Background: Cardiac multimarker strategy is recommended by the IFCC, ESC and the ACC for an early risk stratification in non-ST-segment elevation (NSTE) ECG patients with chest pain. A new approach, based on protein biochip array technology, performs simultaneously: cTnI, CK-MB, myoglobin, CAIII, GFBB and FABP using a single chip.
Methods: We evaluated the analytical performance of the Randox-Evidence Investigator -biochip cardiac panel according to IFCC recommendations and NCCLS guidelines; a preliminary clinical evaluation was carried out on chest pain NSTE ECG patients, to evaluate the accuracy of the multimarker approach in an early diagnosis of AMI, related to the final diagnosis (ACC/ESC criteria).
Results: Troponin, CK-MB and FABP methods provide reproducible within-run and between-day results (total % CVs from 5.9% to 9.7%), and myoglobin and CAIII methods showed the total % CVs from 16.4% to 25.8%. Our preliminary clinical data suggests that FABP had a better diagnostic performance (sensibility = 100%) than myoglobin (sensibility = 75%) to detect AMI in the first hours after the onset of the chest pain and myoglobin/CAIII ratio (specificity = 92.9%) improved the myoglobin specificity.
Conclusions: Cardiac markers have different diagnostic roles and, in this contest, biochip technology could be an interesting approach supporting clinical expectations.