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Clinical Chemistry Analyser, Dry

­Purpose
A dry chemistry analyser is a medical laboratory instrument designed to measure
­different chemicals and other characteristics in biological samples such as blood and
other fluids, which may be considered useful in the diagnosis of a disease. The dry
chemistry technology is quite convenient as it eliminates the use of liquid reagents and
there is no need for water, plumbing, vents, or drains. As a result, the instruments are
generally of compact design and are very easy to use. Such type of instruments is ideal
for use in blood banks, physician offices, and hospital labs and is quite suitable for point
of care testing.

­Principle
There are two types of testing approaches in biochemistry for clinical testing: those
utilizing liquid reagents and those in which the tests are based on dry reagents. The
tests based on dry reagent chemistry are easier to handle and depend upon simple ana-
lysers for measurement. The key component in this technique is a slide composed of
dry film layers. All the reagents necessary to perform a specific bioassay and to remove
substances that might interfere with the analyte are contained on the slide. The only
liquid required is 10 μl sample. The diagnostic format is a test pad that is bonded to a
support structure and impregnated with an analyte that will change colour or some
other physical property that can easily be seen or measured when exposed to a test
sample. This quantitative analysis of the chemical reactions is usually done by desktop
analysers. One of the most well‐known applications of dry chemistry technology
is  urine testing. Numerous clinical evaluations have validated the dry chemistry
­technology against conventional wet chemistry analysis.

Dry Chemistry Film

M/s FUJI Films announced for the first time in 1980 a dry chemistry analyser based on
a multilayered film method. The initial product was a dry chemistry slide and an ana-
lyser for measuring glucose concentration by spotting a 6 μl sample of whole blood. The

Compendium of Biomedical Instrumentation, Volume 1, First Edition. Raghbir Singh Khandpur.

© 2020 John Wiley & Sons Ltd. Published 2020 by John Wiley & Sons Ltd.

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 454 Compendium of Biomedical Instrumentation

slide had a special spreading layer made of cloth, which enabled the use of whole blood
samples. Modern instruments using dry film technology work on whole blood, serum,
or plasma samples, making it an extremely simple and flexible system for point‐of‐care
diagnostic applications. Being highly reliable and requiring almost no regular mainte-
nance or servicing, the technology is very useful for remote and rural healthcare
settings.
The dry chemistry‐based systems are now widely used in international markets as
automatic clinical chemistry analysers that fulfil the increasing needs of emergency
testing. Correspondingly, a range of peripheral items have also been developed. For
instance, special pipette tips, now called ’Fuji Clean Tip’, were introduced to enable
automatic spotting. Because the tips do not require wiping, there is little danger of
operator contamination from blood samples. Manual pipetting can be also per-
formed when less sample is available. Dilution, which is generally a time‐consuming
process, is automated in modern instruments. Plasma filter is used to generate
plasma sample by aspirating and separating the whole blood inside the filter within
1 minute.
The dry film slides allow to perform complex sequential reactions that are otherwise
not possible to run in solutions. The multilayer coatings with physical and chemical
properties such as filtration, selective adsorption, or kinetic optimization offer a base
for multiple reactions within a single slide. In the slide, the multilayered analytical ele-
ments are coated on polyester supports. There can be three or more layers: (i) a spread-
ing layer, which receives the sample; (ii) one or more central layers, which alter the
aliquot; and (iii) an indicator layer, where the analyte of interest can be quantified. The
number of layers could vary depending on the assay to be performed. A small amount
of patient sample is put onto the slide that gets evenly distributed to all of the layers. The
spreading layer contains the appropriate substrate and other reagents required for the
reaction. The reagent layer contains enzymes, dye precursor, and buffers necessary for
the analysis of a specific component. The slides are of two types: colorimetric or
potentiometric.

Colorimetric Slide  A typical example of a dry chemistry analyser is that of glucose slide,
wherein the actual measurement is conducted as follows. Ten microlitres of plasma or
serum are spotted on a dry chemistry slide as illustrated in Figure 87.1. After spotting,
the sample spreads uniformly on the spreading layer and diffuses into the underlying

Specimen (10 μl)

Special
spreading layer
Reflection layer

Transparent
Reaction layer support film

Spectrophotometer

Figure 87.1  Dry chemistry‐based glucose concentration analyser by colorimetric technique.

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layer. As the process proceeds, large molecular weight components such as proteins or
dye components are filtrated, and only small molecular weight components are able to
permeate and diffuse into the reagent layer. Glucose oxidase catalyses the oxidization of
sample glucose to generate hydrogen peroxide. Hydrogen peroxide reacts with dye
precursors and finally forms red dye. The slide is incubated at 37 °C for a specified
number of minutes in the analyser and the optical reflection density is measured at
505 nm. The optical reflection density is then converted into the glucose concentration
using a calibration curve preinstalled in the analyser.

Potentiometric Slide  This type of slides is designed for electrolyte analysis. The
analysis is based on measurement of the generated voltage difference between ion‐
selective electrodes applied to a reference solution and to the sample. For example,
ion‐selective electrodes for sodium (Na), potassium (K), and chloride (Cl) are
combined into one slide. A drop of reference sample and a drop of patient sample are
spotted on the slide, each on its respective electrode. When the samples interact with
coated reagent layers, a pair of electrochemical half‐cells are generated. The drops
spread towards one another across the paper bridge, meeting at the centre and
forming a stable liquid junction. A voltmeter measures the potential difference of the
two half‐cells. This difference potential is sent to a microprocessor, which calculates
and records the electrolyte concentration. Figure  87.2 shows the constructional
details of a potentiometry‐based slide.

Measurement
When a specific test is required, a slide is automatically dispensed from the cartridge
that holds the slides for specified tests. A small drop of the patient’s blood is applied to
the slide by the analyser. The analyte in the sample catalyses the reaction sequence to
develop products of specific colours. The colour measurements are made at wave-
lengths in the visible region (340–680 nm). The basic principle of dry chemistry is based
upon the reflectance spectrophotometry. A reflectance spectrophotometer is similar to
a standard UV–visible spectrophotometer. Reflectance measurements are made using
both diffused and specularly reflected light. In diffused reflectance, light is scattered in
all directions from the sample. The scattered light can be collected onto an optical
detector, and the surface reflectance is measured either at a given wavelength or by

Specimen (50 μl)

Reference Bridge
solution
Multilayered
film electrode
Electrode Partition
Cl K
terminal Na materials

Potentiometer

Figure 87.2  Dry chemistry‐based electrolyte measurement by potentiometric technique.

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performing a scan over a range of wavelengths. Such a wavelength scan can then be
used to characterize colour.
Modern dry film‐based instruments are capable of analysing over 20 biochemistry
parameters using single or multiparameter strips. Multiparameter strips can carry out
several tests on a single sample and are available for analysing kidney, liver, heart, and
many other parameters simultaneously.

­Specifications
Sample: Serum, plasma, and whole blood
Parameters: Colorimetry (28 tests), electrolyte (3 tests)
Warm‐up: 10 minutes (25 °C)
Processing speed: 120 tests/h
Data storage: 100 measurements
Calibration: Calibration by magnetic card

­Applications
Applications of the dry chemistry include patient screening, use in health clinics, mobile
health services, polyclinics, and hospital in‐patients including point‐of‐care testing in
critical care areas.

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