HPV Test in Screening for Cervical Intraepithelial Neoplasia

care hpv test

care hpv test

Abstract

Background:

Cervical cancer is the fourth leading cause of cancer death in women worldwide. Persistent infection with a high risk human papillomavirus (HR-HPV) is the main etiological factor, so that early early detection of HR-HPV is very important. The aim of this study was to investigate the efficacy of Care™ HPV, a new method, as compared with Pap smear, PCR, and biopsy for screening purposes.

Material and Method:

In this cross-sectional study, 200 sexually active women aging from 25-50 years referred to the oncology clinic of Shahid Sodoughi Yazd Hospital in 2015 with a variety of cervix epithelial lesions or a need for colposcopy were enrolled. Results for Care™ HPV test (cervical), Pap smear, PCR, and biopsy were analyzed using SPSS 15 software and chi-square test, McNemar, and ROC curve analysis. Qualitative variables were compared using a Chi-square test.

Results:

Care™ HPV test sensitivity in detecting cervical intraepithelial neoplasia grade II (CIN-II) and also positive and negative predictive values were higher as compared to with other tests (p<0.05). The Pap smear test specificity was highest. There was no significant differences between Care™ HPV and PCR tests regarding detection of HPV-DNA in cases of CIN-II and worse (p>0.05).

Conclusion:

The Care™ HPV test has high sensitivity and predictive values for detecting HPV infection, with higher efficacy than the Pap smear test for tracking CIN-II. Therefore it may be recommended for use as a screening test in low-income areas.

Keywords: Care™ HPV, human papillomavirus, cervical cancer, CIN-II
care hpv test
care hpv test

Introduction

Cervical cancer is a global health problem (Munoz et al., 2006). According to global reports, cervical cancer is the fourth leading cause of cancers death in women worldwide and the fourth most common cancer in terms of incidence among women around the world (Torre et al., 2015). The prevalence of this cancer is about 470,000 new cases and about 233,000 deaths among women around the world. According to global statistics, nearly 500,000 people around the world have been diagnosed with this disease, which about 80 % are in developing countries and almost half of them lose their lives (Stewart et al., 2015).

In developed and industrial countries due to screening programs and proper infrastructure strategies, incidences of this cancer are remarkably on a decline (Torre et al., 2015). On the other hand, in countries with low-income and in developing countries, the incidence of this cancer and associated pre-cancers are on a rise for various reasons including lack of proper quality control systems, continuous screening infrastructure, and low efficiency monitoring systems with poor tools used during performance (Wentzensen et al., 2015).

This cancer is considered one of the most important diseases caused by the human Papillomavirus (HPV). HPV, especially high-risk types (high-risk HPV), is a cause factor for this cancer and for related lesions such as Cervical Intraepithelial Neoplasia (CIN) and Atypical squamous cells of undetermined significance (ASCUS) (Huh et al., 2015; Giorgi-Rossi et al., 2015). The incidence of this virus is substantially growing (Ahdieh et al., 2001).

Screening programs and routine tests such as Pap smear and Tien Prep have false negative results and require skilled people for diagnoses (Lorenzi et al., 2013) for example, previous studies have shown that the sensitivity of cytopathology Pap smears to detect cancer or pre-cancerous is equal to 53% (Cuzick et al., 2006), which leads up to a 50% increase in false negative results (Sprenger et al., 1996), and with 80% sensitivity and 98% specificity (Soost et al., 1991).

Cervix persistent infection is caused by approximately 13 virus types (Sundström et al., 2015). Screening programs including the HPV- DNA tests were approved by FDA (Kang et al., 2014) to decrease the incidence of cervical cancer in 4-5 recent years. In addition, over the last 8 years the mortality rate has decreased (Torre et al., 2015; Patra et al., 2015). DNA-HPV test is a useful tool in screening women with high risk factors and has more sensitivity than Pap smear cytology (Cox and Cuzick, 2006; Franco and Cuzick, 2008; Gravitt et al., 2010; Shastri et al., 2005; Basu et al., 2013; Zhao et al., 2012), among these methods it can point to Care™ HPV, which has FDA confirmation with confirmed sensitivity and specifity (Lorenzi et al., 2013; Qiao et al., 2008; Zhao et al., 2013; Gage et al., 2012; Trope et al., 2013).

Care™ HPV is a quick, efficient and a simple method that does not require special laboratory equipment (Ying et al., 2014). It doesn’t depend on a person’s skills, and in comparison to Pap smear test, it is more sensitive and operational (Zhao et al., 2012; Ho et al., 1998). It takes approximately about 2 hours and 30 minutes. The short time of this test allows doctors to track patients in a short visit and give more attention to them. The accuracy of this method is 90% and is very economical. In this method after pouring high risk types of HPV- DNA samples, antibodies specifically bind to it then are read via chemiluminescence signals (Ying et al., 2014). The DNA- HPV test improved CIN II and worse detection in developing countries, particularly in rural areas, in fact it preferred in rural areas to cytology test where facilities are not available (Torre et al., 2015; Lazcano et al., 2011). These results indicate that Care™ HPV could be more suitable for the primary screening of cervical cancer and associated pre-cancers. Therefore, the aim of this study was to compare results of cervical lesions checkings by Pap smear (liquid based), PCR, biopsy, and Care™ HPV.

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