Clinical diagnostic products for cervical cancer

Product Introduction

To make up for the shortcomings in the existing diagnostic plans for cervical cancer, Onkai conducted big data screening based on the public database of cervical cancer related methylation sites, combined with algorithm optimization, and ultimately selected four high-performance targeted gene sites Based on this, a DNA methylation detection product for cervical exfoliated cells was developed This product detects the DNA methylation status of four genes related to cervical lesions through qPCR, achieving precise detection of precancerous lesions

Detection principle

This testing project involves extracting DNA from cervical exfoliated cells, converting it to bisulfite, and using fluorescence quantitative PCR technology to detect the methylation levels of four genes related to cervical cancer or precancerous lesions. Based on the Ct value of the target gene methylation test results, the corresponding methylation levels are calculated to evaluate the risk of cervical cancer or precancerous lesions in the test subject.

User group

User group
Having a family history of cervical cancer;
Long term smoking, malnutrition, and weakened immunity;
People who value their own health

Vaginoscopy testing and cervical cancer screening for patients;
HPV positive patients;
Patients with lsil, hsil, asc_us

Have a history of genital warts;
Cervicitis or menstrual abnormalities, unexplained vaginal bleeding;
People with a history of unclean sexual activity or long-term reproductive tract infections

Clinical significance

1. Manage false positives in HPV and TCT test results through shunt management to avoid excessive biopsy;
2. Positive methylation test: indicates a high risk, and further diagnosis is recommended through colposcopy/biopsy;
3. Methylation test negative: indicates low risk, combined with other clinical tests, it is recommended to have regular follow-up.

Product performance

1. High precision: Cervical cancer (sensitivity 100%; specificity 95.1%); HSIL+(sensitivity 86.5%, specificity 95.1%)
2.4 Target genes: more comprehensive and accurate detection
3. Safe and convenient: cervical detachment cells can be retrieved by oneself