Package No. 250 – a comprehensive cervical examination combining a Pap test using liquid-based cytology (BD SurePath), Cytology Passport (BD FocalPoint GS Imaging System), and PCR. HPV HR 14 types.
Provides maximum sensitivity and accuracy through the combination of liquid-based cytology, artificial intelligence, and HPV testing for 14 oncogenic virus types. Complies with the requirements of Order of the Ministry of Health No. 1057 and international cervical cancer screening standards.
Learn more about the technology and the Cytological Passport.
Pap test based on liquid-based cytology is a modern and highly accurate method for the early detection of cervical cancer and precancerous changes. At Synevo Ukraine laboratory, the study is performed using a double expertise approach that combines the experience of cytologists and the BD FocalPoint GS Imaging System – an AI-based digital microscopy system combined with the ZEISS Axioscope 5 microscope. This approach significantly increases the sensitivity and reliability of detecting pathological changes. The test allows the identification of cells with signs of precancerous or malignant transformation at early stages, when treatment is most effective.
In Ukraine, cervical cancer ranks among the top three most common oncological diseases in women. According to Order of the Ministry of Health of Ukraine No. 1057 dated 18.06.2024, women aged 21-65 are recommended to undergo cytological screening every 3 years or HPV testing every 5 years between the ages of 30 and 65.
The BD SurePath technology ensures maximum cell preservation in a liquid medium, provides a clean, uniform preparation free of mucus, blood, and inflammatory cells, and forms a monolayer of cells with a diameter of 13 mm, optimal for analysis. The advantages of BD SurePath compared to conventional cytology include a 107% increase in LSIL detection, a 64.4% increase in HSIL detection, a 58% reduction in unsatisfactory samples, and a 75% improvement in differentiation between inflammatory changes and ASC-US atypia. From a single sample, co-testing can be performed – simultaneous HPV and Pap testing.
Cytological preparations made using the BD SurePath technology are additionally analyzed using the BD FocalPoint GS Imaging System with artificial intelligence. The result is based on dual expertise – cytologist assessment and AI analysis. The BD FocalPoint methodology is officially approved by the U.S. Food and Drug Administration (FDA) for routine use in cervical cancer screening. This system improves sensitivity for ASC-H detection by 9.2%, LSIL+ by 9.8%, HSIL by 19.6%, and cervical cancer by 24.5%. Each result is accompanied by automated individual digital images of diagnostically significant cells evaluated according to the Bethesda system (2014). The analysis complies with Order of the Ministry of Health of Ukraine No. 1057 dated 18.06.2024 “Standard of Medical Care. Cervical Cancer Screening.” PCR.
HPV HR 14 (cobas HPV, FDA approved) is a modern screening test for detecting 14 oncogenic HPV types with separate genotyping of HPV 16 and 18. The study is performed by real-time PCR on the cobas 6800 platform (Roche Diagnostics, Switzerland). The test identifies HPV 16 and 18 separately and in a group of 12 other high-risk types – 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. It covers the complete list of types recommended by the Ministry of Health Order No. 1057, FDA, and WHO.
HPV is the most common sexually transmitted infection worldwide – up to 90% of women come into contact with the virus during their lifetime. In most cases, the infection is transient, but persistence of HPV types 16 and 18 is associated with cervical intraepithelial neoplasia (CIN I–III) and cervical cancer. The test is fully automated, minimizing human error, and has high analytical sensitivity and specificity confirmed by the FDA. It allows to perform the early detection of types 16/18, which pose the highest risk of developing CIN2+/CIN3+, and identifies all 14 types in a single test.
Package No. 250 is recommended for routine screening and diagnosis of precancerous cervical diseases, after abnormal HPV or Pap results, after CIN treatment and/or conization, in cases of dysplasia or inflammation, in the presence of STIs, and for treatment monitoring. As a primary cervical cancer screening method according to the Ministry of Health Order.
Package No. 250 is the 'gold standard' of cervical screening, combining three key technologies with the highest level of evidence and compliance with international recommendations: BD SurePath – modern liquid-based cytology, BD FocalPoint – artificial intelligence for visualization and accuracy enhancement, and cobas HPV – precise PCR testing for 14 high-risk HPV types.
