Biochip Langdao (Tianjin)Medical Technology Limited

1.Product Overview

  [product name] : Procalcitonin (PCT)

  [Package Specification] : 30 tests/kit;60 tests/kit

  [Applicable Device] : CLite-160i

  [Specimen Type] : serum

  [Storage] : 2-8℃

  [Product validity] : 12 months

  [Detection method] : magnetic particle chemiluminescence method

2.technique principle

  Double antibody sandwich method was used in the kit. The detection principle is: the sample to be tested, R1 reagent, R2 reagent and M reagent are mixed for incubation, and the fluorescein (FITC) labeled PCT antibody 1 in R1 reagent and the alkaline phosphatase (ALP) labeled PCT antibody 2 in R2 reagent are combined with the PCT antigen molecules in the sample to form an immune complex. The immune complex is further captured by anti-FITC antibodies coupled to the surface of the magnetic particle and adsorbed to the surface of the magnetic particle. After washing, the unbound material was removed and the luminescent substrate was added, ALP catalyzed the luminescence of the substrate, and the relative luminescence intensity (RLU) was determined

3.The clinical significance

  PCT has the characteristics of high specificity and sensitivity. When there is obvious bacterial infection and inflammatory response in the body, the level of calcitonin in the body increases sharply, and the degree of increase is positively correlated with the severity of the infection.

PCT is an important biomarker for early diagnosis of neonatal sepsis. The sensitivity and specificity of diagnosis can reach up to 100%. PCT is not affected by mild infections, but begins to rise after systemic bacterial infections and sepsis. At present, PCT is considered as an early diagnostic indicator that can understand the severity of bacterial infections, evaluate therapeutic effects, and determine prognosis.

PCT is a protein that increases in plasma levels when severe bacterial, fungal, parasitic infections, sepsis, and multiple organ failure occur. PCT does not increase during autoimmune, allergic, and viral infections. Localized limited bacterial infections, mild infections, and chronic inflammation will not cause their elevation. Bacterial endotoxins play a crucial role in the induction process. PCT reflects the activity level of systemic inflammatory response. The factors that affect PCT levels include the size and type of infected organs, the type of bacteria, the degree of inflammation, and the status of immune responses. In addition, PCT can only be measured 1-4 days after major surgery in a few patients..

4.Product features and indicators

High sensitivity: the detection limit is not higher than0.05ng/mL;

Wide linear range: samples in the range of 0.05-100 (ng/mL) do not need to be diluted;

Good correlation: c correlation R > 0.95 with ROCHE reagent;

Good stability: the calibration cycle can be up to 14 days, and the reagent can be stored at 4℃ for 1 year;

Fast results: only 16-18 minutes to get results.