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By

Gurunathan Ganesan
Direct Solid-Phase Competitive Solid-Phase
Advantages Issues
Established Technology Unclear Patent Situation
Manufacturing ease
Scalability Handling of very
Shelf lives of 12-24
months minimal Sample volumes
Ease of use Multiplexing
Minimal sample volume
High sensitivity, Sensitivity issues in
specificity
Low cost & short some systems
timeline for
development Reproducibility
Purpose: Bind proteins at the test and control
areas and to maintain their stability and
activity over the shelf-life of the product.
Material: Nitrocellulose, Nylon, polyvinylidene
fluoride (PVDF)
Purpose: To accept the conjugate, hold it
stable over its entire shelf life, and release it
efficiently and reproducibly when the assay is
run.
Variations in conjugate deposition, drying,
and release from the membrane constitute
major contributions to the CV.
Material: Glass fibres, polyesters, or rayons.
Purpose: The role of the sample pad is to
accept the sample, treat it such that it is
compatible with the assay, and release the
analyte with high efficiency.
Sample treatments includes, filtering out of
particulates or red blood cells, changing the
pH of the sample, etc.
Material: Cellulose, Glass fibres, or rayons.
Wick Backing Materials
Purpose: The wick is Purpose: All components
the engine of the strip. of the lateral flow assay
It is designed to pull all are laminated to the
of the fluid added to the backing material to
strip into this region provide rigidity and easy
handling of the strip. The
and to hold it for the backing material is coated
duration of the assay. It with a pressure-sensitive
should not release this adhesive to hold the
fluid back into the assay various components in
or false positives can place.
occur. Material: Polystyrene or
Material: high-density Plastic coated with
cellulose. adhesive.
ISO 13485, for the organization manufacturing medical instruments
ISO 14971, Medical devices Application of risk management to
medical devices
ISO 15223-1, Medical devices Symbols to be used with medical device
labels, labelling and information to be supplied Part 1: General
requirements
ISO 18113-1, In vitro diagnostic medical devices Information supplied
by the manufacturer (labelling) Part 1: Terms, definitions and general
requirements
IEC 61010-1, Safety requirements for electrical equipment for
measurement, control and laboratory use Part 1: General
requirements
IEC 61010-2-101, Safety requirements for electrical equipment for
measurement, control and laboratory use Part 2-101: Particular
requirements for in vitro diagnostic (IVD) medical equipment
IEC 61326-2-6, Electrical equipment for measurement, control and
laboratory use EMC requirements Part 2-6: Particular requirements
In vitro diagnostic (IVD) medical equipment
IEC 62366, Medical devices Application of usability engineering to
medical devices
EN 980, Symbols for use in the labelling of medical devices