About the Delphi Screener
- What does the Delphi Screener look like?
The Delphi Screener has a blue handgrip to handle the device and a white tube with a rounded top, like a tampon or vaginal cream applicator, that is inserted smoothly into the vagina. The Screener has been designed for optimal use in the vagina.
- How long is the Delphi Screener?
The total length of the Screener is 22,5 centimeters (8,86 inches). The white insertion part is 10 centimeters (3,94 inches).
- Why is the Screener this length?
For easy handling and to collect a good sample. It is important to get a sample as high as possible in the vagina (close to the cervix, neck of the womb). The average length of the vagina is approximately 10 centimeters
- Is the Delphi Screener available in different sizes?
No, the Delphi Screener is only available in one size. Research has shown that this size is optimal for use and appropriate for almost every woman. Gynaecologists have been involved in the development of the Screener and have found this size to be effective.
- What is the liquid inside the Screener made of?
The lavage liquid is sterile, water-based saline (physiological salt solution). It is body-friendly and widely used in the medical world, like the solution as often found in eye drops.
- Where is the Screener being produced?
The Screener is produced in the Netherlands.
- How do I know that I am using a real Screener, and not a copy of one?
The Screener is patent protected which means it cannot be manufactured by others. Only Delphi Bioscience and partners have the authority to distribute the Screener.
- Where is the Delphi Screener available?
We are currently using the Screener in many countries around the world to collect local information on the use (Netherlands, Finland, Italy, Germany, Malta, USA, Singapore.
- Will the Delphi Screener only be available through prescription?
This depends on the country. The Screener can be offered for free through the government, or can be bought at the pharmacy, or be provided by a general practitioner or gynaecologist.
- Will purchasing the Delphi Screener be reimbursed by health insurance?
This situation will differ country by country.
Use of the Delphi Screener
- If I purchase the Screener, within how much time do I have to take a sample?
The expiration date of the device is printed on the pouch. You must use the Screener before this date.
- If I receive the Screener at home, within how much time do I have to take a sample?
The instructions in the kit will tell you how much time you have to take a sample. This should not be later than the expiration date as is printed on the pouch.
- How do I use the Delphi Screener?
The User Instructions explain clearly how to use the Screener. You can download these instructions here. Also we have animation videos which show very clearly how you use the Screener.
- Is it safe to use the Screener?
The Screener is especially developed for the female body. The round top is smooth and within the vagina automatically glides into the right direction towards the cervix (neck of the womb). It is painless to use.
- The pouch is open?
If the pouch was open or damaged before use please contact your provider. The Screener is not sterile anymore. You may get a new device.
- I am not sexually active, should I use the Screener?
If you have never had sexual intercourse before, your risk of cervical cancer is very low and generally cervical cancer screening is not recommended.
- Can I use the Delphi Screener if I have had a hyste-rectomy, in other words I have no uterus (womb)?
If you have never had pre-cancer of the cervix and your last pap smear prior to your total hysterectomy was normal, cervical screening is generally not recommended. Check with your doctor to make sure that you do not need to be screened.
- Can I use the Delphi Screener when I am having my period?
No, you should not use the Screener when you are having your period (use of 2 or more tampons/pads per day), in the same way that you should not go to the doctor for a pap smear. The test result can possibly be influenced when the sample is collected during the menstrual period.
- I found blood on the white tube?
Some blood on the insertion part of the device after use will not have an effect on the test performance. There is no reason to be concerned.
- Can I use the Screener with other vaginal products such as lubricants, vaseline, or douche?
We do not have information on the use of vaginal products together with the Screener. Still, we do not recommend using douche, spermicides, vaseline, or antifungal (such as medication for yeast infections) within two days of using the Screener. Water-based lubricants, vaginal rings, and condoms are fine.
- Can the collection of another vaginal sample prior to using the Screener affect the test outcome?
There is some data available that shows that the use of another vaginal collection device prior to using the Screener does not harm the quality of the lavage sample. However, the use of a lavage device just prior to sampling with the Screener does possibly negatively affect the sample quality and test outcome.
- Can I use the Delphi Screener when I am pregnant?
We have no user experiences of pregnant women available. We do however not expect any adverse effect from the sterile water or size of the insertion part on the pregnancy. If you find out that you are pregnant after having used the Screener there is no reason to be concerned.
- Will the Delphi Screener affect my ability to get pregnant?
No, the Screener has no effect on your ability to get pregnant.
- Can I use the Screener when I have a Mirena or other IUD?
There is no reason to believe that the use of the Screener has a negative effect on the functionality of an IUD. It does not seem likely that the lavage disturbs the performance of the IUD. However, no specific research has been done yet to confirm this.
- Can I use the Screener if I use a vaginal ring for contraception?
Yes, just be sure that the ring is in place after using the Screener, or take the ring out and re-insert it into your vagina after using the Screener.
- Can I be allergic to the liquid in the Screener?
No, the liquid is sterile and body friendly. It is a physiological salt solution which is also used in for instance eye drops.
- Can the liquid disappear in my body?
No, the liquid cannot disappear in your body. The cervix is located at the end of the vagina. There is only a very small opening to the womb through which the water cannot escape. Water that is not collected back into the Screener, will leak out of your vagina.
- Why do I have to transfer the sample into a test-tube? The device is not developed to also store the specimen yet. In the future we expect that the sample can be stored and transported within the device. The test-tube is no longer needed then.
- There is just very little fluid in the test-tube after I transferred my sample from the Screener into the tube. This is not a problem. Don’t feel insecure about it. Only a small amount of fluid is needed for the test to be done. In the rare case that there is not enough fluid the laboratory will contact you.
- I forgot to wash my hands before use?
It is more hygienic to wash your hands before use, but it is not necessary to collect a sample with washed hands. It will not affect the test.
- How do I know that I used it correctly?
Collecting a sample yourself can hardly go wrong. In the rare case that there is not enough fluid the laboratory will contact you, but they only need a little bit, so send them what you have.
- Can I reuse the Screener?
No, the Screener is for single use only. After use, the Screener should be thrown away in the garbage or returned to the provider. This will be explained to you in the User Instruction.
Delphi Screener and Cervical Cancer Screening
- Can the Delphi Screener be used to prevent cervical cancer?
Yes, the Delphi Screener can be used to test for the HPV virus, a virus which can cause cervical cancer. The Screener can help identify women who are at risk for cervical cancer and who can be treated before cancer develops.
How reliable is the Delphi Screener in identifying (pre-stages of) cervical cancer?
The Delphi Screener is very reliable. Collecting a sample yourself can hardly go wrong. In the rare case there is anything wrong with the sample, the laboratory that tests the sample will generally be able to tell and may ask you to take another sample. It has been shown that there is almost no difference between testing for the HPV virus on self-collected samples with the Screener versus testing for the HPV virus on a sample collected by a physician or nurse. Furthermore the HPV test is reliable in identifying cervical abnormalities (precancer): through a HPV test more than 92% of abnormalities will eventually be indentified, while through the standard Pap smear this percentage is substantially lower (55-80%).
Who can use the Delphi Screener for cervical cancer screening?
In principle, the Delphi Screener can be used by all women that should be screened for cervical cancer. While guidelines are different depending on the country and region, women 25 years of age and older are usually recommended to be screened for cervical cancer regularly. If you have no uterus (womb) anymore you do not need to be screened on cervical cancer. If you are experiencing symptoms such as bleeding between periods, blood in vaginal discharge, or loss of blood during or after sexual intercourse you should see your doctor immediately.
Why is the Screener not suitable for younger women when used for cervical cancer screening?
An HPV infection with the types of HPV that can lead to cancer, known as ‘high-risk’ HPV, are more common in young women (shortly after their sexual debut and with multiple partners). Also cervical cancer can only develop when an HPV infection is persistent, but young women who get infected with these types of HPV often clear the infection on their own within a year. If the Screener is used to test on HPV only to detect risk for cervical cancer, it does not make sense for young women. Many cervical cancer screening programs therefore recommend the HPV test only for women above a certain age (such as 30 years).
- Do doctors and healthcare organizations support the Screener?
Yes, the Delphi Screener has been developed by a team of people such as important national and international gynaecologists, scientists and laboratories, including the VU University medical center in Amsterdam, the Netherlands. Two large studies using the Screener within the national screening setting have been approved by the Dutch Health Council.
The Screening Process
- What do I need to do with my sample after collection?
If you purchase (at the pharmacy) or receive (eg. through an organized screening program) the Screener kit, the instructions inside the kit explain how to return the sample. It is also possible that you obtained the Screener at for example a clinic, in which case the instructions are also given by the doctor. You may be asked to send the sample by postal mail to a central laboratory, the pre-paid and pre-addressed return envelope or mail box is then part of the kit. Or you may be asked to drop off the sample at a pharmacy or at the clinic.
- How much time do I have to mail or drop off the specimen after I collect it?
You should send or return the sample as soon as possible. We recommend returning the sample within 24 hours, as the sample contains no preservatives to maintain the quality of the sample.
- Which laboratory will test my sample?
Only certified laboratories will be allowed to test the sample, although the exact laboratory used will differ by country and region.
- Which tests are done on my sample?
The information in the kit that you purchased at the pharmacy or received through an organized screening program tell you on which disease or infection your sample will be screened. It is also possible that you obtained the Screener at for example a clinic, in which case this information will also be given by the doctor. The laboratory is not allowed to do other tests on your sample other than indicated in this information!
- Is the self-sampling test confidential?
Yes. If you purchase a kit at the pharmacy you are only identified by means of an unique code. In other settings you can be identified by a unique code, a national unique screening number or full name. In all cases your sample will be treated confidentially.
- What happens with my sample after testing?
After testing your sample will be kept for 2 months in case a repeat test is needed. Thereafter your sample will be destroyed according to the standard procedures of the certified laboratory.
- How and when do I get the result back (including personal advice if applicable)?
This will depend on how and from whom you obtained the Delphi Screener. If you obtained a kit through a pharmacy or organized screening program, the information inside the kit explains how you get the result back and how long it will take. It is also possible that you obtained the Screener at for example a clinic, in which case the doctor will inform you how and when you get the result back including advise on what to do next. Possible methods to get the results are: retrieval from the website, receipt of a registered letter, text message on mobile phone, email, or a telephone call. Again, depending on where you are. We recommend contacting the helpdesk or your doctor if you do not receive the result within the indicated period of time.