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2. Laboratory Reagents, Kits & Materials 2 KEMRI-Wellcome Trust Research Programme

3. Definition  Reagent  any chemical substance used to dissolve, digest, extract, react with or otherwise interact with any samples or analytical component of the sample.  A substance used for the detection or determination of another substance by chemical or microscopical means, usually in solution.  A substance used to produce a chemical reaction so as to detect, measure or examine another substance, or to transform it by causing a reaction.  A substance or compound that is added to a system in order to bring a chemical reaction or is added to see if a reaction occurs.  Kit: a set of components used to perform Laboratory test. 3

4. Laboratory Reagents and Kits Registration Labeling Receipt Identification Temperature Control Storage Protection Disposal 4

5. TYPES OF REAGENTS 1: General Purpose Reagents (GPR) Chemical reagent that has general laboratory application. used to collect, prepare and examine specimen from the human body for diagnostic purposes 5

6. Types of Reagents 2) Analyte Specific Reagents (ASRs) Antibodies with specific receptor proteins, ligands, nucleic acid sequences, enzymes and similar reagents, which, through specific binding or chemical reaction with substances in a specimen. use in diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimen. 6

7. Reagents & Kits Performance Characteristics 1) Measuring Range: range of concentrations within which the assay is accurate and precise 2) Linear Range : concentration range over which intensity of the signal obtained is directly proportional to the analyte producing the signal. 3) Sensitivity : Minimum detectable level 7

8. Reagents & Kits Performance Characteristics 4) Stability: Ability of an invitro diagnostic reagent, when kept under specified conditions, to retain throughout the shelf life its characteristics and performance within limits specified by the manufacturer 8

9. Reagents & Kits Performance Characteristics 5) BATCH/LOT # Diagnostic reagent applications require products with very precise specifications Level of impurities in raw materials used in making diagnostic reagents, can vary from batch to batch leading to unacceptable variation in the performance of the reagents Concentration, specificity, ph etc, of the various components of the reagent/kit can vary from batch to batch 9

10. Reagent Procurement  Purchase from commercial suppliers  Identify the Reagent / kit required and its characteristics  Identify the Manufacturer  Identify the Reagent/Kit supplier  Liaise with the Procurement department  Determine the amount of reagent / kit to be ordered  Obtain the expiry date before delivery.  10

11. Reagent Preparation  In-House Laboratory prepared reagent.  Standard Operating Procedures for preparation required.  Lyophilized (Freeze-Dried) Reagent  Liquid Reagent  Reagent prepared by Laboratory Name of reagents. Date of preparation. Content of the reagent. Strength or concentration. Storage conditions. Expiration date. 11

12. Reagent/Kit Procurement Shelf life: the length of time that a product (kit/reagent) stored and handled as described in product labeling will meet its performance claims.  Use life: the length of time that an opened (unpackaged) reagent test will meet its performance claims.  Reagent/Kit or lot validation shall be performed before a new lot number is put into use.  reagents from different lot numbers should not be interchanged without prior functional validation 12

13. Reagent Labeling  Reagents & Kits labeled : Date of receipt. Date open. Initials of receiving staff. Expiration date. 13

14. Reconstituted Reagent Labeling The reagents should be labeled with the identity of the reagent, concentration, date of preparation or expiration, and the identity of the individual preparing the reagent. 14

15. Reagent/Kit Storage  All reagents shall be properly stored according to manufacturer’s instructions.  Storage conditions: Ambient Storage: requires temperature conditions up to 30 o C. Cold storage requires temperature refrigeration between 2 o C to 8 o C Frozen storage requires a temperature of frozen conditions -20 o C. to -80 o C. 15

16. Reagent/Kit Expiry Date Expired reagents shall NEVER be used for Clinical testing. Expiration date: the date after which a product loses its potency. 16

17. Reagent / Kit Quality Control reagents from different lot numbers should not be interchanged without prior functional validation Appropriate distilled/de- ionized water should be used for reagent reconstitution. 17

18. Examine Lot Number & Expiry Date 18

19. Material Safety Data Sheet (MSDS) Always carefully read: the reagent label the material safety data sheet (MSDS) Some Lab reagent may poses a severe or potentially life- threatening hazard to the user. If in doubt seek clarification with COSHH : Control of Substances Hazardous to Health. 19

20. Disposal of Expired Reagent EXPIRED REAGENTDISPOSAL All expired reagents shall be delivered to the Laboratory COSHH officer. The expired reagents shall be disposed in accordance to the KEMRI-Wellcome Trust Wastes Disposal procedures. 20