Global HPV DNA PP 2021 technical report, a summary report of WHO HPV evaluation, was released recently. The WHO HPV LabNet evaluated Hybribio 37 HPV GenoArray Diagnostic Kit, 23 HPV Genotyping Real-Time PCR Kit, 21 HPV GenoArray Diagnostic Kit, and 14 High-risk HPV with 16/18 Genotyping Real-time PCR Kit in several laboratories, and the test results confirmed 100% proficiency, with the overall results ranking the first among the participating products.

    One of the purposes of the WHO HPV Laboratory Network is "to harmonize and standardize laboratory testing procedures and to establish a network of HPV laboratories worldwide" to facilitate consistent laboratory assessments of regional disease burden (i.e., WHO HPV Quality Assessment). WHO regularly conducts HPV DNA typing proficiency assessments through the HPV Laboratory Network to evaluate the typing specificity and sensitivity of HPV testing reagents routinely used by laboratories worldwide, to analyze problems with different testing methods, and to guide the development of HPV vaccines and the implementation of HPV vaccination programs worldwide.

    Hybribio HPV assays have previously taken part in WHO HPV LabNet five times consecutively, with findings meeting the clinical application level and laboratory capacity requirements each time. This year, Hybribio participated in the evaluation again, and the accuracy rate of the products remained 100% as usual. Hybribio has never wavered in its commitment to thorough product quality control.

    On July 6, 2021, the latest WHO Guidelines for the Screening and Treatment of Cervical Pre-cancer Lesions for cervical cancer prevention released recommended the use of HPV-DNA testing as the preferred method for cervical cancer screening instead of VIA or cytology. In 2022, the National Health Commission released the Cervical Cancer Screening Work Program, which clearly proposed High-Risk HPV testing as the primary screening method for cervical cancer.

    For more than 20 years, Hybribio has been a leader in the field of HPV testing in China. Hybribio fully meets the clinical diagnostic needs with its independent R&D strength in the pursuit of HPV industrialization, forming a total solution for cervical cancer screening that integrates testing, service, treatment, academia, platform, and informationization, allowing advanced scientific and technological products to benefit more people.

    Hybribio has the most complete HPV product portfolio, channels and service system in the IVD industry, and has accumulated a large amount of supporting data in screenings for Chinese. In 2017, Hybribio initiated a multi-center, prospective clinical validation trial of large data screening in Henan, Shanxi and Guangdong. The baseline year clinical study data analysis revealed that Hybribio 14 High-risk HPV with 16/18 Genotyping Real-time PCR Kit has a high sensitivity and negative predictive value in ≥ CIN2 and ≥ CIN 3. The sensitivity and negative predictive value for detection at ≥CIN2 and ≥CIN3 levels are high, which can fully play a role in triaging the ASC-US population; the results of both primary and combined screening indicate that the cumulative absolute risk values of developing ≥CIN2 and ≥CIN3 in subjects with negative baseline HPV test results are sufficiently low, which demonstrates the protective effect of the reagent on the negative population; The relative risk values for subjects with positive baseline HPV test results to develop for ≥CIN2 and ≥CIN3 were significantly higher than those for HPV-negative subjects at baseline, indicating that the reagent is useful for guiding the clinical management of cytologically normal women. With three-year follow-up, the results suggest that the risk of CIN2/3+ for either HPV16/18 or other HPV infections increases within three years, and that the risk of CIN2/3+ for HPV16/18 positive is higher within three years compared to other HPV type infections. [Note 1]

    Over the years, Hybribio has conducted large-scale cervical cancer screenings in Guangdong, Xiamen, Shanghai, Tibet, Shandong, Daqing, Hunan, and etc., to promote national two-cancer screening. Hybribio prefers HPV testing as a primary screening method, benefiting over 40 million women with advanced technologies.

    Hybribio has maintained 100% product proficiency for many years consecutively in the HPV DNA typing test capability assessment of the WHO global HPV laboratory network. Hybribio has passed the LabNet quality assessment with scores of 100% proficiency from several laboratories that participated in the product assessment and test. The result once again affirms Hybribio comprehensive strength in HPV products, testing capability and quality management.

 [Note 1] Part of the content is from "The value of human papillomavirus typing test in cervical pre-cancer and cervical cancer screening".