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PRODUCT TECH NOTE
High-Sensitivity Cardiac Monoclonal Antibody Pairs
INTRODUCTION
Cardiac biomarkers play a critical role in diagnosing and stratifying patients with chest pain, suspected acute coronary syndrome (ACS), heart failure, pulmonary embolism, and related conditions. They can be grouped into markers of myocardial necrosis (CK- MB, myoglobin, cardiac troponins), ischemia (ischemia-modified albumin), stress (natriuretic peptides), and inflammation/ prognosis (CRP, sCD40L, homocysteine).
Of these, cardiac troponins have become the gold standard for ACS diagnosis, now central to the definition of acute myocardial infarction (MI) in European Society of Cardiology (ESC) and American College of Cardiology (ACC) guidelines. These guidelines recommend cardiac troponin as the only biomarker for MI diagnosis, reflecting its superior sensitivity and accuracy. With the advent of high-sensitivity assays and multi-marker panels, cardiac testing is now evolving to deliver earlier detection, improved risk stratification, and more comprehensive clinical insights.
High-throughput cardiac biomarker testing (e.g., troponin, CK-MB, BNP, NT-proBNP, D-dimer) is predominantly carried out on automated immuno- assay analyzers using chemiluminescent (CLIA) or electrochemiluminescent (ECL) detection. Platforms such as the Abbott Architect i-Series and Siemens ADVIA Centaur (CLIA), the Roche Cobas e-Series (ECL), and the Beckman Coulter Access systems (CLIA) provide the sensitivity, precision, and dynamic range required for routine cardiac diagnostics. Fluorescence immunoassays (FIAs) are also used in certain high-sensitivity or moderate-throughput settings. While all three formats rely on antigen– antibody binding, they differ in signal generation: CARDIAC HIGH-THROUGHPUT ASSAYS
CLIAs use enzyme-mediated oxidation reactions to generate chemiluminescence; ECL assays produce light through electrochemical excitation of ruthenium-based labels; and FIAs measure fluorescence emitted from excited fluorophores. These detection mechanisms drive distinct performance characteristics. ECL typically offers the highest analytical sensitivity and widest dynamic range, followed by CLIA, while FIA generally provides good but comparatively lower sensitivity due to higher optical background and narrower linearity. Across all platforms, specificity depends on antibody affinity, cross-reactivity control, and overall assay design.
BUILDING RELIABLE HIGH-SENSITIVITY CARDIAC IMMUNOASSAYS Delivering earlier detection, better risk stratification & deeper clinical insights
www.meridianbioscience.com/lifescience
CARDIAC HIGH-THROUGHPUT ASSAY TECHNOLOGIES
Comparison of fluorescent and chemiluminescent immunoassay technologies used in high-throughput cardiac biomarker testing
FEATURE
FIA | Fluorescence Immunoassay
CLIA | Chemiluminescent Immunoassay Enzyme-labeled antibodies catalyze light-emitting reactions measured without external excitation
Fluorophore-labeled antibodies emit light upon optical excitation; signal intensity proportional to analyte concentration
DETECTION PRINCIPLE
Fluorescence emission
Chemiluminescence emission
SIGNAL TYPE
Typically picogram per milliliter (pg/mL) range; may be limited by background fluorescence or optical noise Determined by antibody affinity & assay design; generally comparable to CLIA Used in certain high-sensitivity & electro- chemiluminescent (ECL) platforms; including Roche Cobas analyzers
Often femtogram per milliliter (fg/ mL) range; high signal amplification & broader dynamic range
DETECTION SENSITIVITY
Also antibody-dependent; comparable specificity to FIA
SPECIFICITY
Standard in automated high-throughput systems such as Abbott Architect, Siemens ADVIA Centaur, Roche Cobas e-Series, Beckman Coulter Access Very high sensitivity, wide dynamic range, optimized for continuous, high-volume testing
COMMON APPLICATIONS
High sensitivity, rapid detection, suitable for compact analyzers
PERFORMANCE SUMMARY
EVALUATION METHOD
Antibody pairs specific to cTnI , CRP , NT-proBNP , and CK-MB were evaluated in a two-step sandwich format using either a fluorescence immunoassay (FIA) or a chemiluminescent immunoassay (CLIA). In FIA, capture antibodies were coated on a nitrocellulose (NC) membrane and detection antibodies were conjugated to Europium. In CLIA, capture antibodies were coated on magnetic beads and detection antibodies were conjugated to alkaline phosphatase (ALP). The limit of detection (LOD) was determined for each antibody pair.
TWO-STEP SANDWICH ASSAY
DETECTION ANTIBODY CONJUGATE FIA | Ab-Europium Conjugate CLIA | Ab-AKP Conjugate
ADD SAMPLE
ADD DETECTOR
ANTIGEN
FIA | Coated on NC Membrane CLIA | Coated on Magnetic Bead CAPTURE ANTIBODY
PRODUCT TECH NOTE CARDIAC MAb PAIRS
PERFORMANCE SUMMARY
Anti-Troponin I
CAPTURE DETECTION APPLICATION LIMIT OF DETECTION
IDEAL APPLICATORS
BN1243 BN1244
CLIA
1.46 ng/mL
High-throughput clinical diagnostics
Correlation between Meridian antibodies (Cat. No. BN1243 and Cat. No. BN1244 ) in a CLIA assay and the Roche Elecsys ® Troponin I STAT (Cobas e411) using clinical samples. The assay showed a strong linear correlation ( R 2 = 0.94 ) across the tested Troponin I concentration range.
COMPARATIVE CORRELATION CLIA | Meridian & Roche
y = 0.8922x + 0.1828 R 2 = 0.94
Roche (ng/mL)
Anti-Human CRP hs
CAPTURE DETECTION APPLICATION LIMIT OF DETECTION
IDEAL APPLICATORS
1 CLIA
High-throughput clinical diagnostics Point-of-care, multiplex panels
0.001 µ g/mL
BN1246 BN1247
2 FIA
1 µ g/mL
1 COMPARATIVE CORRELATION CLIA | Meridian & Roche
2 COMPARATIVE CORRELATION FIA | Meridian & Roche
y = 0.9789x — 2.1199 R 2 = 0.96
y = 1.0301x — 0.0091 R 2 = 0.99
Roche (ng/mL)
Roche (mg/L)
[ 1 ] Correlation between Meridian antibodies (Cat. No. BN1246 and Cat. No. BN1247 ) in a CLIA assay and the Roche Elecsys ® CRP STAT (Cobas C702) using clinical samples. The assay showed a strong linear correlation ( R 2 = 0.96 ) across the tested CRP concentration range.
[ 2 ] Correlation between Meridian antibodies (Cat. No. BN1246 and Cat. No. BN1247 ) in a FIA assay and the Roche Elecsys ® CRP STAT (Cobas C702) using clinical samples. The assay showed a strong linear correlation ( R 2 = 0.99 ) across the tested CRP concentration range.
Anti-Human NT-proBNP
CAPTURE DETECTION APPLICATION LIMIT OF DETECTION
IDEAL APPLICATORS
BN1240 BN1241
CLIA
7 pg/mL
High-throughput clinical diagnostics
a.
2
1
COMPARATIVE CORRELATION CLIA | Meridian & Roche
COMPARATIVE CORRELATION CLIA | Meridian & Roche
y = 0.9998x - 0.4563 R 2 = 1
y = 0.9963x + 101.93 R 2 = 0.99
Roche (pg/mL)
Roche (pg/mL)
[ 1 ] Correlation between Meridian NT-proBNP antibody pair ( BN1240 and BN1241 ) and the Roche Elecsys ® proBNP II assay (Cobas e411) using the Bio-Rad NT-proBNP reference panel (human serum-based, multi-analyte control). [ 1a ] Overall correlation across concentrations up to approximately 3,400 pg/mL. [ 1b ] Expanded view of the lower concentration range (up to 140 pg/mL), demonstrating the strong correlation between antibody pair BN1240 & BN1241 and the Roche reference method at low NT-proBNP levels. [ 2 ] Correlation between Meridian NT-proBNP antibody pair ( BN1240 & BN1241 ) and the Roche Elecsys ® proBNP II (Cobas e411) using clinical samples ( ~ 30-30,000 pg/mL, R 2 = 0.99 ).
b.
y = 1.2111x - 6.7141 R 2 = 0.98
Roche (pg/mL)
CAPTURE DETECTION APPLICATION LIMIT OF DETECTION
IDEAL APPLICATORS
1 CLIA
55 pg/mL
High-throughput clinical diagnostics Point-of-care, multiplex panels
BN1240 BN1242
Serum: 112 pg/mL Whole Blood: 60 pg/mL
2 FIA
COMPARATIVE CORRELATION CLIA | Meridian & Roche 1
FIA | Meridian & Roche 2
COMPARATIVE CORRELATION
y = 0.7875x — 54.703 R 2 = 0.96
y = 1.3086x + 570.1 R 2 = 0.93
Roche (pg/mL)
Roche (pg/mL)
[ 1 ] Correlation between Meridian NT-proBNP antibodies ( BN1240 & BN1242 ) in a CLIA assay and the Roche Elecsys ® proBNP II (Cobas e411) using clinical samples. The assay demonstrated a linear correlation ( R 2 = 0.96 ) with the Roche reference method.
[ 2 ] Correlation between Meridian NT-proBNP antibodies ( BN1240 & BN1242 ) in a FIA assay and the Roche Elecsys ® proBNP II (Cobas e411) using clinical samples. The assay demonstrated a linear correlation ( R 2 = 0.93 ) with the Roche reference method.
DEC | 2025
PRODUCT TECH NOTE CARDIAC MAb PAIRS
Anti-CK-MB
CAPTURE DETECTION APPLICATION LIMIT OF DETECTION
IDEAL APPLICATORS
BN1248 BN1249
FIA
4.11 ng/mL
Point-of-care, multiplex panels
Correlation between Meridian antibodies (Cat. No. BN1248 and Cat. No. BN1249 ) in a FIA assay and the Roche Elecsys ® CK-MB STAT (Cobas e411) using clinical samples. The assays showed a strong linear correlation ( R 2 = 0.96 ) across the tested CK-MB range.
COMPARATIVE CORRELATION FIA | Meridian & Roche
y = 0.9789x — 2.1199 R 2 = 0.96
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