FAQs. |More information on systems, tests and service

Magnet Group Signaling (MGS^®) is the core of the AXINON^® System. MGS^® enables AXINON^® to reproducibly elucidate metabolite constellations from a NMR (nuclear magnetic resonance spectroscopy) spectrum and thus allows a new dimension of NMR use for diagnostic purpose. 

• Standardized algorithms based on Artificial Intelligence (AI)
• Reproducible multi-variable signal fitting
• Quantitative multi-signal interpretation
• Validated extraction of even interfered information from NMR-spectra
• Sophisticated SCORE calculation  

Nuclear magnetic resonance (NMR), is a physical phenomenon which occurs when an atomic nucleus is placed in a very strong magnetic field. The resulting signal is defined by the type and number of surrounding nuclei as well as from the electron shell. NMR is utilized in medicine and several scientific and technical fields of application.

NMR spectroscopy is widely used in, but not limited to, the field of biomedical research. On the one hand it is used to elucidate the structure and dynamics of nucleic acids, amino acids, peptides and proteins as well as to decipher their interaction with active ingredients. Structure elucidation by NMR can be done directly in solution - in contrast to X-ray structural analysis.

High-resolution NMR spectroscopy is also a key technology in the field of metabolomics/metabonomics research. The metabonomics approach uses the entirety of metabolites to draw conclusions about physiological or pathophysiological metabolic states.

Many complex questions in various biological systems can be answered using this approach. To date, metabolomics has mainly been used in research. In the future this powerful methodology and therefore NMR spectroscopy is bound to find wider application, particularly in laboratory diagnostics.

In the field of laboratory diagnostics, NMR techniques are being used increasingly successfully to determine the concentrations of metabolic products (metabolites) in body fluids such as plasma, serum or urine.

numares is certified as a manufacturer of in vitro diagnostic medical devices according to EN ISO 13485: 2016.

The proprietary AXINON^®System  - now with FDA clearance - incorporates diagnostic testing algorithms into nuclear magnetic resonance (NMR) spectroscopy. We use this technology to develop diagnostic tests for chronic heart, kidney and liver diseases. 

The AXINON^® System is the first modular software-based system for clinical diagnostics, providing hardware, operating system, Magnetic Group Signaling (MGS^®) processor and individual test applications. It provides the framework for analyzing serum samples using nuclear magnetic resonance (NMR) spectroscopy.

Here's what it does:

The US Food and Drug Administration has cleared the AXINON^®LDL-p Test System, as a new tool physicians can use to measure lipoproteins for patients at risk for cardiovascular disease. Currently, Numares is the only company in the US selling an FDA-cleared NMR test.

The FDA clearance also includes the company’s core technology platform, the proprietary AXINON^®System, that incorporates diagnostic testing algorithms into nuclear magnetic resonance (NMR) spectroscopy. Numares uses this technology to develop diagnostic tests for chronic heart, kidney and liver diseases. This FDA clearance of the AXINON^® technology provides a pathway for more rapid FDA clearance of other tests currently in development.

A second Numares assay is expected to gain FDA 510(k) clearance later this year, the AXINON^® GFR(NMR) kidney function assay.

In the EU, the AXINON^®lipoFIT^®-S100 measuring lipoprotein subclasses in serum and AXINON^® renalTX-SCORE^®-U100 determining renal allograft rejection from a urine sampleare available.

Numerous other tests are in development.

Yes. The FDA-cleared AXINON^® System is a platform that simultaneously supports various Numares diagnostic tests. If all tests have the same requirements, you can run multiple tests on one sample, and also reprocess samples for different Numares tests. For details contact our sales team.

In the daily routine, AXINON^® can be operated by a single person. Only for parts of the maintenance a second person is required.

Each trained laboratory employee can operate the system. Previous knowledge in the field of NMR spectroscopy is not required.

With manual pipetting, sample preparation takes about 45 minutes for about 100 serum samples. Preparation of Urine Samples may take longer as an additional centrifugation step is necessary. Thanks to the 96 tube format of the racks, liquid handling can be easily automated.

The measurement time of an analytical sample takes, depending on the specimen type, test and device, 2 to 3 minutes.

At full capacity, more than 300 serum samples can be measured within 24 hours with the AXINON^®lipoFIT^®-S100 test. Other tests or combinations of tests may have a lower or higher throughput.

With manual sample preparation, the hands-on time is approximately half a minute per serum sample. Urine samples may take longer due to an additional centrifugation step.

The operation of the software requires only about 2 minutes per analytical run (up to 93 analytical samples).

AXINON^® is very easy to use and requires only a few operator interactions. The system is designed for minimal hands-on time and maximum walk-away time. At full loading of the sample changer, up to 465 samples can be measured without the user having to interact with the test system. Even at full capacity for the AXINON^® lipoFIT^®-S100 of about 300 samples a day, the operator need only spend 15 minutes interacting with the device and software. Manual pipetting requires approximately 2.5 h for sample preparation.

The software automatically creates a csv result file. Moreover, the results can be exported to a PDF report in or printed directly.

In recent years, there has been increasing evidence that not only the cholesterol itself, but also its "packaging" in lipoprotein particles is critical to the risk of cardiovascular disease. It has been shown, that especially small LDL particles with higher density, so-called small dense LDL (sdLDL), are associated with an increased risk [1]. Thus, a more accurate picture of lipoproteins would help to uncover an otherwise undetected cardiovascular risk and countermeasures could be introduced in good time, e.g. through a change in lifestyle or medication.

[1] Krauss, RM, lipoprotein subfractions and cardiovascular disease risk. Curr Opin Lipidol, 2010. 21 (4): 305-11.

Current standard recommendation for the test is fasting. 

Blood samples should be collected aseptically by qualified personnel using approved blood sampling techniques [1]. numares recommends the S-Monovette® blood serum collection tubes made by Sarstedt. Please note that BD Vacutainer^® SSTTM tubes containing separating gel are not suitable for AXINON^® lipoFIT^®.

[1] H.-P. Seelig, T. Schmidt-Wieland et al, Pre-analysis -. Acceptance and transportation of samples. 2011.

numares recommends the Sarstedt S-Monovette^® serum tubes. Please note that BD Vacutainer^® SSTTM tubes containing separating gel are not suitable for AXINON^® lipoFIT^®

The S-Monovette^® Serum (Sarstedt) has been tested and approved for use with AXINON^®lipoFIT^® . Any other tubes must be approved.

A minimum of 700 μl of serum or urine is required for the analysis.

Serum specimens should be stored as follows:

•  2-8°C: up to 4 hours
• -20°C and below: up to one month
• -70°C and below: extended storage

Please avoid repeated freezing and thawing. Specimens are to be shipped frozen at -10°C to -30°C. 

After the one-time installation of AXINON^® System in which the AXINON^® Software and AXINON^®lipoFIT^® software are installed on a standard PC and a suitable 600 MHz NMR device is connected, you only need the AXINON^® serum kit and NMR tubes from numares for sample preparation. For Urine Samples a Centrifuge capable of 10.000*g for 10 min at room temperature is needed. All measurement data is saved in a local or network instance of a Microsoft SQL Database.

Precision measurements were conducted according to an internal protocol on the basis of guideline CLSI EP5-A2 (1). Reproducibility was assessed at three study sites. Repeatability (within-run imprecision), intermediate precision (between-runs and between-days imprecision) and reproducibility (between-sites imprecision) were determined in serum pools at three concentrations.

Depending on the respective parameter, coefficients of variation ranged below 4.5% (within-run), below 4.9% (between-run), below 4.0% (between-day) and below 5.1% (between-site). The mean total imprecision between 3 different systems was 3.7%, demonstrating an overall excellent precision.

(1) CLSI. Evaluation of Precision Performance of Quantitative Measurement Procedures; Approved Guideline-Second Edition. CLSI document EP5-A2. Clinical And Laboratory Standards Institute; 2004.

AXINON^®lipoFIT^® has been validated for human serum only.

To upgrade an existing NMR device with the AXINON^® System the following specifications have to be met:

• BRUKER NMR device (600 MHz) with shim and damping system
• AVANCE II+/III (HD)/NEO console with 2 frequency channels, 2 H lock channel and temperature control unit
• Triple resonance 5 mm room temperature probe with an inverse configuration and 1H and 13C channel. A 2H lock, z-gradient and automatic tune and match unit is required
• TopSpin 3.2pl2 or higher including automation software (IconNMR)
• SampleJet sample changer for up to 480 5mm NMR tubes in racks of 96 samples with temperature control unit

If your existing NMR device does not fulfill the specifications mentioned above, the compatibility has to be checked individually.

For more requirements, please contact the numares sales team.

The following specifications are required to install one AXINON^® System within your lab:

• room size > 3x3m - ceiling height > 3.15m
• floor loading capacity > 1500 kg
• absence of magnetic environment (e.g. fire-extinguisher)
• compressed air supply
• room air conditioning capable of keeping the room temperature within +- 0.5°C
• oxygen level sensor
• fire detection system

Additionally the lab environment should be free of vibrations.

For more details, please contact the numares sales team.

If you are interested in an AXINON^® System, we will initially send someone to conduct site planning inside your lab. If your lab meets the required specifications and you decide to have an AXINON^® System, the technical service department will start planning installation.

That means: ordering the NMR device from the manufacturer, and preparing the installation schedule in conjunction with you and the manufacturer. The time between receipt of the order and delivery of the device can vary but is approximately 6 months. We will keep you updated regularly.

When the device is delivered to your site, it is the manufacturer who will initially be responsible for setting up the magnet. After about 2.5 weeks, the device will be taken over by our service specialist. Within a further 3 weeks the analytical platform as well as the test software will be installed and the system will be completely qualified.

After successful qualification the device including all qualification documents will be handed over to you. In addition, you will receive comprehensive initial and maintenance training to ensure self-confident usage of your new system.

The maintenance resource is manageable und requires:

• about 15 minutes per day
• about 2-2.5 hours per week
• additional 2-2.5 hours per month
• additional 2 hours quarterly.

For appropriate operation of the system, the NMR magnet has to be filled regularly with liquid nitrogen and liquid helium.

Additionally, numares recommends continuous checks of spectra quality and specifications using standard measurements. A few minor checks should be done routinely.

When the system is installed, numares provides a maintenance guide including detailed instructions on how to perform the required maintenance tasks.

The AXINON^® system is an easy-to-use-system with very few steps. There is no need for an NMR specialist.

All you need to know to use and operate the system will be taught to you at the outset and in follow-up training sessions by our technical support team.

During the installation process, numares provides comprehensive training on the entire system. Software handling, NMR basics, maintenance as well as basic troubleshooting are part of this training.

If additional training is required, numares can offer this. Please contact the numares sales team.

numares offers, besides the initial training, the following training options:

• basics
• advanced
• specialist
• maintenance

In general, each training course consists of two parts: a theoretical part as well as a practical part where knowledge learned is applied.

Initial training after installation as well as further training courses are approximately one week each.

Customized (e.g. shortened or extended) training sessions are possible after mutual agreement.

Of course several employees may be registered on one training course.

Please note, every course is limited to 5 participants to provide sufficient practical training.

Please contact the technical support team of numares.

Our associates will contact you promptly and organize the delivery of spare parts.

Of course. The technical support team of numares will support you in exchanging spare parts.

numares will provide detailed instructions and phone support for simple exchanges, which can be performed by yourself.

For complex exchanges, on-site repair visits are carried out by a specialist.

In the case of a hardware exchange or a firmware upgrade a member of our technical service department will be on site to ensure functionality by performing qualification tests.

Please do not hesitate to contact us via email or via phone at +49 941 280 949-49 (Europe) or +1 833-numares (US). Our technical support team will process your requests during general office hours (working days 9 am until 5 pm both CET (Europe) and EST (U.S.)).

numares offers service contracts. Please contact our numares sales team for more information.

To order new consumables, please contact the numares sales team.

If you are interested in purchasing an AXINON^® System, please send your request to the numares sales team.

A numares representative will contact you promptly.