A comprehensive solution for the diagnosis of cervical pathologies that allows simultaneous assessment of epithelial cell condition, detection of the presence and type of human papillomavirus (HPV), and identification of the most common sexually transmitted infections (STIs). This integrated approach provides the most complete information and helps the physician choose the optimal patient management strategy.
The package includes: 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 changes of the cervix.
At Synevo, the test is performed using the dual-expertise principle:
- by experienced cytologists;
- with the BD FocalPoint™ GS Imaging System (Becton Dickinson, USA) – a digital microscopy system based on artificial intelligence – combined with a ZEISS Axioscope 5 microscope (Carl Zeiss, Germany).
This approach significantly increases the sensitivity and reliability of detecting abnormal cells, allowing diagnosis at early stages when treatment is most effective. HPV PCR test for 28 genotypes (qualitative determination with genotyping) – the study covers 19 high-risk carcinogenic genotypes (16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 69, 73, 82) and 9 low-risk genotypes (6, 11, 40, 42, 43, 44, 54, 61, 70), which primarily cause benign lesions (condylomas). The test allows detection of HPV presence, identification of the specific genotype, and assessment of the risk of developing precancerous conditions depending on the virus type.
PCR screening for 7 STIs – detects the most common infections that can cause inflammation and complicate the course of HPV infection:
- Chlamydia trachomatis.
- Neisseria gonorrhoeae.
- Mycoplasma genitalium.
- Mycoplasma hominis.
- Ureaplasma urealyticum.
- Ureaplasma parvum.
- Trichomonas vaginalis.
Timely diagnosis of these infections helps prevent complications (chronic cervicitis, infertility, pregnancy complications) and improves the accuracy of differential diagnosis in cases with atypical cytology results.
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 that ensures: maximum preservation of cells due to fixation in a liquid medium, a clean and uniform preparation free of mucus, blood, and inflammatory cells, and the creation of a 13 mm monolayer of cells ideal for analysis.
Advantages of BD SurePath™ compared to traditional cytology:
- +107% – detection of LSIL (low-grade squamous intraepithelial lesion);
- +64.4% – detection of HSIL (moderate and severe dysplasia);
- -58% – reduction of unsatisfactory samples requiring recollection;
- +75% – better differentiation between inflammation and atypia such as ASC-US (atypical squamous cells of undetermined significance).
Co-testing capability – simultaneous HPV test and Pap test from a single sample.
BD FocalPoint™ is an artificial intelligence–based imaging system (Cytology Passport). Cytology preparations prepared using BD SurePath™ technology are additionally analyzed using the BD FocalPoint™ GS Imaging System.
The result is formed on the basis of dual expertise, combining the experience of a cytology laboratory expert with AI-based microscopy capabilities. 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 provides rapid and effective detection of potentially abnormal cells in cytology samples, making results as reliable and reproducible as possible.
The BD FocalPoint™ methodology (Becton Dickinson, USA) is officially approved by the FDA (USA) for routine use in cervical cancer screening, detection of precancerous lesions, and atypical cells based on cervical scraping Pap test performed using the liquid-based cytology method 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 with 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, individualized digital images created and processed by the BD FocalPoint™ GS Imaging System, visualizing fields with diagnostically significant cells in the cytology sample, followed by assessment according to the Bethesda system (2014).
PCR. HPV 28 (genotyping, qualitative detection)
Human papillomavirus (HPV) is the main factor in the development of cervical cancer. The test covers 28 of the most clinically significant genotypes, including:
- 19 high-risk (oncogenic) genotypes: 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 69, 73, 82.
- 9 low- and intermediate-risk genotypes: 6, 11, 40, 42, 43, 44, 54, 61, 70, and others that usually cause benign lesions (condylomas, papillomas).
Test capabilities:
- determination of HPV presence and specific genotype;
- differentiation between transient and persistent infections with a risk of progression;
- assessment of CIN2+ risk depending on genotype;
- assistance to the physician in choosing tactics (observation, treatment, monitoring).
Advantages:
- full coverage of clinically significant HPV types;
- combination with cytology significantly increases prognostic value;
- complies with international screening standards (ASCCP, ESGO, WHO).
PCR. Screening for 7 STIs
This test aims to detect the most common infections that can complicate HPV infection, provoke inflammatory processes of the cervix, and affect reproductive health.
The study includes detection of 7 pathogens:
- Chlamydia trachomatis – one of the most common asymptomatic infections associated with infertility and CIN risk.
- Neisseria gonorrhoeae – the causative agent of gonorrhea, causes purulent-inflammatory processes of the cervix.
- Mycoplasma genitalium – causes cervicitis, complicates the course of STIs.
- Mycoplasma hominis – associated with bacterial vaginosis and chronic infections.
- Ureaplasma urealyticum and Ureaplasma parvum – may cause chronic inflammation, affect fertility and pregnancy outcomes.
- Trichomonas vaginalis – parasitic infection that provokes chronic cervicitis.
Advantages:
- Detection of even asymptomatic infections;
- Explanation of inflammatory changes in cytological smears;
- Timely treatment reduces the risk of complications (infertility, chronic cervicitis, pregnancy complications);
- Increases accuracy of differential diagnosis for atypical Pap test results.
Advantages of combining cytology, PCR HPV 28, and PCR screening for 7 STIs
- Comprehensive approach – simultaneous detection of cellular changes (Pap test), human papillomavirus (28 genotypes), and the most common sexually transmitted infections.
- Comprehensive risk assessment – cytology shows morphological changes, HPV testing determines specific high- and low-risk genotypes, and STI screening identifies co-infections that can enhance inflammation and promote HPV persistence.
- Early diagnosis – allows detection of precancerous conditions and infections before symptoms appear.
- Personalized management – provides the physician with the most complete picture to select optimal management: observation, treatment, or post-therapy follow-up.
- Reduced risk of complications – timely detection of STIs and HPV helps prevent chronic cervicitis, infertility, and pregnancy complications.
- Compliance with international standards – the approach is based on ASCCP, ESGO, WHO recommendations and the Order of the Ministry of Health of Ukraine No. 1057 (2024).
The package provides three levels of diagnostics: cytology + HPV 28 (genotyping) + STIs 7, offering the most complete picture of the condition of the cervix and a woman’s reproductive health.
