Human papillomavirus in Women with Pre-Cancerous Lesion and Cervical Cancer: the Use of Urine as an Alternative Specimen

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Addis Ababa University


Background: In a country where the coverage cervical cancer screening is low optimization of the uptake is critical. The implementation of high precision test is advocated by WHO. To augment the implementation human papillomavirus (HPV) based screening in Ethiopia we compared the performance urine HPV DNA test with cervical swab. Methods: Paired samples (n=103) of first void urine and cervical swab were collected from patients Gynecology Clinic of Tikur Anbessa Specialized Hospital (TASH). After extraction of DNA using QIAamp® DNA Mini Kit (Qiagen) the HPV infection, coinfection and type-specific HPV distribution was determined using the Anyplex HPV28 DNA genotyping kit (Seegene, Seoul, Korea) and CFX96 IVD (In Vitro Diagnostic) Real-Time PCR System. The kit simultaneously detects, differentiate, and semi-quantify 28 HPV genotypes 19 high risk (Hr)-HPV types; HPVs 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 69, 73 and 82 and 9 LR-HPV types; HPVs 6, 11, 40 ,42, 43, 44, 54, 61 and 70. Additionally, blood sample was collected to detect HPV16 L1 anti-capsid antibody using Prevo-check ® (Abvirus Germany GmbH). It is immunologic rapid test that directs against a protein that is produced by HPV 16 infected cells which interferes with cell division. Pap smear was done by a pathologist and histology results was collected from the chart of the patients and a clinical form was used to collect basic information from the patients by the attending midwife nurses. Result: Of the 103 paired samples, HPV infection prevalence was 83.5% in cervical and 77.7% in urine samples. HPV 16 is the most prevalent in both samples with 56.8% in cervical swab and 54.6% in urine sample followed by HPV 18 (5.8%) in cervical swab and HPV 18 and HPV 39 (6.2%) in urine samples. Multiple infection rate (infection more than one type of HPV) was 22.4% in urine samples and 32.0% in cervical swab. The agreement in the detection of HR-HPV between urine and cervical samples was moderate with a kappa value of 0.57 at 95% CI. Using the cervical HPV results as a reference, the anaylitical sensitivity of urine HPV testing was 88.4% (76/86) and specificity of 76.5% (13/17) and ROC area of 0.82 with (0.7-0.9) 95% CI. The Prevo-check HPV16 L1 antibody test has detected antibody from seven patients have a low clinical sensitivity but specificity of 100%. Of 93 histology result; 69.9% of the participants were diagnosed with SCC. HR-HPV detected in 76.2% and 79.7% from cervical and urine samples. Conclusion: In a country with low cervical cancer screening uptake collection of urine specimen can be considered as an alternative sample since the sample is easy to obtain, showed good diagnostic performance and may increases uptake of cervical cancer screening in Ethiopia. HPV16 and 18 were the predominant HPV detected from women with CIN2+ and above patients.



Human papillomavirus, Urine, Cervical cancer, TASH