Package No. 129.6 is an advanced cervical screening option that combines morphological and immunochemical methods. It allows not only to detect cellular changes in the cervix but also to assess the biological activity of HPV infection and the risk of its progression.
The package includes: Pap test using BD SurePath™ liquid-based cytology with automated BD FocalPoint™ analysis (Cytology Passport) – a modern and highly accurate method for early detection of precancerous and malignant cervical changes.
At Synevo, this test is performed through a dual-expertise approach:
- by experienced cytologists;
- and with the support of an AI-based digital microscopy system – BD FocalPoint™ GS Imaging System (Becton Dickinson, USA) combined with the ZEISS Axioscope 5 microscope (Carl Zeiss, Germany).
This approach significantly increases the sensitivity and reliability of detecting pathological changes. The test helps identify epithelial cells showing signs of precancerous or malignant transformation at early stages when treatment is most effective. Markers p16 and Ki-67 are biomarkers used to assess the risk of progression of precancerous lesions. Co-expression of p16 and Ki-67 indicates a high probability of CIN2+, helping clinicians make evidence-based decisions and reducing the number of unnecessary biopsies.
Capsid test (HPV L1) – shows the phase of HPV infection:
- positive L1 → productive phase, low risk of progression;
- negative L1 → high probability of persistent infection and risk of developing CIN2+. This test allows for more accurate prediction of the disease course and helps determine whether active treatment is required or monitoring is sufficient.
Learn more about the technology and the Cytological Passport.
BD SurePath™ – a modern liquid-based cytology method recommended by the FDA (USA) and CE directives, which ensures: maximum preservation of cells due to fixation in a liquid medium, a clean and uniform specimen free from mucus, blood, and inflammatory cells, and the creation of a 13 mm cell monolayer, ideal for analysis.
Advantages of BD SurePath™ compared to conventional cytology:
- +107% – detection of LSIL (low-grade dysplasia);
- +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 atypia of the ASC-US type.
Co-testing capability – simultaneous performance of HPV testing and Pap testing from a single biomaterial.
BD FocalPoint™ – an artificial intelligence visualization system (Cytological Passport). Cytological preparations prepared using BD SurePath™ technology are additionally analyzed using the BD FocalPoint™ GS Imaging System.
The test result is based on dual expertise, combining the experience of a laboratory cytology expert and the capabilities of AI-based microscopy. The analysis is performed using the modern laboratory visualization system BD FocalPoint™ GS Imaging System (Becton Dickinson, USA) in combination with the high-tech microscope ZEISS Axioscope 5 (Carl Zeiss, Germany). This innovative, high-precision automated technology enables fast and effective detection of potentially abnormal cells in a cytological sample, making the results maximally 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 lesions, and atypical cells, based on the analysis of a cervical scraping Pap test using liquid-based cytology technology BD SurePath™ (Becton Dickinson, USA).
The BD FocalPoint™ GS Imaging System (Becton Dickinson, USA) statistically significantly increases the sensitivity of detecting cervical cancer and precancerous lesions compared to traditional approaches, 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 18.06.2024 “Standard of medical care. Cervical cancer screening. Management of patients with abnormal screening results and precancerous cervical conditions.”
Additionally, each result includes automated individual digital images created and processed by the BD FocalPoint™ GS Imaging System, which visualize fields containing diagnostically significant cells of the cytological sample, with further evaluation according to the Bethesda System (2014) classification.
Markers p16 and Ki-67
p16 – a protein that indicates the integration of high-risk HPV into cells. Its expression is closely associated with a high risk of CIN2+.
Ki-67 – a marker of cellular proliferation. Detection of Ki-67 together with p16 confirms the activity of the pathological process.
Advantages:
- improved diagnostic accuracy for ASC-US, ASC-H, LSIL;
- the ability to stratify risk – from transient changes to precancerous conditions;
- reduction of unnecessary biopsies.
Capsid test (HPV L1)
The capsid test determines the presence of L1 protein – the main structural protein of the human papillomavirus (HPV). If L1 protein is detected, it means that the infection is in a productive phase and the risk of developing dangerous changes is low. If L1 protein is not detected in the presence of HPV and/or cellular changes, this indicates a high probability of process progression (CIN2+ risk), and the patient requires closer monitoring or treatment.
Advantages of the capsid test:
- refines clinical risk in patients with ASC-US, LSIL, and other equivocal results;
- allows differentiation between transient and persistent high-risk infections;
- helps avoid unnecessary biopsies and overtreatment;
- is used worldwide as a risk stratification test in cervical screening.
Advantages of combining cytology, p16/Ki-67, and the capsid test
- Maximum informativeness – combines morphological assessment of cells (Pap test), proliferation and transformation markers (p16/Ki-67), and determination of the HPV infection stage (L1 capsid protein).
- Accurate risk assessment – makes it possible to distinguish transient changes from precancerous conditions (CIN2+) and identify low- and high-risk groups.
- Reduction of unnecessary interventions – helps avoid premature biopsies and aggressive treatment in cases of equivocal cytological results.
- Increased diagnostic accuracy – the combination of methods reduces false-negative results and improves detection of ASC-US, LSIL, HSIL.
- Prognostic value – p16/Ki-67 indicate the biological activity of the lesion, while the capsid test shows the phase of HPV infection, allowing prediction of the disease course.
- Compliance with international protocols – this approach aligns with the recommendations of ASCCP, ESGO, WHO, and the Order of the Ministry of Health of Ukraine No.1057.
- Personalized management, providing the most complete information for choosing monitoring or treatment.
