CTnI Rapid Diagnostic Blood Test Strips Gold Colloidal Easy Operation For

Product Specification

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

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