Quantitative In Vitro Diagnostic Rapid

                       Test Kits For PCT (serum)

Methodology                                                                                 

Fluorescence Immunoassay

Intended use                                                                                

Procalcitonin(PCT),also known as the Pre calcitonin, is composed of 116 amino acids.

Its molecular weight approximately 12.7kD. PCT is expressed by neuroendocrine

cells(includingC cells of the thyroid gland, lung and pancreas), and is decomposed 

into three particles of thyrocalcitonin (immature), carboxyl terminal peptide and 

amino terminal peptide by enzyme digestion.

Only a small amount of PCT is contained in the blood of healthy people. 

PCT will be significantly increased after bacterial infection. 

PCT is a specific marker of inflammatory disorder with bacterial infection and a 

significant indicator of SIRS and sepsis caused by bacterial infection, especially for

severe sepsis and septic shock sepsis. 

PCT plays an important role in differentiating inflammatory disorder caused by

infection and non-infection (such as autoimmune inflammation and acute rejection 

after transplantation). 

Meanwhile, PCT detection is of great significance in guiding the rational use of 

antibacterials,evaluating therapeutic effect and shorten the using time of 

antibacterials.

Fluorescence Immunoassay Analyzer                               

Fluorescent Immunoassays (FIA)                                       

Fluorescent Immunoassays are simply a different type of immunoassay, 

The key variable is the biochemical technique used for detecting the binding

 of the "detection" antibody and the analyte molecule.

PCT  Serum                                                                                   

  1.Convenient and accurate solution of bacterial infection;

  2.Evaluation indicator of infection degree;

  3.Guidance of antibiotics use.

 Test Method                                                                                                                                                                 

1.Please read the manual and instrument operation carefully before using.

2.Check whether the equipment can operate regularly, and prepare other related materials. 

3. Allow the test device, PCT buffer and specimen balanced to room temperature (15-30℃) prior to testing. 

4.Minimizing exposure to damp air.

Test Procedure        

1.Open the Immune-fluorescence quantitative analyzer.

2.Check whether the batch number of IC card and reagent box is consistent, and then insert

IC card into the instrument to get the curve we wanted.

3.Remove the test device from the protective pouch and place it on a flat surface. Draw in 

30ul of whole blood sample to the centrifugal tube, and dilute with 90ul of PCT whole blood

buffer. After gently mix the sample, add 90ul of diluted whole blood sample into the sample

well. Place the test strip at room temperature for 15 minutes.

4.Insert the test card into the hole of immune-fluorescence quantitative analyzer, and click 

start, the instrument will scan the test card automatically.

5.Immune-fluorescence quantitative analyzer detects results automatically and calculates

the content of PCT in the sample.

6.Specimens, used strip and transfer pipettes may be potentially.

Interpretation of test results                                              

1.The analysis of test results are accomplished by  immune-fluorescence  quantitative 

analyzer of  our company's NORMAN series;

2.The concentration of PCT in the unknown samples can be read directly in the 

corresponding batch of ID card standard curve by fluorescence signal value we measured.

The default results use ng/ml as a unit.

Expected values/Reference range                                       

1.The reference range study was conducted based on PCT content of 95% of the 

distribution range of statistical analysis in 120 healthy people, the result was as follows:

2.Normal reference values:<0.05ng/ml;

3.It is recommended that each laboratory established its own reference range, which may

be unique to the population it serves depending upon geographical, patient, dietary, or 

environmental factors.

Notice of detection result                                                       

1.The test results should take clinical symptoms,health history,other laboratory tests, etc.

into account,just for clinical reference,nor as a sole factor of clinical diagnostic;

2.The concentrations of PCT in body as followed patients are higher than normal, but not as 

the main basis for its determination of systemic infection.For instance,the first day after the

trauma, major surgery, burns, treatment with OKT3 antibodies, other drugs to stimulate 

the release of inflammatory mediators cell, small cell lung cancer, medullary thyroid C cell 

carcinoma; infants born within 48 hours;there are long-term or severe patients with 

cardiogenic shock, and long-term patients with severe organ perfusion abnormalities, etc;

3.All operation must be strictly in accordance with operating procedures to get the correct 

result. The accuracy of test results may be affected by any changes to operational 

procedures;

4.Possible causes of false positive results: heterophilic antibodies;some non-specific blood 

components which have similar epitopes to capture the fluorescent labeled antibody.

PCT  serum show                                                                        

Package & Delivery                                                                    

About us                                                                                         

Nanjing Norman Biological Technology Co., Ltd is dedicated to R&D and manufacturing of

automated chemiluminescence system. Founded in 2008, Norman biological has been

upholding the idea that R&D shapes future ,and concentration determines success. Ever 

since the beginning,Norman has been focusing on developing and manufacturing

chemiluminescence and immunofluorescence reagents.

Norman's manufacture center is located in the Yuhua District and owns an over 2,000m2

GMP-approved clean workshop. The R&D base, which is over 2,000m2 , is located in 

state-level new Jiangbei district. Now there are over 100 R&D engineers, 40% of which 

hold a PhD or master's degree.

Powered by advanced technology and excellent talents in the IVD field, Norman has been 

consistently improving its innovation platform , and increasing R&D investment. Self-

innovation, combined with long-term strategic cooperation with universities and research

institutes and with outsourced technologies, ensures consistent improvement on product

quality. Norman's R&D field has covered instruments, reagents, and raw materials, and has

been entrusted by the Nanjing government to build a R&D center specialized in biological 

chemistry and immunity diagnosis. Up to now, Norman has acquired over 20 patents.

Being an expert in automated chemiluminescence analysis , Norman owns independent 

and completed intellectual property rights, and its products provide top-notch sensitivity,

precision and accuracy . Thanks to the self-developed antigens and self-manufactured 

antibodies, Norman's products features minimized intra-and inter- batch difference.

After 8 years development, Norman is now on the fast track. An over 30,000m2 global

R&D center is in construction, and will hold more than 1,000 R&D engineers in the future.

R&D shapes future, and concentration determines success. Driven by the commitment to 

"provide complete solution to improve human health", Norman will consistently do its 

utmost to drive the IVD industry forward and contribute more to human health.

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