General questions about the marker

 

What is the Ruma marker?

The mar­ker is a low-mole­cu­lar po­ly­ethy­le­ne gly­col (PEG). The PEGs we use are not me­ta­bo­li­sed. This me­ans that they pass through the bo­dy wit­hout any re­ac­tion. They are ex­creted in the uri­ne en­ti­re­ly. The mar­ker is neit­her a me­di­cal de­vice nor a me­di­cinal pro­duct. Fur­ther in­for­ma­ti­on on as­sess­ment by the EMA (Eu­rope­an Me­di­cal Agen­cy) and the FDA (Food and Drug Ad­mi­nis­tra­ti­on) can be found he­re. 

What substances does the liquid marker contain?

The liquid marker consists of a combination of different low molecular polyethylene glycols in water. 

What substance does the marker capsule contain?

The capsule contains a combination of monodisperse polyethylene glycols. The food dye Brilliant Blue was added to the capsule as well. The capsule shell consists of vegan hard gelatine. 

What does the marker do in the body?

The polyethylene glycol markers are inert substances. This means that they do not interact with the organism at all and are excreted unchanged via the kidneys and thus in the urine. The markers are harmless and do not have any side effects.

What dye does the capsule contain?

The dye used is Brilliant Blue (E133), which is also frequently used as food colouring in food.

What is the best way to store the marker?

The marker can be stored easily at room temperature. It can also be kept in a refrigerator. However, the polyethylene glycols will solidify in this case. Once they are taken out of the refrigerator, the markers will liquefy again after spending some time at room temperature.

How long do I have to wait after taking the marker capsule before I can take my urine sample?

You must wait at least 60 minutes after taking the capsule. 

May I wait for more than 60 minutes before taking my urine sample after taking the marker?

Yes, you may. This is not a problem as long as you collect the first urine passed after taking the marker.

May I take the marker in the evening and collect my urine sample in the morning?

Yes, this is not a problem. It is important to use the first urine passed after taking the marker. The marker will remain in your bladder until you empty it.

Why do I have to chew the sherbet candies?

Chewing the sherbet candies will stimulate the flow of saliva. This causes the capsule in the mouth to dissolve quickly. This exposes any attempt of hiding the capsule in the oral cavity in order to transfer it to clean urine. If you try to hide the capsule in your mouth, your tongue and oral cavity will turn blue.

How do I store my urine sample until handing it in to my physician/dispatching it?

Store your urine sample in your refrigerator or freeze it until dispatch.

I am unable to urinate after 60 minutes. What do I do now?

The urine sample can also be collected later. The laboratory merely must receive the first urine passed after you take the marker.

I went to the toilet after taking the marker and forgot to collect the urine sample. What do I do now?

In this case, you must take another marker.

I made a mistake while recording the video. What do I do now?

Please ask your physician how to proceed.

Why am I not allowed to drink anything after taking the marker?

Additional drinking during the waiting period will dilute the urine and the marker concentration may drop below the detection limit.

Why should I use the toilet before taking the marker?

If your bladder is already full when you take the marker, the marker concentration may be diluted to below the detection limit.

What happens if the patient stores their urine sample improperly?

This may render the sample unusable. Bacterial growth on the urine or other processes may impair laboratory analysis. The marker itself, however, will not be affected by this.

The patient can do anything with their urine after collecting their urine sample. How is manipulation excluded at this point?

Manipulation attempts will be discovered in the laboratory. All manipulation attempts are reliably detected by analysing the marker, measuring the creatinine value, the pH value, and performing specific tests (oxidant test, sample check, synthetic urine) for interfering substances. The influence of substances interfering with urine sample analysis has been subject to intense scientific investigation. Both interfering substances that are supposed to produce a false negative result and those supposed to interfere with the analysis itself were considered in this. This study shows that only a few interfering substances have any significant effect on the GC-MS result. All of these can be detected by the manipulation tests applied.

Ru­ma Di­gi­tal-Sys­tem (for patients)

Hard­ware and technology
What are the requirements to my mobile phone in order to use the app Ruma Digital System?

The smart­pho­ne must have at least one 720P ca­me­ra (both front and rear ca­me­ra). At least An­dro­id 5.0 or iOS 12 must be in­stal­led as the ope­ra­ting sys­tem. En­su­re that the­re is enough free me­mo­ry space to re­cord a vi­deo.

Do I need an internet connection to use the app?

Yes, the app requires a stable internet connection.

I cannot scan the QR code on the marker box. What do I do now?

Check that you are using the cor­rect ca­me­ra: Plea­se use the rear ca­me­ra to scan the QR codes on mar­ker box and mar­ker con­tai­ner. Your smart­pho­ne ca­me­ra al­so may not meet the ne­cess­a­ry re­qui­re­ments. The smart­pho­ne must have at least one 720P ca­me­ra (both front and rear ca­me­ra). At least An­dro­id 5.0 or iOS 14 must be in­stal­led as the ope­ra­ting sys­tem. Ano­ther op­ti­on is that the QR code has be­en out­ward­ly da­ma­ged af­ter be­ing as­si­gned by the phy­si­ci­an and that the ca­me­ra does not re­cogni­se it as a re­sult. In eit­her ca­se, plea­se con­sult your phy­si­ci­an. They can eit­her as­sign you a new mar­ker or su­per­vi­se the in­ta­ke di­rect­ly in the phy­si­ci­an’s of­fice.

I do not have an internet connection. Can I record a video anyway?

No, you cannot. A stable and uninterrupted internet connection is necessary for recording the intake video with the app. The app will verify this before it begins.

My phone’s battery is not sufficiently charged. What can I do?

Please make sure that your phone is charged to at least 25%. Otherwise, the intake video cannot be recorded.

I cannot scan the QR codes and I cannot reach anybody in the office. What can I do?

Please try again later. Please contact your physician as soon as possible if the problem continues.

I have lost my mobile phone, or my mobile phone is defective. What do I do now?

You can easily reconnect to the physician’s tablet at their office with a new smartphone.

What does blockchain technology mean?

The Ruma app uses up-to-date blockchain technology for manipulation-proof data transmission between physician and patient. When a record (block) is generated it is encoded and added to a chain of records (blockchain). In this chain, each new record contains some information of the previous one. The complete history of this data chain can be traced back all the way to its origin. Individual data cannot be manipulated without changing the entire chain of data. Such changes are detected on the side of the software. Furthermore, all data are stored in a decentralized and failure-resistant manner on multiple servers.

Ru­ma Di­gi­tal-Sys­tem (for patients)

App, general
How do I pair my smartphone with the physician’s tablet?

You can only pair your smartphone with your physician’s tablet in the physician’s office. Select “Pair with physician” after starting the app. Then scan the QR code displayed on your physician’s tablet.

What function does the “Messages” button perform?

This function gives you an overview of the messages your physician has sent you in the app.

What do I need to consider when recording the video?

Make su­re that you re­cord the vi­deo at a free ta­ble whe­re nothing will ob­scu­re your ac­tions. Your fo­re­arms must be un­con­cea­led as well. Plea­se fol­low the in­st­ruc­tions in the ma­nu­al or the in­st­ruc­tion vi­deo.

How do I find out whether my marker intake has been assessed as completed correctly?

Only your attending physician can tell you whether your video was valid or not.

When is taking the marker considered to have failed?

Your video will be considered failed if any accident or a mistake not due to your fault occurs when you take the capsule.

When is a marker intake assessed as “manipulated”?

Your physician will assess your actions during the video-documented marker intake carefully. Any deviation from the prescribed procedure that conceals your actions may be assessed as a manipulation attempt.

I have changed physicians. How can my new physician watch my intake videos? Will they get access to my old videos?

You can easily link your smartphone to your new physician’s tablet. Your previous physician’s link will automatically be removed. Your new physician can then watch any newly recorded videos as usual but will not receive any access to your old videos.

Ru­ma Di­gi­tal-Sys­tem (for patients)

Data privacy
Will the intake videos be stored on my smartphone?

The videos are only temporarily stored on the smartphone for the duration of encryption, which takes about 3-4 seconds. They are thereafter removed once they have been sent to the physician.

Who can view my videos?

Only your attending physician will have access to your videos. Neither Ruma nor the laboratory or the physician’s staff can access your videos.

What happens to my data and where are they stored?

Your data are stored in the blockchain in encrypted form. They can only be viewed by your attending physician. Only your attending physician has access to your data. 

When will the data be deleted?

Your data will not be deleted. They will remain securely encrypted on the server.

Can I rewatch the video myself?

No, the video is encrypted at once after recording and deleted from the phone after it is sent.

Can the physician forward the video to other doctors?

No, they cannot.

Can I delete the video after recording it?

No, you cannot.

Can the physician delete videos I have taken?

No, you cannot.Nein.

How are the data encrypted and how secure is this encryption?

Patient data are encrypted using Advanced Encryption Standard (AES) 256. Videos are encrypted using AES 128.