|Place of Origin:||CN|
|Certification:||ISO 13485, CE|
|Minimum Order Quantity:||1000|
|Price:||US 1.50-2.50 Kit|
|Packaging Details:||Colorful Paper Box|
|Delivery Time:||7 Days|
|Payment Terms:||L/C, T/T|
|Supply Ability:||10000 Kits per Week|
|Product Name:||S100-β Rapid Quantitative Test Kit||Sample Buffer:||25 Vials|
|Warranty:||12 Months||Applicable Instruments:||NIR-1000 Dry Fluorescent Immunoassay Analyzer|
|Package Specification:||25 Tests||Feature:||High Sensitivity, High Accuracy|
S100-β Rapid Quantitative Test Kit,
POCT Rapid Quantitative Test Kit
Diagnostic Kit for S100β protein(Immunochromatographic assay)
The kit is used for quantitative determination of S100β in human whole blood, serum or plasma. Clinically, by detecting the expression of S100β protein, we can judge the degree of brain injury and evaluate the prognosis of patients.
The Diagnostic Kit for S100β is a one-step chromatographic sandwich immunoassay designed for the quantitative measurement of S100β. The S100β antigen in the sample was first bound with the conjugated compound of fluorescent labeled S100β monoclonal antibody, then moved and combined with another S100β monoclonal antibody fixed on the nitrocellulose membrane, and the double antibody sandwich complex was formed at the detection line of the cellulose nitrate membrane. The quantitative detection results were obtained by NIR-1000 dry fluoroimmunoassay analyser.
|Test cards||25||The product consists of fluorescent pat (coated with fluorescently-labeled S100β monoclonal antibody), nitrocellulose membrane (coated with S100β monoclonal antibody ), absorbent paper and PVC soleplate.|
|Sample diluent||25 (200µL/ tube)||Tris-HCl buffer|
|ID card||1||With specific stand curve file|
The components in different batches of kits cannot be used interchangeably.
【Storage Conditions and Validity】
The kit should be stored at 4℃~30℃, out of direct sunlight. It is valid for 18 months. The test card should be used within 15 minutes after unsealing under the environment of 15℃~30℃ and 20% ~ 90% relative humidity. The sample buffer is disposable and used immediately after opening the cap.
The production date, batch number and expiration date are shown in the outer package of the product.
NIR-1000 dry fluoroimmunoassay analyser produced by WWHS Biotech. Inc.
S100β normal reference value is less than 0.20ng/mL. It is strongly recommended that each laboratory should determine its own normal and abnormal values.
【Interpretation of test results】
【Limitation of test method】
3. The triglyceride content in the sample does not exceed 15mg/mL, the hemoglobin content does not exceed 5mg/mL, the bilirubin content does not exceed 0.5mg/mL, the content of neuron-specific enolase does not exceed 200ng/mL, the content of glial fibrillary acidic protein does not exceed 5ng/mL, the content of IL-6 does not exceed 200pg/mL, the content of tumor necrosis factor does not exceed 200pg/mL, the content of albumin does not exceed 60mg/mL, the content of fibroblast growth factor does not exceed 20ng/mL, the cholesterol does not exceed 10mg/mL, the content of total protein does not exceed 120mg/mL, and the relative deviation of the measurement results does not exceed ±15.0%.
4. When S100β concentration of samples reaches 40.00ng/mL, there is no hook effect.
6. When RF concentration of samples is less than 2000IU/mL, relative deviation of test result is limited to ±15.0%.
7. For samples exceeding the linearity range, test cannot be conducted after dilution.
1. Limits of detection
No higher than 0.05ng/mL
The relative deviation to the target value is limited to ±15.0%.
The within and between assay coefficient of variations are within 15%.
Within the linear range [0.05,10.00]ng/mL, the linear correlation coefficient R≥0.990.
1. The kit can be used for in vitro diagnosis only.
2. Test card and buffer solution are single-use and they cannot be reused.
3. Please check the integrity and validity of the kit package before use, and then open the package. When it is stored at low temperature, it should be restored to room temperature (15℃ ~ 30℃) before opening the package for use. The reagents with damaged inner package and beyond the validity period cannot be used.
4. Take the test card out of the aluminum foil bag and carry out experiment in 15min. Do not place it in the air for a long time to avoid dampness.
5. It is required to strictly comply with the requirements for sample collection and storage. If the sample is turbid, please centrifuge and precipitate it before use.
6. The kit used should be disposed of as latent infective material, and all samples, reagents and latent contaminants should be disinfected and disposed of according to relevant local regulations.
WWHS POCT Assay List
|cat#.||Product item||Specimen||Reaction Time||Measure Range||Clinical Range||Itended Use|
|1||cTnI||WB/Serum/Plasma||12min.||0.1-40ng/ml||<0.3ng/ml||several heart diseases including myocardial infarction and heart failure.|
|2||Myo||WB/Serum/Plasma||12min.||5-400ng/ml||<58ng/ml||acute myocardial infarction (AMI) in early stage.|
|3||CK-MB||WB/Serum/Plasma||12min.||1-200ng/ml||<5ng/ml||acute myocardial infarction (AMI) in early stage.|
|heart failure .|
|5||D-Dimer||WB/Plasma||10min.||40-10000ng/ml||<500ng/ml||disseminated intravascular coagulation (DIC),deep vein thrombosis (DVT),pulmonary embolism (PE), myocardial infarction, cerebral infarction, etc.|
|6||cTnI+Myo+CKMB||WB/Serum/Plasma||12min.||same with single item||same with single item||Triple marker of myocardial infarction.|
|7||ST2||WB/Serum/Plasma||10min.||10-400ng/ml||<35ng/ml||heart failure .|
|8||Lp-PLA2||WB/Serum/Plasma||10min.||10-900ng/ml||<175ng/ml||Risk evaluation of ACS and atherosclerotic ischemic stroke patients.|
|9||S100-β||WB/Serum/Plasma||10min.||0.05-10ng/ml||<0.2ng/ml||Cerebral infarction, cerebral injury.|
|10||CRP / hs-CRP||WB/Serum/Plasma||3min.||0.5-200mg/L||CRP<10mg/L,hs-CRP<1mg/L||nonspecficity inflammatory marker.|
|13||CRP+SAA||WB/Serum/Plasma||5min.||same with single item||same with single item||inflammation&infection.|
|15||TSH||Serum/Plasma||15min.||0.3-100mU/L||0.35-5mU/L||hyperthyroidism and hypothyroidism|
|19||CEA||Serum/Plasma||15min.||1-200ng/ml||<5ng/ml||colon cancer, colorectal cancer,etc.|
|20||NSE||Serum/Plasma||15min.||1-400ng/ml||<16ng/ml||non-small cell lung cancer|
|21||FOB||fecal specimens||10min.||50-1000ng/ml||<100ng/ml||Abnormal recessive gastrointestinal bleeding|
|22||PG II||Serum/Plasma||15min.||1-100ug/L||PGI/PGII>3.0||gastric abnormalities|
|23||PG I||Serum/Plasma||15min.||2.5-200ug/L||>70ng/ml||gastric abnormalities|
|27||CA15-3||Serum/Plasma||15min.||10-400U/ml||< 25 U/mL||breast cancer|
|28||HE4||Serum/Plasma||15min.||50-2000pmol/L||<140 pmol/L||ovarian cancer|
|29||CA19-9||Serum/Plasma||15min.||10-400U/ml||< 27 U/mL||pancreatic cancer|
|30||β-HCG||Serum/Plasma||15min.||5-400mIU/ml||<10 mIU/mL||Early pregrancy, ectopic HCG cancer,incomplete abortion|
|31||CK19(Cyfra21-1)||Serum/Plasma||15min.||0.5-50ng/ml||<2.5ng/ml||non-small cell lung cancer|
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
Packing and Delivery
Packing: Standard packing, neutral packing, OEM packaging are welcome;
Delivery: According to the specific quantity of the product;
Payment: Credit Card, Paypal, Local Bank, Western Union, T/T, etc.
Shipping: International Express, by Air, by Sea, etc;
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