Accuracy is the feature of our assays

Accuracy

Mercer EXPert Assays products are immunoassays.

The main features of our assays are : -

- ELISA based assays.

- Monoclonal Antibodies used.

the use of monoclonal antibodies enables us to offer an extremely high degree of high specificity and sensitivity. it also helps us control the drift in our assays over production lots over a period of time as we use the same source for our antibodies. Both our capture and detection antibodies are monoclones selected for their high degree of affinity to insulin

- Validation.

 

All our assays are well validated for following parameters :

Sensitivity

Specificity

Precision (with intra assay)

                 (with inter assay)

Recovery

Data Reduction

We use B/B0 % to interpret our data. The data was graphically plotted presenting the quality control data. The concept of control charts was first developed in 1934 by Walter Shewhart to describe output of a manufacturing process. They can be useful in demonstrating statistical control monitoring the measurement process, diagnosing measurement problems, and documenting measurement uncertainties. Control charts consist of some measured parameter or statistic such as a mean or a precision estimate plotted sequentially or as a function of time.

Recommended assay characteristics included absorbance of a zero concentration standard; factors which describe the calibration such as displacement (B/Bo ratios) for each standard and statistical description of the calibration curve such as coefficient of correlation, slope and/or intercept; and recovery of results on control samples. It is important to be able to relate the specifications for a parameter to expected reliability of the result. Our in-house standard defined was r=0.990.