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تعداد آیتم قابل مشاهده باقیمانده : -12 مورد

Examples of HPV tests used for cervical cancer screening

Examples of HPV tests used for cervical cancer screening
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 HPVħ

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:

  • Primary testing: HPV testing is performed alone, without cervical cytology.
  • Co-testing: HPV and cytology testing are collected, and results are provided concurrently.
  • Reflex testing: HPV testing is performed automatically on a sample when the cytology result returns positive for atypical squamous cells of undetermined significance.
  • Self-collection: When access to a speculum examination is limited or for those who are reluctant to undergo a pelvic examination, self-collected samples may be used for selected HPV tests.

¶ 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.

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