CardiacTroponin I Test
The Troponin I Test is a rapid one-step chromatographic immunoassay for the qualitative detection of human cardiac Troponin I in whole blood, serum or plasma as an aid in the diagnosis of myocardial infarction (MI).
The Troponin I Test is a qualitative, membrane based immunoassay for the detection of cTnl in whole blood, serum or plasma. The membrane is pre-coated with capture reagent on the test line region of the test. During testing the Troponin I in the whole blood, serum or plasma specimen reacts with two specific anti-cTnl antibodies. One of the antibodies mediates binding to Troponin the capture reagent, the other antibody is color labelled. The mixture migrates upward on the membrane by capillary action. In the test line region the cTnI-antibody complex is captured by the immobilised capture reagent so that a red line is generated. The presence of a red line in the test line region indicates a positive result. If the sampled does not contain cTnI no line will form in the test result line region indicating a negative result. In addition a red line must form in the control line region (C) independent of the cTnI concentration in the sample. The control line serves as a procedural control and indicates that sufficient volume of specimen has been added and membrane wicking has occurred.
STORAGE AND STABILITY
Store as packaged in the sealed pouch at room temperature (2-30°C/36-86 °F). The Troponin I Test is stable until the expiration date printed on the sealed pouch. The test device must remain in the sealed pouch until use.
· Do not freeze.
· Do not use beyond the expiration date
· Separate serum or plasma from blood as soon as possible to avoid hemolysis.
· Heparin, EDTA or citrate blood can be used for the plasma extraction.
· Use only clear, non-hemolyzed specimens.
· Testing should be performed immediately after specimen collection. Do not leave the specimens at room temperature for prolonged periods. Serum and plasma specimens may be stored at 2-8°C for up to 3 days. For long-term storage, specimens should be kept below -20°C. Whole blood collected by venipuncture should be stored at 2-8°C if the test is to be run within 2 days of collection. Do not freeze whole blood specimens. Whole blood collected by fingertip should be tested immediately.
· Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly.
· If specimens are to be shipped, they should be packed in compliance with local regulations covering the transportation of etiologic agents.
· Troponin I Test devices
· Disposable pipettes (inside pouch)
· Lancets (only for whole blood from fingertip)
· Package insert