The application of the Ruma® Marker-System using the example of the liquid marker Ruma® Classic
The Ruma Marker-System offers maximum safety and protection against manipulation attempts in urine testing.
Manipulation attempts in urine testing are a common problem. There are numerous ways to try and achieve a false-negative result.
The Ruma Marker-System addresses this problem and ensures that the urine sample to be tested originates from the right person and is available in the appropriate quality.
The practical application is simple and can be integrated easily into the existing routines. The key to our success lies in our quality controlled pre-analytical procedures and precise laboratory analysis in accordance with state-of-the-art science and technology.
Ruma® Digital System and Ruma® Digital System Pro
The unbeatable app team for location independent urine testing.
Combine the reliability of the Ruma® Marker-System with the mobility of the digital world.
The benefits for all parties involved are obvious:
- Scientific reliability instead of guesswork during direct observation
- Conclusive and comprehensive results provide certainty and reliability
- Verified integrity of the sample instead of just excluding sample substitution
- Physician-patient relations are not compromized by degrading direct observation
- Reduced time requirements and streamlined practice operations
- No additional personnel expenses due to same-sex escort to the bathroom
No other procedure offers these advantages.
The Ruma Markers we use are polyethylene glycols – also called macrogols – which only pass through the body due to their specific properties and are excreted unchanged through the urinary bladder. We use this complete lack of effect to mark the patient's urine sample without any risk or possible interaction with other substances and thus to prove the identity of the urine donor.
At present, we use 6 different marker substances that present very distinct analytical results. As neither the patient nor the physician are aware which marker is administered in any given situation, the swapping of already marked urine samples is also easily detectable.
Under normal circumstances the marker requires 30 minutes to reach the bladder naturally. In rare cases, 1:250,000, a slightly longer waiting period is required for delayed urination.
Because this distinction made some of our users uncertain as to when the longer waiting period should apply, we set the waiting period between Marker intake and sample collection to 40 Minutes for all patients. It is our hope that this slight adjustment will make the Marker-System even more user friendly.
Hence, 40 Minutes is the minimum time that must elapse untill submission of the urine sample. Longer waiting periods, even several hours, are also possible. The lab just requires the first urine after marker intake.
Click here to learn more about the scientific background.
Clinical application of the urine marker solution
Mix the marker substance with a beverage sweetened with regular household sugar and have the patient drink the mix right in front of you. The patient can collect the sample on their own after at least 40 minutes.
The collected urine sample is then prepared for transport to one of our authorized partner labs. You will receive the results through electronic communication or by fax.
Sample collection for forensic purposes must meet specific requirements. Please request our designated Sample Collection Protocol for Forensic Purposes in these instances.
Convenient - Clean - No-fuss
All the advantages of the tried and tested Ruma® Marker-System in a new form
We developed the capsule as an alternative administration form for the well-known Ruma® marker substances. In addtion to the established PEGs it containes the colorant Brilliant Blue. If the capsule remains in the mouth too long, e.g. for the purpose of manipulation, it dissolves and releases the dye: the mouth cavity turns blue. This makes oral cavity checking much easier and there's no need to add sugar as is done with the liquid markers.
Brilliant Blue is a harmless food additive that is used in many products such as cakes, ice cream but also mouthwasch and gel toothpaste. The colorant is excreted without being digested and it does not have any effect on the color of urine.
Dedicated to this new field of application, we developed a new form of administration for the tried and tested Ruma Markers - the Ruma Capsule!
Clean, easy to apply, and ready to use without further preparation.
Multilayered security features on secondary and primay packaging are verified by the app to protect against substitution of the individually marked capsule.
To do so, we are using the guidelines and recommendations of the EU Falsified Medicines Directive 2011/62/EU in order to integrate the Ruma Marker-System even more smoothly into the health care system.
The capsule itself contains, in addition to the marker substances themselves ,a blue dye that performs the job of the sugar with the liquid markers: the capsule dissolves in the mouth if not swallowed in a timely manner, releasing the dye and coloring the oral cavity blue. This way, attempts to not actually swallow the capsule become immediately and reliably visible.
Wir haben die neue Darreichungsform wissenschaftlich überprüfen lassen. Die Studie zur Ausscheidungskinetik belegt, dass auch hier die Marker zu 100% im Labor detektiert werden. Die Wartezeit bis zur Abgabe der Urinprobe beträgt für die Kapsel 60 Minuten.
Die vollständigen Studienergebnisse können Sie hier herunterladen. We had the new form of administration tested in a scientific study. This study on excretion kinetics demonstrates that this form as well has a laboratory detection rate of 100%. Using the capsule the waiting period until the urine sample can be collected is 60 minutes.
You can download the complete results of the study here.
Convenient and Location-Independent
Whether at home or on the go - App and capsule can be used any time. In total privacy. Visiting your health care provider is only necessary to create the initial link between sample collector and sample donor.
Short introduction into the correct application of the Ruma® Marker Capsule in the medical office/institution
The Marker Analysis determines whether the urine sample contains the administered marker and whether it is present in sufficient quantity. Complete absence of the marker is an indication of sample substitution. Very little marke volume suggests dilution. This applies to dilution with “clean” urine as well.
The Ruma Marker-System is more than just the search for the administered marker. We use 4 pillars to test the urine samples for manipulation from all perspectives:
- Marker analysis
- Creatinine analysis
- Glucose analysis
- Sample integrity analysis
Urine samples are often subject to various manipulation attempts. This is a well-known and often bemoaned problem.
That's why scientific research has been looking for quite some time for an alternative that might be less susceptible to such manipulations. Below we would like to show why urine is still the matrix of choice by investigating two such alternatives:
Much more pressing in the current situation, however, is the question how the risk of infection during collection of urine samples can be minimized.
Numerous addiction treatment facilities are already closed, and it has become a challenge to ensure health care for patients in MAT. Because addiction patients face an extreme risk due to comorbidities.
In order to alleviate the pressure treatment facilities are facing, take home is used as an alternative. This is where the app package Ruma® Digital System and Ruma® Digital System Pro can help to keep communication between doctor and patient in tact. It allows location independent urine testing and reduces the number of necessary visits to the medical office.
FAQ - Answers to Frequently Asked Questions
We are often asked about the Ruma Marker-System and its practical application. Below please find answers to relevant questions that were posed in the past. We hope they also contribute to a better understanding of our procedure.
Please don't hesitate to contact us should you have any questions that are not answered below.