D-Dimer-Magnetic Particle Chemiluminescence Method (Acridinium Ester)/Fluorescence Immunochromatography Solution

 

 

Project Background

 

D-dimer is a specific degradation product resulting from the fibrinolytic hydrolysis following the cross-linking of fibrin monomers by activated factor XIII. It serves as an indicator of coagulation function and fibrinolytic activity within the body, offering insights into thrombosis and secondary hyperfibrinolysis. Elevated D-dimer levels are observed in conditions such as deep vein thrombosis, pulmonary embolism, disseminated intravascular coagulation, severe hepatitis, and following thrombolytic treatment. D-dimer is a valuable observation marker for assessing the effectiveness of thrombolytic treatment due to its high sensitivity and negative predictive value. Clinically, D-dimer negativity is crucial for excluding the formation of pulmonary embolism (PE) and deep venous thrombosis (DVT).

 

Various methods are currently employed for D-dimer detection, including enzyme-linked immunosorbent assay (ELISA), enzyme-linked immunofluorescence (ELFA), non-enhanced latex agglutination test, latex-enhanced immunoturbidimetric method, chemiluminescence method, and immunochromatography (POCT). These methods differ in terms of convenience, detection duration, sensitivity, and result reporting (qualitative/semi-quantitative/quantitative). The introduction of monoclonal antibodies against the D-dimer D-domain has significantly improved detection specificity and sensitivity. However, results can vary across different detection methods, particularly in terms of detection sensitivity (negative excluding value), with most not being verified or recognized by authorities.

 

In the 2022 "Expert Consensus on Joint Detection of Cardiovascular Markers for Emergency Chest Pain," Recommendation 12 emphasizes that due to the lack of internationally certified internal controls or calibrators for D-dimer testing, results from different laboratories are not comparable. The consensus strongly recommends dynamic monitoring using the same method.

 

 

Performance

 

Chemiluminescence (Acridinium Ester) Platform:

 

Combination: D-Dimer Monoclonal Antibody (Cat. No.: EKY0088G) coated carboxyl magnetic beads + D-Dimer Monoclonal Antibody (Cat. No.: EKY0088Y) labeled acridinium ester;
Linear range: 0.05mg/L-10mg/L;

 

Chemiluminescence (Acridinium Ester) Platform Calibration Curve

 
Fluorescence Immunochromatography (Lanthanide Eu Chelate Filling) Platform:

 

Combination: D-Dimer Monoclonal Antibody (Cat. No.: EKY0088Y) labeled fluorescent microspheres + D-Dimer Monoclonal Antibody (Cat. No.: EKY0088X) for streaking;
Linear range: 0.1mg/L-20mg/L.

 
Fluorescence Immunochromatography Platform Calibration Curve and Clinical Relevance

 
 
Chemiluminescence (Acridinium Ester) Platform:

 

The clinical correlation with Shanghai Sun Biotechnology D-Dimer reagent tested on the CS5100 instrument is R2>0.95.

 

 
The clinical correlation R2>0.94 with Roche Tina-quant D-Dimer Gen.2 reagent detection.

 

 

 

 

Fluorescence Immunochromatography (Lanthanide Eu Chelate Filling) Platform:

 

The clinical correlation R2>0.95 with Shanghai Sun Biotech D-Dimer reagent tested on the CS5100 instrument.

 

The clinical correlation R2>0.95 with Roche Tina-quant D-Dimer Gen.2 reagent detection.

 

 

 

Chemiluminescence (Acridinium Ester) Platform:

Antigen to be tested: D-Dimer antigen (Cat. No.: EKN0230B), sample/standard adding volume: 20ul;
Reagent 1: D-Dimer Monoclonal Antibody (Cat. No.: EKY0088G) coated carboxyl magnetic beads coated-magnetic bead dilution, dosage 50ul/test;
Reagent 2: D-Dimer Monoclonal Antibody (Cat. No.: EKY0088Y) labeled-acridinate dilution, dosage 50ul/test;
Luminescence instrument used in the test: Cosmai SMART 500S; a chemiluminescence instrument compatible with various acridinium ester systems (such as Sichuan Mike, Shenzhen Yahuilong, Shandong Kanghua Bio, Getein Bio, Nanjing Norman, etc.).
Fluorescence Immunochromatography (Lanthanide Eu Chelate Filling) Platform:

 

Antigen to be tested: D-Dimer antigen (Cat. No.: EKN0230B), 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; an instrument compatible with various fluorescence systems (excitation wavelength 365nm, emission wavelength 615nm) (such as Guangzhou Labsim, etc.).

 

 

product name	Item number	Recommended pairing
D-Dimer monoclonal antibody	EKY0088G	D-Dimer (D-Dimer) monoclonal antibody (Cat. No.: EKY0088G) coated carboxyl magnetic beads + D-Dimer (D-Dimer) monoclonal antibody (Cat. No.: EKY0088Y) labeled acridinium ester（Luminous Pairing Set） D-Dimer (Cat. No.: EKY0088Y) monoclonal antibody labeled fluorescent microsphere + D-Dimer (Cat. No.: EKY0088X) monoclonal antibody (Cat. No.: EKY0088X)（Fluorescence pair combination）
D-Dimer monoclonal antibody	EKY0088X
D-Dimer monoclonal antibody	EKY0088Y
D-Dimer antigen	EKN0230B
D-Dimer monoclonal antibody (Cat. No.: EKY0088G)-Carboxyl Magnetic Bead Concentrate	DKY1314A
D-Dimer monoclonal antibody (Cat. No.: EKY0088Y)-acridinate concentrate	DKY1314B
D-Dimer monoclonal antibody (Cat. No.: EKY0088Y) labeled fluorescent microsphere concentrate	DKY1314C
Carboxy magnetic beads (superparamagnetic), 1um	DEG0091B-1-100mg
Carboxy magnetic beads (superparamagnetic), 3um	DEG0091A-3-100mg
Time-resolved fluorescent microspheres, carboxyl (200nm）	AEG0786B

 

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