CINtec PLUS P16/Ki67 – a test recommended for liquid-based cytology

• The material is stored for four weeks from the date of LBC collection to allow for CINtec PLUS P16/Ki67 or HPV testing. To perform the test, the patient must register, order, and pay for the test.

• It's best to perform the test at least 4 days after your last period and no later than 4 days before your period starts. Vaginal medications should not be used for at least 4 days before the test. At least 1 day should have passed since your last gynecological examination/transvaginal ultrasound.
• The patient should not do any vaginal rinsing or have sexual intercourse for 24 hours before the examination.

Samples brought in from outside the laboratory are not accepted for testing.
Only liquid-based cytology (LCC) can be used for testing.

Clinical significance of the test:
Tests are performed to further diagnose precancerous lesions and cervical cancer when Pap smear results are abnormal or inconclusive.
Cervical cancer is the second most common cancer worldwide.
Approximately 3,500 cases are diagnosed in Poland each year, with half of these patients dying due to late diagnosis. One of the leading causes of cervical cancer is the human papillomavirus (HPV). Cervical cancer is a malignant tumor that develops from the epithelium covering the cervix or cervical canal. Approximately 200 types of the virus have been identified to date, but only a few are sexually transmitted and are associated with high-grade dysplasia and cervical cancer. Due to their varying oncogenic potential, high-risk (HR) HPV viruses are distinguished – HPV 16, HPV 18, HPV 31, HPV 33, and HPV 45, which are associated with over 80% of precancerous cervical cancer cases – and low-risk (LR) HPV viruses – HPV 6 and HPV 11, which are associated with benign, lower-grade intraepithelial lesions or the development of genital warts.
During acute infection with a high-risk HPV virus, viral genes are expressed in mature epithelial cells and their cell cycle is disrupted. This leads to uncontrolled cell proliferation, reflected by the production of the p16 and ki 67 proteins, known as biomarkers of infection.
The p16 protein plays a key role in cell cycle control, and the Ki-67 protein is a cell proliferation protein.
The CINtec plus test detects both of these proteins, allowing for the detection of cancerous changes at the cellular level at a very early stage of their development. The test is characterized by high sensitivity and specificity.
The p16/Ki-67 test, combined with a Pap smear and HPV testing, is essential for the most accurate diagnosis and interpretation of difficult cases, such as ASCUS, LSIL, ASC-H, or glandular lesions.
The most comprehensive, reliable, and sensitive method of testing for cervical cancer is a liquid-based cytology test (LBC) supplemented with HPV testing and CINtec plus.
The combination of these three diagnostic tests is particularly important when the Pap smear result is abnormal or difficult to interpret.

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