The performance of microdot® Test Strips has been evaluated both in laboratory and in clinical tests.
Range:
The measurement range of the microdot® System is 20 to 525 mg/dL.
Accuracy:
The accuracy of the microdot® System was assessed by comparing blood glucose results obtained by 102 patients at one clinical center with those obtained using a YSI 2300 laboratory Instrument.
Clark error grid analysis:
- 98% A region;
- 2 % B region
- Correlation coefficient R = 0.977.
- Range tested 45 to 472 mg/dL (2.5 to 26.2 mmol/L).
- Slope 0.973y-Intercept 3.96 mg/dL (0.22 mmol/L).
This means that the microdot® system compared well to a laboratory method.
Intended Use
microdot® Test Strips are used to measure glucose (sugar) in capillary whole blood outside of the body (in vitro diagnostic use). Use microdot® Test Strips only with the microdot® Blood Glucose Test System. microdot® Test Strips are plasma calibrated to allow easy comparison of results with laboratory methods.
Storage and Handling
Store the strips in their original vial in a cool, dry place between 50° and 86° F (10°-30° C).
Keep away from sunlight and heat.
Do not refrigerate or freeze.
When you take a strip from the vial, close the cap immediately. Use the strip immediately.
Do not use microdot® Test Strips more than 90 days after the vial is first opened.
Write the discard date on the vial when you first open it.
Check the expiry date on the vial. If the expiry date has passed do not use the strips.
Always code the meter for each new vial of strips according to the user manual.
