Use after reading this “Instructions for Use” For veterinary use only

Plasma/Serum test for amylase

Date of issue: 1/Jan/2011
FUJI DRI-CHEM SLIDE v-AMY-P
[Warnings and precautions] [Procedure]
1. Only the required number of slides should be taken out of the refrigerator and 1. Read in the new QC-card when you switch to a new box of slides.
warmed up to room temperature before opening the individual packages. 2. Set slides on FUJI DRI-CHEM ANALYZER.
2. Do not touch either the center part of the surface or the back of the colorimetric 3. Set a sample tube in the specified sample rack.
slide. 4. Set the reference fluid in the specified position.
3. A new slide must be used for each measurement. Do not reuse. 5. Input a sequence No. and a sample ID if appropriate.
4. Handle all patient specimens, control serum and used tips carefully as 6. Press the “START” key to initiate testing.
biohazardous samples. Wear proper gloves, glasses and other protective gear For further details of operation procedure, consult “INSTRUCTION MANUAL”
for your safety. for FUJI DRI-CHEM ANALYZER.
5. Used slides are categorized as infectious waste. Make sure to dispose them
in accordance with the Waste Disposal Law and other related regulations,
[Performance characteristics]
which prescribe the proper method of disposal, such as incineration, melting,
1. Dynamic range 100–2500 U/L (1.67–41.75 μkat/L)
sterilization or disinfection.
2. Accuracy Concentration range Accuracy
100–2500 U/L Within ± 20%
[Composition of the slide]
1. Multi-layered structure 3. Precision Concentration range Precision
Specimen
↓ 100–2500 U/L CV <
=6%

Spreading layer
1

4. Known interfering substances

Water absorbing layer
(1) Maltose gives minus bias.
5

Transparent support
(2) The effects on the measured value were examined by adding substances as
4

shown below to a serum sample obtained from a healthy volunteer or a control

3

Barcode side
serum. No significant effect was observed to the following concentration for
0

2. Ingredients per slide each substance.

9

• 4,6-ethylidene-4-nitrophenyl-a-D-maltoheptaoside 0.42 mg (0.32 μmol) Ascorbic acid 0.57 mmol/L

1

• a-Glucosidase 0.8 U Bilirubin 255 μmol/L*

Total protein 40– 95 g/L
Glucose 16.6 mmol/L
[Intended use]
v-AMY-P

(3) Presence of macroamylase in the sample is known to give minus bias.

Quantitative measurement of amylase activity in plasma or serum. These results are representative;
For veterinary use only. • Test condition may have some influence on your results.
• Interferences from other substances are not predictable.
*At the normal range of amylase activity.
[Principle of the measurement]
10 μL of plasma or serum is deposited on a v-AMY slide.
The specimen is distributed uniformly by the spreading layer and reacts with [Internal quality control]
the substrate (4,6-ethylidene-4-nitrophenyl-a-D-maltoheptaoside : Et-G7-PNP). 1. The accuracy and precision of this product can be evaluated with control
The product generated by amylase is further decomposed by a-glucosidase materials such as pooled serum.
to release p-nitrophenol. The increase of absorbance by the generated dye is 2. Concentration levels of the control materials should be adjusted in accordance
measured from 1.5 min to 3 min at 400 nm by reflective spectrophotometry and with clinically significant levels or individual purpose.
the amylase activity is calculated according to the installed formula. 3. The control materials should be measured in the same way as patient samples.
Amylase 4. We recommend that control limits be established for assayed analytes so as to
Et-G7-PNP Et-Gm + Gn-PNP (m+n=7, n=2, 3, 4) enable assessment of the control status.
α-Glucosidase If results are found outside of the control limits, investigate the cause before
Gn-PNP Gn+ PNP
submitting reports.
[Additional special equipment]
Analyzer: FUJI DRI-CHEM ANALYZER [Traceability of calibrators and control materials]
Other implements: FUJI DRI-CHEM QC CARD (attached) The calibration of this product has already been accomplished in our factory
: FUJI CLEAN TIPS or FUJI AUTO TIPS before shipping using internal calibrators which are not commercially available.
: F UJI HEPARIN/PLAIN TUBE or Blood collection tube Calibration data are supplied by a QC card enclosed in this package. Assigned
specified in the “INSTRUCTION MANUAL” for FUJI DRI- values of the internal calibrators for AMYL are traceable to a method with
CHEM ANALYZER 4,6-ethylidene-4-nitrophenyl-a-D-maltoheptaoside as a substrate.

[Specimen requirements] [Storage and shelf life]

1. After collecting the blood specimen, immediate measurement is recommended. 1. Storage: This product must be stored between 2 –8 °C (35.6–46.4 °F) before use.
2. For plasma, heparin is recommended to use as an anticoagulant. 2. Expiry date is printed on the carton.
When using heparin, less than 50 units of heparin should be used per 1 mL of 3. Use immediately after opening the individual package.
whole blood. Do not use EDTA salt, sodium fluoride, citric acid, oxalic acid and
monoiodoacetic acid.
3. Avoid using plasma or serum with precipitate such as fibrin. [Contents]
4. Do not use hemolytic plasma or serum. : Slide 24
5. When the measured value exceeds the upper limit of the dynamic range, dilute : QC card 1
the sample with saline. Since the data obtained by dilution may deviate more
widely than usual, the data should be treated as estimation. Do not use distilled
http://www.fujifilm.com/products/medical/
water for dilution.
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