An optimal solution that not only detects cervical cell changes but also assesses the activity of HPV infection. The package combines: Pap test using BD SurePath™ liquid-based cytology with automated BD FocalPoint™ analysis (Cytology Passport) – a modern, high-precision method for early detection of precancerous and malignant cervical changes.
At Synevo, the study is performed under a dual-review system involving:
- experienced cytologists;
- a digital microscopy system powered by artificial intelligence – BD FocalPoint™ GS Imaging System (Becton Dickinson, USA) combined with the ZEISS Axioscope 5 microscope (Carl Zeiss, Germany).
This approach significantly enhances the sensitivity and reliability of detecting pathological cells, allowing diagnosis at the earliest stages when treatment is most effective. Capsid test (HPV L1) – detects the presence of the L1 protein, which indicates the productive phase of HPV infection. This allows distinguishing between transient infections, which tend to resolve spontaneously, and persistent infections capable of progressing to precancerous lesions (CIN2+). The combination of cytological morphology and capsid testing greatly increases diagnostic accuracy, helps avoid unnecessary biopsies, and meets modern international standards for cervical screening (ASCCP, WHO, ESGO). In Ukraine, cervical cancer remains among the top three most common cancers in women. According to Order No. 1057 of the Ministry of Health of Ukraine (June 18, 2024), women aged 21–65 years are recommended to undergo cytological screening every 3 years, or HPV genotyping testing every 5 years between the ages of 30–65 years.
Learn more about the technology and the Cytological Passport.
BD SurePath™ is a modern liquid-based cytology method recommended by the FDA (USA) and CE directives. It ensures maximum cell preservation through fixation in a liquid medium, producing a clean, uniform preparation free of mucus, blood, and inflammatory cells, and creating a 13 mm monolayer of cells that is ideal for analysis.
Advantages of BD SurePath™ compared with conventional cytology:
- +107% – detection of LSIL (low-grade squamous intraepithelial lesion);
- +64.4% – detection of HSIL (moderate and severe dysplasia);
- -58% – reduction in the number of unsatisfactory samples requiring repeat collection;
- +75% – better differentiation between inflammation and atypical cells of the ASC-US type.
Co-testing capability – allows simultaneous HPV testing and Pap testing from a single sample.
BD FocalPoint™ – an artificial intelligence-based imaging system (Cytology Passport). Cytology preparations made using BD SurePath™ technology are additionally analyzed with the BD FocalPoint™ GS Imaging System.
The test result is generated based on dual expertise, combining the experience of a cytology laboratory expert and the capabilities of AI-based microscopy. The analysis is performed using the advanced BD FocalPoint™ GS Imaging System (Becton Dickinson, USA) in combination with the high-tech ZEISS Axioscope 5 microscope (Carl Zeiss, Germany). This innovative, high-precision automated technology provides rapid and effective detection of potentially abnormal cells in cytological samples, making the results highly reliable and reproducible.
The BD FocalPoint™ methodology (Becton Dickinson, USA) is officially approved by the FDA (USA) for routine use in cervical cancer screening, precancerous lesion detection, and identification of atypical cells based on Pap smear analysis using the BD SurePath™ liquid-based cytology technology (Becton Dickinson, USA).
The BD FocalPoint™ GS Imaging System (Becton Dickinson, USA) statistically significantly increases the sensitivity of cervical cancer and precancerous lesion detection compared with traditional methods, namely:
- 9.2% increase in detection of ASC-H (Atypical squamous cells cannot exclude HSIL – atypical cells that may indicate severe precancerous changes);
- 9.8% increase in detection of LSIL+ (Low-grade squamous intraepithelial lesion – low-grade intraepithelial lesion of squamous epithelium);
- 19.6% increase in detection of HSIL (High-grade squamous intraepithelial lesion – high-grade intraepithelial lesion of squamous epithelium);
- 24.5% increase in detection of cervical cancer.
The analysis complies with the Order of the Ministry of Health of Ukraine No. 1057 dated June 18, 2024, “Standard of Medical Care. Cervical Cancer Screening. Management of Patients with Abnormal Screening Results and Precancerous Cervical Conditions.”
Each result is accompanied by automated individual digital images, created and processed by the BD FocalPoint™ GS Imaging System, which visualize diagnostic areas containing significant cytological cells, with subsequent evaluation according to the Bethesda System (2014) classification.
PCR test for high-risk HPV (14 genotypes, quantitative determination)
Human papillomavirus (HPV) is the main cause of cervical cancer. The most dangerous are considered the high-risk genotypes (16, 18, and 12 additional types).
The quantitative PCR method allows to:
- determine the presence of HPV DNA in the sample;
- identify exactly 14 high-risk genotypes;
- assess the viral load, which helps distinguish a transient infection from a persistent one (which carries a high risk of progression to precancerous lesions).
Capsid test (HPV L1)
The capsid test detects the presence of the L1 protein – the major structural protein of the human papillomavirus (HPV). If the L1 protein is detected, it means that the infection is in the productive phase, and the risk of developing significant changes is low. If the L1 protein is not detected in the presence of HPV and/or cellular abnormalities, it indicates a high likelihood of disease progression (CIN2+ risk), and the patient requires closer monitoring or treatment.
Advantages of the capsid test:
- refines clinical risk assessment in patients with ASC-US, LSIL, and other equivocal results;
- allows differentiation between transient and dangerous persistent infection;
- helps avoid unnecessary biopsies and aggressive treatment;
- used worldwide as a risk-stratification test in cervical screening.
Advantages of combining cytology, PCR high-risk HPV testing, and the capsid test:
- Comprehensive assessment – simultaneous analysis of cervical cellular changes (Pap test), detection and quantification of high-risk HPV DNA (PCR), and infection phase identification (capsid protein L1).
- Risk differentiation – cytology reveals morphological changes, PCR detects the virus, and the capsid test shows whether the infection is active or persistent, helping determine the real risk of progression.
- Fewer unnecessary interventions – in cases with positive PCR and minor cytological changes, a positive L1 result helps avoid premature biopsies or aggressive treatment.
- Patient stratification – allows more accurate identification of low- and high-risk groups, enabling clinicians to select a personalized management strategy.
- Compliance with international standards – this approach aligns with modern European and American patient management algorithms for abnormal screening results.
- Higher prognostic value – the combination of three methods enables prediction of whether the detected changes are transient or carry a risk of progression to CIN2+ or cervical cancer.
