Magellan LeadCare Ultra, Руководство пользователя

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LeadCare Ultra
®
Blood Lead Testing System User’s Guide 5-2
5.3 How Often Should You Test Controls?
According to CLIA guidelines for Moderately Complex tests, a minimum of two levels of controls should
be:
•
Tested each day or shift before patient samples are tested for lead concentration.
•
Prepared and tested by each analyst who prepares samples.
•
Run to test the technique of new users.
• Run at any other time you wish to verify system performance.
NOTE:
Some certification programs may have additional QC requirements. Follow
the applicable federal, state, and local guidelines to ensure compliance.
For additional important information on QC, refer to the package insert provided with the test kit.
5.4 Safety Precautions
You must understand and follow these precautions when performing QC testing using the LeadCare
Ultra Blood Lead Testing System.
CAUTION: When performing QC testing:
• Keep the sensors in their container and the container closed until you need them.
The sensor vial contains a desiccant which controls the humidity. If the sensors are
exposed to humidity for an extended period of time this could lead to a false test
result.
•
Do NOT touch the “X” on the sensors, except when applying the control. This could
cause contamination and a false test result.
• Make sure the sensor is inserted under the sensor guides and sits flush on the
sensor deck. Inserting the sensor above the guides could cause inaccurate test
results.
•
Do NOT allow the inside of the treatment reagent vial or the vial cap to touch
anything. This could cause false blood lead test results.
•
Mix the control with the treatment reagent thoroughly. Gently invert the tube 10 times
to mix thoroughly. Avoid creating foam and air bubbles.
•
Do NOT leave the treatment reagent vial uncapped other than to add the control or
remove the control/reagent solution. The tube and its contents could be
contaminated, causing false test results.
• Before placing the mixture on the sensor, make sure the “Load the Sample” message
appears in the channel box.
•
Wear powder-free gloves to prevent lead contamination. Because there is lead in the
environment, it is easy to contaminate controls, collection tubes, and test kit items.
Contamination of the work environment can cause inaccurate blood lead test results.