Cardiac Troponin T (cTnT) - Magnetic Particle Chemiluminescence Method (Acridinium Ester) / Fluorescence Immunochromatography Solution

1. Project Background

Troponin T (TnT) is a crucial component involved in striated muscle contraction. While the function of TnT remains consistent across all striated muscles, cardiac muscle-produced Troponin T (cardiac TnT, molecular weight 39.7 kDa) differs from skeletal muscle TnT. Due to its high tissue specificity, cTnT serves as a cardiac-specific and highly sensitive marker for myocardial injury. Post-acute myocardial infarction (AMI), cardiac troponin T experiences a rapid increase and persists for approximately two weeks.

The early detectability of elevated cTn in the blood hinges on the analytical sensitivity of the specific troponin assay employed. In various studies, high-sensitivity cardiac troponin (cTnT-hs) has been instrumental in reducing observation time from 6 hours to 3 hours. It is recommended by both the 2011 European Society of Cardiology (ESC) and 2014 National Institute for Health and Care Excellence (NICE) guidelines for non-ST-segment elevation myocardial infarction (NSTEMI). The 2015 and 2020 ESC NSTEMI guidelines further advocate for shortening the observation time to 0h/1h. The accelerated approach for confirming or excluding AMI within 0h/1h necessitates high-sensitivity cardiac troponin (hs-cTn) testing, coupled with medical history information, clinical examination results, electrocardiograms, other laboratory tests, and imaging information, as per these guidelines.

The specificity algorithm value of cTnT-hs has been validated through three studies: APACE, APACE-2015, and 2020 TRAPID-AMI, alongside other prospective trials. Additionally, alternative methods employing cTnT-hs within 2 hours to confirm or rule out AMI, with or without risk scoring, have also been developed.

In contrast to ST-segment elevation myocardial infarction (STEMI), cTn results are more valuable for the diagnosis of NSTEMI. According to the new universal definition of myocardial infarction, when the blood cTn level is higher than the 99th percentile of the reference value (normal population), and there are manifestations of myocardial ischemia (symptoms, electrocardiogram (ECG) changes, or imaging results ), myocardial infarction can be diagnosed. This requires that the imprecision (coefficient of variation) of the cTn detection method at the 99th percentile is less than or equal to 10%.

cTnT is an independent prognostic diagnostic marker that can predict the short-term, mid-term and even long-term outcomes of ACS.

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2.Performance

2.1 Chemiluminescence (acridinium ester) platform:

Combination: cardiac troponin T (CTNT) antibody (Cat. No.: EKY0107D) coated carboxyl magnetic beads + cardiac troponin T (CTNT) antibody (Cat. No.: EKY0107C) labeled acridinium ester;

Linear range: 5pg/mL-10000pg/mL;

Combination: cardiac troponin T (CTNT) antibody (Product No.: EKY0107C) labeled fluorescent microspheres + cardiac troponin T (CTNT) antibody (Product No.: EKY0107D) for drawing;

Linear range: 50pg/mL-3000pg/mL (This time, semi-dry evaluation (fluorescent microspheres in liquid) is used. Customers can evaluate based on pure dry method (fluorescent microspheres on the binding pad), and the linear range may be wider) .

3. Clinical relevance

3.1 Chemiluminescence (acridinium ester) platform:

Clinical correlation with R brand hs-cTnT reagent R2>0.98;

The correlation between the low value part (≤800pg/mL) and R brand hs-cTnT reagent is R2>0.96.

3.2 Fluorescence immunochromatography (lanthanide Eu chelate filling) platform:

Clinical correlation with R brand cTnT reagent R2>0.97;

The correlation between the low value part (≤900pg/mL) and R brand cTnT reagent is R2>0.96.

4. Test plan

4.1 Chemiluminescence (acridinium ester) platform:

Antigen to be tested: cardiac troponin T (cTnT) antigen (catalog number: EDD0128B), sample/standard: adding volume 50ul;

Reagent 1: Cardiac troponin T (CTNT) antibody (Cat. No.: EKY0107D)-carboxy magnetic bead dilution, dosage 50ul/test;

Reagent 2: Cardiac troponin T (CTNT) antibody (Cat. No.: EKY0107C)-acridinate dilution, dosage 50ul/test;

Reaction conditions: incubation temperature 37°C, sample + reagent 1 + reagent 2 (10 min);

Luminescence instrument used in the test: Cosmai SMART 500S; chemiluminescence instrument that can be used for various acridinium ester systems (such as Sichuan Mike, Shenzhen Yahuilong, Shandong Kanghua Bio, Getein Bio, Nanjing Norman, etc.)

4.2 Fluorescence immunochromatography (lanthanide Eu chelate filling) platform:

Antigen to be tested: cardiac troponin T (cTnT) antigen (catalog number: EDD0128B), sample/standard: adding volume 10ul;

Reaction conditions: mix sample + fluorescent solution, load sample, reaction time (10min-15min);

Fluorescence instrument used for testing: Hemai FIC-S100; instruments that can be used in various fluorescence systems (excitation wavelength 365nm, emission wavelength 615nm) (such as Guangzhou Labsim, etc.)

5. Product information

Product name	Item number	Recommended pairing
Cardiac troponin T (cTnT) antibody, coated	EKY0107D	Cardiac troponin T (CTNT) antibody (Cat. No.: EKY0107D) coated carboxyl magnetic beads + cardiac troponin T (CTNT) antibody (Cat. No.: EKY0107C) labeled acridine（Luminous Pairing Set） Cardiac Troponin T (CTNT) Antibody (Product No.: EKY0107C) Fluorescent Microspheres + Cardiac Troponin T (CTNT) Antibody (Product No.: EKY0107D) Drawing（Fluorescence pair combination）
Cardiac Troponin T (cTnT) Antibody, Labeled	EKY0107C
Cardiac Troponin T (cTnT) Antigen	EDD0128B
Cardiac Troponin T (CTNT) Antibody, Coated-Carboxyl Magnetic Bead Concentrate	DKY1310A
Cardiac Troponin T (CTNT) Antibody, Labeled-Acridinium Ester Concentrate	DKY1310B
Cardiac troponin T (CTNT) antibody, labeled fluorescent microsphere concentrate	DKY1310C
Carboxy magnetic beads (superparamagnetic), 1um	DEG0091B-1-100mg
Carboxy magnetic beads (superparamagnetic), 3um	DEG0091A-3-100mg
Time-resolved fluorescent microspheres, carboxyl (200nm）	AEG0786B