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
Expired reagents shall NEVER be used for
Clinical testing.
• Expiration date: the date after which a
product loses its potency.

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 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.

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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 life-
threatening 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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