The approach comprises
- a unique calibrator system
- an automated and standardized measurement and data analysis process
- internal quality controls
- and many other actions.
This overcomes individual spectrometer variability and other contributors to variation to achieve reproducible results even on different devices.
Nuclear magnetic resonance (NMR), is a physical phenomenon based on the magnetic interaction of atomic nuclei with each other, with the electron shell of the molecule and with external magnetic fields. NMR is utilized in medicine and several scientific and technical fields of application.
NMR spectroscopy is widely used in 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.
A PDF document with further background information can be found here (german version only).
numares is certified as a manufacturer of in vitro diagnostic medical devices according to EN ISO 13485: 2016.
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.
AXINON® supports the analysis of human samples using nuclear magnetic resonance spectroscopy (NMR).
Yes, AXINON® is a platform solution that has been specially designed to simultaneously support different tests.
In the daily routine, AXINON® can be operated by a single person. Only for maintenance is a second person 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 samples. 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, a few minutes.
At full capacity, more than 300 serum samples can be measured within 24 hours.
With manual sample preparation, the hands-on time is approximately half a minute per sample.
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 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 result file. Moreover, the results can be exported to Excel format, saved as a report in PDF format 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 .
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.
The patient does not necessarily have to fast prior to blood sampling. However, for better comparability of blood fats, it is recommended to use fasting samples.
Blood samples should be collected aseptically by qualified personnel using approved blood sampling techniques . 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 lipoFIT®.
 H.-P. Seelig, T. Schmidt-Wieland et al, Pre-analysis -. Acceptance & 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 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 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.
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.
To upgrade an existing NMR device with the AXINON® system the following specifications have to be met:
- BRUKER NMR device (600 MHz or 400 MHz) with shim and damping system
- AVANCE II+/III (HD) console with 2 frequency channels, 2 H lock channel and temperature control unit
- Triple resonance probe with 2H lock, z-gradient and automatic tune and match unit
- 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 the 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
- oxygen level sensor
- fire detection system
Additionally the lab environment should be free of vibrations.
For more details, please contact the numares sales team.
It 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.
numares offers, besides the initial training, the following training options:
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.
Within the demo lab you are allowed to test the AXINON® system and associated tests. You can bring your samples and test out the system for yourself. Additionally, you could send us samples, which our service department will process for you.
Of course. We would like to give you access to our demonstration laboratory and welcome you to a product demonstration. Please make an appointment with our sales department.
Please contact our sales department which will take care of your request and is in charge of scheduling. Depending on sample loads and lab capacity processing time could differ. Of course, we will handle your request as fast as possible.
Unfortunately, numares does not offer analysis of private blood samples.
Please contact our sales department, they will be pleased to assist you in finding a medical laboratory using the AXINON® system.
Please contact the technical support of numares.
Our associates will contact you promptly and organize the delivery of spare parts.
Of course. The technical service 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.
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.
Please do not hesitate to contact us via email or via phone at +49 941 280 949-49. Our technical support team will process your requests during general office hours (working days 9 am until 5 pm).
numares offers service contracts. Please contact our sales department for more information.