SAMPLE TAKING WITHOUT A SPECULUMMía by XytoTest®: Instructions for Use
This procedure can be performed by a healthcare professional or as a self-sampling technique by the patient herself.
Mia Comprehensive Cervical Cancer Test The most comprehensive, comfortable and convenient test for Cervical Cancer
The Mia Comprehensive Cervical Cancer Test is the only HPV test that identifies both high-risk HPV strains
associated with cervical cancer and automatically detects whether the HPV infection is active and capable of causing the disease. This is achieved without requiring a second sample collection
!
Problem: Cervical cancer kills although it is 100% preventable
Cervical cancer can be prevented if an active high-risk HPV infection is identified early through testing for both high-risk HPV DNA and E6/E7 mRNA overexpression, which indicates oncogenic activity.
✓
Solution: Mia Comprehensive Cervical Cancer Test
can determine not only if a high-risk HPV infection is present, but active, carcinogenic activity and aiding in the prevention or early identification of cervical cancer.
Comfortable self-collection without requiring a speculum as easy as using a tampon.
Detection of high-risk HPV strains clinically linked to Cervical Cancer.
Samples positive for high-risk strains are tested for active E6/E7 gene activity which is more predictive of developing cancer than high risk strain tests alone.
Clear actionable results clarify follow up decisions. Reduce unnecessary follow ups, procedures and referrals.
Medical DevicesMía by XytoTest®
Self-sample Collection Kit
Say goodbye to speculums for cervical cancer prevention
Mía by XytoTest® is a self-collection vaginal sampling device for cervical cancer screening and HPV risk assessment, under healthcare professional supervision.
HR-HPV and the Link With Cervical Cancer
What is HPV?
1 Centers for Disease Control and Prevention
HR-HPV and Cervical Cancer
Having high-risk Human Papillomavirus is NOT THE SAME as having Cervical Cancer.
Most HPV infections are asymptomatic and short-lasting and are cleared by the body’s own immune system. However, infections caused by one or more of the 14 high-risk HPV genotypes (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) can be long-lasting and lead to precancerous lesions, which can develop into Cervical Cancer if left untreated.
Cervical Cancer is the only cancer that is 100% preventable.
World figures: 2
2 World Health Organization. International Agency for Research on Cancer IARC. December 31, 2018
Myths and Facts
Triage E6/E7 mRNA Tumor Markers
Triage – with E6/E7 mRNA biomarkers that detect seven specific HR-HPV genotypes – helps women avoid unnecessary treatment. 3 Overexpression of E6/E7 oncoproteins in active HR-HPV infections also guides decisions regarding future disease risk. 4
3 Massimo Origoni et al, Cancer Medical science. Milan, Italy April 29, 2015
4 Virol J. 2018 Mar 27;15(1):52. doi: 10.1186/s12985-018-0957-z.
A negative test result does not confirm the absence of cervical cancer. Patients with a negative test result should discuss with their doctor when they need to be tested again. False-positive and false-negative results can occur.
-
1
Check the barcodes.
Check that the barcodes match on all kit items (informed consent, test tube, and safe storage bag).
-
2
Fill out the informed consent form.
After completing all the fields in the informed consent form, wash hands and/or put on gloves before using the device.
-
3
Place the patient in the lithotomy position.
With the patient lying on her back with her knees flexed, take the device out of the packet, remove the protective cap, and discard it.
-
4
Insert the device.
Separate the labia and without a speculum carefully insert the device into the vagina until the rim of the device base touches the skin. Rotate the device three times (through 360°) in a clockwise or counterclockwise direction.
-
5
Remove the device.
Carefully withdraw the device from the vagina and immediately place it in the transport tube provided. Close the tube. Place the tube and completed informed consent form in the safe storage bag.
-
6
Send the sample to the lab.
Send the sample for testing as soon as possible, following the laboratory’s shipping instructions.
-
See How to Use it
YOUR QUESTIONS ANSWEREDFAQs About Mía
Do young women get HPV too?
Yes. More than two-thirds of young adult women get HPV within two years of becoming sexually active.
Is Mía by XytoTest® suitable for my patients?
Mía by XytoTest® is a molecular test suitable for all sexually active women over the age of 25.
Is Mía by XytoTest® a painful test?
No. Mía by XytoTest® is a user-friendly device that is not painful or even uncomfortable.
What are the benefits of using Mía by XytoTest® without a speculum?
Mía by XytoTest® is designed for use without a speculum to achieve a more even, representative sample of the whole of the vagina, and to collect more cervicovaginal cells.
Can Mía by XytoTest® be used in menstruating women?
Yes. Mía by XytoTest® can be used during a woman’s period, although avoiding the first three days of heavy blood flow will prevent getting clots in the sample.
Are there any contraindications to performing Mía by XytoTest®?
Yes. Ovules, gels, creams, lubricants, and vaginal douches should not be used for 24 hours prior to the sampling procedure.
What does a Mía by XytoTest® result show?
The result indicates the presence or absence of one or more of the 14 HR-HPV genotypes. Genotypes 16 and 18 are reported separately, while the 12 other genotypes are reported as a pool.
If the HR-HPV DNA test is positive, a second test is performed to identify E6/E7 mRNA in HR-HPV genotypes 16, 18, 31, 33, 45, 52, and 58. This co-test shows whether the HR-HPV infection has already triggered oncogenic activity.
What does it mean if a test is positive for HR-HPV in the DNA test but then negative for E6/E7 mRNA?
Having an HR-HPV infection is not the same as having Cervical Cancer. A positive HR-HPV test and a negative E6/E7 mRNA test simply warns that the virus exists. A healthcare professional should assess the results together with other tests and the patient’s medical record.
What do positive results for both HR-HPV and E6/E7 mRNA mean?
A positive result in both tests shows that the HR-HPV infection has triggered oncogenic activity and that this is not simply a passing infection. A healthcare professional should assess the results together with other tests and the patient’s medical record.
How often should patients have a Mía by XytoTest® test?
A test is recommended every 3-5 years for patients with negative molecular tests, known medical records, and a single sexual partner. However, healthcare professionals should decide on test frequency.
Molecular TechnologyOur Products
We develop medical devices and safe, state-of-the-art molecular technologies that empower you to take control of your health through prevention.
Understand Our Research
Learn about the new technologies we’re developing for personalized medicine.
Have Questions? Our team is happy to answer any questions you may have.
