Intended Use
Use these controls with the Cardio Chek ST CardioChek PA, HDL Cholesterol Test Strips as a quality control material to check for proper performance of your test system.
Summary and Explanation
The PTS HLD Cholesterol controls contain cholesterol, which reacts with the test strip to produce a color. The darker the color, the higher the HDL Cholesterol concentration is. The result for each level of control should be in the range specified on control range sheet enclosed with the test controls. Controls should be run to verify the test system performance. You should run a control if results obtained are questionable.
Precautions
Storage and Handling
Store at room temperature below 86°F (30°C). Do not freeze. Product is ready to use. Use care not to contaminate dropper tip. Do not use beyond the expiration date on the vital.
Procedure
Materials provided:
Two (2) vitals of HDL Cholesterol
control (one each of Level 1 and Level 2)
Analyzers that can be tested:
CardioChek ST or CardioChek PA
Material provided, but not provided:
- PTS HDL Cholesterol Test Strips
Test Procedure:
- Insert new, unused strip into meter.
- Wait until meter displays "Apply Sample",
- Shake control vial vigorously.
- Immediately remove cap, invert bottle and hold bottle straight above test
strip reaction area.
- Carefully, squeeze vial to deliver one drop of control to strip.
- Result will be displayed in about a minute.
(Refer to your CardioChek and CardioChek PA User Guide)
NOTE: Be sure to shake vial vigorously before use and use immediately.
Expected Results
Results for the control should fall in the range specified. If results are above or below the range specified, make sure that neither the strips nor the controls are past their printed expiration date. Clean the meter and retest.
(*Bioscanner 2000 was discontinued by mfg on 3/31/03 and replaced by an improved CardioChek analyzer)