Module 6. Laboratory reagents, kits and materials
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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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