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Step 2 | Test Calibration

1. Download and install Dx Studio

The software applications need to interact with Igloo in order to process the obtained data.

Install Dx Studio on your computer or laptop.

The download link is https://support.Igloo.today/dxstudio. You can also find it at the bottom of

the device and on the device’s packaging.

Dx Studio is available for Windows and MacOS. 

2. Before you begin

Prepare a work area for your Igloo.

Place Igloo on a flat surface away from any liquids as they could damage the device.

The work area should have enough free space to be able to easily insert and eject the test

cassette adapter (cartridge).

For the initial startup, launch Dx Studio and connect your Igloo to your computer via the

supplied USB-C cable. 

To turn Igloo on, press the button on the bottom of the device.


You can now start working with your Igloo.



Launch Dx Studio.

Select Laboratory mode.

The Laboratory mode is intended for calibration, cv (coefficient of variation) and clinical studies.

Click New project.

The application will prompt you to connect the device unless it is already connected.

Dx Studio and Igloo will connect automatically, as signaled by the device indicator flaring.

Before starting the calibration, make sure that you have prepared test cassettes with different

known concentrations.Fill in Laboratory Project. Specify the test information: Test name, LOT number, REF number,

Vendor and Expiration date. Choose a folder on your computer to save the project.

The application will open Cartridge profile. Follow the application prompts.

Place one test cassette into the cassette adapter with the test strip facing up and insert them

together into the device slot according to the adapter direction. The sample well of the test

cassette must remain outside the device.

The application will show a photo of the test and detect test and control lines (markers)

automatically. Correct the strip area or line position if needed. Select the basic data for the

assay: test name per LOINC guide and units. Move to the next page by clicking Next.

Enter Incubation time and Range Interpretation (Reference Value) on the Interpretation page

and mark the checkbox next to the Range that is considered Normal for the test type in

question.

Select Calibration for the type of study, choose Measurement type and Specimen type.

Create your Measurement plan. Fill in the data for various concentration values, including the

required sample volume, buffer volume and the number of repeated measurements for each

concentration.

It is recommended to fill in at least five (5) different concentration values. After completing the

steps for every concentration value, you can print out the plan.

The application will prompt to insert test cassettes with different concentrations one after

another in line with the concentration Values and the Number of repetitions for each of

them according to your Measurement plan.

Complete the measurements. The application will then create the calibration curve on

the Workspace page. You can always go back to the Measurement plan page and correct the

data if needed.

Click Export to save the calibration report or record the calibration data on an NFC tag.

Prepare a new test cassette adapter. Check the NFC tag on the underside of the test cassette

adapter. Insert them together into the device slot according to the adapter direction.

Click NFC Write to start writing the calibration data on the NFC tag.

Double-check all the steps before saving the data.

Now your Igloo can read tests of the type/batch for which it was calibrated.Experiment X Germany GmbH

Perleberger Straße 42d

D-10559 Berlin

Germany

If you ever need to use your Igloo with another test type/batch, repeat the calibration procedure

as described above.

Select Control mode in the application main menu to read a test, as described in the next

chapter.

Incorrect calibration will lead to incorrect measurement results. The device manufacturer

explicitly disclaims any responsibility if this is the case.

Measurement

Launch Dx Studio and switch on your Igloo.

Select Control mode.

The device indicator will on breathe fast.

The application will prompt you to insert an adapter with the test cassette into the device.

Use gloves.

Prepare the test cassette following its instructions for use.

Igloo reads the incubation time and other important test information from the NFC-tag.

Prior to the measurement, make sure the NFC-tag is located on the underside of the cassette

adapter.

Incorrect preparation of the test cassette can lead to incorrect test results.

Place the test cassette into the cassette adapter with test strips facing up and insert them

together into the device slot according to the adapter direction. The sample well on the test

cassette must be facing the outside of the device.Experiment X Germany GmbH

Perleberger Straße 42d

D-10559 Berlin

Germany

The device is intended for use with various cassette adapters, but the test cassette must

be suitable for the test cassette adapter.

Always check that you are using the appropriate cassette adapter with a specific test

cassette. A cassette adapter with an NFC-tag from another test batch or type can lead to

incorrect measurement results.

Dx Studio starts the measurement, with the device indicator rotating and the application

showing the measurement progress.

If you have inserted the cassette adapter with the test cassette into the device before launching

the application, eject the adapter and insert it again.

The measurement process always starts with the countdown of the incubation time. Note

that this process cannot be undone or paused once started.

Do not eject the cassette adapter until the reading is complete. If you eject the adapter

for more than 10 seconds, the incubation time will be reset and the application will ask to start

the measurement again. In this case inserting of the same test may lead to incorrect

measurement results.

Do not disconnect the USB-C cable until the reading is complete as this may terminate the

measurement or lead to incorrect results.Experiment X Germany GmbH

Perleberger Straße 42d

D-10559 Berlin

Germany

Do not move the device during the measurement as this may cause the cassette adapter

to get ejected without your noticing it or lead to incorrect measurement results .

Upon successful measurement, the device indicator will stop rotating and star to breathe fast

while Dx Studio retrieves the result from Igloo. Once done, the application will and show the

result on the screen.

If the test result is invalid or cannot be obtained from Igloo, the application will show an

appropriate message. In this case, use another test cassette to perform the test from the

beginning.

Remember that the test results can be false positive or false negative for a variety of

reasons. Make sure to always have professionals double-check the results obtained using the

device using approved comparable diagnosis technique.

The manufacturer does not recommend starting a measurement if the battery level is

below 9%, as the device might run out of charge before the procedure is completed.

Nevertheless, the application will be warning about a critical battery level.

Eject the cassette adapter and remove the used test cassette.

A test cassette can only be used once.

Remember that the biological fluids introduced into the test cassette are classified as

infectious biological waste.

Always follow the instructions for the correct disposal of used test cassettes.

Some lateral flow test manufacturers do not recommend evaluating test results after a

certain time has passed.

The device is reusable. To continue measurements, save or abort the test result using the

application menu.Experiment X Germany GmbH

Perleberger Straße 42d

D-10559 Berlin

Germany

Dx Studio will ask to insert a cassette adapter with a test cassette. To make another test, follow

the instructions above.

You can save the measurement result as a project file. When the measurement is complete,

close the application and switch off Igloo.

When saving the result, make sure not to mix up the data between different

measurements. The manufacturer explicitly disclaims its responsibility for the correct

placement and safety of measurement results.