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MD- 280016 m16 c – Page 1/4
Revised 2017/03
TROPONIN I-CHECK-1
Quantitative determination of Troponin I
in whole blood, serum or plasma samples
Ref. 28091
FOR EASY READER® AND EASY READER+® USE ONLY
I- PRINCIPLE
Troponin I (TnI) is one of the thin filament-associated regulatory
proteins of muscle (1). It is encoded by three different genes that are
differentially expressed by the various muscle tissues, resulting in
slow – and fast skeletal and cardiac TnI isoforms (2).
The unique amino acid sequence of cTnI makes it an ideal candidate
for the laboratory detection of acute myocardial infarction (AMI) and
has facilitated the development of monoclonal antibodies that do not
cross-react with skeletal muscle troponins (3). Published studies from
various groups have demonstrated the utility of cTnI measurement
for detection of AMI (3, 4, 6, 7).
CK-MB and cTnI both elevated beyond normal reference limits
within 4-6 hours after infarction. Typical reference limits were, as
reported by Bodor et al (3), 6.7 ng/mL for CK-MB and 3.1 ng/mL for
cTnI.
Likewise, each report sites similar time frames for the peak values of
CK-MB and cTnI : CK-MB peaked in 13-15 hours, cTnI in 11-15
hours. Typical ranges were 39 –185 ng/mL for CK-MB and 18.5 –
188 ng/mL for cTnI (5).
However, CK-MB level returns to normal after 36-48 hours, while
levels of cTnI remains elevated for up to 6-10 days. The level of cTnI
is very low in normal healthy people, and not detected in patients
with skeletal muscle injury. Therefore, cTnI is a specific marker for
diagnosis of AMI.
TROPONIN I-CHECK-1 is a rapid quantitative assay for the
detection of cardiac Troponin I in serum, plasma or whole blood
samples. The method employs a unique combination of monoclonal
dye conjugate and polyclonal solid phase antibodies to identify
troponin in the test samples with a high degree of sensitivity.
As the test sample flows through the absorbent device, the antibody-
dye conjugate binds to the troponin forming an antibody-antigen
complex. This complex binds to the anti troponin antibody in the
reaction zone (T) and produces a pink-rose colour band.
In the absence of troponin, there is no band in the reaction zone (T).
The reaction mixture continues flowing through the absorbent device
past the reactive zone (T) and control zone (C). Unbound conjugate
binds to the reagents in the control zone (C), producing a pink-rose
colour band, demonstrating that the reagents are functioning
correctly.
II. TROPONIN I-CHECK-1 KIT COMPONENTS
Each kit contains everything needed to perform 10 or 20 tests.
1- TROPONIN I -CHECK-1 reaction devices: 10 20
2- Disposable plastic pipettes: 10 20
3- Diluent in a dropper bottle: 2.5mL 5mL
4- Instruction leaflet: 1 1
5- Controls (Optional):
Positive control (ref. V280) and Negative control (ref. V281): a
freeze-dried preparation of a non-infectious compound in diluted
human serum, tested and found negative for anti-HIV, anti-HCV and
HBs antigen, containing 0.05 % sodium azide is optionally available
as a positive and negative control (1x 0.25 mL). The concentration
range is indicated on the vial label.
III- STORAGE AND STABILITY
1- All TROPONIN I -CHECK-1 kit components, including
optional control before reconstitution with distilled water,
should be stored at any temperature between +4°C and +30°C
in the sealed pouch.
2- Do not freeze the test kit.
3- The TROPONIN I -CHECK-1 kit is stable until the expiry
date stated on the package label.
IV- PRECAUTIONS
1- This test is designed for in vitro diagnostic use and professional
use only.
2- Read carefully the instructions before using this test.
3- Handle all specimens as if they contained infectious agents. When
the assay procedure is completed, dispose of specimens carefully
after autoclaving them for at least one hour. Alternatively, they can
be treated with 0.5% to 1% solution of sodium hypochlorite for one
hour before disposal.
4- Wear protective clothing such as laboratory coats and disposable
gloves while assaying samples.
5- Do not eat, drink or smoke in the area where specimens and kit
reagents are handled.
6- Avoid any contact between hands and eyes or nose during
specimen collection and testing.
7- Do not use beyond the expiry date which appears on the package
label.
8- Do not use a test from a damaged protective wrapper.
V- SPECIMEN COLLECTION AND PREPARATION
1- TROPONIN I rapid test is performed on human serum, plasma or
whole blood.
2- The specimen should be collected under the standard laboratory
conditions (aseptically in such a way as to avoid haemolysis).
3- If anticoagulant is needed, only citrate, EDTA or heparin
should be used.
4- Each specimen should be treated as if potentially infectious.
5- Whole blood samples should be tested immediately (< 4 hours).
Finger prick samples should be assayed just after collection.
6- If the test is to be run within 48 hours after collection the specimen
should be stored in the refrigerator (+2°C to +8°C). If testing is
delayed more than 48 hours, the specimen should be frozen. The
frozen specimen must be completely thawed, thoroughly mixed and
brought to room temperature prior to testing. Avoid repeated freezing
and thawing.
7- In case of cloudiness, high viscosity or presence of particulate
matter into the serum specimen, it should be diluted with equal
volume (V/V) of diluting buffer (not provided but available upon
request) before testing.
