CE Approved Blood Procalcitonin Rapid test Kit in cassette

Diagnostic Kit for  free Procalcitonin (fluorescence immunochromatographic assay)

1.SUMMARY

Procalcitonin (PCT) is a prohormone composed of 116 amino acids. Its molecular weight is about 12.7KD. In normal physiological condition, PCT is secreted by thyroid C cells. In blood of healthy people, PCT concentration is very low, less than 0.05ng/mL. In state of inflammatory stimulation, especially bacterial infection/sepsis, each tissue, and various types of cells in the body may generate PCT and release them into blood circulation system. PCT is measurable in the first 3 hours after infection onset and reaches the peak after 6-12 hours. Compared with traditional biological marker, PCT has a half-life close to 24 hours and is hardly affected by renal function state and hormonotherapy. Therefore, PCT determination can be used as one of the methods for identifying bacterial infection.

2.PRODUCTS INFORMATION 

♦ Name:Diagnostic Kit for Procalcitonin ♦ Model Number: PCT ♦ Methodology: fluorescence immunochromatographic assay ♦ accurancy: 99% ♦ Certificate: CE/ISO13485 ♦ Shelf time : 24 months ♦ after sale service: online technical support ♦ Packing: 25tests/kit,30boxes/ctn ♦ OEM/ODM service :Avaliable ♦ Storage:2'C-30'C

3.FEATURE

♥ Speciments are easy to collect: Human Serum or plasma. ♥ Easy to carry, Rapid test in 15 mins, Cost effective . ♥ Highly  Accuracy rate  ♥ Application:simple operation ,suitable for bedside,outpatient,ICU ,outdoor and so on .

4.TEST PROCEDURE 

♦ Open the aluminum foil bag package of reagent, and take out the test device;

♦ Horizontally insert the test device into the slot of immune analyzer;

♦ On home page of operation interface of immune analyzer, click “Standard” to enter test interface;

♦ Click “QC Scan” to scan the QR code on inner side of the kit; input kit related parameters into instrument, and select sample type;

Note: Each batch number of the kit shall be scanned for one time. If the batch number has been scanned, then skip this step;

♦ Check the consistency of “Product Name”, “Batch Number” and etc. on test interface with information on the kit label;

♦ After information consistency is confirmed, take out sample diluents, add 80µL of serum/plasma/whole blood sample, and sufficiently mix;

♦ Add 80µL of above mixed solution into the sample hole of test device;

♦ After complete sample addition, click “Timing” and remaining test time will be automatically displayed on the interface.

♦ Immune analyzer will automatically complete test and analysis when test time is reached.

♦ After test by immune analyzer is completed, test result will be displayed on test interface or can be viewed through “History” on home page of operation interface.

5.Clinical performance

Clinical evaluation performance of the product is assessed through collecting 165 clinical samples. The corresponding kit of listed electrochemiluminescence method is used as the control reagent. The test results are compared, and their comparability is studied with linearity regression. The correlation coefficients of the two tests are Y=0.997X+0.041 and R=0.9896, respectively.

6.STORAGE AND STABILITY

♦ The kit is 24 months shelf-life from the date of manufacture. Store the unused kits at 2-30°C. DO NOT FREEZE. Do not use beyond the expiration date.

♦ Do not open the sealed pouch until you are ready to perform a test, and the single-use test is suggested to be used under the required environment (temperature 2-35℃, humidity 40-90%) within 60 mins as quickly as possible.

♦ Sample diluent is used immediately after being opened.

7.CERTIFICATE 

8.FACTORY

RELATED PRODUCTS

1.Portable Immune Analyzer-WIZ A101

2.Diagnostic kit for C-reactive protein

3.Diagnostic Kit for Serum Amyloid A