LeadCare
®
II User's Guide 3-2
How Often Should You Test Controls
According to CLIA guidelines for Waived Laboratories, controls should be run
according to the manufacturer's instructions, which are:
2
• Each new lot.
• Each new shipment of materials, even if it’s the same lot previously received.
• Each new operator (i.e., operator who has not performed the test recently).
• Monthly, as a check on continued storage conditions.
• When problems (storage, operator, instrument, or other) are suspected or
identified.
• If otherwise required by your laboratory's standard QC procedures.
Non-Waived
Some certification programs may have additional quality
control requirements. Follow your federal, state and local
guidelines to ensure compliance.
Testing Controls
Test the LeadCare II Lead Control material as you would any whole blood
sample. You must run both the Level 1 and Level 2 controls to verify the
performance of the system.
CAUTION: When testing controls, make sure that the
value falls within the acceptable range for each control. Do
NOT proceed to patient samples if the control results are
outside acceptable limits. Refer to the Troubleshooting
section of the User's Guide, or call Product Support at
1-800-275-0102 to help you resolve any problem.
Testing controls consists of the following steps:
A) Prepare the Sample
1. Label a treatment reagent tube, "Level 1".
2. Gently swirl the control vial. Remove the cap from the Level 1 control and
place it top down on a clean surface.
3. Fill one capillary tube with the control material. To accomplish this tilt the
control vial, insert the capillary tube into the liquid while holding the green
end of the capillary tube almost horizontally. Capillary action will fill the
tube to the black line.
4. Use a clean wipe to remove excess control material from the outside of
the capillary tube.
2
Benson, Carol 2008, 'Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA)
Waiver Applications for manufacturers of in Vitro Diagnostic Devices', Guidance for Industry and FDA Staff:,
p.34, viewed 26 January 2009.
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