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  • Validation and Verification...
    Devanath, Anitha; Vani, Girish K.S; Bijoor, Anita R

    Indian journal of clinical biochemistry, 05/2022, Letnik: 34, Številka: S1
    Journal Article

    Majority of automated instruments are validated and verified for serum and urine chemistry parameters. However, manufacturers do not provide performance verification for body fluids. Since body fluids such as ascitic, pleural, CSF, dialysate and pericardial fluid specimens form a part of testing panel for variety of analytes, it becomes important to verify/validate the performance of these fluids. The accreditation bodies that certify and accredit labs follow ISO 15189:2012 that states validation should be carried out whenever there is a deviation from stated procedure. The aim of this study was to establish performance characteristics for commonly requested analytes in body fluids. Left over samples were utilised for validation/verification of ten common analytes specific to each of the above-mentioned body fluids on Abbott Architect ci8222 integrated system. Performance characteristics that were verified are as follows: Imprecision, accuracy, reportable range, stability and interference. Assay imprecision for body fluid assays were comparable to imprecision obtained for serum. Accuracy was evaluated with recovery experiment after spiking the sample with a known concentration of substance. Reportable range was found to be comparable to serum parameters. Chemistry analytes for body fluid analytes was found to be stable for a period of 20 days at -20degrees C. It is mandatory for lab to establish validation/verification of body fluid assays for commonly requested analytes. This would improve the reliability of the testing system.