acceptable spike recovery range

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0000003495 00000 n 0000006497 00000 n 0000143623 00000 n However, they may still be useful to help understand the nature of any bias revealed in the comparison of methods experiment. 0000071280 00000 n Spike-and-recovery experiments 1. 0000001167 00000 n acceptance criteria for matrix spike recovery.

0000011053 00000 n Appendix. For calcium, for example, the CLIA criterion for acceptable performance is 1 mg/dL. 0000002527 00000 n Calculation of the Matrix Spike Duplicate Results • Matrix spike duplicate accuracy is expressed as percent recovery; it is calculated by using the same

0000001621 00000 n The error is often caused by a substance in the sample matrix that reacts with the sought for analyte and therefore competes with the analytical reagent. 0000090646 00000 n 0000001600 00000 n

matrix spike duplicate analysis. They complement the comparison of methods experiment by allowing quick initial estimates of specific errors - the interference experiment for constant systematic error and the recovery experiment for proportional systematic error. For additional information and to view other sections of the … Dilution Errors Errors can occur with test dilutions, especially with those relating to the dilution of endotoxin and creating a standard curve. In contrast, no assays from Competitor 1, and only one assay from Competitor 2 fell within the acceptable range. The range that is generally considered acceptable for spike recovery is 70% - 130% (horizontal red bars).

0000007615 00000 n 0000008701 00000 n 0000013333 00000 n 0000011031 00000 n Ideal recovery is 100.0%. 0000012267 00000 n B. %PDF-1.3 %���� Method validation studies for unmodified moderate or high complexity tests tend to focus on the experiments for linearity or reportable range, replication, and comparison of methods, which have been described in previous lessons.

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To perform a spike and recovery experiment, … (See analytical quality requirements.) 0000013311 00000 n Recovery studies, therefore, are used rather selectively and do not have a high priority when another analytical method is available for comparison purposes. • Use steps described in the Log # 112 “Matrix Spiking – Why Spike and How to Do It” for the matrix spike duplicate preparation and analysis. Here's a step by step procedure for calculating the data:The judgment on acceptability is made by comparing the observed systematic error with the amount of error that is allowable for the test.

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