Abstract
BackgroundThe identification of suited early detection tests is one among the multiple requirements to reduce cervical cancer incidence in developing countries.MethodsWe evaluated p16INK4a/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).ResultsValid 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 p16INK4a/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. p16INK4a/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.Conclusionsp16INK4a/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 p16INK4a/Ki-67 cytology compared to HPV DNA testing in a Kenyan screening population. VIA/VILI missed all histology-proven CIN2/3.
Highlights
The identification of suited early detection tests is one among the multiple requirements to reduce cervical cancer incidence in developing countries
After exclusion of women with incomplete personal information, no visual inspection by acetic acid (VIA)/VILI and/or invalid laboratory results in either Pap cytology, p16INK4a/Ki-67 cytology and/or human papillomaviruses (HPV) DNA, 477 samples remained for evaluation
P16INK4a/Ki-67 cytology was positive in all 6 women with CIN3 lesions, in one of the two CIN2 lesions and in only 8.3 % (1/12) of women with normal histology in the punch biopsy
Summary
The identification of suited early detection tests is one among the multiple requirements to reduce cervical cancer incidence in developing countries. In Kenya, the annual crude incidence rate of cervical cancer is 16.5 per 100,000 women with a leading mortality rate of 13.5 in 100,000 women [1, 2]. Implementation of nationwide screening for cervical cancer has been successful in reducing the incidence and mortality rates of cervical cancer in many countries [3]. A further reduction in disease incidence is suggested to be reached by prophylactic HPV vaccinations, if they are combined with continued screening [4]. While the vast majority of women clear the infection, upon persistent HPV infections premalignant alterations (cervical intraepithelial neoplasia, CIN) may occur after several years, which precede the development of cervical cancer. Cervical cancer is largely preventable by detecting premalignant alterations and treat them by ablation or excisional means [5]
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