Accu-chek Linearities
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Hi ALL!
First of all, Thank YOU ALL for this amazing group of POCers. I am so glad to have this group support.
So I have one question: when running accu-chek glucose linearities, is it necessary to run all levels twice? Can someone please help me find the CAP literature on this. Thank you in advance!
Michelle
Example of the worksheet I found at my new job.
| TEST RESULT (mg/dL) | LEVEL 1 | LEVEL 2 | LEVEL 3 | LEVEL 4 | LEVEL 5 | LEVEL 6 |
| RUN 1 | 27 | 44 | 117 | 308 | 507 | 555 |
| RUN 2 | 27 | 44 | 116 | 307 | 509 | 554 |
| Mean | 27 | 44 | 116.5 | 307.5 | 508 | 554.5 |
| Target Value | 28 | 45 | 118 | 307 | 511 | 559 |
| Target Range | 13-43 | 30-60 | 100-136 | 261-353 | 434-588 | 475-643 |
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I have not seen any CAP lit on running all levels twice. Since this is waived, CAP would revert back to manufacturer's instruction. Roche has never told me, nor have I seen any lit, stating to run levels twice.
Hello,
As per the Roche, all linearity are performed in duplicate. Please review copy section of the package insert for clear definition.
LINEARITY TEST KIT Procedure
• Put the meter on a flat surface, such as a table. Remove
the linearity solution bottle cap. Wipe the tip of the bottle with a lint free
wipe. Squeeze the bottle until a tiny drop forms at the tip. Touch
the drop to the front edge of the yellow window of the test strip.
The meter will indicate when sufficient linearity solution is in the test
strip. Wipe the tip of the bottle with a lint-free wipe, then cap the
bottle tightly. The result appears on the display. Record the result.
Remove and discard the used test strip per facility policy. Test each
linearity level twice and average the results for each level.
Have a Wonderful Day
Me either
I would check the product insert for the linearity product. It will likely specify.
Even if the product insert does specify - common lab practice for both non-POC and POC linearity/reportable range is to run each level multiple times, so that both precision (%CV) and accuracy are assessed. You cannot calculate precision with a single run, and barely can with only 2 runs.