• Document: Validation of reagents and mixes in haematology. Tine Venken
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Validation of reagents and mixes in haematology Tine Venken Molecular Biology and Cytometry Course 23-24/03/2017 Overview ISO 15189:2012 Validation of reagents Validation of mixes Daily practice Conclusions 2 International Standard ISO 15189:2012 5.3.2.3 Reagents and consumables — Acceptance testing “Each new formulation of examination kits with changes in reagents or procedure, or a new lot or shipment, shall be verified for performance before use in examinations. Consumables that can affect the quality of examinations shall be verified for performance before use in examinations.” ISO 15189:2012 5.3.2.3 Reagents and consumables — Acceptance testing “Each new formulation of examination kits with changes in reagents or procedure, or a new lot or shipment, shall be verified for performance before use in examinations Consumables that can affect the quality of examinations shall be verified for performance before use in examinations” Patient risk  Broader interpretation “Each new formulation of examination kits with changes in reagents or procedure, or a new lot or shipment, or consumables that can affect the quality of examinations, shall be verified for performance before reporting the results” 4 Validation of reagents Antibody-fluorochrome combination Titration Validation/verification of antibody-fluorochrome combinations and mixes Ab-fluorochrome combination Specific MoAbs with high sensitivity Bright fluorochromes to detect weak antigens Spectral overlap MoAbs titration Standardisation/harmonisation Literature Company Price 6 Ab-fluorochrome combination Lymphoid Screening Tube Euroflow Euroflow: LST - Lymphoid Screening Tube FITC PE PerpCP-Cy5.5 PE-Cy7 APC APC-H7 Pacific Blue Pacific Orange CD8 and CD56 and CD19 and CD5 SmCD3 CD38 CD20 and CD4 CD45 SmIgλ SmIgκ TCRγδ ZNA: LST16 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 FL1 FL2 FL3 FL4 FL5 FL6 FL7 FL8 FL9 FL10 APC- APC- FITC FITC PE PE ECD ECD PC5 PC7 APC APC APCH7 V450 PB KO AF700 AF750 CD8 Lambda CD56 Kappa CD34 CD117 CD5 CD19 CD3 CD71 CD10 CD14 CD38 CD20 CD4 CD45 7 Reagents – Titration Evaluation by intensity Signal to noise ratio (S/N) Separation parameter (SP) # events Fluorescence intensity 8 Reagents – Titration # events Evaluation by intensity MFI positive population Fluorescence intensity Evaluation by intensity CD3+CD4+ MFI CD3+CD4- 1 1/2 1/4 1/8 1/16 1/32 1/64 1/128 1/1280 1/12800 MoAb Titration (1/x) 9 Reagents – Titration # events Signal to noise ratio Fluorescence intensity 40.00 Signal to noise ratio 35.00 30.00 25.00 S/N 20.00 CD3+CD4+ 15.00 10.00 5.00 0.00 1 1/2 1/4 1/8 1/16 1/32 1/64 1/128 1/1280 1/12800 MoAb Titratie (1/x) 10 Reagents – Titration # events Separation parameter (SP)

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