【Product name】
Diagnostic Kit for C-reactive Protein (Immunochromatographic
assay)
【Package specification】
25 Tests/kit
【Intended use】
It is used for quantitative detection of C-reactive protein
(CRP) in human serum, plasma and whole blood. CRP is mainly used as
a non-specific inflammatory index.
【Test principle】
The kit is used the principle of fluorescence
immunochromatography. The CRP antigen in the sample first combines
with the fluorescent labeled CRP monoclonal antibody conjugate, and
then continues to move and combine with another CRP monoclonal
antibody fixed on the nitrocellulose membrane to form a double
antibody sandwich immune complex at the detection line of
nitrocellulose membrane. The quantitative detection results are
obtained by NIR-1000 dry fluoroimmunoassay analyser.
【Main components】
name Loading capacity component
Test card 25 It is composed of fluorescent pad (coated with
fluorescent labeled CRP monoclonal antibody), nitrocellulose
membrane (coated with CRP monoclonal antibody and Goat anti mouse
IgG antibody), absorbent paper and backing
Sample diluent 25 Phosphate buffer
ID card 1 Record the standard curve information of this batch of
reagents
The components in different batches of kits cannot be used
interchangeably.
【Storage conditions and validity period】
4℃ - 30℃, dry, dark, no freezing, sealed in aluminum foil bag,
valid for 18 months. The test card should be returned to room
temperature (15-30)℃ before use, and should be used within 15
minutes after unsealing under the environment of temperature
(15-30) ℃ and relative humidity (20% - 90%).
The production date, batch number and expiration date are shown in
the outer package of the product.
【Applicable instruments】
NIR-1000 dry fluoroimmunoassay analyser produced by WWHS Biotech.
Inc.
【Test procedure】
1. Before the test, please read the instructions completely. If the
test card and sample are stored in cold storage, they should be
balanced at room temperature (15-30)℃ for not less than 30min
before use.
2. Start NIR-1000 dry fluoroimmunoassay analyser according to the
instruction manual of the instrument, and carry out quality control
verification according to the instruction manual of the
instrument(Note: the reagent has been calibrated in advance, and
the calibration curve parameters of each batch of reagent have been
stored in the ID card. The test can be carried out only after the
quality control is passed. Otherwise, the cause should be found out
before testing.)
3. Remove the test card from the aluminum foil bag and use it
within 15 minutes.
4. Place the test card on a clean horizontal table and mark it
horizontally.
5. Add 5μL sample to sample diluent (1500μL), mix well and add
100μL diluted sample to the sampling hole.
6. Insert the test card into dry fluoroimmunoassay analyser, press
the “timing test” key, automatically time for 3 minutes,
automatically judge the test results, and display the quantitative
results on the screen. Or insert the test card into the analyzer
after 3 minutes, and press the “Instant test” key, and the
instrument will automatically interpret the results.
【Reference interval】
252 healthy people aged 19-80 were tested. The upper limit of CRP
reference value was 10mg/L at 95th percentile. Reference interval:
CRP<10mg/L.
It is suggested that each laboratory should establish its reference
range according to the characteristics of local population.
【Interpretation of test results】
1. This reagent is only used for auxiliary detection. If the test
results are abnormal, it should be reviewed in time and judged in
combination with clinical symptoms.
2. For samples with CRP concentration lower than 0.5mg/L and higher
than 200mg/L, the test results were reported as "<0.5mg/L " and
">200mg/L" respectively.
【Limitations of test methods】
1. This kit is only used to detect human serum / plasma / whole
blood samples.
2. Due to the limitations of serological methods for antigen and
antibody reactions, the results obtained by detection cannot be
used as the only basis for clinical diagnosis, but should be
evaluated together with all existing clinical and experimental
data.
3. The contents of triglyceride, hemoglobin and bilirubin in the
samples were not more than 20 mg/ml, 10 mg/ml and 0.4 mg/ml,
respectively, and the relative deviation of the test results was
not more than 0.5%±10%.
4. When the concentration of C-reactive protein was less than 400
mg/L, there was no hook effect.
5. When the concentration of human anti mouse in the sample is less
than 50ng/ml, HAMA effect will not be produced.
6. When the RF concentration in the sample is less than 2000 IU/ml,
the relative deviation of the detection results is not more
than±10%.
【Performance】
1. Detection limit: No higer than 0.5mg/L.
2. Accuracy: the relative deviation from the target value is not
more than±10%.
3. Repeatability: coefficient of variation (CV) should be no more
than 10%.
4. Inter batch difference: the relative range (R) between batches
should be no more than 15%.
5. Linear range: within the specified linear range of
0.5mg/l-200mg/l, the linear correlation coefficient R ≥ 0.990.The
absolute deviation of the linear range in [0.5-5] mg/L is not more
than ±5 mg/L, the linear range is (5-200] mg/L, the relative
deviation is less than±10%.
【Note】
1. The kit is only used for in vitro diagnosis.
2. The test card is disposable and cannot be reused.
3. Please check the integrity and validity of the kit package
before use, and then open the package. When it is stored at low
temperature, it should be restored to room temperature (15-30) ℃
before opening the package for use. The reagents with damaged inner
package and beyond the validity period cannot be used.
4. The test card should be taken out from the aluminum foil bag and
tested within 15 minutes to avoid being placed in the air for a
long time and causing damp.
5. The requirements of specimen collection and storage should be
strictly observed. If the specimen is turbid, it should be
centrifuged and discarded before use.
6. The kit contains products from animals. The qualified
information of animal source and health status cannot guarantee the
existence of infectious pathogens. Therefore, it is suggested that
these products should be treated as potential infectious
substances, and all samples, reagents and potential pollutants
should be disinfected and treated according to the relevant local
regulations.
7. Hematocrit too high or too low may affect the results of whole
blood test, it is recommended to use other detection methods for
verification.
Interpretation of Test Results
1. The kit can be used for auxiliary test only. If test result is
abnormal, retest timely and judge combined with clinical symptoms.
2. For samples whose cTnI concentration is lower than 0.1ng/mL and
higher than 40ng/mL, test result is “<0.1ng/mL” and “>40ng/mL”
respectively.
Package and Delivery
Packing Details : Standard carton package or as demand.
Delivery Details : 5-15days after payment
We support a variety of transportation modes, including land
transportation, sea transportation, air transportation, DHL,
Fedex,TNT and other international logistics express.