User Manual

User Manual
APPLICABLE DEVICE
Cardiac Troponin I Fast Test Kit
For in vitro Diagnostic Use
FIA8000 Quantitative Immunoassay Analyzer
Cat.# CG1001
User Manual
INTENDED USE
STORAGE AND STABILITY
Store the test card at 4~30℃ with a valid period of 24 months.
Use the test card within 1 hour once the foil pouch is opened.
Cardiac Troponin I Fast Test Kit is intended for in vitro qualitative and
semi-quantitative determination of cardiac Troponin I (cTnI) in serum, plasma
or whole blood. This test is used as an aid in the diagnosis of myocardial
injury such as Acute Myocardial Infarction (AMI), Unstable Angina, Acute
Myocarditis and Acute Coronary Syndrome (ACS).
SUMMARY
Troponin, a molecular complex that is bound to the thin filament (actin) of
striated muscle fibers, acts with intracellular calcium to control the interaction
of the thin filament with the thick filament (myosin), thus regulating muscle
contraction. Troponin consists of three subunits: T, which connects the
troponin complex and tropomyosin (another cardiac muscle regulatory
protein); I, which prevents muscle contraction in the absence of calcium; and
C, which binds calcium. Cardiac Troponin I (MW 22.5 kDa) and the two
skeletal muscle isoforms of Troponin I have considerable amino acid
sequence homology, but cTnI contains an additional N-terminal sequence
and is highly specific for myocardium.
Clinical studies have demonstrated the release of cTnI into the blood stream
within hours following acute myocardial infarctions (AMI) or ischemic damage.
Elevated levels of cTnI are detectable in blood within 4 to 6 hours after the
onset of chest pain, reaching peak concentrations in approximately 8 to 28
hours, and remain elevated for 3 to 10 days following AMI. Due to the high
myocardial specificity and the long duration of elevation, cTnI has become an
important marker in the diagnosis and evaluation of patients suspected of
having an AMI.
The current guideline of The Joint European Society of Cardiology/American
College of Cardiology Committee support the use of cTnI as a preferred
marker of myocardial injury. Several major studies have shown that cTnI is
also a predictor of cardiac risk in patients with unstable angina. The American
College of Cardiology and the American Heart Association’s current
guidelines recommend using troponin results when making treatment
decisions regarding unstable angina and non-ST segment elevation MI
(NSTEMI).
PRINCIPLE
The test uses an anti-human cTnI monoclonal antibody conjugated with
colloidal gold and another anti-human cTnI monoclonal antibody coated on
the test line. After the sample has been applied to the test strip, the
gold-labelled anti-human cTnI monoclonal antibody binds with the cTnI in
sample and forms a marked antigen-antibody complex. This complex moves
to the test card detection zone by capillary action. Then marked
antigen-antibody complex is captured on the test line by the anti-human cTnI
monoclonal antibody resulting in a purplish red streak appears on the test line.
The color intensity of the test line increases in proportion to the amount of
cTnI in sample.
CONTENTS
A kit contains:
1. Getein cTnI test card in a sealed pouch with desiccant ····················25
2. Disposable pipet·······································································25
3. User manual ··········································································1
4. SD card ·················································································1
5. Whole blood buffer····································································1
A test card consists of:
A plastic shell and a reagent strip which is composed of a sample pad, a
colloid gold pad (coated with gold-labelled anti-human cTnI monoclonal
antibody), nitrocellulose membrane (the test line is coated with anti-human
cTnI monoclonal antibody, and the control line is coated with rabbit
anti-mouse IgG antibody), absorbent paper and liner.
Whole blood buffer composition:
Phosphate buffered saline, proteins, detergent, preservative, stabilizer.
Note: Do not mix or interchange different batches of kits.
Store the whole blood buffer at 0~30℃ with a valid period of 24 months.
Store the whole blood buffer at 2~8℃ for better results.
PRECAUTIONS
1.
2.
3.
4.
5.
6.
7.
8.
For in vitro diagnostic use only.
For professional use only.
Do not use the kit beyond the expiration date.
Do not use the test card if the foil pouch is damaged.
Do not open pouches until ready to perform the test.
Do not reuse the test card.
Do not reuse the pipet.
Handle all specimens as potentially infectious. Proper handling and
disposal methods should be followed in accordance with local regulations.
9. Carefully read and follow user manual to ensure proper test performance.
SPECIMEN COLLECTION AND PREPARATION
1. This test can be used for serum, plasma and whole blood samples.
Heparin can be used as the anticoagulant for plasma and whole blood.
Samples should be free of hemolysis.
2. Suggest using serum or plasma for better results.
3. Serum or plasma can be used directly. For whole blood sample, one drop
of whole blood buffer must be added before testing.
4. If testing will be delayed, serum and plasma samples may be stored up to
7 days at 2~8℃ or stored at -20℃ for 6 months before testing(whole
blood sample may be stored up to 3 days at 2~8℃).
5. Refrigerated or frozen sample should reach room temperature and be
homogeneous before testing. Avoid multiple freeze-thaw cycles.
6. Do not use heat-inactivated samples.
7. SAMPLE VOLUME: 120 μl.
TEST PROCEDURE
1. Collect specimens according to user manual.
2. Test card, sample and reagent should be brought to room temperature
before testing.
3. Confirm SD card lot No. in accordance with test kit lot No.. Perform “QC
(SD)” calibration when necessary (Details refer to 8.2.1 of FIA8000 User
Manual).
4. On the main interface of FIA8000, press "ENT" button to enter testing
interface.
5. Remove the test card from the sealed pouch immediately before use.
Label the test card with patient or control identification.
6. Put the test card on a clean table, horizontally placed.
7. Using sample transfer pipette, deliver 120 μl of sample (or 4 drops of
sample when using disposable pipet) into the sample port on the test card
(for whole blood sample, one drop of whole blood buffer must be added
after loading 120 μl sample on the test card).
8. Reaction time: 15 minutes. Insert the test card into FIA8000 and press
"ENT" button after reaction time is elapsed. The result will be shown on
the screen and printed automatically.
Notes:
1. It is required to perform “QC (SD)” calibration when using a new batch
of kits.
2. It is suggested to calibrate once for one batch of kits.
3. Make sure the test card insertion is correct and complete.
TEST RESULTS
Valid: When a purplish-red band appears at the control area(C), use FIA8000
to analyze the test card and get the result.
Invalid: If no colored band appears in the control area (C), the test result is
invalid. The test should be repeated and if the same situation happened again,
please stop using this batch of products and contact your supplier.
EXPECTED VALUE
DESCRIPTION OF SYMBOLS USED
The expected normal value for cTnI was determined by testing samples from
500 apparently healthy individuals. The 99th percentile of the concentration for
cTnI is 0.5 ng/ml. cTnI concentration less than 0.5 ng/ml can be estimated as
normal.
It is recommended that each laboratory establish its own expected values for
the population it serves.
The following graphical symbols used in or found on Cardiac Troponin I Fast
Test Kit are the most common ones appearing on medical devices and their
packaging. They are explained in more details in the European Standard EN
980:2008 and International Standard ISO 15223-1:2007.
Key to symbols used
PERFORMANCE CHARACTERISTICS
Measuring Range
0.5~50.0 ng/ml
Lower Detection Limit
≤ 0.5 ng/ml
Within-Run Precision (n=10)
≤10%
Between-Run Precision
≤15%
Recovery
95% (mean)
Method Comparison:
The assay was compared with SIEMENS IMMULITE 2000 and its matching
cTnI test kits with 200 serum samples (60 positive samples and 140 negative
samples). The correlation coefficient (r) for cTnI is 0.952.
LIMITATIONS
1. As with all diagnostic tests, a definitive clinical diagnosis should not be
made based on the result of a single test. The test results should be
interpreted considering all other test results and clinical information such as
clinical signs and symptoms.
2. Samples containing interferents may influence the results. The table below
listed the maximum allowance of these potential interferents.
Interferent
Hemoglobin
Triglyceride
Bilirubin
Concentration (Max)
5 g/L
10 g/L
0.2 g/L
REFERENCES
1. Mauro Pantaghini; Undefined International Federation of Clinical Chemistry
and Laboratory Medicine (IFCC).Scientific Division Committee on
Standardization of Markers of Cardiac Damage. Clin Chem Lab Med, 1998,
36: 887~893.
2. Antman EM, Anbe DT, Armstrong PW, et al. ACC/AHA guidelines for the
management of patients with ST-elevation myocardial infarction: a report of
the American College of Cardiology/American Heart Association Task Force
on Practice Guidelines (Committee to Revise the 1999 Guidelines for the
Manage 2004).
3. EN ISO 18113-1:2009 In vitro diagnostic medical devices - Information
supplied by the manufacturer (labelling) - Part 1: Terms, definitions and
general requirements.
4. EN ISO 18113-2:2009 In vitro diagnostic medical devices - Information
supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents
for professional use (ISO 18113-2:2009).
Manufacturer
Expiration date
Do not reuse
Date of manufacture
Consult instructions
for use
Batch code
Temperature
limitation
In vitro diagnostic
medical device
Sufficient for
Authorised
representative in the
European
Community
CE mark
Thank you for purchasing Cardiac Troponin I Fast Test Kit.
Please read this user manual carefully before operating to ensure proper use.
Version: WCGDL-SM-01-01
GeTein BioMedical Inc.
4640 SW Macadam Avenue, Suite 130C;
Portland, OR 97239, USA
Tel: 1-971-407-3868
Fax: 1-971-407-3868
E-mail: sales@geteinbio.com; support@geteinbio.com
Website: http://www.geteinbio.com
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