Concordance of Anyplex™ II HPV HR assays with reference HPV assays in cervical cancer screening: Systematic review
Genital infection with certain types of human papillomaviruses (HPVs) is a major cause of premalignant dysplasia and cervical cancer globally. Identification of 14 high-risk human papillomaviruses (HR-HPV) is immensely important in elucidating molecular epidemiology, patient monitoring, and evidence-based treatment. HPVs testing has become an essential part of current clinical practice in the management of cervical cancer and precancerous lesions. Thus, HPV assays are increasingly used for primary cervical screening and HPV genotyping, for monitoring vaccination-effect and determining changes in the epidemiology of viral genotypes across the globe. Testing for high-risk HPV is more effective in primary cervical cancer screening than in the cytological examination of a Pap smear. Separate genotyping may be useful for triage in both HPV-based and cytology-based screening. It should be used only for clinically validated tests. To evaluate the concordance of Anyplex™ II HPV HR with other HPV assays in cervical cancer screening. Validation studies of Anyplex™ II HPV HR assay from PubMed, google scholar, google database and Scopus were used to search articles. Articles published in English from 2013 onwards were systematically searched using keywords. Besides, other databases like Google Scholar and the Google database were searched manually for grey literature. The last search was done in December 2020. Then study eligibility, extracted data, and assessed risk of bias were assessed. Due to the great clinical heterogeneity of the included articles, the diagnostic performance of the anyplex II ™ HR HPV test was unlikely to be pooled. Rather, I did a descriptive presentation of the test performance to gather the best synthesis of evidence for the anyplex II ™ HR HPV test for the detection of CIN2+. Studies that evaluate the performance of the assay in terms of its sensitivity, specificity, reproducibility and positive and negative predictive values to comparator assays and/or histology were included in this review. Anyplex™ Ⅱ HPV HR showed consistently high absolute clinical sensitivity for CIN2+ and CIN3+, as well as comparative clinical sensitivity relative to the currently most widely used HPV test. Because of the significantly diff ;erent composition of the referral populations, Anyplex™ Ⅱ HPV HR absolute clinical specificity for CIN2+ and CIN3+ varied across studies but was comparable relative to reference assays. Five validation studies of Anyplex™ Ⅱ HPV HR performance in cervical cancer screening settings showed its consistently high absolute clinical sensitivity for both CIN2+ and CIN3+, still comparative clinical sensitivity and specificity relative to HC2 and GP5+/6 + PCR. Anyplex™ Ⅱ has evaluated HPV HR in several settings and population groups. It is considered clinically validated for primary cervical cancer screening and triage in referral population settings.