FujiFilm FUJI DRI-CHEM IMMUNO AU CARTRIDGE vf-SAA User manual

[Warnings and precautions]
Only the required number of cartridges should be taken out of the
refrigerator and warmed up to room temperature before opening the
individual packages.
Do not touch either the Excitation Light Entrance or the Detection
Window of the cartridge.
Do not touch the seal on the cartridge. Do not Use a cartridge with
broken seals.
When a cartridge is once set to an ANALYZER and the ‘START’ key
is pressed, the seal will be broken. Do not reuse besides the following
exceptions.
- A cartridge can be used again as long as, i) the error code shown
below is displayed on the analyzer, and ii) a cartridge seal is broken
within 60 minutes.
- During a process of dispensing specimen in measurement with
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
10 minutes. (For further details on error code, consult “INSTRUCTION
MANUAL” for FUJI DRI-CHEM IMMUNO AU10V.)
Error code
E0102 (Suction clog error)
E0112 (No sample aspirated)
E1013 (Liquid surface error)
E1014 (Sample shortage error)
Do not use a cartridge dropped to the floor. There is a possibility that
the cartridge is damaged.
A new cartridge must be used for each measurement. Do not reuse.
Handle all patient specimens carefully as biohazardous samples. Wear
proper gloves, glasses and other protective gear for your safety.
Used cartridges are categorized as infectious waste. Make sure to
dispose them in accordance with the Waste Disposal Law and other
related regulations, which prescribe the proper method of disposal,
such as incineration, melting, sterilization or disinfection.
Use pharmaceutical grade saline for diluting the specimen.
Once the diluent has been dispensed, immediately set the specimen
and press the start button as instructed. If the time elapsed after the
diluents has been dispensed exceeds 10 minutes, a test results error
will occur (“@” mark will be shown with the results). Measure the
specimen again.
Test results from manually diluted specimen are not guaranteed to be
accurate.
Be sure to set a specimen after the diluent has been dispensed in
measurements with dilution. (If the diluent is set as a specimen, a test
result within the dynamic range may be obtained.)
[Composition of the cartridge]
1. Top side of the cartridge
Excitation Light Entrance
Detection Window
Seal
2. Ingredients enclosed in the cartridge
·Fluorescence particle-labeled anti- Serum amyloid A (SAA) mouse
monoclonal antibody
·Anti- Serum amyloid A (SAA) mouse monoclonal antibody
[Intended use]
Quantitative measurement of SAA concentration in plasma or serum from
feline.
For veterinary use only.
[Principle of the measurement]
The FUJI DRI-CHEM IMMUNO AU CARTRIDGE vf-SAA test is based
on Sandwich Immunoassay method. When a specimen is applied to a
cartridge, the specimen and the dried fluorescence particle-labeled anti-
SAA mouse monoclonal antibody (referred to as “fluorescence particle-
labeled antibody” from hereon) enclosed in the cartridge are mixed. SAA
in the specimen reacts with a fluorescence particle-labeled antibody.
The mixture then reacts continuously with Anti-SAA mouse monoclonal
antibody (referred to as “solid-phase antibody” from hereon) immobilized
on the cartridge. The fluorescence particle-labeled antibody-SAA complex
in the specimen binds to the solid-phase antibody. These fluorescence
particles are activated by excitation light (excitation wavelength 650-
665nm) through the gold coating film. The fluorescence generated is
directly proportional to the SAA concentration of the specimen.
1)Fluorescence particle-labeled anti - SAA mouse monoclonal antibody + SAA
Fluorescence particle-labeled anti - SAA mouse monoclonal antibody : SAA
2)Fluorescence particle-labeled anti - SAA mouse monoclonal antibody : SAA + Anti - SAA
mouse monoclonal antibody (solid-phase)
Fluorescence particle-labeled anti - SAA mouse monoclonal antibody : SAA : Anti - SAA
mouse monoclonal antibody
[Additional special equipment]
Analyzer :FUJI DRI-CHEM IMMUNO AU10V
Other implements :FUJI DRI-CHEM AUTO TIPS
:FUJI HEPARIN/PLAIN TUBE (0.5 mL or 1.5 mL)
:Pharmaceutical grade saline (Used as a diluent)
[Specimen requirements]
Immediately carry out the measurement after collecting the blood
specimen.
For plasma, heparin can be used as the anticoagulant. When using
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
acid and monoiodoacetic acid.
Collect the specified amount of blood into the blood collection tube
as instructed by the manufacturer, when using blood collection tube
containing a separation gel.
Avoid using plasma/serum with precipitate such as fibrin.
[Procedure]
Prepare the FUJI DRI-CHEM IMMUNO AU CARTRIDGE vf-SAA, the
specimen containing FUJI PLAIN TUBE (or FUJI HEPARIN TUBE), the
diluent containing FUJI PLAIN TUBE and tips.
Input Sequence No. and Sample ID, if necessary.
Simultaneously press the right (>) and down (V) cursor keys to switch
to the measurement with dilution mode. [SET TIP & DILUENT then
START] will be displayed. The specimen will be diluted 10 folds prior to
measuring.
Set a FUJI DRI-CHEM IMMUNO AU CARTRIDGE vf-SAA, a diluent
containing FUJI PLAIN TUBE and a tip in the analyzer.
Close the sample set cover and press the “START” key.
The machine will automatically dispense the diluents. After dispensing,
the diluent containing FUJI PLAIN TUBE and cartridge will return back
to their consumables set positions. [SET TIP & SAMPLE then START]
will be displayed.
Take out the diluents containing FUJI PLAIN TUBE.
Set a specimen containing FUJI PLAIN TUBE (or FUJI HEPARIN
TUBE) and a tip in the analyzer.
Close the sample set cover and press the “START” key.
The analyzer will dispense the specimen into the cartridge and
will automatically perform the fluorescence measurement. The
calibration of this product has already been accomplished in our
factory before shipping using internal calibrators which are not
commercially available. Based on the calibration data stored in QR
Code pasted on the cartridge, a test result will be displayed. Test
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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Test Code
215
Date of issue:1/June/2019
Use after reading this “Instructions for Use”
Plasma/Serum test for Serum amyloid A(SAA)
FUJI DRI-CHEM IMMUNO AU CARTRIDGE vf-SAA
１／２
For veterinary use only

[Reference interval]
<5.49 g/mL
The reference interval (97.5 percentile) given here was determined
using blood samples from 83 healthy cats at the laboratory of FUJIFILM
Corporation.
As the reference interval depends on the population of the test, it is
required that each laboratory sets its own reference interval. The clinical
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.
[Performance characteristics]
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
20.00 - 225.0 g/mL Within ± 20%
3. Precision Concentration range Precision
3.75 - 20.00 g/mL SD < 3.00 g/mL
20.00 - 225.0 g/mL CV < 15%
4. Correlation
Correlation was evaluated between Latex Agglutination Immuno-assay
and FUJI DRI-CHEM IMMUNO AU CARTRIDGE vf-SAA using feline
sera.
This examination was carried out at the laboratory of FUJIFILM
Corporation.
n Slope Intercept Correlation
Coefficient
Feline Serum 60 0.98 1.41 0.969
Correlation was evaluated between plasma and serum from feline
using FUJI DRI-CHEM IMMUNO AU CARTRIDGE vf-SAA.
This examination was carried out at the laboratory of FUJIFILM
Corporation.
n Slope Intercept Correlation
Coefficient
Feline 50 0.93 1.80 0.997
5. Known interfering substances
No significant effect was observed up to the following concentration for
each substance.
Chyle 2000 FTU
Hemoglobin 4000 mg/L
Bilirubin 340 mol/L
Total protein 60g-80 g/L
When high density lipoprotein cholesterol (HDL-C) concentration is
low, the result may have a plus bias. If HDL-C is high, the results may
have a minus bias.
In specimen having non-specific reactive substances such as
heterophilic antibody, interference to the reaction system occurs. In
this case, measurement may not be accurate. Clinical 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.
These results are representative;
·
· Test condition may have some influence on your results.
·
· Interferences from other substances are not predictable.
[Internal quality control]
The accuracy and precision of this product can be evaluated with
control materials such as pooled feline serum.
Concentration levels of the control materials should be adjusted in
accordance with clinically significant levels or individual purpose.
The control materials should be measured in the same way as patient
samples.
We recommend that control limits be established for assayed analytes
so as to enable assessment of the control status.
If results are found outside of the control limits, investigate the cause
before submitting reports.
[Storage and shelf life]
Storage: This product must be stored between 2–8 °C (35.6–46.4 °F)
before use.
Expiry date is printed on the carton.
Use immediately after opening the individual package.
[Contents]
: Cartridge 10
http://www.fujifilm.com/products/medical/
For EU only : Imported by :
FUJIFILM Europe B.V.
Oudenstaart 1, 5047 TK Tilburg, The Netherlands
26-30, Nishiazabu 2-Chome, Minato-ku, Tokyo, 106-8620, JAPAN
[Symbols]
Do not reuse
Lot number
Use by
Temperature limitation
Contains sufficient for <n> tests
Consult instructions for use
Manufacturer
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２／２ 9905120