CLIA Kit for Procalcitonin (PCT)

Pro-Calcitonin

Specificity

This assay has high sensitivity and excellent specificity for detection of Procalcitonin (PCT).
No significant cross-reactivity or interference between Procalcitonin (PCT) and analogues was observed.

Recovery

Matrices listed below were spiked with certain level of recombinant Procalcitonin (PCT) and the recovery rates were calculated by comparing the measured value to the expected amount of Procalcitonin (PCT) in samples.

Matrix Recovery range (%) Average(%)
serum(n=5) 81-95 90
EDTA plasma(n=5) 90-104 94
heparin plasma(n=5) 80-93 89

Precision

Intra-assay Precision (Precision within an assay): 3 samples with low, middle and high level Procalcitonin (PCT) were tested 20 times on one plate, respectively.
Inter-assay Precision (Precision between assays): 3 samples with low, middle and high level Procalcitonin (PCT) were tested on 3 different plates, 8 replicates in each plate.
CV(%) = SD/meanX100
Intra-Assay: CV<10%
Inter-Assay: CV<12%

Linearity

The linearity of the kit was assayed by testing samples spiked with appropriate concentration of Procalcitonin (PCT) and their serial dilutions. The results were demonstrated by the percentage of calculated concentration to the expected.

Sample 1:2 1:4 1:8 1:16
serum(n=5) 94-102% 94-102% 80-95% 95-105%
EDTA plasma(n=5) 91-98% 99-105% 79-102% 86-101%
heparin plasma(n=5) 97-105% 78-90% 92-105% 79-92%

Stability

The stability of kit is determined by the loss rate of activity. The loss rate of this kit is less than 5% within the expiration date under appropriate storage condition.
To minimize extra influence on the performance, operation procedures and lab conditions, especially room temperature, air humidity, incubator temperature should be strictly controlled. It is also strongly suggested that the whole assay is performed by the same operator from the beginning to the end.

Reagents and materials provided

Reagents Quantity Reagents Quantity
Pre-coated, ready to use 96-well strip plate 1 Plate sealer for 96 wells 4
Standard 2 Standard Diluent 1×20mL
Detection Reagent A 1×120µL Assay Diluent A 1×12mL
Detection Reagent B 1×120µL Assay Diluent B 1×12mL
Substrate A 1×10mL Substrate B 1×2mL
Wash Buffer (30 × concentrate) 1×20mL Instruction manual 1

Assay procedure summary

1. Prepare all reagents, samples and standards;
2. Add 100µL standard or sample to each well. Incubate 1 hours at 37°C;
3. Aspirate and add 100µL prepared Detection Reagent A. Incubate 1 hour at 37°C;
4. Aspirate and wash 3 times;
5. Add 100µL prepared Detection Reagent B. Incubate 30 minutes at 37°C;
6. Aspirate and wash 5 times;
7. Add 100µL Substrate Solution. Incubate 10 minutes at 37°C;
8. Read RLU value immediately.

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Magazine Citations
Scandinavian Journal of Infectious Diseases Evaluation of neutrophilic CD64, interleukin 10 and procalcitonin as diagnostic markers of early- and late-onset neonatal sepsis PubMed: 20085423
International Journal of Radiation Oncology ? Biology ? Physics Effects of Berberine Against Radiation-Induced Intestinal Injury in Mice PubMed: 20637981
Ulus Travma Acil Cerrahi Derg Diagnostic and prognostic value of procalcitonin and phosphorus in acute mesenteric ischemia PubMed: 21935794
Egyptian Journal of Bronchology Serum procalcitonin and its relation to the outcome of ventilator-associated pneumoniain children Essbronchology: Source
University of Waikato The Assessment of Vitamin D, Antimicrobial Peptides and Procalcitonin in Bronchiectasis Waikato:Source
Egyptian Journal of Medical Microbiology Evaluation of the Diagnostic Utility of Fc Gamma Receptor Type 1 (nCD64) and Procalcitonin in Comparison with Conventional Methods for Diagnosis of Early Onset Neonatal Sepsis Ejmm:Source
Nigerian Medical Journal Efficacy of measuring procalcitonin levels in determination of prognosis and early diagnosis of bacterial resistance in sepsis Pubmed:25657488
Wiley online library The use and value of procalcitonin in solid organ transplantation PubMed: 25996831
Balkan Med J Diagnostic Value of Procalcitonin Levels in Acute Mesenteric Ischemia PubMed: 26185718
The Journal of Clinical Endocrinology & Metabolism Macrocalcitonin is a novel pitfall in the routine of serum calcitonin immunoassay PubMed: 26647152
Journal of Human Hypertension Procalcitonin and Pentraxin-3: Current biomarkers in inflammation in white coat hypertension PubMed: 26040439
Medical Science Monitor Variation of Circulating Inflammatory Mediators in Staphylococcus aureus and Escherichia coli BloodstreamInfection. Pubmed:26772168
International Immunopharmacology Consistency and pathophysiological characterization of a rat polymicrobial sepsis model via the improved cecal ligation and puncture surgery Pubmed:26802602
Pancreatology. Early prediction of intestinal mucosal barrier function impairment by elevated serum procalcitonin in rats with severe acute pancreatitis. Pubmed:26804005
Acta Medica Risk Factors of Acute Pancreatitis in Oral Double Balloon Enteroscopy. pubmed:27638962
The Clinical Respiratory Journal Changes in inflammatory mediators as a result of intermittent hypoxia in obstructive sleep apnea syndrome pubmed:28960823
SHOCK INTERLEUKIN-1 RECEPTOR 2: A NEW BIOMARKER FOR SEPSIS DIAGNOSIS AND GRAM-NEGATIVE/GRAM-POSITIVE BACTERIAL DIFFERENTIATION pubmed:27984536
Cellular Physiology and Biochemistry Hepatic Macrophages are the Cell Source of Hepatic Procalcitonin in Acute Liver Failure Pubmed:29913443
Archives of Medical Science Inflammatory mediators in the diagnosis and treatment of acute pancreatitis: pentraxin-3, procalcitonin and myeloperoxidase Pubmed:29593801
Journal of Thoracic Disease Expression pattern of soluble triggering receptor expressed on myeloid cells-1 in mice with Acinetobacter baumannii colonization and infection in the lung Pubmed:29707313
Asian Journal of Psychiatry Procalcitonin and C-reactive protein as peripheral inflammatory markers in antipsychotic drug-free schizophrenia patients Pubmed:29723719
European Review for Medical and Pharmacological Sciences The predictive value of joint detection of serum amyloid protein A, PCT, and Hs-CRP in the diagnosis and efficacy of neonatal septicemia. Pubmed: 31298341
Medicina Modestly Elevated Serum Procalcitonin Levels in Patients with Rheumatoid Arthritis Free of Active Infection Pubmed: 33080909
MEDIATORS OF INFLAMMATION Reevaluation of Lung Injury in TNF-Induced Shock: The Role of the Acid Sphingomyelinase Pubmed: 32410851
Early label-free analysis of mitochondrial redox states by Raman spectroscopy predicts septic outcomes
Journal of Immunology Research Moesin Is a Novel Biomarker of Endothelial Injury in Sepsis 33628853
Journal of Medical Biochemistry Circulating nuclear factor-kappa B mediates cancer-associated inflammation in human breast and colon cancer 33776564
Surg Endosc Original contribution: sleeve gastrectomy reduces soluble lectin-like oxidized low-density lipoprotein receptor-1 (sLOX-1) levels in patients with morbid obesity Pubmed:35044516
Bone Res Procalcitonin is expressed in osteoblasts and limits bone resorption through inhibition of macrophage migration during intermittent PTH treatment Pubmed:35087025
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