4281. Package #129.5 (Cervical screening with capsid test: PAP test by liquid cytology method (BD SurePath technology, FDA approved). CYTOLOGICAL PASSPORT (BD FocalPoint technology, FDA approved), Capsid test)

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.

• in cases of ASC-US or LSIL results combined with a positive HPV test;
  
• after a positive HPV test, to determine the optimal management strategy;
  
• after CIN treatment, to monitor treatment effectiveness;
  
• in cases of repeated equivocal cytology results.
  

• Site-specific scrapings collected depending on the test