One Step cTnI Rapid Diagnostic Test, detection of bedside Troponin
I, gold colloidal method,quickly
Intended Use:
For the rapid qualitative detection of cardiac troponin I (cTnI) in
human whole blood, serum and plasma as an aid in the diagnosis of
myocardial infarction in emergency room, critical care,
point-of-care, and hospital settings.
The Troponin I Assay provides a qualitative analytical test result.
The qualitative nature of this assay does not provide information
about change - either the rise or fall - in the concentration of
cTnI with single testing. Aquantitative method should be used, if
desired, to determine the concentration of cTnI at any given time.
Only with serial testing could a temporal change in the level of
cTnI be concluded. Clinical consideration and professional
judgement should be applied when interpreting the results of the
Troponin I Assay, especially when single testing results are used.
SUMMARY:
The troponin complex is formed of three subunits, troponin T (TnT),
troponin C (TnC) and Troponin I (TnI). The three troponin subunits
have distinct functions with TnC as the Ca++-binding, TnT as the
tropomyosin binding, and TnI as the inhibitory subunits.1 The
troponin complex, together with tropomyosin, form the main
component that regulates the Ca++-sensitive ATPase activity of
actomyosin in striated muscle (skeletal and cardiac). Different
isoforms of TnI exist in the skeletal and cardiac muscles (sTnI and
cTnI, respectively) with distinct structural heterogeneity between
these isoforms that allow the production of isoform-specific
antibodies.These isoform-specific antibodies have been utilized to
assemble various detection methods that are isoform-specific.
Recent reports have investigated the utility of determining the
serum levels of the different isoforms of TnI.
Detection of cTnI in the serum was investigated as an aid in the
determination of myocardial damage in patients with acute
myocardial infarction (AMI).5 Several clinical reports have
demonstrated the diagnostic value of determining the serum level of
cTnI in identifying patients with AMI. The temporal relation of
release of cTnI into the serum has been investigated and compared
to the other established cardiac markers such as CK-MB, myoglobin
and TnT.6,7 Cumulative data from several reports documented that in
patients with AMI, cTnI is released into the circulation with
levels exceeding the upper reference limit of normal 4-6 hours
after the onset of symptoms and peak levels are reached after 12-24
hours.8 This early release profile is similar to CK-MB. However,
CK-MB levels return to normal values after 72 hours, while levels
of cTnI remains elevated for up to 5-7 days. Due to the distinct
structure of cTnI and the availability of highly-specific detection
methods for cTnI, the utility of this marker for the diagnosis of
AMI in complex clinical conditions that involve skeletal muscle
damage have been investigated. The high specificity of cTnI
measurements for the identification of myocardial damage has been
demonstrated in conditions such as perioperative period, after
marathon runs, and blunt chest trauma. The release of cTnI into
blood has been documented in clinical conditions that involve
myocardial damage, other than AMI, such as unstable angina,
congestive heart failure, and ischaemic damage due to coronary
artery by-pass surgery. Measurements of cTnI have been investigated
and documented to be valuable in identifying patients with AMI
presenting to the ED with chest pain.
Test Principle:
Troponin I Test employs solid-phase chromatographic immunoassay
technology to qualitatively detect the presence of cTnI above an
established cutoff level in human blood, serum and plasma samples.
After a specimen has been dispensed into the sample well, plasma or
serum is transferred into a region containing monoclonal anti-cTnI
antibody-dye conjugates and rabbit polyclonal anti-cTnI antibodies.
These antibodies bind to cTnI in the sample to form complexes,
which migrate through the reaction strip. The antigen/antibody dye
complexes are then captured by immobilized avidin in the TnI area.
Additional protein-dye conjugates not bound in the Test (TnI) area
are later captured in the Control (C) area.
Visible purplish horizontal bands will appear in the TnI and C
areas if the level of cTnI is above the established cutoff level.
Avisible purplish band in the C area indicates the assay is working
properly. If a band is present only in the C area, the result is
read as negative, indicating that the level of cTnI is below the
cutoff level. If no band is present in the C area, the test should
be considered invalid and another test must be run, regardless of
the presence or absence of a band in the TnI area.
TEST PROCEDURE
INTERPRETATION OF RESULTS
POSITIVE:* Two lines appear. One colored line should be in the control line
region (C) and another apparent colored line should be in the test
line region (T).
*NOTE: The intensity of the color in the test line region (T) will
vary depending on the concentration of TP antibodies present in the
specimen. Therefore, any shade of color in the test line region (T)
should be considered positive.
NEGATIVE: One colored line appears in the control line region (C). No line
appears in the test line region (T).
INVALID: Control line fails to appear. Insufficient specimen volume or
incorrect procedural techniques are the most likely reasons for
control line failure. Review the procedure and repeat the test with
a new test. If the problem persists, discontinue using the test kit
immediately and contact your local distributor.
PERFORMANCE CHARACTERS:
Sensitivity and Specificity
The Troponin I Rapid Test Device (Whole Blood/Serum/Plasma) has
been evaluated with a leading commercial cTnI EIA test using
clinical specimens. The results show that the sensitivity of the
Troponin I Rapid Test Device (Whole Blood/Serum/Plasma) is 98.3%
and the specificity is 98.4% relative to the leading EIA test.
Troponin I Rapid Test Device vs. EIA
| Method | EIA Test | Total Results |
| Troponin I Rapid Test Device | Results | Positive | Negative |
| Positive | 113 | 6 | 119 |
| Negative | 2 | 493 | 495 |
| Total Results | 115 | 499 | 614 |
Relative Sensitivity: 98.3%(93.9%-99.8%)*
Relative Specificity: 98.4%(97.4%-99.6%)*
Accuracy: 98.7%(97.5%-99.4%)*
*95% Confidence Interval
| ORIENT NEW LIFE MEDICAL CO., LTD. |
| Contact: | Jerry Meng |
| Email: | Jerry @ newlifebiotest .com |
| Tel. | +86 18657312116 |
| SKYPE | enetjerry |
