Intended Use

The kit is to be used for the in vitro quantitative determination of human cardiac troponin I (cTnI) and heart-type fatty acid-binding protein (H-FABP) in serum, plasma or whole blood samples.

Main Components

Troponin I / H-FABP rapid testsPipette tip Sample diluent

Specimen Collection and Preparation

This kit is suitable for whole blood, serum or plasma.Plasma or serum can be used as samples. The whole blood should be collected in a tube containing heparin or citrate as the anticoagulant. If the serum procedure is used, collect blood in a tube without anticoagulant and allow clotting. Hemolyzed samples should not be used.It is highly recommended to apply the fresh samples to the test device as soon as possible instead of keeping the samples at room temperature for a long time. If specimens are to be stored, the red blood cells should be removed. Plasma or serum samples may be refrigerated for 24 hours at 2-8°C. If plasma or serum samples are stored for more than 24 hours, they should be stored frozen at -20°C or below. Whole blood samples should not be frozen.The samples must be brought to room temperature (18-26°C) before use. Frozen samples should be completely thawed and mixed well prior to use. Repeated freeze-thaw cycles should be avoided.

Test Procedure

Bring all materials and specimens to room temperature.Open the foil pouch and lay the cassette on a level surface.Label the cassette with the patient's name or control number.Pipette 80μl sample (whole blood,serum/plasma) into the sample diluent, and mix it with a pipette; then pipette 80μl of the mixed sample and add it to the sampling hole of the test card . During the whole process of sucking and loading, pay attention to not produce obvious bubbles.Read the test result at 15 minutes according to the operation manual of the Reader.Assays can be performed in or out of the machine, operation process are as follows.

Performance

Sensitivity: cTnI≤0.2ng/ml, H-FABP≤2.0ng/ml;Cut-off value: cTnI 0.3ng/ml, H-FABP 7.0ng/ml;Precision: CV≤15%(n=10);The linear range: cTnI: 0.2~50ng/ml, r≥0.95, H-FABP: 2~120ng/ml, r≥0.95

Invalid Result:

Any result of no control line is invalid.