Assay acceptability ค่าการยอมรับสำหรับการทดสอบ Elisa

There are four main criteria that should be assessed when evaluating your data:

1.) Your standard curve R2 must be ≥ 0.98. If this condition fails, all results must be discarded and the assay must be rerun.

2.) % CVs of Absorbance Values:

• Standard Absorbance Values must be ≤ 10%.

• One absorbance CV may between 10-15% as long as the rest are < 10%.

• Control and Samples Absorbance CV values should be ≤ 15%.

• If the standard absorbance criteria are not met, you should rerun the assay as this could impact the curve fit which could

produce inaccurate results.

• If the sample criteria are not met for a single sample, you can accept your results for the passing samples and

rerun the failing sample with your next run.

3.) Control concentrations should be within their acceptable ranges.

For assay and control specific ranges, please reference the user’s guide found in the kit of your assay.

If this condition fails, it may indicate a problem with the standard curve. Results should be discarded and rerun.

4.) Standard 0 Absorbance Value should be between 0.800 and 3.000.

If the absorbance value of standard 0 is outside of this range this could indicate that there may be an issue

with one of the assay’s reagents or possibly one of the steps in the procedure was not executed properly.

If this condition fails, all results must be discarded and the assay must be rerun.