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[Product Name] PCT.pdf
Procalcitonin (PCT) Rapid Quantitative Test (Fluorescence immunoassay)
The kit uses immunochromatographic assay. First, PCT antigen in the sample combines with the fluorescently-labeled PCT monoclonal antibody conjugate. Then, it continues to move and combines with another PCT monoclonal antibody fixed on the nitrocellulose membrane to form double-antibody sandwich immune complex in the position of the nitrocellulose membrane test line and analyze and obtain quantitative test result using NIR-1000 dry fluoroimmunoassay analyser.
|The product consists of fluorescent mat (coated with fluorescently-labeled PCT monoclonal murine antibody), nitrocellulose membrane (coated with PCT monoclonal murine antibody and goat anti mouse IgG antibody), absorbent paper and bottom lining.
|Record standard curve information of this batch of reagents
Ingredients of kits of different batch numbers cannot be exchanged.
[Storage Conditions and Validity]
The product should be stored at 4℃-30℃ in a dry and dark place, sealed using aluminum foil bag and must not be frozen. The storage life is 12 months. The test card should be unpacked at room temprature (15℃-30℃) and should be used in 15min after unpacked at a temperature of (15-30)℃ and relative humidity of 20%-90%.
See outer packing for production date, batch number and expiry date.
NIR-1000 dry fluoroimmunoassay analyser produced by WWHS Biotech. Inc.
Determine 254 healthy people aged 18-68 and carry out statistical analysis. Result shows that the upper limit of the reference value is 0.5ng/mL at the 95th percentile, so the reference interval is less than 0.5ng/mL.
The laboratory should establish a reference range according to characteristics of local people.
[Interpretation of Test Results]
1. The kit can be used for auxiliary test only. If test result is abnormal, retest timely and judge combined with clinical symptoms.
2. For samples whose PCT concentration is lower than 0.2ng/mL and higher than 100ng/mL, test result is “＜0.2ng/mL” and “＞100ng/mL” respectively.
[Limitation of Test Method]
1. The kit can be used to test whole blood, plasma and serum specimens of human body only.
2. Due to limitations of serological methods for antigen and antibody response, the test result cannot be used as the only basis for clinical diagnosis and should be evaluated together with all existing clinical and experimental data.
5. When human anti mouse concentration of samples is less than 50ng/mL, HAMA effect will not be observed.
6. When RF concentration of samples is less than 2000 IU/mL, the test result will not be affected.
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