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O n l y o n e d ro p …
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… Fu l l t i m e Re a l t i m e .
O n l y o n e d ro p …
GUIDE
… Fu l l t i m e Re a l t i m e .
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O n l y o n e d ro p …
GUIDE
… Fu l l t i m e Re a l t i m e .
Clinical
Clinical tests and [Clinical Tests]
Clinical tests are a scientific approach to diagnosing a disease based on objective information
are like a mirror reflecting the physiological state of the patient, and Cerebrospinal fluid tests,
Body fluids seminal fluid test
biochemical tests form the basis of clinical tests that play a key role in
addition to the physical examination. Pathological tests
Tissues and cells (To identify cancer or viral infections)
In Biochemical tests, urine and spinal fluid are sometimes used aside
from blood. Test using blood as a sample is called blood chemistry test.
Endoscope
Imaging
X-rays
tests
Ultrasonic
MRI
Direct CT
tests
Brain waves
ECG (electrocardiogram)
Function
tests Blood pressure
EMG (electromyogram)
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Clinical
FUJI DRI-CHEM can use [Blood processing and types of samples]
Whole blood drawn from a patient coagulates when it leaves the body [Laboratory Tests]
and the components change their form, so it is unstable and therefore Blood cell
Anticoagulant (+ glycolysis inhibitor) Blood tests
not appropriate as a specimen for most of the tests. Stable samples separating agent [Hematological tests]
Number, shape, color, and
for biochemical tests can be plasma obtained by centrifuging whole type of RBC, WBC, and
=
platelets, hemorrhaging,
blood, or serum obtained after centrifuging coagulated whole blood. coagulation
Also, because glucose in blood is consumed after blood sampling, a
Bacteriological tests
glycolysis inhibitor is used in conjunction with anticoagulants in blood Whole Heparin whole blood
(EDTA whole blood)
[microbiologic tests]
blood Bacteria tests
used for glucose tests.
Immunological tests
[Serum tests, serum
Centrifugation Centrifugation immunological tests]
Testing for infectious diseases,
etc. using antigen-antibody
reaction
Serum Plasma
[Types of Blood Sampling] Biochemical tests
Blood Clot Hemocyte portion [Blood chemistry tests]
(sticky and [hematocrit (Ht)] Measurement of amounts and
Venous blood samples static) (redispersed by shaking) activities of chemical
The conventional components contained within
Fibrin matrix Fibrinogen this liquid portion of blood
blood sampling Capillary blood samples (fibers) (cellulose, soluble)
method. Blood is
withdrawn by syringe Ear lobe blood sampling (capillary)
or vacuum into a
tube or syringe.
Hematology-related technical terms Glycolysis inhibitors
Since erythrocytes are still alive after blood has been withdrawn they
Vacuum blood sampling tubes continue to consume glucose, resulting in decrease of the measured
Arterial blood samples Anticoagulant
Vacuum blood sampling tubes, Components such as heparin, EDTA, and citric acid that prevent
value of glucose. Glycolysis inhibitors stabilizes the blood glucose value.
Used primarily for the which are used most often, blood clotting. Hematocrit (Ht, Hct)
measurement of Blood cell separating agents When whole blood is centrifuged the solid components such as
blood gases. may already contain, erythrocytes, leucocytes, and platelets go to the bottom. The hematocrit is
Blood cell separating agents, which are gels that have a specific gravity
depending on the usage, an partway between blood clots and plasma, produce better separation defined as the percentage of the total volume accounted for by these
solid components. (Normal range: 38% to 47%)
anticoagulant, coagulation between the solid blood components (blood clots and blood cells) and
plasma and serum during centrifugation and stabilizes plasma and Hemolysis
accelerator, or blood serum. The rupturing of the membrane of sac-shaped erythrocytes with the
separating agent. Coagulation accelerators release of the internal contents of the cells, such as hemoglobin, is referred
Substances such as silica powder, glass powder, snake venom, etc. to as hemolysis. Plasma in which hemolysis has advanced is not a suitable
that accelerate the fibrination of fibrinogen, accelerate coagulation, and specimen for biochemical tests because it contains the liquid contents
shorten the length of time to arrive at the serum fraction. from erythrocytes with markedly different amounts of chemical components.
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Clinical
Test items
Na, K, and Cl
Na, K, and Cl are very useful biochemical
test parameters for diagnosing the
abnormal state of a patient.
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Clinical
Special characteristics of [Comparison of measurement procedure]
merely placing a drop of specimen on a small slide containing dry reagents. Standard
biochemical test methods that use liquids are suitable if large sample volumes are processed all Measurement cell
at once. However, the measuring equipment tends to be bulky and there are various
time-consuming and laborious steps involved, such as rinsing with water, management of liquid
reagents, preparations before and clean-up after the measurements. Practice and skill is required
Incubation
for precision control and other aspects of the liquid method. On the other hand, the FUJI 37 C (98.6F)
DRI-CHEM method, which maximizes the advantages of dry chemistry, does not require any Measurement cell
rinsing with water, the measuring equipment is compact, and the procedure is simple and straight Transmission Measurement Reflex colorimetry Measurement
colorimetric measurement
forward. This means it is ideal for obtaining immediate measurements in emergency situations. measurement Light method
method source
No water needed Simple procedure
●There is no need to prepare purified water that is used to ●The basic procedure involves only 3 simple steps: “Setting of Display of measurement results
rinse the cells, or other parts inside the equipment, etc. in the slide and pipette tip”, “Setting the sample”, and “Pressing
liquid-based measurement methods. the start button”.
5 to 10 minutes
1 hour
Approximately
cleaning and rinsing needed by standard methods that use from the new lot . Correction using a QC card is not needed for (ii) Check amount of reagent remaining (ii) Preparation and replacement of
liquids are not required. electrolytes. (fill if necessary) Fuji Auto Tips and reference solution
●There are no substances or chemicals to dispose of. (iii) Calibration RE (for electrolytes)
(iv) Data check and confirmation of (iii) Preparation of slide of items
Minute amounts of samples normal state to be measured
●As only a minute amount of sample is required for a single
measurement [colorimetry: 10μL, electrolytes: 50μL (Na, K, Calibration
Cl)], the impact of blood sampling on newborns, the elderly, The liquid measurement method has built-in
Measurement
or a severely injured person can be greatly decreased.
reagent tanks inside the apparatus for each test (i) Rinsing/cleaning, check cell (i) Emptying of waste box
1 minute
30 minutes
Approximately
Automatic Dilution Function item. The calibration must be checked everyday, (ii) Turn power button to OFF (ii) Turn power button to OFF
●The troublesome dilution procedure can be done calibrator (liquid) must be measured regularly,
automatically. Just by setting a dilution fluid with the sample, and the reagent and equipment are corrected.
dilution will be performed with the assigned dilution factor.
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Clinical
Measurement principles [Potentiometric method slide]
Analyzer of FUJI DRI-CHEM slides concentration of electrolytes are applied to the slide. The concentrations of the electrolytes are measured by
the change in potential between two electrodes. One slide contains 3 types of film electrodes (Na, K, and
Cl) and all three can be measured at once simultaneously in only 1 minute.
There are 2 types of FUJI DRI-CHEM slides with a different measurement Example: Measurement of Na, K, Cl
principle, neither type requires the preparation of any reagents. External view of slide
Composition of slide
Example: Glucose Reference solution
Specimen
Filament bridge Measurement principle
External view of slide
Multilayer film electrode
Support medium
Distribution material Silver layer
Silver chloride layer
GLU-P (Cl)
(K)
(Na)
Electrolyte layer
Ion selection layer
Electrode Distribution material
terminal Reference solution Specimen Filament bridge
Electrometer
Electrometer
Front Back
Plastic mount
Reagent layer
After applying the drop of sample, the reagent reacts with the
sample and show colors
Spectrophotometer
Optically measures the level of color density corresponding to the amount
of the substance being tested for in the sample.
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Clinical
Stable manufacturing of Points in
Man : The same person or a person with the same skill
Material : Using a constant standard, degree of purity and material
We apply advanced technologies we have cultivated for photo film. "Stabilizing the manufacturing process" brings high precision into reality.
We apply manufacturing technologies of photo film cultivated for over 80 years in manufacturing Assuring reliability of measurement data in the biochemical analysis should be the condition to
FUJI DRI-CHEM slides. Technologies include the machining accuracy of the transparent support which highest priority should be given. FUJI DRI-CHEM slides have programmed manufacturing
media (film base) comprising of a multilayer structure and the technology to apply a reagent layer processes such as procurement of raw material, prepared liquid, film-based film-forming,
that reacts to the object substance in a sample and a reflection layer that blocks off blood pigments. application of the reagent layer/reflection layer, drying, bonding of the spreading layer and cutting
The world’s top level fine chemistry, processing technology and quality control have built a new and manufacturing environment in great detail. Thoroughly "stabilizing the manufacturing
possibility called dry chemistry in biochemical tests. condition" stabilizes the quality or establishes high precision. They are compliant with ISO13485.
Film-forming process
Prepared liquid Application and drying Cutting
Gelatin
Bonding of
spreading layer
Enzyme
Additive
Film base
We use only procured raw
materials satisfying our unique Processes from prepared liquid to
standard. We try to stabilize application and drying are repeated After the film is cut to a little less than 2 cm2,
the quality of the raw material. several times depending on the slide item. they are stored on the plastic mount.
Film-forming process Prepared liquid process Application process Drying process Cutting process
A rolled long strip-shaped This is the prepared liquid of the The reagent prepared on The film applied with the After the spreading layer is
film base (transparent reagent applied on the film base. The the film base running reagent is continuously fed to bonded, the rolled dry film is
Spreading layer
support medium) is formed type, the mixing ratio, the mixing order, and accurately the drying process. In addition set on the slitter (cutting
using PET (Polyester) as the the temperature and the time are controlled in a constant to stabilizing the indoor machine). The wide roll is Reagent layer
raw material. The machining strictly programmed by item and layer speed is applied to 0.1 condition, dry air is finely set to cut in round slices of about Transparent support
accuracy of this thin film is for gelatin, enzyme, pH buffering micron accuracy. This the temperature and humidity 1.2 cm in width and cut medium
evenly controlled to 0.1 agent, color fixing agent and additives application process and per item and layer considering again to about 1.3 cm in
micron paying due attention and prepared to always show a the subsequent drying the deactivation of enzymes length direction to form
to the permeation property constant reaction against the object process are carried out and then blown. The time to chips as small as
and the polarization ratio of substance in the specimen. As the under an indoor finish drying is accurately approximately 2 cm2 or less.
light. Multiple layers of a FUJI reagent layer and the reflection layer condition where light is controlled by improving the These film chips are stored
DRI-CHEM slide are formed vary depending on the item and always kept constant accuracy of the drying process on the plastic mount to
by overlapping other layers consist of a single layer or multiple and minute dust in addition to the prepared protect them and finish a
on this lowest layer. layers, the liquid is prepared per layer. particles are kept out. liquid and application. FUJI DRI-CHEM slide.
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Clinical
Features of Automated Measurement for
=
A lot
Correction coefficient suitable
manufactured with the same degree of for compensating the difference Faster and more accurate
shown by the green arrows.
quality, in fact, when judged from the (secondary)
Parameter identification
The test parameter and slide lot are identified by the barcode
or 2D dot code printed on the back of the slide. (The sample Waste box
application amount, measurement wavelength, reaction time, After use, slides and tips
and other information are also loaded at the same time.) are automatically
dropped into a waste
Sample application box. This eliminates
A predetermined amount of sample is applied to the slide time-consuming cleanup
quickly and accurately. and minimizes contact
with the sample.
Incubation and measurement
The sample is incubated for a certain reaction time at 37°C
(98.6°F), which is nearly the temperature of the human body,
and measured at a specific wavelength, and the calculated
measurement results are displayed and printed out.
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Immunological Analyzer
Pituitary gland
Adrenal gland
Thyroid
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Competitive method
For low molecular substances like T4 (thyroxine) and COR (cortisol)
Principle of Immunological Test System Measurement principles of T4
Light absorption
The equipment performs fluorometry using Surface Plasmon enhanced Fluorescence (SPF) method, T4
T4 T4
a technology based on Surface Plasmon Resonance (SPR), within a small cartridge. The SPF
BSA
technology has two major advantages which made
the realization of a compact sized Fluorescent beads (1) Test area (2) Control area 0 Antigen amount
Immunological Analyzer
When a specimen is applied to a cartridge, the specimen and the dried fluorescence particle-labeled anti T4 mouse monoclonal
advantage is it does not require a washing antibody enclosed in the cartridge are mixed. T4 in the specimen reacts with a fluorescence particle-labeled antibody. The mixture then
process for surplus fluorescent beads, making the reacts with T4-BSA, the solid phase antigen. Here, the T4 non-binding fluorescence particle-labeled antibody binds to the solid phase
antigen. These fluorescence particles are activated by excitation light through the gold coating film. The fluorescence is inversely
mechanical process of the equipment simple. proportional to the T4 concentration of the specimen.
Antigen
Second, since the fluorescence is enhanced by
SPR, a low power beam is sufficient eough to Antibody
TSH
Reagent Cup
Light absorption
TSH antibody
BSA
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For serum or
Category Parameter name plasma
1 Lipase v-LIP-P
Enzyme
2 Amylase v-AMY-P
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