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Dri-Chem Book
Dri-Chem Book
Dri-Chem Book
O n l y o n e d ro p …
BOOK
… Fu l l t i m e Re a l t i m e .
O n l y o n e d ro p …
BOOK
… 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 …
BOOK
… 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 (ie, test data),
are like a mirror reflecting the physiological state of the patient, and Cerebrospinal fluid tests, gastroduodenal
Body fluids fluid tests, seminal fluid tests, amnio tests
biochemical tests form the basis of clinical tests that play a key role in
addition to the physical examination. For example, most people are Pathological tests
Tissues and cells (To identify cancer or viral infections)
familiar with tests related to adult-onset diseases such as glucose
In Biochemical tests, urine and spinal fluid are sometimes used aside
(blood sugar), which is indispensable in the diagnosis of diabetes, total from blood. Test using blood as a sample is called blood chemistry test.
Imaging
X-rays
tests
Ultrasonic
MRI
Direct
tests CT
Brain waves
Blood pressure
Function
tests ECG (electrocardiogram)
EMG (electromyogram)
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O n l y o n e d ro p …
BOOK
… Fu l l t i m e Re a l t i m e .
Clinical
FUJI DRI-CHEM can use [Blood processing and types of samples]
=
or serum obtained after centrifuging coagulated whole blood. Also, Bacteriological
tests
because glucose in blood is consumed after blood sampling, a [microbiologic tests]
glycolysis inhibitor is used in conjunction with anticoagulants in blood Whole Heparin whole blood
(EDTA whole blood) Plasma
Bacteria tests
blood Asplration
used for glucose tests.
accumulation
Blood cell Immunological
tests
separating
membrane
Glass fiber [Serum tests, serum
Centrifugation Centrifugation
layer for immunological tests]
blood cell
separation Testing for infectious diseases,
etc. using antigen-antibody
Sample reaction
Tube
Serum Plasma
[Types of Blood Sampling] Plasma Filter
Biochemical tests
Blood Clot Hemocyte portion Plasma Filter(PF) can cut the turn [Blood chemistry tests]
(sticky and [hematocrit (Ht)] around time and the pre-treatment
process of the sample. It can Measurement of amounts and
Venous blood samples static) (redispersed by shaking) generate plasma sample by
activities of chemical
aspirating and separating the whole
The conventional blood inside the PF within 1 minute. components contained within this
Fibrin matrix Fibrinogen Just set the PF on top of the liquid portion of blood
blood sampling Capillary blood samples (fibers) (cellulose, soluble) sample tube and press START.
method. Blood is
withdrawn by syringe Ear lobe blood sampling (capillary)
or vacuum into a Fingertip prick blood sampling
tube or syringe.
Heel cut blood sampling (newborns) Hematology-related technical terms Glycolysis inhibitors
Since erythrocytes are still alive after blood has been withdrawn they
continue to consume glucose, resulting in decrease of the measured
Arterial blood samples Anticoagulant
value of glucose. Glycolysis inhibitors stabilizes the blood glucose value.
Components such as heparin, EDTA, and citric acid that prevent
Used primarily for the blood clotting. Hematocrit (Ht, Hct)
measurement of Vacuum blood sampling tubes Blood cell separating agents When whole blood is centrifuged the solid components such as
blood gases. erythrocytes, leucocytes, and platelets go to the bottom. The hematocrit is
Vacuum blood sampling tubes, Blood cell separating agents, which are gels that have a specific gravity
defined as the percentage of the total volume accounted for by these
partway between blood clots and plasma, produce better separation
which are used most often, may between the solid blood components (blood clots and blood cells) and solid components. (Normal range: 38% to 47%)
plasma and serum during centrifugation and stabilizes plasma and
already contain, depending on serum.
Hemolysis
The rupturing of the membrane of sac-shaped erythrocytes with the
the usage, an anticoagulant, 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
coagulation accelerator, or that accelerate the fibrination of fibrinogen, accelerate coagulation, and specimen for biochemical tests because it contains the liquid contents
blood separating agent. shorten the length of time to arrive at the serum fraction. from erythrocytes with markedly different amounts of chemical components.
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BOOK
… Fu l l t i m e Re a l t i m e .
Clinical
Test items
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O n l y o n e d ro p …
BOOK
… Fu l l t i m e Re a l t i m e .
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 (CRP is an exception). Correction using a QC (ii) Check amount of reagent remaining (ii) Preparation and replacement of
liquids are not required. card is not needed for 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]
Assays the electrolytes in the specimen. The specimen and an electrolyte reference solution with a fixed
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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Analyzer
for infectious diseases
Nasal Throat Corneal and
conjunctival
swab swab swabs
When pathogens such as bacteria or viruses infect people, they multiply
Nasal Nasal
in the blood and at the local infected area. These pathogens and aspirate discharges
biogenic substances (components) are called immunological
parameters because antigen-antibody reactions (immunological
reactions specific for each component) are used to analyze them.
Detection of these immunological parameters helps the diagnosis of
some infectious diseases.
Immunological Analyzer
Extract
Respiratory Illness
FluAB Influenza virus type A Nasal swab
and B antigen It is a sample specimen collected by inserting a sterilized cotton swab intranasally and then delicately scrubbing the
StrepA Group A beta-hemolytic nasoturbinate with the swab.
streptococcus antigen Nasal aspirate
Adeno Adenovirus antigen It is a specimen collected with an aspirate swab. Collect the nasal aspirate by inserting the aspirate tube in the inner
nasal cavity.
Throat swab
It is a specimen collected by inserting a sterilized cotton swab to the throat through the mouth cavity then rubbing the
posterior wall of the pharynx and the reddened area of the tonsils.
Nasal discharges
Specimen collected by sneezing onto a tissue paper.
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2.Spread of
washing buffer
Washing buffer
sending pad
Porous carrier
3.Spread of Ag+ Solution
Ag+ solution
Immunological Analyzer
Absorber
Sample drop Conjugate pad Detection line Control Line The figure above shows the structure of the IMMUNO AG cartridge FluAB, an influenza
section Labeled antibody Antibody that will react Antibody which reacts virus detection kit. The sample spreads to the test trip like the conventional methods (1).
with the Antigen (virus) Labeled antibody
After the spreading and reaction of the sample with the reagents, excess labeled
antibodies are removed by washing with buffer (2). This is to prevent false positive results.
Next, silver amplification is performed to increase the sensitivity of the detection (3).
Reducing agent and silver ions run through the membrane forming silver clusters around
Sample liquid
the gold particles. The SEM images (below) were taken before and after silver
Antigen (virus)
Flow of sample liquid amplification, showing the increase size of the complex after amplification.
Through the silver halide photography technology, the detection sensitivity of the virus has
significantly improved. This enables the detection even for samples from the initial onset
stage of the disease, where the virus quantity is small.
The detection line is colored The line is colored when the
when virus exists. liquid has properly spread. MAb conjugated with Silver particle
gold nano particle after amplification
before silver (6 μm)
amplification (50 nm)
Amplify the size
by 100-fold
When a sample liquid containing an antigen (virus) is dropped onto the sample drop section,
the labeled antibody in the conjugated pad is specifically bound to the antigen. The sample Before After
liquid is spread horizontally by the capillary force of the porous carrier and absorbed by the Silver particle after amplification
absorber. The detection line on the porous carrier is coated with an antibody that reacts Ag+ + Fe2+ Colloidal gold
Ag + Fe3+ (10 μm)
specifically with a virus. The label is fixed to the detection line with the virus sandwiched
between the antibody and the labeled antibody. That colors the detection line and indicates MAb conjugated with gold nano particle
before silver amplification (50 nm) Ag
that the result is positive.
Au Ag ion
Conjugated antibody Au
+ Reducing reagent
Antigen
Capture antibody
Test line
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For
For plasma
Category Parameter name whole
and serum
blood
10 Cholinesterase CHE-P
11 Lipase LIP-P
1 Glucose GLU-PⅢ
2 Blood urea nitrogen BUN-PⅢ
3 Creatinine CRE-PⅢ
4 Uric acid UA-PⅢ
5 Total cholesterol TCHO-PⅢ
6 HDL cholesterol HDL-C-PⅢD
7 Triglycerides TG-PⅢ
General 8 Total bilirubin TBIL-PⅢ
chemistry 9 Direct bilirubin DBIL-PⅡ
10 Calcium Ca-PⅢ
11 Inorganic phosphorus IP-P
12 Total protein TP-PⅢ
13 Albumin ALB-P
14 Ammonia NH3 -PⅡ NH3 -WⅡ
(for plasma)
15 Magnesium Mg-PⅢ
1 Sodium
3 Chloride
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