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Quality Control (QC)
A quality control program should be performed on a regular basis to verify the MyCare Insite Analyser
is working properly and providing reliable results. Data integrity can only be assured when controls and
Good Clinical Laboratory Practice are used routinely. The frequency of performing QC differs from
laboratory to laboratory; please comply with your national quality control regulations.
QC materials
Quality control material is defined in the MyCare Insite Test package inserts.
To run QC:
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Prepare Sample Collector and Cuvette - allow at least 10 minutes to come to room temperature.
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Place the provided RFID card from the test kit package in the RFID card well on top of the
Analyser.
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Prepare the control according to the instructions in the control package insert.
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Enter the control level and control lot number instead of the patient data.
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Prepare the test like a patient sample according to the instructions in the control package insert
and start the measurement.
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The result is displayed on the Touch Screen.
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Record the result according to your laboratory's quality guidelines.
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The result will be saved in the device's memory – just like a patient's result.
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If desired, export the result(s) to an (optional) external computer, print the result with an
(optional) external printer or send it via Email (see p. 28).
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Verify that the result is within the mandatory limits for the control material (according to the
control package insert).
Be sure to follow the detailed instructions for the test that are provided in the operation sections (page
25) and comply with the information provided in the package insert enclosed with each MyCare Insite
Test kit.
Handling QC control materials
Please refer to the package insert provided with each control kit for detailed instructions
on storage and handling of control materials.
Follow the instructions in the "Testing a Patient Sample" sections (starting on p. 26) on how to properly
perform a control test. The measured values must be within the range of target values specified in the
control package insert. If the control results fall within the specified range, the testing of patient
samples may begin.
If one or more controls tested are outside the specified control range:
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Verify that the control materials have been stored according to the directions and that the open
vial stability claim and expiration date have not been exceeded.
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