Primary HPV test screening cytology HPV COBAS OPTIMA

Primary HPV test screening

cytology HPV

COBAS OPTIMA HC

COBAS • HPV DNA OPTIMA • m. RNA E 6, E 7 HC • HPV DNA

Primary Screening HPV test increase reduce complexity sensitivity cost

For example: ATHENA

HPV test primary screening Age 25 28% Age 30 24%

HPV TEST primary screening NPV: 100%

Cytology versus HPV testing for cervical cancer screening in the general population Cochrane Systematic Review - August 2017

Test Disease threshold studies Pooled sensitivity (95% CI) Pooled specificity (95% CI) CC (ASCUS+) CIN 2+ 16 65. 87% (54. 94 to 75. 33) 96. 28% (94. 72 to 97. 39) LBC (ASCUS+) CIN 2+ 15 75. 51% (66. 57 to 82. 68) 91. 85% (88. 43 to 94. 32) CC (LSIL+) CIN 2+ 9 62. 84% (46. 79‐ 76. 50) 97. 73% (96. 09‐ 98. 70) LBC (LSIL+) CIN 2+ 10 70. 33% (59. 73 to 79. 11) 96. 20% (94. 57 to 97. 36) HC 2 (1 pg/m. L) CIN 2+ 25 92. 60% (99. 45 to 95. 30) 89. 30% (87. 03 to 91. 20) PCR (> 12 types) CIN 2+ 6 95. 13% (89. 50 to 97. 84) 91. 89% (83. 79 to 96. 13) APTIMA CIN 2+ 3 92. 66% (31. 77 to 99. 71) 93. 31% (47. 30 to 99. 54) CC (ASCUS+) CIN 3+ 9 70. 27% (57. 87 to 80. 30) 96. 67% (94. 56 to 98. 00) LBC (ASCUS+) CIN 3+ 13 75. 97% (64. 72 to 84. 49) 91. 19% (87. 21 to 94. 01) CC (LSIL+) CIN 3+ 5 74. 43% (67. 81 to 80. 10) 96. 86% (94. 87 to 98. 10) LBC (LSIL+) CIN 3+ 5 71. 91% (51. 68 to 86. 00) 96. 05% (93. 53 to 97. 60) HC 2 (1 pg/m. L) CIN 3+ 19 96. 50% (94. 00 to 97. 90) 89. 20% (86. 70 to 91. 30)

INTERNATIONAL JOURNAL OF CANCER Int J Cancer. 2018 May 1; 142(9): 1952– 1958

MIDDLE INCOME COUNTRY • 1000, 000 women • CIN 1: 708 • CIN 2: 285 • CIN 3: 436 • INVASIVE : 85 • HPV INCIDENCE: 3. 5% • HC 2