65000159 Rev. 008 (06/17) 21
Control Testing
When to Control Test
Control testing ensures that you are running the test correctly and that your FastPack
®
IP System is
working properly.
When control testing is performed, two control levels must be used. Qualigen recommends that users run
controls whenever:
Patient testing is performed.*
A calibration is performed.
Repair maintenance is performed.
Improper storage or handling of FastPacks
®
is suspected.
Questionable patient results are obtained.
Users should follow proper state and federal quality control guidelines.
* Review the Individualized Quality Control Plan (IQCP) Guidelines implemented by CMS. These guidelines are based on individual
risk factors involved in the performance of each test run in your laboratory. IQCP is voluntary and provides laboratories with
flexibility in customizing QC policies and procedures based on the unique aspects and test systems found in your laboratory and
may allow for the reduction in the frequency of control testing required.
Visit www.qualigeninc.com for additional regulatory information.
What You Need
1. FastPack
®
IP System
2. FastPack
®
IP
3. FastPack
®
IP Control Kit
Control Vials (2)
4. Control Range Card
5. Pipette
* Use 25 µL pipette for hCG.
6. Pipette Tips
7. Medical Gloves – used to avoid contact with
biohazard materials such as human blood, etc.
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