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. HOOK effect
does not appear when cTnI concentration is
≤**0ng/mL,
4. If the
sample test result shows more than *0ng/mL, 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 0.1ng/mL ~*0ng/mL, 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 0.5ng/mL ±*5%
at *5 minutes.
(2) Detection
with the enterprise internal control accuracy reference
C2, the instrument measurement range is 5ng/mL ±*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 ≤0.1ng/mL.
6.Specificity
Detection with
the enterprise internal control specificity reference
(C3, C4, C5), the instrument measurement value at *5
minutes should be less than
0.1ng/mL.
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.
