3. Please
check the integrity and expiration date of the kit package
before use, then open the package, and when stored at low
temperature, it should be restored to *0~*0ºC before
opening the package for use. Direct use at low temperature
will affect the test results.
4. Whether
the patient has inflammatory bacterial infection should
be judged by the physician in combination with clinical
features and symptoms, as well
as other
diagnostic methods of the patient.
Limit of the
Test Method
1. The test
results can only be used as an aid to physicians or other
diagnoses, and need to be combined with other clinical
and laboratory data; if the
test results do
not match the clinical assessment, further examination is
required.
2. Bilirubin
≤0.5mg/mL, triglycerides ≤*0mg/mL, hemoglobin ≤5mg/mL,
within ±*0% deviation to the test results.
3. The HOOK
effect will not occur when the HbA1c concentration
content in the sample is ≤*0%.
4. If the
sample test result shows more than *4%, it is recommended
to dilute the sample with saline (the maximum dilution
should not exceed 1:5), and
the concentration
value of the test obtained after its dilution, then
multiply the dilution times to calculate the sample
concentration value.
Performance
Characteristics
1. Linear
range
In the range
of 4%**4%, the r value should be ≥ 0.**0.
2.
Accuracy
Detected
with the enterprise internal control accuracy reference
(C1, C2), the test results should be within the following
ranges.
(1)
Detection with the enterprise internal control accuracy
reference C1, the instrument measurement range is 6.4%
±*5% at *5 minutes.
(2)
Detection with the enterprise internal control accuracy
reference C2, the instrument measurement range is 8.4%
±*5% at *5 minutes..
3.
Intra-batch precision
Using the
enterprise internal control precision reference (C9, C*0)
each parallel test *0 times, at *5 minutes
instrumentation, the concentration
value coefficient
of variation CV≤*5%.
4.Inter-batch
precision
For three
batches of reagent kits, *0 times of parallel testing
with each enterprise internal control precision reference
(C9, C*0), and the
instrument measurement
at *5 minutes, the concentration coefficient of variation
CV≤*5%.
5.Detection
limit
Detection
with the enterprise internal control of the detection
limit reference L1, instrumentation at *5 minutes, the
results should be ≤4%.
6.Specificity
Detection
with the enterprise internal control specificity
reference (C3, C4, C5), the instrument measurement value
at *5 minutes should be less than 6%.
Notes
1. This kit
is only for in vitro diagnosis, one-time use, please do
not reuse.
2. Kits
should be treated as containing infectious
material.
3. Please
check the integrity of the kit packaging and expiration
date before use.
4. Please
read the instructions for use of this reagent and
instrument in detail before all operations.
5. Please
operate in strict accordance with the requirements of the
instructions. After the test starts, it cannot be stopped
halfway. If it is stopped halfway,
the test cannot
be resumed. If you need to retest, you must update the
reagents and retest.
6. Each
batch of reagents has corresponding parameters in the
supporting instrument, and the manufacturer updates the
parameters in the
instrument regularly.
If the new batch of reagents is not recognized by the
instrument, please contact the manufacturer to update the
parameters in time.
7. The test
card should not be used for more than 1 hour after
opening.
8. Reagents
with different batch numbers cannot be mixed, and ID
cards and test cards cannot be used with different batch
numbers.
9. Excessive
experimental temperature should be avoided, and the test
card stored at low temperature needs to be restored to
room temperature before opening to
avoid moisture absorption.
