About Seebio
Pioneer of Core Raw Materials for Functional Food Ingredients and Healthcare Supplements in China.
Project Background
"-Guiding Principles for Technical Review of Registration of Procalcitonin Assay Kits"
Procalcitonin (PCT) is the prohormone of calcitonin, consisting of 116 amino acids with a molecular weight of approximately 12.8 kD. It is a glycoprotein without hormonal activity and serves as an endogenous non-steroidal anti-inflammatory substance. Produced by the thyroid gland during infection, various cells in multiple organs secrete procalcitonin in response to pro-inflammatory stimuli, especially in bacterial infections. Its metabolism is largely independent of kidney function, unaffected by renal failure, and not influenced by steroid hormones. In 1993, a study revealed a correlation between elevated PCT levels during severe infection, indicating a worse prognosis and severity of sepsis.
In clinical diagnosis, procalcitonin concentration rises early in patients with sepsis, aiding doctors in early diagnosis and monitoring. Literature reports indicate that serum PCT begins to increase within 2-4 hours of systemic infection, peaks within 8-24 hours, and persists for days or weeks. A certain threshold value suggests a risk of severe sepsis and septic shock. Importantly, procalcitonin is a marker distinguishing bacterial infections from other inflammatory reactions, as it remains unaffected by viral infections, allergies, autoimmune diseases, or transplant rejection. The current consensus outlines PCT concentrations for different systemic responses, making it an ideal indicator for serious bacterial infections, sepsis, and related conditions.
Performance
2.1 Chemiluminescence (Acridinium Ester) Platform:
2.1.1 Combination 1
Human procalcitonin (PCT) monoclonal antibody AG (Product No.: EKY0132AG) coated carboxyl magnetic beads +
Human procalcitonin (PCT) monoclonal antibody AF (Product No.: EKY0132AF) labeled acridinium ester;
Linear range: 0.02 ng/ml-100 ng/ml;
Stability: Luminescence value changes around ±13% under thermal acceleration at 37°C for 7 days;
Enterprise working calibration product (liquid) 7-day stability at 37°C thermal acceleration: Luminescence value changes around ±10%.
2.1.2 Combination 2
Human procalcitonin (PCT) monoclonal antibody AF (Product No.: EKY0132AF) coated carboxyl magnetic beads +
Human procalcitonin (PCT) monoclonal antibody AG (Product No.: EKY0132AG) labeled acridinium ester;
Linear range: 0.02 ng/ml-100 ng/ml;
Stability: Luminescence value changes around ±13% under thermal acceleration at 37°C for 7 days;
Enterprise working calibration product (liquid) 7-day stability at 37°C thermal acceleration: Luminescence value changes around ±10%.
2.2 Linear Range: Fluorescence Chromatography (Lanthanide Eu Chelate Filling) Platform:
Human Procalcitonin (PCT) Monoclonal Antibody AI (Cat. No.: EKY0132AI) labeled fluorescent microspheres + Human Procalcitonin (PCT) Monoclonal Antibody AH (Cat. No.: EKY0132AH) to draw membrane, linear range 0.1 ng/ml-50 ng/ml.
Clinical Relevance
3.1 Chemiluminescence (Acridinium Ester) Platform:
Clinical correlation with R brand PCT reagent: R² > 0.97.
3.2 Fluorescence Chromatography (Lanthanide Eu Chelate Filling) Platform:
Correlation of low-value part (≤4 ng/ml) with R brand PCT reagent: R² > 0.96.
Test Procedure
4.1 Chemiluminescence (Acridinium Ester) Platform:
Antigen to be tested: Human Procalcitonin protein (EKY0134B), sample/standard adding volume: 20 ul.
Reagent 1: PCT EKY0132AG/AF monoclonal antibody-magnetic bead dilution, dosage 50 ul/test.
Reagent 2: PCT EKY0132AF/AG monoclonal antibody-acridinate dilution, dosage 50 ul/test.
Reaction conditions: Incubation temperature 37°C, sample + reagent 1 + reagent 2 (6 min-10 min).
Luminous instrument: Cosmai SMART 500S.
Luminescence instrument used in the test: Cosmai SMART 500S; chemiluminescence instrument suitable for various acridinium ester systems (such as Sichuan Mike, Shenzhen Yahuilong, Shandong Kanghua Bio, Getein Bio, Nanjing Norman, etc.).
4.2 Fluorescence Chromatography (Lanthanide Eu Chelate Filling) Platform:
Antigen to be tested: Human Procalcitonin protein (EKY0134B), sample volume 10 ul.
Reaction conditions: Mix sample + fluorescent solution, load sample, reaction time (10 min-15 min).
Fluorescence instrument: Hemai FIC-S100.
Fluorescence instrument used in the test: Hemai FIC-S100; can be applied to various fluorescence systems (excitation wavelength 365 nm, emission wavelength 615 nm) (such as Guangzhou Labsim, etc.).
Product Information (luminescent large packaging reagents available)
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Product
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Item number
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Recommended pairing
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Human procalcitonin (PCT) monoclonal antibody AG
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Human procalcitonin (PCT) monoclonal antibody AG (Cat. No.: EKY0132AG) coated carboxyl magnetic beads + human procalcitonin (PCT) monoclonal antibody AF (Cat. No.: EKY0132AF) labeled acridinium ester (luminescent pairing combination1）
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Human procalcitonin (PCT) monoclonal antibody AF
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Human procalcitonin (PCT) monoclonal antibody AF (Cat. No.: EKY0132AF) coated carboxyl magnetic beads + human procalcitonin (PCT) monoclonal antibody AG (Cat. No.: EKY0132AG) labeled acridinium ester (luminescent pairing combination2）
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Human procalcitonin (PCT) monoclonal antibody AH
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Human procalcitonin (PCT) monoclonal antibody AI (Cat. No.: EKY0132AI) labeled fluorescent microspheres + human procalcitonin (PCT) monoclonal antibody AH (Cat. No.: EKY0132AH) drawing (fluorescence chromatography pairing combination）
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Human procalcitonin (PCT) monoclonal antibody AI
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human procalcitonin protein
Human Procalcitonin protein
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Human procalcitonin (PCT) monoclonal antibody AG-carboxy magnetic beads concentrate
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DKY1300A
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Human procalcitonin (PCT) monoclonal antibody AF-carboxy magnetic beads concentrate
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DKY1300B
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Human procalcitonin (PCT) monoclonal antibody AG-acridinate concentrate
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DKY1300C
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Human procalcitonin (PCT) monoclonal antibody AF-acridinate concentrate
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DKY1300D
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Human procalcitonin antigen diluent
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DKY1301A
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Human procalcitonin (PCT) monoclonal antibody-carboxy magnetic bead concentrate diluent
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DKY1302A
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Human procalcitonin (PCT) monoclonal antibody-acridinate concentrate diluent
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DKY1303A
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Time-resolved fluorescent microspheres, carboxyl 200nm
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AEG0786B
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Human procalcitonin (PCT) monoclonal antibody AI-carboxy fluorescent microsphere concentrate
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DKY1304A
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Carboxy magnetic beads (superparamagnetic), 1um
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DEG0091B-1
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Carboxy magnetic beads (superparamagnetic), 3um
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DEG0091A-3
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