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Test Code
215
Plasma/Serum test for Serum amyloid A (SAA)
Date of issue:1/June/2019
FUJI DRI-CHEM IMMUNO AU CARTRIDGE vf-SAA
[Warnings and precautions] [Principle of the measurement]
1. Only the required number of cartridges should be taken out of the The FUJI DRI-CHEM IMMUNO AU CARTRIDGE vf-SAA test is based
refrigerator and warmed up to room temperature before opening the on Sandwich Immunoassay method. When a specimen is applied to a
individual packages. cartridge, the specimen and the dried fluorescence particle-labeled anti-
2. Do not touch either the Excitation Light Entrance or the Detection SAA mouse monoclonal antibody (referred to as “fluorescence particle-
Window of the cartridge. labeled antibody” from hereon) enclosed in the cartridge are mixed. SAA
3. Do not touch the seal on the cartridge. Do not Use a cartridge with in the specimen reacts with a fluorescence particle-labeled antibody.
broken seals. The mixture then reacts continuously with Anti-SAA mouse monoclonal
4. When a cartridge is once set to an ANALYZER and the ‘START’ key antibody (referred to as “solid-phase antibody” from hereon) immobilized
on the cartridge. The fluorescence particle-labeled antibody-SAA complex
is pressed, the seal will be broken. Do not reuse besides the following
in the specimen binds to the solid-phase antibody. These fluorescence
exceptions.
particles are activated by excitation light (excitation wavelength 650-
- A cartridge can be used again as long as, i) the error code shown
665nm) through the gold coating film. The fluorescence generated is
below is displayed on the analyzer, and ii) a cartridge seal is broken
directly proportional to the SAA concentration of the specimen.
within 60 minutes.
1)Fluorescence particle-labeled anti - SAA mouse monoclonal antibody + SAA
- During a process of dispensing specimen in measurement with Fluorescence particle-labeled anti - SAA mouse monoclonal antibody : SAA
dilution, a cartridge can be used again as long as i) the error code
shown below is displayed on the analyzer, and ii) re-start is done within 2)Fluorescence particle-labeled anti - SAA mouse monoclonal antibody : SAA + Anti - SAA
mouse monoclonal antibody (solid-phase)
10 minutes. (For further details on error code, consult “INSTRUCTION Fluorescence particle-labeled anti - SAA mouse monoclonal antibody : SAA : Anti - SAA
MANUAL” for FUJI DRI-CHEM IMMUNO AU10V.) mouse monoclonal antibody
Error code
E0102 (Suction clog error) [Additional special equipment]
E0112 (No sample aspirated) Analyzer :FUJI DRI-CHEM IMMUNO AU10V
E1013 (Liquid surface error)
Other implements :FUJI DRI-CHEM AUTO TIPS
E1014 (Sample shortage error)
:FUJI HEPARIN/PLAIN TUBE (0.5 mL or 1.5 mL)
5. Do not use a cartridge dropped to the floor. There is a possibility that :Pharmaceutical grade saline (Used as a diluent)
the cartridge is damaged.
6.A new cartridge must be used for each measurement. Do not reuse. [Specimen requirements]
7. Handle all patient specimens carefully as biohazardous samples. Wear 1. Immediately carry out the measurement after collecting the blood
proper gloves, glasses and other protective gear for your safety. specimen.
8. Used cartridges are categorized as infectious waste. Make sure to 2. For plasma, heparin can be used as the anticoagulant. When using
dispose them in accordance with the Waste Disposal Law and other heparin, less than 50 units of heparin should be used per 1 mL of
whole blood. Do not use EDTA salt, sodium fluoride, citric acid, oxalic
related regulations, which prescribe the proper method of disposal,
acid and monoiodoacetic acid.
such as incineration, melting, sterilization or disinfection.
3. Collect the specified amount of blood into the blood collection tube
9. Use pharmaceutical grade saline for diluting the specimen.
as instructed by the manufacturer, when using blood collection tube
10. Once the diluent has been dispensed, immediately set the specimen
containing a separation gel.
and press the start button as instructed. If the time elapsed after the 4.Avoid using plasma/serum with precipitate such as fibrin.
diluents has been dispensed exceeds 10 minutes, a test results error
will occur (“@” mark will be shown with the results). Measure the [Procedure]
specimen again. 1. Prepare the FUJI DRI-CHEM IMMUNO AU CARTRIDGE vf-SAA, the
11. Test results from manually diluted specimen are not guaranteed to be specimen containing FUJI PLAIN TUBE (or FUJI HEPARIN TUBE), the
accurate. diluent containing FUJI PLAIN TUBE and tips.
2. Input Sequence No. and Sample ID, if necessary.
12. Be sure to set a specimen after the diluent has been dispensed in
3. Simultaneously press the right (>) and down (V) cursor keys to switch
measurements with dilution. (If the diluent is set as a specimen, a test
to the measurement with dilution mode. [SET TIP & DILUENT then
result within the dynamic range may be obtained.)
START] will be displayed. The specimen will be diluted 10 folds prior to
[Composition of the cartridge] measuring.
1. Top side of the cartridge 4. Set a FUJI DRI-CHEM IMMUNO AU CARTRIDGE vf-SAA, a diluent
Excitation Light Entrance containing FUJI PLAIN TUBE and a tip in the analyzer.
5. Close the sample set cover and press the “START” key.
6. The machine will automatically dispense the diluents. After dispensing,
Detection Window the diluent containing FUJI PLAIN TUBE and cartridge will return back
to their consumables set positions. [SET TIP & SAMPLE then START]
will be displayed.
Seal 7. Take out the diluents containing FUJI PLAIN TUBE.
8. Set a specimen containing FUJI PLAIN TUBE (or FUJI HEPARIN
2. Ingredients enclosed in the cartridge TUBE) and a tip in the analyzer.
9. Close the sample set cover and press the “START” key.
· Fluorescence particle-labeled anti- Serum amyloid A (SAA) mouse
10. The analyzer will dispense the specimen into the cartridge and
monoclonal antibody
will automatically perform the fluorescence measurement. The
· Anti- Serum amyloid A (SAA) mouse monoclonal antibody
calibration of this product has already been accomplished in our
[Intended use] factory before shipping using internal calibrators which are not
Quantitative measurement of SAA concentration in plasma or serum from commercially available. Based on the calibration data stored in QR
feline. Code pasted on the cartridge, a test result will be displayed. Test
For veterinary use only. results from measurements with dilution are shown with “D” marks.
If a measurement is made without dilution by mistake, >225 g/mL is
displayed. Check the D mark.
QR Code is registered trademark of DENSO WAVE INCORPORATED.
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[Reference interval] [Contents]
< 5.49 g/mL : Cartridge 10
The reference interval (97.5 percentile) given here was determined
http://www.fujifilm.com/products/medical/
using blood samples from 83 healthy cats at the laboratory of FUJIFILM
Corporation. For EU only : Imported by :
As the reference interval depends on the population of the test, it is FUJIFILM Europe B.V.
required that each laboratory sets its own reference interval. The clinical Oudenstaart 1, 5047 TK Tilburg, The Netherlands
diagnosis must be carried out by the veterinarian in charge based on the
measured results in the light of clinical symptoms and other test results. 26-30, Nishiazabu 2-Chome, Minato-ku, Tokyo, 106-8620, JAPAN
[Performance characteristics] [Symbols]
1. Dynamic range 3.75 - 225.0 g/mL
2. Accuracy Concentration range Accuracy
3.75 - 20.00 g/mL Within ± 4.00 g/mL Do not reuse
20.00 - 225.0 g/mL Within ± 20%
9905120
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