p16(INK4a)/Ki-67 dual stain cytology for cervical cancer screening in Thika district, Kenya.
BACKGROUND
The identification of suited early detection tests is one among the multiple requirements to reduce cervical cancer incidence in developing countries.


METHODS
We evaluated p16(INK4a)/Ki-67 dual-stain cytology in a screening population in Thika district, Kenya and compared it to high-risk human papillomavirus (HR-HPV) DNA testing and visual inspection by acetic acid (VIA) and Lugol's iodine (VILI).


RESULTS
Valid results for all tests could be obtained in 477 women. 20.9 % (100/477) were tested positive for HR-HPV DNA, 3.1 % (15/477) had positive VIA/VILI and 8.2 % (39/477) positive p16(INK4a)/Ki-67 cytology. Of 22 women that showed up for colposcopy and biopsy, 6 women were diagnosed with CIN3 and two with CIN2. All women with CIN2/3 were negative in VIA/VILI screening and positive by HR-HPV DNA testing. But HPV was also positive in 91.7 % (11/12) of women with normal histology. p16(INK4a)/Ki-67 cytology was positive in all 6 women with CIN3, in one of the two CIN2 and in only 8.3 % (1/12) of women with normal histology.


CONCLUSIONS
p16(INK4a)/Ki-67 cytology is an interesting test for further studies in developing countries, since our findings point to a lower fraction of false positive test results using p16(INK4a)/Ki-67 cytology compared to HPV DNA testing in a Kenyan screening population. VIA/VILI missed all histology-proven CIN2/3.
College of Health Sciences, Jomo Kenyatta University of Agriculture and Technology, Nairobi, Kenya.
Caroline Wangari
CW
Ngugi
Institute of Pathology, A2.2 Mannheim, Germany.
Dietmar
D
Schmidt
Thika District Hospital, Thika, Kenya ; Faculty of Science, Jomo Kenyatta University of Agriculture and Technology, Nairobi, Kenya.
Karanja
K
Wanyoro
Faculty of Science, Jomo Kenyatta University of Agriculture and Technology, Nairobi, Kenya.
Hamadi
H
Boga
Centre for Public Health Research- Kenya Institute of Medical Research, Nairobi, Kenya.
Peter
P
Wanzala
Faculty of Science, Jomo Kenyatta University of Agriculture and Technology, Nairobi, Kenya.
Anne
A
Muigai
Department of Medical Laboratory Sciences, Kenyatta University, Nairobi, Kenya.
John
J
Mbithi
Department of Applied Tumor Biology, Institute of Pathology, University of Heidelberg, and Clinical Cooperation Unit, German Cancer Research Cancer (DKFZ), 69120 Heidelberg, Germany.
Magnus
M
von Knebel Doeberitz
Department of Applied Tumor Biology, Institute of Pathology, University of Heidelberg, and Clinical Cooperation Unit, German Cancer Research Cancer (DKFZ), 69120 Heidelberg, Germany.
Miriam
M
Reuschenbach
Cervical cancer; Developing countries; HPV; Ki-67; Screening; p16INK4a