GIM A S.p.A .
Via Marconi, 1
200 60 Gess ate ( MI) – I taly
www .g imaitaly.com
Invalid: if after performing the test, no color band for the reference band or
the control band is visible within the Result Window, the result is
considered invalid. Some causes of invalid results are not following the
directions correctly, such as insufficient amount of sample or buffer added
or the test may have deteriorated beyond the expiration date.
Note: a positive result will not change once it has been established at 7
minutes. However, in order to prevent any incorrect results, the test result
should not be interpreted after 7 minutes. Interpreting test results after 7
minutes, the sensitivity of the test will be higher than 1 mg/L. Some
specimens with a high rheumatoid factor concentration may yield a
nonspecific positive result
Limitations of the Test
Although the CRP Test is very accurate in detecting CRP, a low incidence of
false results can occur. Other clinically available tests are required if
questionable results are obtained.
As with all diagnostic tests, a definitive clinical diagnosis should not be based
on the results of a single test, but should only be made by the physician after
all clinical and laboratory findings have been evaluated.
Warnings
1. The same lancet needle should be used for one person only and
should not be shared with another person, because the used needle
is a biohazard.
2. Decontaminate and dispose of all specimens, reaction kits, lancet
needles and potentially contaminated materials, as if they were
infectious wastes, in a biohazard container.
3. Do not use the kit after the expiration date.
4. For professional in vitro diagnostic use only.
REV.0-02.19
Ameritech Diagnostic Reagent Co., Ltd
K4-2 Science Technology Garden, Economic Development Zone,
Tongxiang, ZJ, China
MADE IN CHINA
24527 / SQ182-116
CEpartner4U BV,
ESDOORNLAAN 13, 3951DB MAARN, THE NETHERLANDS
FOR PROFESSIONAL USE
Code 24527 Semi Quantitative hsCRP Test Disk
For Serum, Plasma or Whole Blood Specimen
Explanation of the Test
A C-reactive protein immunological test system is a device that
consists of the reagents used to measure by immunochemical
techniques the C-reactive protein in whole blood. Measurement of
C-reactive protein aids in evaluation of the amount of injury to body
tissues. For professional use only.
The Semi Quantitative CRP test is a highly sensitive test used to
detect CRP in whole blood. The sensitivity of the test is 1 mg/L CRP.
Materials Provided
The CRP test kit contains the following items to perform the test:
1. CRP test device.
2. Buffer.
3. Instructions.
4. Disposable sample dropper.
Precautions
The CRP test kit should be stored at room temperature or 4-30oC
(40- 86oF). The test device is sensitive to humidity as well as to heat.
Perform the test immediately after removing the test device from
the foil pouch. Do not use it beyond the expiration date.
Procedure of the Test
1. Remove the test disk from the foil pouch, and place it on a flat,
dry surface.
2. Collect fingertip blood if necessary (or venous
blood/serum/plasma) as shown in Figure 1.
3. Holding the sample dropper above the test disk and add 2
hanging drops of whole blood or 1 hanging drop of
serum/plasma into the Sample Well. (Figure 2).
4. Open the buffer bottle and hold it upside down. Make sure
holding the bottle vertically (note: drops may contains airbubbles if not holding the buffer bottle vertically), slowly add 3
to 4 hanging drops of buffer into the sample well. Note: add
the next drop after the previous drop is absorbed into the
sample well. (Figure 3)
5. As the test begins to work, you will see purple color dyes move
across the Result Window in the center of the test disk.
6. Interpret test results at 5 minutes. Do not interpret test results
after 7 minutes.
Caution: the above interpretation time is based on reading the
test results at room temperature of 15 to 30 degrees C. If your
room temperature is significantly lower than 15 degrees C, then
the interpretation time should be properly increased.
Interpretation of the Test (Figure 4):
1. A color band will appear at the left section of the Result
Window to show that the test is working properly. This
band is the Control Band (“C” band).
2. The middle section of the Result Window indicates the
Reference Band (“R” band).
3. The right section of the Result Window indicates the Test
Band (“T” band).
CRP concentration of less than 1 mg/L: there is no visible test
line (T).
CRP concentration of 1 mg/L or less than 3 mg/L: the intensity of
the test line (T) is weaker than reference line (R) indicating that
CRP level is 1 mg/L to less than 3 mg/L.
CRP concentration of 3 mg/L: the intensity of the test line (T) is
similar to the reference line (R) indicating that CRP level is 3 mg/L
CRP concentration higher than 3 mg/L: the intensity of the test
line (T) is darker than the reference line (R) indicating that CRP
level is higher than 3 mg/L.
Note: Generally, the higher the CRP level in the specimen, the
stronger the “T” band color will be. Very higher CRP level specimens
can cause reduced “T” line color intensity (Hook Effect).
Read instructions carefully
For in vitro diagnostic use only
Store between 4° and 30°C
Contains sufficient for “n” tests
Expiration date (see box / package)
Lot number (see box / package)
Authorized representative in the
European community
Disposable device, do not re-use
Product code
Keep away from sunlight
Keep in a cool, dry place
Read instructions carefully
Product complies with European
Directive no. 98/79/EC on In Vitro
diagnostic devices
Manufacturer
REV.6 - 02.18
Index of Symbols
Loading...