High sensitivity and specificity rates of cobas® HPV test as a primary screening test for cervical intraepithelial lesions in a real-world setting

Abstract

Cervical carcinoma (CC) is the fourth most common malignancy among women. Screening with Papanicolau smear is linked to a reduction in CC incidence rates when screening programs have been developed. However, this technique has several limitations, including moderate sensitivity rates for detection of cervical preneoplastic HPV-related lesions. In this real-world study, we proposed to evaluate the sensitivity and specificity rates of cobas® test, which amplifies target DNA fragments by polymerase chain reaction and hybridization of nucleic acids for the detection of 14 HR-HPV types in a single analysis) used as primary screening test for CC and preneoplastic lesions in women aged 25–65 years in a large University Hospital in Buenos Aires. A total of 1044 patients were included in the sample (median age: 46 years); sensitivity and specificity rates for the HR-HPV test used as primary screening test were 98.66% (95% confidence interval [95CI]: 97.67–99.3%) and 87.15% (95CI: 84.93–89.15%), respectively. The positive predictive value was 88.47% (95CI: 86.54%-90.42%) and the negative predictive value was 98.48% (95CI: 97.75%-99.23%). The cobas® HR-HPV testing was highly sensitive and specific for the detection of CC and preneoplastic lesions in real practice.

Enhancing Cervical Cancer Screening: Review of p16/Ki-67 Dual Staining as a Promising Triage Strategy

“…Recent advancements in cervical cancer screening have increased the efficacy of the p16/Ki-67 dual-staining technique, particularly for triaging human papillomavirus (HPV)positive women [64,65]. A growing body of research indicates that this dual-staining method outperforms traditional cytology in several key aspects, notably sensitivity and negative predictive value (NPV), albeit with a trade-off in specificity [14,56]. These findings have significant implications for early detection and management of high-grade cervical lesions.…”

“…Patients with mild cervical lesions, such as low-grade squamous intraepithelial lesions (LSIL) and atypical squamous cells of undetermined significance (ASCUS), face the risk of progression to more severe conditions, necessitating careful triage strategies [13]. Although HPV testing has high sensitivity, its low specificity leads to a significant number of unnecessary colposcopies, particularly in younger women [14]. In this context, p16/Ki-67 dual-staining cytology emerges as a potential biomarker with high sensitivity and specificity for identifying high-grade cervical intraepithelial neoplasia (HGCIN) [15,16].…”

Cervical Squamous Cell Carcinoma Diagnosis by FTIR Microspectroscopy

“…Currently, the screening methods for these types of tumors are performed through the cytopathological Papanicolaou (Pap) Smear test which has a high specificity (>90%), although the sensibility varies from 74 to 98%; High Risk-Human Papillomavirus (HPV-HR) test, with 97–99% sensibility and 84–89% specificity; and colposcopy, which has 90% sensibility and 35–50% specificity [ 14 , 15 , 16 , 17 ]. However, there is apprehension regarding the precision of the aforementioned methods and their subsequent efficacy in facilitating precise screening and early diagnosis of cervix cancer [ 18 ].…”