3393. Пакет №152 (ПЛР. ВПЛ 6, 11 та ВПЛ ВКР 14 (сobas HPV схвалений FDA))

Package №152 – PCR for HPV 6,11 and screening test for 14 oncogenic HPV types.

The package provides qualitative detection of HPV types 6 and 11 (low oncogenic risk) and screening testing for 14 high-risk carcinogenic HPV types.

The testing is performed using real-time PCR on the Cobas system (FDA approved).

The package complies with the requirements of the Ministry of Health of Ukraine Order No. 1057 regarding primary and repeat screening.

PCR testing for HPV is a modern and highly accurate method for diagnosing an infection that can cause cervical intraepithelial neoplasia (CIN), precancerous conditions, and malignant tumors of the cervix, vagina, vulva, anal canal, and oropharynx.

Package No. 152 includes: PCR. HPV 6, 11 (qualitative detection). Detects the presence or absence of two virus types that cause: anogenital warts, mucosal papillomas. These types are not associated with cancer but are important for differential diagnosis.

An automated test for detecting 14 high-risk oncogenic human papillomavirus (HPV) types with separate genotyping of HPV 16 and 18. The study is intended for qualitative detection of HPV DNA in cervical cells. It is performed on the Cobas 6800 platform (Roche, Switzerland) using multiplex amplification and real-time fluorescent detection.

The test separately identifies: HPV 16 and HPV 18 – the most oncogenic types responsible for up to 70% of cervical cancer cases. Additionally, it detects 12 other high-risk HPV types – 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68. This test covers the full list of oncogenic types recommended for screening by the Ministry of Health of Ukraine (Order №1057), the FDA (USA), and WHO.

This is important because HPV is the most common STI in the world: up to 90% of women encounter the virus during their lifetime. In most cases the infection is transient: the immune system eliminates the virus within 1-2 years. Chronic persistence of HPV (especially types 16 and 18) is associated with the development of cervical intraepithelial neoplasia (CIN I–III), cervical cancer (including adenocarcinoma), and HPV-associated cancers of other sites (vulva, vagina, anal canal, oropharynx).

DNA is extracted from cervical cells. Using multiplex PCR, the system detects the presence of oncogenic HPV types. In case of a positive result: HPV 16/18 – immediate further evaluation is recommended (colposcopy, biopsy). Other high-risk HPV types – management is determined individually based on combined factors: Pap test, age, medical history, presence of dysplasia.

Advantages of this test:

• complete automation – minimization of human error;
  
• high sensitivity and specificity (FDA clinical validation);
  
• early detection of HPV 16/18 – highest risk of CIN2+/CIN3+;
  
• 14 types in one report – comprehensive result; • compliance with international and Ukrainian protocols (Order №1057 of the Ministry of Health of Ukraine).
  

PCR. HPV HR 14 (cobas HPV, FDA approved) is a modern, fully automated and clinically validated method for detecting high-risk HPV that enables timely diagnosis of precancerous lesions and cervical cancer. Its use complies with international screening standards and significantly improves risk-based patient management.

• Site-specific scrapings collected depending on the test
• Scrapes from various sites depending on the test