Transcript Module 6. Laboratory reagents, kits and materials

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Laboratory Reagents, Kits &
Materials
KEMRI-Wellcome Trust Research Programme
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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.
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Laboratory Reagents and Kits
 Registration
 Labeling
 Receipt
 Identification
 Temperature Control
 Storage
 Protection
 Disposal
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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
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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.
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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
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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
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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
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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.

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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.

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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
•
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Reagent Labeling
 Reagents & Kits labeled:
 Date of receipt.
 Date open.
 Initials of receiving
staff.
 Expiration date.
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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.
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Reagent/Kit Storage
All reagents shall be properly stored
according to manufacturer’s
instructions.
 Storage conditions:
 Ambient Storage: requires
temperature conditions up to 30 oC.
 Cold storage requires temperature
refrigeration between 2 oC to 8 oC
 Frozen storage requires a
temperature of frozen conditions
-20 oC. to -80 oC.

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Reagent/Kit Expiry Date

•
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Expired reagents shall NEVER be used for
Clinical testing.
Expiration date: the date after which a
product loses its potency.
Reagent / Kit Quality Control
 reagents from different lot
numbers should not be
interchanged without prior
functional validation
 Appropriate distilled/deionized water should be
used for reagent
reconstitution.
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Examine Lot Number & Expiry Date
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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 lifethreatening hazard to the user.
• If in doubt seek clarification with
COSHH: Control of Substances
Hazardous to Health.
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Disposal of Expired Reagent
EXPIRED REAGENT
DISPOSAL
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.

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