Near patient-testing PCT test kits

Methodology                                                                                 

Fluorescence Immunoassay

Fluorescence is the emission of light by a substance that has absorbed light

or other electromagnetic radiation.It is a form ofluminescence. In most cases, 

the emitted light has a longer wavelength, and therefore lower energy, than the 

absorbed radiation.

Procalcitonin   PCT                                                                    

Procalcitonin (PCT) is a peptide precursor of the hormone calcitonin, the latter being

involved with calcium homeostasis. It is composed of 116 amino acids and is produced 

by parafollicular cells (C cells) of the thyroid and by the neuroendocrine cells of the lung 

and the intestine.

The level of procalcitonin in the blood stream of healthy individuals is below the limit of 

detection (0.01 µg/L) of clinical assays.

The level of procalcitonin rises in a response to a proinflammatory stimulus, especially

of bacterial origin. In this case, it is produced mainly by the cells of the lung and the

intestine. It does not rise significantly with viral or non-infectious inflammations. 

With the derangements that a severe infection with an associated systemic response 

brings, the blood levels of procalcitonin may rise to 100 µg/L. In serum, procalcitonin

has a half-life of 25 to 30 hours. Remarkably the high procalcitonin levels produced

during infections are not followed by a parallel increase in calcitonin or a decrease 

in serum calcium levels.

Diagnosis and prognosis of sepsis                                       

Measurement of procalcitonin can be used as a marker of severe sepsis caused by bacteria 

and generally grades well with the degree of sepsis,although levels of procalcitonin 

in the blood are very low. 

PCT has the greatest sensitivity (85%) and specificity (91%) for differentiating patients 

with systemic inflammatory response syndrome (SIRS) from those with sepsis, 

when compared with IL-2, IL-6, IL-8, CRP and TNF-alpha.

Evidence is emerging that procalcitonin levels can reduce unnecessary antibiotic prescribing

to people with lower respiratory tract infections.

Currently, procalcitonin assays are widely used in the clinical environment.

Product Description                                                                  

1.The test kit is primarily for the in vitro quantitative determination of procalcitonin(PCT) 

content in human whole blood;

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

3.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.

Principle of the Procedure                                                     

The reagent is based on immunefluorescence sandwich assay to detect PCT concentrations 

quantitatively. Using the pipette provided, drop sample into the sample well. 

During testing, specimen reacts with the particles coated with anti- monoclonal antibody I 

which has conjugated with fluorescent latex. The mixture migrates upward on the 

nitrocellulose membrane by capillary action to react with anti-PCT monoclonal antibody II 

on the test line.

The intensity of fluorescent antibody signal reflects the amount of captured PCT. 

Immunefluorescence quantitative analyzer produced by our company can detect the 

concentration of PCT in the sample.

Applicable Instruments                                                           

The test has to be performed on the series of immunofluorescent analyzer 

from Nanjing Norman Biological Technology Co. Ltd

Main components                                                                      

General Name:PCT Test Kit(Immunofluorescence)

Test card: Aluminum foil pouch  1pc/bag, desiccant

Package size: 25pcs/box

Performance Indicators                                                          

1. Detection limit:<0.05ng/ml

2. Linear range:0.05-100ng/ml,the linear correlation coefficient r should not be less than 

0.9900 in this range.

3. Accuracy should be in accordance with one of the following requirements:

a) The relative deviation of the measurement results should not be greater than 20% when

used reference substance as a sample for testing.

b) When using comparative test method to test the kit, there should be that the results of 

the correlation coefficient r≥0.975, relative deviation≤20%.

4.  Repeatability:CV≤15%.

5. Difference between batches:CV≤15%.

Product Show                                                                              

Exhibition Show                                                                          

Part of work shop                                                                       

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.

Certifications                                                                                

Realated kits for test                                                                 

Inflammation/Infection

PCT(whole blood), PCT (surum),  hs-CRP

Cardiovascular

NT-proBNP, D-Dimer

cTnI,CK-MB, MYO

Nephropathy

NAGL, RBP,Cys-c, mAlb, B2-MG

Gastrosis

PGⅠ, PGⅡ, PGR, HP,FOB

Rheumatism

RF

Diabetes

C-Peptide

About us                                                                                         

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 providem 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.

Agent Wanted                                                                              

If you are interested in working with us, please feel free to contact.

Why us                                                                                            

Manufacturer and Exporter for nearly 10 years with self R&D Research Center;

Professional After-Sale service with On-site support worldwide; 

CE/ISO13485 Certifications

OEM and ODM are available !