Place of Origin:
CN
Brand Name:
WWHS
Certification:
CE
Model Number:
Lp-PLA2
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Product name】
Diagnostic Kit for Lipoprotein-Associated Phospholipase A2(Immunochromatographic assay)
【Package specification】
25 Tests/kit
【Intended use】
This kit is used for quantitative determination of Lp-PLA2 in human whole blood, plasma and serum.
Clinically, it is mainly used to evaluate the degree of atherosclerosis inflammation and the auxiliary diagnosis of cardiovascular and cerebrovascular diseases caused by atherosclerosis.
【Test principle】
The Lp-PLA2 Rapid Test is a one-step chromatographic sandwich immunoassay designed for the quantitative measurement of Lp-PLA2. The Lp-PLA2 antigen in the sample was first bound with the conjugated compound of fluorescent labeled Lp-PLA2 monoclonal antibody, then moved and combined with another Lp-PLA2 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.
【Components】
Name | Quantity | Component |
Test cards | 25 | It is composed of fluorescent pad (coated with fluorescent labeled Lp-PLA2 monoclonal antibody), nitrocellulose membrane (coated with Lp-PLA2 monoclonal antibody and Goat anti mouse IgG antibody), absorbent paper and backing |
Sample diluent | 25(600μL/tube) | Phosphate 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 production date, batch number and expiration date are shown in the outer package of the product.
【Applicable instruments】
NIR-1000 dry fluoroimmunoassay analyser produced by WWHS Biotech. Inc
【Sample requirements】
【Test procedure】
【Reference interval】
Healthy non-pregnant adults are expected to have serum Lp-PLA2 values below 175.00ng/mL. It is strongly recommended that each laboratory should determine its own normal and abnormal values based on population.
【Interpretation of results】
【Limitations of methods】
【Performance】
1. Limits of detection
No more than 10.00ng/mL.
2. Accuracy
The relative deviation from the target value is within ±15%.
3. Precision
The within and between assay coefficient of variations are within 15%.
4. Linear range
Within the linear range (10.00~ 900.00ng/mL), the linear correlation coefficient R≥0.990.
【Note】
1. This kit is only used for in vitro diagnosis.
2. The test card and sample diluent are disposable and 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. The requirements of specimen collection and storage should be strictly observed. If the specimen is turbid, it should be centrifuged and discarded before use.
5. The used kits should be treated as potential infectious substances, and all samples, reagents and potential pollutants should be disinfected and treated according to the relevant local regulations.
Assay list | ||||||
Cardiac | ||||||
cat#. | Product Item | Specimen | Reaction Time | Measure Range | Clinical Range | Intended 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. |
4 | NT-proBNP | WB/Serum/Plasma | 10min. | 20-35000pg/ml | Under 75:0~347pg/mL, Over 75:0~449pg/mL |
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. |
Why Choose WWHS
1. Precision
Deviation is less than 3.0%
2. Upgraded data storage
10000 data storage
3. Long life
Support to use 3 years
Quality Control
A procedural control is included in the test. A colored line appearing in the control region (C) is the internal procedural
control. It confirms sufficient specimen volume and correct procedural technique.
Control standards are not supplied with this kit; however, it is recommended that a positive control and a negative control control be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.
FAQ:
1. What is the MOQ?
Generally if you choose the different products, our minimum order qty. also will be different. One sample available.
2. What about the delivery time?
The goods need 7-21 work days to be made upon deposit.
3. What's your shipping method?
We provide comprehensive shipping methods.
For small quantity orders we ship by DHL Air-Express, or EMS/TNT/UPS/FEDEX Express service, it is safe and fast.
For large quantity orders we ship by Air transportation or sea transportation, we can also ship order to buyer’s cargo agent in China.
Send your inquiry directly to us