FAQs. |More information on systems, tests and service

General

What is <i>Magnetic Group Signaling (MGS)<sup>®</sup></i>?

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  

What is NMR?

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.

Is numares certified?

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

<i>AXINON<sup>®</sup></i> System</i>

What is <i>AXINON<sup>®</sup></i>?

AXINON® is a modular system that supports different tests for in vitro diagnostic (IVD) or research use.

The AXINON® Software supports the measurement of samples prepared using AXINON® reagents on a qualified NMR spectrometer. In conjunction with integrated test-specific software modules for in vitro diagnostic (IVD) or research use provided by numares HEALTH, the AXINON® Software enables the simple and parallel quantification of a variety of analytes which can support the diagnosis, prevention, monitoring or treatment of disease.

The AXINON® Software is intended for professional use only.

What method is <i>AXINON<sup>®</sup></i> based on?

AXINON® supports the analysis of human serum and urine samples using nuclear magnetic resonance spectroscopy (NMR).

What tests are available?

Currently the tests AXINON®lipoFIT®-S100 for the determination of lipoprotein subclasses in serum and AXINON® renalTX-SCORE®-U100 for renal allograft rejection diagnostics in urine are available. Numerous other tests are in development.

Can I install different tests on the system and process samples with new or other tests?

Yes, AXINON® is a platform solution that has been specially designed to simultaneously support different numares tests. As long as all test share the same requirements multiple tests can be executed on one sample. As long as a new test has the same or less requirements for the acquired data it is possible to reprocess already acquired data with a new numares test. For details contact the numares’ sales team.

How many personnel are required to operate <i>AXINON<sup>®</sup></i>?

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

Who can use <i>AXINON<sup>®</sup></i>?

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

How long does it take to prepare the sample?

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.

How long does it take to measure a sample?

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

How many samples can be measured daily?

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

What is the actual hands-on time per sample?

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.

What is the actual hands-on time using the software?

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

How time-consuming is it to operate the system?

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.

Which output formats are supported by <i>AXINON<sup>®</sup></i> to provide the results?

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

<i>AXINON<sup>&reg;</sup> lipoFIT<sup>&reg;</sup>-S100</i>

Why should lipoprotein subclasses be determined?

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.

What data are delivered by <i>AXINON<sup>®</sup></i> <i>lipoFIT<sup>®</sup></i><i>-S100</i>?

AXINON®lipoFIT®-S100 delivers 16 parameters from serum.

The data can be exported as to csv or pdf formats. If there is a LI(M)S connection, results are automatically delivered in csv format which can be customized to meet the needs of the respective LI(M)S

Must the patient fast prior to blood sampling?

Current standard recommendation for the test is fasting. 

What special rules apply for blood sampling? How should the samples be taken?

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®-S100.

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

What serum tubes should be used?

numares recommends the Sarstedt S-Monovette® serum tubes. Please note that BD Vacutainer® SSTTM tubes containing separating gel are not suitable for AXINON®lipoFIT®-S100.

Which blood collection systems are compatible with <i>AXINON<sup>®</sup></i> <i>lipoFIT<sup>®</sup></i><i>-S100</i>?

The S-Monovette® Serum (Sarstedt) has been tested and approved for use with AXINON®lipoFIT®-S100. Any other tubes must be approved.

What volume of sample is required for <i>AXINON<sup>®</sup></i> <i>lipoFIT<sup>®</sup></i><i>-S100</i>?

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

How should the samples be stored and transported?

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. Shipping on Dry-Ice is possible but not recommended.

What do I need to analyze samples with <i>lipoFIT<sup>®</sup></i><i>-S100</i> or different tests?

After the one-time installation of AXINON® System in which the AXINON® Software and AXINON®lipoFIT®-S100 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.

What is the reproducibility of <i>AXINON<sup>®</sup> lipoFIT<sup>®</sup></i><i>-S100</i>?

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.

Can I analyze serum samples from other species, for example mice, on <i>AXINON<sup>®</sup></i> <i>lipoFIT<sup>®</sup></i><i>-S100</i>?

AXINON®lipoFIT®-S100 has been validated for human serum only.

Installation

Would it be possible to install <i>AXINON<sup>®</sup></i> with an existing NMR device?

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.

Which specifications are required for installation of the <i>AXINON<sup>®</sup></i> System?

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 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.

What is the installation procedure?

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.

Maintenance

What maintenance resource is required?

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.

How does the system have to be maintained?

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.

Training

Will an NMR specialist be required to operate <i>AXINON<sup>®</sup></i>?

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.

What training is necessary to ensure safe and self-confident operation of the system?

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.

What type of training courses are offered by numares?

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

  • basics
  • advanced
  • specialist
  • maintenance

How are the training courses organized?

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

How long are the training sessions?

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.

Can several employees be registered on one training course?

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.

Spare parts

How could I order spare parts?

Please contact the technical support team of numares.

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

Will there be support for exchanging 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.

Technical support

How and when can I address my technical questions and requests?

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 (USA)).

Does numares offer service contracts?

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

Ordering

How and where can I order new supplies?

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

Who can I contact if I want to buy an <i>AXINON<sup>®</sup></i> system?

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.