Yes, but you have to buy two reagents additionally: Washing Solution bottle (250ml – concentrate), otherwise the amount of washing solution will be insufficient for the amount of tests – and Stop Solution (10ml): it is not possible to use the original bottle of Stop Solution for automatic processing due to its size.
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Frequently Asked Questions
Can I also use a reagent kit for manual processing (02-2001-00) for processing on the 9k?
Can I process FOX and ALEX2 tests together in one run?
No. Either ALEX2 or FOX arrays can be measured in one run. A combination of ALEX2 and FOX cartridges or reagents is prohibited.
Can I process FOX and ALEX² tests together in one run?
No. Either ALEX² or FOX arrays can be measured in one run. A combination of ALEX² and FOX cartridges or reagents is prohibited.
Can I use barcoded sample tubes in the MAX 45k?
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.
Can I use RAPTOR Server without internet connection?
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@macroarraydx.com.
Can I use the 50 array ALEX² kit (Art.nr.: 02-5001-01) for the manual processing system (ImageXplorer)?
No! The ALEX² kit (Article Number: 02-5001-01) is intended for the automated processing only.
Can I use the tubes with barcodes in the MAX 9k?
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.
Do I always have to run 50 samples in one assay run on the MAX 45k?
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.
Do I always have to start a run with 10 samples, or is it possible to run with fewer samples?
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/FOX Kit for the MAX 9k is 5.
Do I have to be present at a MAX 9k run? What happens if the Washing Solution or system water runs out during the run?
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.
Do I need to be present during an assay run of the MAX45k? What if the washing solution or the water container gets empty during the run?
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.
How do I activate the RAVEN interpretation guidance software?
Contact support@macroarraydx.com and you will receive a license key free of charge.
How do I generate customised Multiplex on Demand (MOD) allergen panels?
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.
How do I maintain the ImageXplorer?
The ImageXplorer is a sensitive imaging device and should be handled carefully. For accurate results, it is essential that the instrument be maintained 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.
How do I perform maintenance of the MAX 45k device?
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.
How do I prevent air in the washing solution tube and insufficient washing in the MAX?
Make sure all the tube connections and the washing solution dispenser needle is tight. After manipulation of the washing solution container or tubing, it is normal that air is present in the system. Residual air is normally removed during the initial priming after starting a run.
How long can I store processed arrays for re-analysis?
The arrays can be stored in the dark and dry for 4 weeks. After that, the signals become weaker and the background becomes higher.
I finished a run but I do not see the results on the New Measurements page on RAPTOR SERVER. How can I retrieve the results?
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.
I forgot my log-in details. What should I do?
Please write an e-mail to support@macroarraydx.com with the name of your tenant.
I have less than the recommended sample volume, can I still perform an ALEX² test with the manual processing system (ImageXplorer)?
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.
I have locked myself out of the RAPTOR Server account. How do I get back in?
Please contact support@macroarraydx.com.
ImageXplorer agent is not connected. What should I do?
Check your Image-Xplorer 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 an USB Power HUB with power connection to provide extra power to ImageXplorer
In our allergy lab, we often have only very small amounts of serum from pediatric samples. Can we still use these samples in the MAX 45k?
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@macroarraydx.com
In our allergy lab, we often have only very small amounts of serum from pediatric samples. Can we still use these samples in the MAX 9k?
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@macroarraydx.com
Is ALEX² certified according to IVD regulations?
Yes. ALEX² has been certified as a Class C IVD diagnostic device in accordance with EU IVDR guidelines.
Is the amount of 2% disinfectant solution used for monthly maintenance for 9k device the same as for MAX 45k?
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.
Is the application of the devices the same?
There are no differences in the application concept. Both are controlled via the RAPTOR SERVER software.
Is the duration of a run shorter on the MAX 9k than on the MAX 45k?
No, the duration of a run is always the same for both devices.
Is the MAX 45k device a certified CE medical device?
The MAX 45k is an In-Vitro Diagnostic device, and certified according to IVDR (Regulation (EU) 2017/46).
Is the MAX 9k device a certified CE medical device?
Yes, the MAX 9k is an In-Vitro Diagnostic device, certified according to IVDR (2017/746).
Is the monthly maintenance (cleaning) for the MAX 9k the same as for the MAX 45k?
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.
Is the RAPTOR Server GDPR compliant?
Yes, the RAPTOR Server is GDPR conform. For detailed information, please contact support@macroarraydx.com.
My sample barcodes could not be read. What could be the problem?
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.
Reasons for discrepant results between ALEX² and other in-vitro test systems and/or skin prick test (SPT)
As ALEX² is the only IgE testing system which blocks CCD specific antibodies, results from other in-vitro test systems could display falsely elevated results
Were the tests performed from the same blood drawing or from different time points?
Please check for sample mix-up (one of the most common reasons for discrepant results!)
SPT measures the reactivity of cutaneous mast cells, in-vitro systems measure free IgE
Comparison of extracts and molecular allergen test results is not recommended. Allergen extracts can lack allergens or can be contamined with non-related allergens (e.g. mite allergens in dog epithelia).
Differences can result from different isoforms of the molecular components. Molecular components can be produced naturally or recombinantly.
The test array run does not finish, what do I do?
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@macroarraydx.com
Unfortunately, my kit delivery is taking longer. Are the reagents and arrays stable even with longer delivery times?
Sure! The reagents and arrays can tolerate longer delivery times.
What are the basic requirements for installing a MAX 9k in my laboratory?
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.
What can be the reasons for QC failed?
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 array
Temperature during assay procedure was too low or too high (Optimum temperature: 20-26°C)
What happens if my Agent disconnects during a run, or I have internet problems during a 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.
What is the difference between the MAX 45k and 9k?
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.
What is the shelf life of ALEX²?
ALEX² 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.
What is the shelf life of FOX?
FOX has a shelf life of 2 years . We make every effort to only send kits that have a shelf life of at least 15 months. The reagents and the test are stable for 1 year after opening.
What kind of sample tubes can I use in the MAX 9k?
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).
What precautions do I need to take when moving an ImageXplorer to another location?
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 testarray run to be sure that the ImageXplorer settings are correctly adjusted.
What prerequisites do I need to have a MAX 45k installed in my laboratory?
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.
Where is the server located?
The server is located in Amsterdam.
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Any open questions - write us!