Table 3.

Currently available nucleic acid amplification tests for detection of human papilloma virusa

HPV NAATSerotypes detectedMethodSpecimenFDA indication
Digene Hybrid Capture 2 High-Risk HPV DNA Test (HC2)Pooled subtypes including 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68DNA-based screening assayCervical specimens in PreservCyt solution collected with HC2 collection device or broom-type device(1) Screening patients with ASC-USb cervical cytology results for referral to colposcopy;
(2) screening for presence or absence of hrHPV in conjunction with cervical cytology in women > 30 years of age
Cervista HPV HRPooled subtypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68DNA-based screening assayCervical specimens in PreservCyt solution, collected with broom-type device or endocervical brush or spatula(1) Screening patients with ASC-US cervical cytology results for referral to colposcopy;
(2) screening for presence or absence of hrHPV in conjunction with cervical cytology in women >30 years of age
Cervista HPV 16/1816, 18DNA-based genotyping assayCervical specimens in PreservCyt solution, collected with broom-type device or endocervical brush or spatulaAssessing presence or absence of hrHPV types 16 and 18 adjunctively with Cervista HPV HR test in combination with cervical cytology (1) in women >30 years of age or (2) in patients with ASC-US cytology results
Aptima HPV hrHPV E6/E7Pooled subtypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68HPV E6/E7 mRNA-based screening assayCervical samples in PreservCyt solution collected with broom-type or cytobrush/spatula collection device(1) Screening patients with ASC-US cervical cytology results for referral to colposcopy;
(2) screening for presence or absence of hrHPV in conjunction with cervical cytology in women >30 years of age
Cobas HPV TestcIndividual identification of subtypes 16 and 18 and pooled detection of subtypes 1, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68DNA-based screening assay with concurrent genotypingCervical specimens in PreservCyt solution collected with endocervical brush or spatulaAssessing women ≥21 years of age with ASC-US cervical cytology results for (1) referral to colposcopy or (2) presence or absence of hrHPV genotypes 16 and 18; screening women ≥30 years of age for (1) hrHPV types or (2) presence or absence of types 16 and 18
  • a For the most up-to-date information, always check the package insert for the assay of interest (108, 109).

  • b ASC-US, atypical squamous cells of undetermined significance; HR-HPV, high-risk human papilloma virus subtype.

  • c At the time of writing, the Cobas HPV test is the only assay approved as a first-line primary screening test for cervical cancer.