Page 36 © Boule Medical AB, March 2018. Article no. 1504496
5. Quality Control
Analyzing Control Sample
SECTION 5. QUALITY CONTROL
Analyzing Control Sample
It is advisable that the performance of the Exigo H400 system is checked daily with a certied blood
control authorized by Boule. Comparing the analyzer results to the known values on the Boule
control assay sheet is a good assurance that the system is functioning properly.
Control Handling Recommendations
Handle and prepare controls in accordance to control package insert.
Never use an open vial longer than recommended by the manufacturer, past the expiration
date, or subject any vial to excessive heat or agitation.
As there are no assurances of the absence of HIV, Hepatitis B or C viruses or other infectious
agents in blood samples, controls, and calibrators these products should be handled as
potentially biohazardous. Refer to local regulations and established laboratory protocol for
handling biohazardous materials.
Wipe the aspiration needle with a clean, dry lint free absorbent cloth before each control run.
Not following this technique will impact control accuracy.
Control Use Recommendations
It is recommended to use a control for the following:
Daily analyzer system check.
With a new lot or shipment of reagents to check for damage during transport or storage.
If required by operator’s laboratory protocol or local, state, or federal guidelines.
Possible troubleshooting purposes.
Enter New Control Lot
Follow the instruction to access the QC menu and to input Control/Calibrator Assay Values from the
Assay sheet.
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