Clinical Laboratory Validation Study of a High Sensitivity Troponin I Assay on a POCT (Point of Care Testing) Device

In Acute Coronary Syndrome without ST-segment elevation, the use of high-sensitivity troponins in rapid protocols is considered the gold standard for diagnostic exclusion/confirmation, in conjunction with clinical stratification. The biggest concern regarding the techniques for troponin evaluation is the time required between collection and delivery of the result.

The objective of the present study is the clinical/laboratory validation of a POCT device for TnI.

In the first phase of the study, samples from 108 patients with known troponin values High Sensitivity Automated Troponin T (TnT) assay from Roche Diagnostics were analyzed for analytical comparability between hs-cTnI of the Analyzer Atellica® vTLi and hs-cTnT Cobas®. The second phase of the study was performed with samples from 51 patients who reported to the emergency department with chest pain for a clinical prospective evaluation and correlation between the hs-cTnI assays of the Analyzer Atellica® vTLi, hs-cTnT Cobas® and Atellica IM 1300.

There was a correlation between the POCT Atellica® vTLi and hs-cTnT Cobas® in the serum samples of the control group (r = 0.660, p < 0.0001). Besides, there was a correlation between the Atellica® vTLi, serum hs-cTnT Cobas®, plasma hs-cTnT Cobas®, serum Atellica IM and plasma Atellica IM 1300 platforms in the second phase (p < 0.0001 in all cases).

In the present study, the Siemens POCT Atellica® vTLi device showed excellent performance in laboratory validation and correlation with the high-sensitivity TnT assay in different troponin concentration ranges. Given these results, the device can be used in institutions that intend to use a POCT device for 0- and 1-hour chest pain protocols.