Quality Control (Qc); Qc Materials; Handling Qc Control Materials - Saladax MyCare Insite User Manual

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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. All quality control requirements and testing should be performed in

accordance with local, state and/or federal regulations or accreditation requirements.

Quality control material is defined in the MyCare Insite Test package inserts.

To run QC:

Prepare Cuvette and Reagent Cap - allow at least 10 minutes to come to room temperature

Place the RFID card provided in the test box in the RFID card well on top of the Analyser

Prepare the control according to the instructions in the control package insert

Enter the control level and control lot number instead of the patient data

Add exactly the volume of control specified in the test package insert to the Cuvette

Prepare the test according to the Measuring QC instructions in the package insert

Insert the cartridge into the Analyser and start the test measurment by closing the door

At the end of the measurement:

The door will open; remove cartridge and close door

The result is displayed on the Touch Screen

Record the result according to your laboratory's quality guidelines

The result will be saved in the Touch Screen's memory – just like a patient's result

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 page 30)

Verify that the result is within the limits specified for the MyCare Insite 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

28) and comply with the information provided in the package insert at MyCareInsite.com.

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 page 28) 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.

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