybrid Capture 2 (HC2)Δ | Co-testing Reflex testing | Pooled detection of 13 high-risk HPV subtypes (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68) | DNA |
Onclarity HPVΔ§ | Primary testing Co-testing Reflex testing Self-collection | Specifically reports on the presence or absence of 14 high-risk HPV subtypes (individual results for 6 HPV subtypes [16, 18, 31, 45, 51, and 52] and grouped results for the remaining subtypes [33/58, 35/39/68, and 56/59/66]) | DNA |
Xpert HPV◊ | Primary testing | Pooled detection of 11 high-risk HPV subtypes (31, 33, 35, 39, 51, 52, 56, 58, 59, 66, and 68) and specifically reports on the presence or absence of HPV 16 and 18/45 | DNA |
FDA: US Food and Drug Administration; HPV: human papillomavirus; HR: high risk; WHO: World Health Organization.
* Definitions of approved indications:
¶ A positive pooled result indicates that at least one high-risk HPV subtype was detected. The test cannot identify the HPV subtype or whether one or more HPV subtypes are present, unless otherwise indicated.
Δ FDA approved.
◊ WHO prequalified (important for settings that rely on the WHO to aid in procurement of high-performance tests).
§ FDA approved for self-collection. For self-collection, individuals collect samples from the vagina using the specimen collection kit provided by the manufacturer. These tests should only be performed in a health care setting, when collection by a provider is not feasible.