1. This teaching material has been made freely available by the KEMRI-Wellcome Trust
(Kilifi, Kenya).
You can freely download, adapt, and distribute this presentation under the conditions
that: the Global Health Laboratories and The Global Health Network are referenced; the
work is not used for commercial purposes, and any altered forms of this document are
distributed freely under the same conditions.
www.GlobalHealthLaboratories.org
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.
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4. Laboratory Reagents and Kits
Registration
Labeling
Receipt
Identification
Temperature Control
Storage
Protection
Disposal
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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
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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.
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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
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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
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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
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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.
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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.
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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
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13. Reagent Labeling
Reagents & Kits labeled:
Date of receipt.
Date open.
Initials of receiving
staff.
Expiration date.
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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.
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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 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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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.
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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.
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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.
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20. 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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Editor's Notes
Reagents used in diagnostic and research testing assays are the most fundamental and critical components necessary for a medical Laboratory to function efficiently. Laboratory reagents used in this context shall include the kits, stains, dyes, culture media, chemicals, biochemical, QC materials that in combination with a sample work together to generate accurate, precise, and reliable test results.
Various kinds of reagents are employed for various chemical reactions which lead to various products. These reagents are normally used in chemical and biological lab experiments. they are available in the form of organic or perhaps inorganic compounds consisting of 2 or more elements with defined chemical compositions.
Types of reagents which are used in medical laboratories:
Chemical Reagents: are used extensively in several fields’ health facilities, life science laboratories, biotechnology along with other existing areas in research. These types of reagents play crucial roles in composition investigation for technological progress as well as in quantitative and qualitative examination.
Biological Reagents: reagents such as staining elements are often used in the fields of medicine as well as biology to assist in visualizing structures like those being used in microscopic studies. A good example is evaluating sputum specimen carried out in tuberculosis laboratories. Diverse stains and also dyes react and are also advantageous in marking cells in flow cytometry along with other procedures including electrophoresis.
Analytic Reagents: These are also referred to as diagnostic reagents used in many fields in microbiology, electrochemistry and microscopy. Common analytic reagents include high purity acids and also bases along with other chemical compositions for ultra-trace analysis.
General Reagents: includes hydrochloric, methanoic, boric, and sulphuric acids.
Factors to consider in buying Reagents and Kits
Credible Supplier: regardless of the reagent / kit type, it is a good practice for the Laboratory to usually confirm if they are transacting from respectable distributors. There are plenty of artificial and useless reagents for sale. Take extra measures when acquiring reagents online as well as transact simply with those that are accredited by reagent organizations and therefore are licensed and registered to market different reagents.
Price and Delivery: Be specific about product price as well as delivery.
Product Packaging: Take a look at the product packaging before receiving the shipment. Improper packaging might have an effect on the quality and also functionality of the reagents.
Good care and storage of reagents are necessary. Read labels and instructions for its use cautiously.
Lyophilization is a process which extracts the water from reagents so that the products remain stable and are easier to store at room temperature (ambient air temperature). Lyophilization has been used to stabilize many types of chemical components. In their liquid form, many such biochemical and chemical reagents are unstable, biologically and chemically active, temperature sensitive, and chemically reactive with one another.
Liquid Reagents: the chemicals may have a very short shelf life, may need to be refrigerated, or may degrade unless stabilized. Lyophilization gives unstable chemical solutions a long shelf life when they are stored at room temperature. The process gives a product excellent solubility characteristics, allowing for rapid reconstitution. Heat- and moisture-sensitive compounds retain their viability. lyophilization ensures maximum retention of biological and chemical purity.
Establishing a system for labeling reagents will be very helpful. It is important to label reagents with the date they are opened, and to make sure the expiration date is clearly visible.
Reagents/Kits Receipt and Labeling: All reagents purchased from a commercial vendor and received in the Laboratory shall be marked with the following information;
Date of receipt.
Date open.
Initials of receiving staff.
Expiration date.
All reagents prepared by laboratory shall be labeled to indicate the following unique identifiers:
Name of reagents.
Date of preparation.
Content of the reagent.
Strength or concentration.
Storage conditions.
Expiration date.
All reagents shall be properly stored according to manufacturer’s instructions.
Common storage conditions applied in KEMRI-Wellcome Trust Laboratories are as follows:
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.
Reagent shelf life shall be strictly observed and must not be used when they have exceeded their expiration date, have deteriorated or are of substandard quality.
Reagents which are received without an expiration date are to be assigned expiration date of one year following receipt.
Unless specifically stated in the instructions for preparation all reagents prepared by the laboratory shall be assigned an expiration date of ninety (90) days following preparation.
A kit may contain components that have different expiration dates. Thus, for kits with components containing different expiration dates, the earlier date assigned shall be taken as the date of expiry.
Components of reagent kits of different lot number are not interchangeable unless specified by the manufacturer.
Appropriate distilled water shall be used in reagent / media preparation. Water shall be monitored to ensure that it is maintained at appropriate quality for its intended use as indicated in the test procedure.
Module 11: Inventory Management
Before working with any new and unfamiliar chemical reagent it is always a good practice to consider carefully about the following:Chemical compatibility ,Chemical reactivity, Flammability , Volatility , Toxicity , Handling, Accidents, Emergencies
All reagents shall be labeled with associated hazards i.e. health, fire, reactivity and specific hazards according to COSSH requirements.
Material Safety Data Sheets or MSDSs are intended to provide a comprehensive source of written information about the properties, handling, and transport of chemical reagents. All manufacturers are required to provide users with an MSDS for each reagent that they sell. All employers including academic institutions are required to provide the relevant MSDS to any employee working with that reagent upon request. Material Safety Data Sheet (MSDS) for all reagents/chemicals shall be maintained at proximity to the work site and easily accessible to testing personnel.
Expired Laboratory reagents and kits that need to be disposed shall be identified and documented in the “Expired Materials Log Book” maintained by the Lab Section Head/Supervisor.
The expired Laboratory reagent/kits for disposal shall be logged onto the “Laboratory Reagent/Kit Disposal form”.The form shall accompany the expired reagent to the Laboratory staff responsible for Control of Substances Hazardous to Health (COSHH) who shall sign and date the receipt. The form shall be filed in the originated Lab section and a copy kept by COSHH.
Because many reagents are classified as environmental hazards, proper disposal is regarded important. Check on state laws about removal of detrimental chemicals before disposing several types of reagents.