Frequently Asked Questions

• ALEX²/ALEX³ is the only IgE test system that blocks CCD-specific antibodies. Therefore, the results of other in-vitro test systems may show false-positive results.
• Make sure that the tests were carried out from the same blood sample.
• Please check for sample mix-up (one of the most common reasons for discrepant results!).
• SPT measures cutaneous mast cell reactivity, in-vitro systems measure free IgE.
• Comparison of extract and molecular allergy test results is not recommended. Allergens may be absent from allergen extracts or contaminated with unrelated allergens (e.g. mite allergens in dog epithelia).
• Differences may result from different isoforms of the molecular components. Molecular components can be produced naturally or recombinantly.

Yes, but at your own risk. The minimum sample volume for a manual assay is 100 µl. As a consequence false negative results could be possible.

No! The ALEX²/ALEX³ kit (REF: 02-5001-01) is intended for the automated processing only.

• Background too high or too low

• Guide dots not aligned with grid

• Guide dot results too low

Corrective actions:

• Make sure washing steps are followed precisely

• Make sure substrate incubation time was not too long or too short

• Run test array again and re-analyse respective ALEX²/ALEX³ array

• Temperature during assay procedure was too low or too high (Permissible temperature: 20-26°C)

The arrays can be stored in the dark and dry for 4 weeks. After that, the signals become weaker and the background becomes higher.

ALEX²/ALEX³ has a shelf life of 2 years. We make every effort to only send kits that have a shelf life of at least 18 months. The reagents and the test are stable for 6 months after opening.

Yes. ALEX²/ALEX³ has been certified as a Class C IVD diagnostic device in accordance with Regulation (EU) 2017/746 (“IVDR”).

The Food Xplorer (FOX) is an ELISA (Enzyme-Linked Immunosorbent Assay) based multiplex in vitro test for the semi-quantitative determination of food-specific IgG antibodies. These antibodies serve as an indicator of the body’s humoral immune response. Using macroarray technology, up to 286 food antigens can be analysed simultaneously.

FOX supports the analysis of IgG-mediated reactions to foods and can help experts in the field of nutritional medicine to plan and monitor individual dietary or elimination strategies. Test results should always be interpreted in the context of clinical symptoms.

FOX combines the ELISA (Enzyme-Linked Immunosorbent Assay) detection method with macroarray technology. Food antigens are immobilised on a solid phase, which enables the simultaneous analysis of numerous food-specific IgG antibodies from a single sample.

FOX analyses the IgG response to up to 286 food antigens from various food groups, including:

• Dairy products & eggs
• Meat & fish
• Fruit & vegetables
• Cereals & seeds
• Nuts & legumes
• Herbs & spices
• Novel foods (e.g. aloe, chlorella, guarana, etc.)

You can find the full list of antigens here.

FOX is validated for serum and plasma samples from venous or capillary blood.

A test run takes approximately 3.5 hours, excluding the drying time for the arrays.

The results are analysed automatically and reported semi-quantitatively in µg/ml and in the following IgG classes:

• Negative
• Low
• Moderate
• Significantly elevated

FOX measures food-specific IgG concentrations in the range of 5.0 to 50.0 µg/ml.

No, before making any changes to your diet or starting an elimination diet, the results should always be discussed with a doctor or a specialist in nutritional medicine. Furthermore, you should under no circumstances cut out all trigger foods at the same time, in order to prevent malnutrition.

No. FOX is not intended for the diagnosis of IgE-mediated allergies. The test measures food-specific IgG antibodies and the results should always be interpreted within the overall clinical context. The Allergy Xplorer (ALEX) is available for the diagnosis of IgE-mediated allergies.

The symptoms of an IgG-mediated food reaction usually occur with a time lag of 2 to 72 hours after consuming the food in question. The following symptoms, amongst others, may be associated with this:

• Gastrointestinal symptoms
• Joint pain
• Migraines or headaches
• Fatigue
• Skin-related symptoms, such as dry patches and redness

The analysis is carried out digitally using the RAPTOR Server Analysis Software in combination with the manual ImageXplorer or the automated MAX instruments.

Yes. FOX supports both manual and automated workflows and is compatible with the ImageXplorer, MAX 9k or MAX 45k.

Yes. FOX has built-in quality controls for the automated verification of array orientation, signal quality and background assessment. In addition, the images taken should be checked for possible artefacts or irregularities by trained specialist staff before the results are approved.

Yes. FOX is a CE-marked in vitro diagnostic test.

Array technology enables the parallel analysis of many food antigens using a small sample volume (10/12 µl) and facilitates efficient laboratory work, as staff can be trained quickly and easily to use the test system.

Yes. The FOX test panel also includes modern and novel foods such as:

• Edible insects
• Chia seeds
• Spirulina
• Wakame
• Aloe
• Guarana
• Safflower oil

FOX and its components can be stored at 2–8 °C until the stated expiry date. Opened reagents and opened FOX blister packs remain stable for 6 months provided the recommended storage conditions are observed. The product is shipped at ambient temperature, but must be stored at 2–8 °C immediately upon receipt.

No, FOX is not a self-test. The test was developed to provide experts in nutritional medicine with additional information for the diagnosis of nutrition-related symptoms. Performing the test requires specialised laboratory equipment and can therefore only be carried out in a suitably equipped laboratory.

FOX (Food Xplorer) is currently available as a kit containing 50 arrays. The kit enables the analysis of up to 286 food antigens in a single test run and is suitable for both manual and automated workflows using the MADx MAX systems.

Further information can be found here.

The information provided on this website is for general information purposes only and is based on the currently valid Instructions for Use (IFU) for the FOX Food Xplorer. It is not a substitute for the full Instructions for Use (IFU) nor for professional medical advice, diagnosis or treatment decisions. For detailed information on intended use, test procedure, sample material, performance parameters, limitations, warnings and regulatory requirements, always refer to the currently valid IFU.

Test results must only be interpreted by qualified professionals and always in the context of the patient’s overall clinical situation. Before commencing an elimination diet based on FOX results, these should be discussed with a doctor or a specialist in nutritional medicine.

Abbreviations:

• ALEX: Allergy Xplorer
• ELISA: Enzyme-Linked Immunosorbent Assay
• FOX: Food Xplorer
• IFU: Instructions for Use
• IgE: Immunoglobulin E
• IgG: Immunoglobulin G, µg/ml: micrograms per millilitre

Make sure all the tube connections and the washing solution dispenser needle are tight. After manipulation of the washing solution container or tubing, it is normal that air is present in the instrument. Residual air is normally removed during the initial priming after starting a run.

No. Either ALEX²/ALEX³ or FOX arrays can be measured in one run. A combination of ALEX²/ALEX³ and FOX cartridges or reagents is prohibited.

If you lost connectivity at the end of your run, your results might not have been uploaded to RAPTOR SERVER. If you re-establish your connection, and initialize the MAX 45k again, you will see the message „Missing results detected“ in the status bar of your Automate. If you click on it, you will get to the run logs where you can synchronize the results of the particular run.

Once a run has been started, the connectivity of the Agent Software does not affect the control of the MAX 45k. Your run will finish independently from the connection availability. However, your results might not be uploaded to Raptor Server.

The MAX 45k is available to be used with low-volume tubes, where the minimum required sample volume is only 200 µl. You can reduce the minimum sample volume even further if you manually predilute the samples before you put the tubes into the instrument. Please consult the technical specifications in the Instructions for Use for the applicable tube types and required volumes. Before using any special tube, contact support@madx.com

No, you can freely choose the amount of samples you want to include in an assay run. However, please note that the maximum number of assay runs per kit (50 tests) is 4.

No, the MAX 45k is a true “walk away” analyzer: The necessary amount of reagents, washing solution and rinse water is calculated during the preparation phase of your assay run. After the test run has been started, no further interference or monitoring by the user is necessary.

The MAX 45k requires a space of at least 160cm width, 120cm height, and 80cm depth.

For the operation of the MAX 45k, a steady LAN connection to a PC with internet access is necessary. Therefore, your laboratory needs a PC with two separate network adapters: one for a stable Internet connection (LAN or WIFI), and one which connects the PC with the MAX 45k instrument via a LAN cable. The PC needs to have admin rights, and the website https://Raptor-Server.com must be allowed to be accessed from your lab network. Please note that the MAX 45k is only to be installed by MADx or its distributor.

The MAX 45k is an In-Vitro Diagnostic device and certified according to Regulation (EU) 2017/746 ("IVDR").

A monthly maintenance routine is necessary to ensure proper long-time operation of the device. Monthly maintenance shall be performed by the lab user following the instructions on Raptor Server. Consult the Instruction for Use for more details about maintenance.

Yes, the MAX 45k is equipped with a sample barcode reader, which supports barcode types code128, code39, ean8, codabar, code25. Please consult the Instruction for Use for more information.

Please ensure that your barcodes are printed in the right quality, and they face outwards of the rotor. Please consult the Instruction for Use for the applicable types and dimensions of sample barcodes.

Yes, but you have to buy two reagents additionally: Washing Solution 4x conc.(REF: 00-5003-01), otherwise the amount of washing solution will be insufficient for the amount of tests – and Stop Solution (REF: 00-5007-01): it is not possible to use the original bottle of Stop Solution for automatic processing due to its size.

The major difference between these two devices is the number of tests that can be performed in one run. With the MAX 9k there is a maximum of 10 samples per run. More detailed information you can find in the IFU of the MAX devices under the respective product page.

The procedure of monthly cleaning for both devices is basically the same. The monthly maintenance should be performed by the lab user following the instructions on RAPTOR SERVER platform. Consult the Instruction for Use for more details about maintenance.

No, for system water and waste containers of MAX 9k the volume of 2% disinfectant solution should be 1 liter (1l demineralized water + 20ml of Terralin® Protect or Microcide SQ).

For MAX 45k – 2 l (2l demineralized water + 40ml of Terralin® Protect or Microcide SQ).

For washing solution container - the same.

There are no differences in the application concept. Both devices are controlled via the RAPTOR SERVER software.

No, the duration of a run is always the same on both devices.

The MAX 9k requires a space of at least 120 cm width, 100 cm height, and 60 cm depth. For the operation of the MAX 9k, a steady LAN connection to a PC with internet access is necessary. Therefore, your laboratory needs a PC with two separate network adapters: one for a stable Internet connection (LAN or WLAN), and one which connects the PC with the MAX 9k instrument via a LAN cable.

No. Either ALEX²/ALEX³ or FOX arrays can be measured in one run. A combination of ALEX²/ALEX³ and FOX cartridges or reagents is prohibited.

The MAX 9k is available to be used with low-volume tubes, where the minimum required sample volume is only 200 µl. You can reduce the minimum sample volume even further if you manually predilute the samples before you put the tubes into the instrument. Please consult the technical specifications in the Instructions for Use for the applicable tube types and required volumes. Before using any special tube, contact support@madx.com.

No, you are free to choose the number of samples you want to run in one assay run. However, please note that the maximum number of assay runs per ALEX²/ALEX³/FOX Kit for the MAX 9k is 5.

No, like the MAX 45k, the MAX 9k is a “walk away” analyzer: the required amount of reagents, washing solution and system water is calculated during the setup phase of your test run. After the start of the test run, no further interventions or monitoring by the user are necessary.

Yes, the MAX 9k is an In-Vitro Diagnostic device, certified according to Regulation (EU) 2017/746 ("IVDR").

Yes, the MAX 9k is equipped with a sample barcode reader, which supports barcode types like code128, code39, ean8, codabar and code25. Please refer to the Instructions For Use for more information.

Only Sample tubes with a nominal height of 75mm and a nominal outer diameter of 13mm. For example: Sarstedt tubes 5 ml, 75x13 mm (Order number: 55.475) or Sarstedt false-bottom tubes 2.5 ml, 75x13 mm (Order number: 60.614.010).

Please take out the carriage before moving the ImageXplorer to another location to avoid carriage sliding into the chassis. After the movement, please perform a ConfigXplorer run to be sure that the ImageXplorer settings are correctly adjusted.

The ImageXplorer is a sensitive imaging device and should be handled carefully. For accurate results, it is essential that the instrument be maintained in a dust-free state as much as possible. To this end, the external ImageXplorer housing must be regularly cleaned with a lint-free cloth. Do not use any detergents for cleaning. The carriage which holds the cartridges can be separately cleaned if necessary, using mild detergents or alcoholic solutions. Please do not open the chassis.

• If the error code shows disconnected, then check the quality of internet connection

• Check USB connection PC/Laptop and try to connect the ImageXplorer using different USB ports

• If the problem persists, contact support@madx.com

The server is located in EU West and EU North.

Yes, the RAPTOR Server is GDPR conform. For detailed information, please contact support@madx.com.

Please write an e-mail to support@madx.com with the name of your tenant.

Please contact support@macroarraydx.com.

• Check your ImageXplorer key in the RAPTOR SERVER account

• Check your internet connection

• Check USB connection to PC/Laptop and maybe try to use a different USB port

• Restart RAPTOR agent

• Restart PC/Laptop

• Use a USB Power HUB with power connection to provide extra power to ImageXplorer

• Yes, but cost is higher, and functionality limited (e.g. no RAVEN comments available, limited support, no automatic updates).

• For tailor made solutions please contact support@madx.com.

Contact support@madx.com and you will receive a license key free of charge.

In your Tenant Admin Area you can create customized MOD panels by selecting "manage MOD" --> "create new panel". You will find detailed information in our RAPTOR SERVER IFU.

Sure! The reagents and arrays can tolerate longer delivery times.