Wondfo's new-generation high-sensitivity cardiac troponin I (hs-cTnI) assay, validated on both SmarLumi™ FC-2100 and ACCRE series, has been included in the latest Cardiac Troponin Assay Performance Parameters List released by IFCC.
Cardiac troponin (cTn) is the most important and highly specific biomarker of myocardial injury. Its measurement provides direct evidence of myocardial damage and serves as the cornerstone biomarker for the diagnosis of acute myocardial infarction (AMI). With the advent of high-sensitivity cTn assays, even subtle myocardial injury can now be detected, enabling earlier identification of cardiovascular risk and more timely clinical intervention.
IFCC consensus clearly defines two essential criteria that a cTn assay must meet to be classified as a high-sensitivity method:
1. ≤10% CV at the 99th percentile
2. Detection rate >50% in apparently healthy male and female populations
Only assays that satisfy both criteria can be designated as high-sensitivity cTn assays.
Based on differences in detection rates of cTn in apparently healthy populations, IFCC categorizes detection methods as follows:
| Detection rate <50% |
Level 1 |
Conventional assays |
| Detection rate 50–75% |
Level 2 |
First-generation high-sensitivity assays |
| Detection rate 75–95% |
Level 3 |
Second-generation high-sensitivity assays |
| Detection rate >95% |
Level 4 |
Third-generation high-sensitivity assays |
Wondfo's new-generation hs-cTnI assay of SmarLumi™ FC-2100 is recognized as IFCC-certified third-generation high-sensitivity cardiac troponin assay.
Analytical Performance of Wondfo hs-cTnI Assay
Analytical Performance of SmarLumi™ FC-2100
| Parameter |
Overall |
Female |
Male |
| 99th URL |
17.7 ng/L |
11.8 ng/L |
19.9 ng/L |
| 99th URL CV |
3.0%–3.4% |
2.8%–3.3% |
3.4%–3.7% |
| % normals measured ≥ LoD |
95.6% |
92.2% |
99.0% |
| LoB |
0.6 ng/L |
| LoD |
1.0 ng/L |
| Time to First Result |
12 min |
Analytical Performance of ACCRE series
| Parameter |
Overall |
Female |
Male |
| 99th URL |
19.5 ng/L |
22.5 ng/L |
12.6 ng/L |
| 99th URL CV |
4.0%–4.1% |
5.0% |
3.8% |
| % normals measured ≥ LoD |
88% |
83.2% |
92.9% |
| LoB |
2.0 ng/L |
| LoD |
3.0 ng/L |
| Time to First Result |
15min |
Validated on both SmarLumi™ FC-2100 and ACCRE series, Wondfo's new-generation hs-cTnI assay exhibits a coefficient of variation below 5% at the 99th percentile, as reported in the latest IFCC reference table (v012026). These results underscore the assay's reliability, a critical factor for the rapid and accurate diagnosis of AMI.
In addition to its excellent clinical performance, Wondfo's new-generation hs-cTnI assay delivers rapid testing, with a time to first result of just 12 minutes, meeting the stringent turnaround time (TAT) requirements for patients presenting with chest pain in emergency settings. When integrated with the Wondfo Cloud Laboratory System, the solution enables cross-platform result comparability and unified quality control management. Furthermore, Wondfo offers a comprehensive cardiovascular testing portfolio covering more than 10 key cardiac biomarkers, including hs-cTnI, cTnT, BNP, NT-proBNP, and ST2, providing clinicians with powerful tools for the diagnosis and management of myocardial infarction, heart failure, and other cardiovascular diseases.
Learn more about Wondfo diagnostic solutions:
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