The precision analysis of Enzyme-linked immunosorbent assay kits

Cloud-Clone Corp.

Precision means the testing consistency of measured values obtained by repeated test with same sample under same condition. As one of the basic analytical performance of the detection system, it is the basis of validity assessment for detection system. Well, how to measure the precision of ELISA kit?

The precision of ELISA kit is divided into ‘Intra-assay Precision’ and ‘Inter-assay Precision’. It is shown in coefficient of variation(CV).

Intra-assay Precision (Precision within an assay): 3 samples with low, middle and high level analytes were tested 20 times on one plate, respectively. Then the Mean and standard deviation(SD) were calculated by following formulas. 

Inter-assay Precision (Precision between assays): 3 samples with low, middle and high level analytes were tested on 3 different plates, 8 replicates in each plate. Then the Mean and standard deviation(SD) were calculated by following formulas.

 

According to the enterprise standards for ELISA kits established by Cloud-Clone Corp., the precision for all the kits should fulfilled the following criteria: intra-assay precision: CV<10%; inter-assay precision:CV<12%.

Take SEA072Hu for example, the result of intra-assay precision and inter-assay precision are shown below. In the table, n: test frequency of samples; Mean: average sample value of repeated test for n times; SD: standard deviation of repeated test for n times; CV(%): coefficient of variation.


Intra-assay Precision

Inter-assay Precision

Sample

1
23123

n

202020242424

Mean (pg/ml)

63.47

272.52

1058.24

70.15

318.97

1137.81

SD

4.316

17.169

59.241

4.981

21.690

79.406

CV (%)

6.8

6.3

5.6

7.1

6.8

7.0

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