Point-of-care high-sensitivity troponin-I analysis in capillary blood for acute coronary syndrome diagnostics.

OBJECTIVES: Patients with acute coronary syndrome (ACS) should be referred promptly to the hospital to reduce mortality and morbidity. Differentiating between low-risk and high-risk patients remains a diagnostic challenge. Point-of-care testing can contribute to earlier disposition decisions for patients excluded from ACS. This study describes the validation of the Atellica® VTLi. Patient-side Immunoassay Analyzer for high-sensitivity troponin point-of-care (POC) analysis. (The Atellica VTLi is not available for sale in the USA. The products/features (mentioned herein) are not commercially available in all countries. Their future availability cannot be guaranteed). METHODS: A total of 152 patients with acute chest pain admitted at the cardiac emergency department (ED) were included in the study. Capillary blood was compared with a whole blood and plasma sample obtained by venipuncture. All samples were analyzed using the Atellica VTLi Patient-side Immunoassay Analyzer; in addition, plasma was analyzed by a central lab immunoassay analyzer. RESULTS: No significant difference was observed between venous whole blood vs. plasma analyzed by the Atellica VTLi Patient-side Immunoassay Analyzer. The difference between capillary blood and venous blood showed a constant bias of 7.1%, for which a correction factor has been implemented. No clinically relevant differences were observed for the capillary POC results compared to plasma analyzed with a standard immunoassay analyzer. CONCLUSIONS: The Atellica VTLi Patient-side Immunoassay Analyzer for high-sensitivity troponin analysis shows equivalent results for all sample types, including capillary blood. No clinically relevant discordances were observed between capillary POC and central laboratory results. With additional studies, this could pave the way towards rapid testing of high-sensitivity troponin in the ambulance or the general practitioner's office without the need for hospitalization of patients with acute chest pain.

Point-of-Care: Roadmap for Analytical Characterization and Validation of a High-Sensitivity Cardiac Troponin I Assay in Plasma and Whole Blood Matrices.

BACKGROUND: High-sensitivity cardiac troponin (hs-cTn) assays enable more precise use of traditional diagnostic strategies and earlier rule-out/rule-in at 0/1 h or 0/2 h after presentation of acute myocardial infarction (AMI). Availability of hs-cTn measurements at point-of-care (POC) can improve timely management of AMI patients. A roadmap for regulatory and analytical validation is exemplified with studies with the Atellica VTLi hs-cTnI at POC. METHODS: High-sensitivity performance was assessed with AACC/IFCC expert recommendations. Clinical Laboratory Standards Institute protocols were used for characterizing limit of blank, limit of detection (LoD), limit of quantitation (LoQ), 10% CV, precision, linearity, and analytic specificity with several reagent lots. Bland-Altman, Passing-Bablok, and hematocrit bias plots compared hs-cTnI measurement in lithium-heparin plasma (PL) and whole blood (WB) matrices. RESULTS: LoB was 0.55 ng/L; LoD and LoQ were 1.24 ng/L and 2.1 ng/Lm for PL and 1.60 ng/L and 3.7 ng/L for WB, respectively. The male 99th percentile is 27 ng/L, and female 99th percentile upper reference limit is 18 ng/L; 10% CVs were 6.7 ng/L for PL and 8.9 ng/L for WB. Also ≥50% of hs-cTnI values for healthy cohorts exceeded the LoD, confirming high-sensitivity performance. Linearity spanned from LoQ to 1250 ng/L. Specificity was >90% for 40 potential interferences; no hook effect was detected. WB and PL correlation was WB = 1.02*plasma + 0.3 ng/L (r = 0.996, n = 152). No hs-cTnI association with hematocrit was detected (R2 = 0.003). CONCLUSION: This analytical roadmap showed high-sensitivity performance, good analytic characteristics, and excellent PL and WB agreement for the Atellica VTLi hs-cTnI POC system. Essential clinical performance studies in patients by intended POC users may now commence.

Analytical performance of a single epitope B-type natriuretic peptide sandwich immunoassay on the Minicare platform for point-of-care diagnostics.

Point-of-care B-type natriuretic peptide (BNP) testing with adequate analytical performance has the potential to improve patient flow and provide primary care givers with easy-to-use advanced diagnostic tools in the management of heart failure. We present the analytical evaluation of the Minicare BNP immunoassay under development on the Minicare I-20 platform for point-of-care testing. Analytical performance was evaluated using EDTA venous whole blood, EDTA plasma and capillary whole blood. Method comparison with a lab-testing system was performed using samples from 187 patients. Normal values were determined based on 160 healthy adults, aging from 19 to 70 years. Limit of blank (LoB), limit of detection (LoD) were determined to be 3.3 ng/L, 5.8 ng/L. Limit of quantitation (LoQ) in whole blood at 20% and 10% coefficient of variation (CV) was found < 9 ng/L and <30 ng/L respectively without significant differences between EDTA whole blood and EDTA plasma. Total CV was found to be from 6.7% to 9.7% for BNP concentrations between 92.6 and 3984 ng/L. The sample type comparison study demonstrated correlation coefficients between 0.97 and 0.99 with slopes between 1.03 and 1.09 between the different samples. Method comparison between Minicare BNP and Siemens ADVIA Centaur BNP demonstrated a correlation coefficient of 0.92 with a slope of 1.06. The 97.5% URL of a healthy population was calculated to be 72.6 ng/L. The Minicare BNP assay is a robust, easy-to-use and sensitive test for rapid determination of BNP concentrations that can be used in a near-patient setting.

Analytical evaluation of a new point of care system for measuring cardiac Troponin I.

OBJECTIVES: Point-of-care cardiac troponin testing with adequate analytical performances has the potential to improve chest pain patients flow in the emergency department. We present the analytical evaluation of the newly developed Philips Minicare cTnI point-of-care immunoassay. DESIGN & METHODS: Li-heparin whole blood and plasma were used to perform analytical studies. The sample type comparison study was performed at 4 different hospitals. The 99th percentile upper reference limit (URL) study was performed using Li-heparin plasma, Li-heparin whole blood and capillary blood samples from 750 healthy adults, aging from 18 to 86years. RESULTS: Limit of the blank, limit of detection and limit of quantitation at 20% coefficient of variation (CV) were determined to be 8.5ng/L, 18ng/L and 38ng/L respectively without significant differences between whole blood and plasma for LoQ. Cross-reactivity and interferences were minimal and no high-dose hook was observed. Total CV was found to be from 7.3% to 12% for cTnI concentrations between 109.6 and 6135.4ng/L. CV at the 99th percentile URL was 18.6%. The sample type comparison study between capillary blood, Li-heparin whole blood and Li-heparin plasma samples demonstrated correlation coefficients between 0.99 and 1.00 with slopes between 1.03 and 1.08. The method comparison between Minicare cTnI and Beckman Coulter Access, AccuTnI+3 demonstrated a correlation coefficient of 0.973 with a slope of 1.09. The 99th percentile URL of a healthy population was calculated to be 43ng/L with no significant difference between genders or sample types. CONCLUSIONS: The Minicare cTnI assay is a sensitive and precise, clinical usable test for determination of cTnI concentration that can be used in a near-patient setting as an aid in the diagnosis of acute myocardial infarction.