Intended Use

This cTnI/H-FABP Test Kit (Time Resolved Fluorescence Immunochromatographic Assay) is suitable for quantitative detection of cTnI and H-FABP in human serum/plasma /whole blood in vitro as an aid in the diagnosis of acute myocardial infarction (AMI)

For Medical Professional Use Only!

Product Information

Storage Conditions and Expiry Date

The unopened kit was stored in 2℃~8℃ for 18 months. The product can be stored at temperature (20℃~30℃) for 30 days if expiry printed on the package is not exceeded. The temperature change during transportation (<37℃) has no effect on product quality. The reagent strip and the sample buffer are used in one-to-one mode, that is, a reagent strip is matched with a sample buffer to detect a blood sample.After unsealing, it can be stabilized for 1 hour at room temperature. Under normal humidity and light conditions, store and use according to the above requirements.

Product Performance

Low limit of detection: cTnI:< 0.05 ng/mL, H-FABP:< 1.0 ng/mL

Accuracy: <15%

Measuring range: cTnI:< 0.1-20 ng/mL, H-FABP:< 2-50ng/mL

Within-batch variation: CV≤15%

Batch-to-batch variation: CV≤15%

Cut-off: cTnI:< 0.2 ng/mL, H-FABP:< 7.0 ng/mL

Combining H-FABP & troponin for ruling out ACS

on four clinical studies (total of 1598 patients) on combinations of quantitatively assessed H-FABP and cTn versus cTn alone at presentation [51–53,57] revealed that the addition of H-FABP to cTn increased sensitivity from 42–75% to 76–97% but decreased specificity from 95–100% to 65–93%.