|Place of Origin:||CN|
|Certification:||ISO 13485, CE|
|Minimum Order Quantity:||2000|
|Price:||US 1.50-2.50 Kit|
|Packaging Details:||Colorful Paper Box|
|Delivery Time:||7 Days|
|Payment Terms:||L/C, T/T|
|Supply Ability:||50000 Kits per Week|
|Product Name:||PCT Rapid Quantitative Test Kit||Sample Buffer:||25 Vials|
|Warranty:||12 Months||Applicable Instruments:||NIR-1000 Dry Fluorescent Immunoassay Analyzer|
|Manufacturer:||WWHS Biotech INC||Format:||Cassette|
|Advantage:||High Sensitivity||Production Capacity:||5 Million A Year|
PCT Rapid Test Kit,
Fluorescence Immunoassay Test Cassette
Procalcitonin (PCT) Rapid Quantitative Test (Fluorescence immunoassay)
The product is used to determine the content of procalcitonin (PCT) in whole blood, plasma and serum of human body and is mainly used clinically for auxiliary diagnosis of bacterial infectious diseases.
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.
|Test card||25||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.|
|Sample diluent||25||Phosphate buffer|
|ID card||1||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.
[Product Performance Indicators]
No more than 0.2ng/mL
The relative deviation to the target value is limited to ±15%.
Within-run precision CV≤15%; between-run relative limit R≤15%.
Within the specified linearity range (0.2-100) ng/mL, linearly dependent coefficient r≥0.990.
Interpretation of results
1. This reagent is only used for auxiliary detection. If the test results are abnormal, it should be reviewed in time and judged in combination with clinical symptoms.
2. For samples with AFP concentration lower than 2.5ng/ml and higher than 200ng/ml, the detection results are reported as "< 2.5ng/ml" and "> 200ng /ml", respectively.
Limitations of methods
1. This kit is only used to detect human plasma/whole blood samples
2. Due to the limitations of immunoassay methods of antigen and antibody reaction, the results cannot be used as the only basis for clinical diagnosis, but should be evaluated with all the existing clinical and experimental data.
3. The content of triglyceride in the sample shall not exceed 15mg/ml, the content of hemoglobin shall not exceed 5mg/ml, and the content of bilirubin shall not exceed 0.5mg/ml, and the relative deviation of the test results shall not exceed ±15%.
4. When the concentration of AFP in the sample is less than 20000ng/ml, there is no hook effect.
5. HAMA effect was not produced when the concentration of human anti rat in the sample was less than 50ng/ml.
6. When RF concentration in the sample is less than 2000IU/ml, the relative deviation of the test results is within ±15%.
WWHS NIR-1000 dry fluoroimmunoassay analyser
1) The test card can be used only once at room temperature, do not reuse or use test card out of expiry date.
2) Return all reagents and sample into room temperature before use.
3) Be careful when prepare sample, wear glove and mask.
4) The whole blood need add anticoagulants, not frozen; serum sample can store in frozen, avoid repeated freezing and thawing.
5) This product is only for in vitro rapid diagnostic human use, can be quantified, not only qualitative testing.
6) The product test results for reference only, for confirmation, please refer to the relevant national standard methods.
Contact Person: sales
Address: Rm 505, 1st Building, Shenzhen Biomedicine Innovation Industrial Park, No. 14th, Jinhui Road, East Jinxiu Road, Kengzi Street, Pingshan District, Shenzhen
Factory Address:Rm 505, 1st Building, Shenzhen Biomedicine Innovation Industrial Park, No. 14th, Jinhui Road, East Jinxiu Road, Kengzi Street, Pingshan District, Shenzhen