A direct comparison of four high‐risk human papillomavirus tests versus the cobas test: Detecting CIN2+ in low‐resource settings

Abstract

Low-cost, accurate high-risk human papillomavirus (HR-HPV) tests are needed for cervical cancer screening in limited-resource settings. More than 200 cervical cytological specimens from hospital patients were collected and analyzed for a realworld study. We evaluated the analytical and clinical performance of four widely used HR-HPV test (Tellgen, Hybribio, Liferiver, and Sansure) based on real-time polymerase chain reaction technology platforms, compared with the cobas test. Cervical intraepithelial neoplasia grade 2 or worse lesions (CIN2+) were set as the disease endpoint, and all the five HPV tests were performed with equal sensitivity (McNemar's test; P = 0.971) and specificity (McNemar's test; P = 0.953). All genotyping using the INNO-LiPA HPV test showed that HPV-16, -52, and -54 were the most common types among CIN2+ cases. Overall, the four HR-HPV tests analyzed appear to be as effective as the cobas HPV test in both agreement and clinical performance.Therefore, each of these low-cost HPV test kits could be implemented in limitedresource settings to accelerate the control of cervical cancer. However, we suggest that there is a need to further standardize and optimize testing around clinical sensitivity and specificity. K E Y W O R D S cervical screening, cobas HPV test (cobas) , human papillomavirus (HPV), INNO-LiPA, real-time polymerase chain reaction (PCR)

Evaluation and Optimization of the Clinical Accuracy of Hybribio's 14 High-Risk HPV with 16/18 Genotyping Assay within the VALGENT-3 Framework

“…HPV18 from the pool of 12 other hrHPV types. The China Food and Drug Administration approved HBRT-H14 in 2012, and it has been widely used in Chinese hospitals and laboratories (27). However, only a few data on clinical performance have been published in peer-reviewed literature (24,27).…”

“…The China Food and Drug Administration approved HBRT-H14 in 2012, and it has been widely used in Chinese hospitals and laboratories (27). However, only a few data on clinical performance have been published in peer-reviewed literature (24,27). In 2013, Bian et al (24) evaluated the clinical accuracy of HBRT-H14 and HC2 on 424 SurePath samples (Becton, Dickinson and Company, Sparks, MD, USA) derived from a Chinese screening population.…”

“…In a recent study, Xue et al compared the performance of HBRT-H14 to that of Cobas for detecting CIN2ϩ, using a total of 214 samples from a colposcopy referral population in China (27). HBRT-H14 had a clinical sensitivity of 94.6% (95% CI, 86.9 to 97.9%) and specificity of 66.0% (95% CI, 56.6 to 74.4%) and was considered noninferior to Cobas.…”

“…HBRT-H14 has several advantages: it has high throughput and is a technically undemanding assay providing relatively quick results (2 to 3 h), and it can be operated on the great majority of real-time PCR platforms at low cost (27). Moreover, the analytical performance of HBRT-H14 was evaluated in the 2013 and 2014 WHO HPV LabNet international proficiency studies, showing high proficiency performance (100% proficient on all four data sets) (29).…”

The Performance of Immunocytochemistry Staining as Triaging Tests for High-Risk HPV-Positive Women: A 24-Month Prospective Study

“…e Liferiver PCR Kit detects HPV DNA by nucleic acid hybridization with a pooled probe set of 15 hrHPV types, including HPV16, HPV18, and other 13 high-risk subtypes. e kit shows equal analytical and clinical accuracy compared with Cobas 4800 [10]. All reactions were performed in a 40 μl volume using the ABI PRISM 7000 (Applied Biosystems, US).…”