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Lipoprotein-Associated Phospholipase A2 Lp-PLA2 Rapid Test Kit 5000 Tests/Day

WWHS Biotech.Inc(exclusive marketed by Dawin)

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Address: Rm 505, 1st Building, Shenzhen Biomedicine Innovation Industrial Park, No. 14th, Jinhui Road, East Jinxiu Road, Kengzi Street, Pingshan District, Shenzhen

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Lipoprotein-Associated Phospholipase A2 Lp-PLA2 Rapid Test Kit 5000 Tests/Day

Country/Region china
City & Province shenzhen
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Product Details

Product name           Lp-PLA2.pdf

Diagnostic Kit for Lipoprotein-Associated Phospholipase A2(Immunochromatographic assay)

 

【Intended use】

1,This kit is used for quantitative determination of Lp-PLA2 in human whole blood, plasma and serum.

Clinically.

       2.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】

1,The Lp-PLA2 Rapid Test is a one-step chromatographic sandwich immunoassay designed for the quantitative measurement of Lp-PLA2.

2,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.

3,The quantitative detection results were obtained by NIR-1000 dry fluoroimmunoassay analyser.

4,The kit should be stored at 4℃~30℃, out of direct sunlight. It is valid for 18 months.

 

【Components】

NameQuantityComponent
Test cards25It 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 diluent25(600μL/tube)Phosphate buffer
ID card1With specific stand curve file
 

The components in different batches of kits cannot be used interchangeably.

 

【Sample requirements】

  1. Plasma, serum and whole blood can be used as samples. The whole blood should be collected in a tube containing heparin, citrate or EDTA as the anticoagulant. If the serum procedure is used, collect blood in a tube without anticoagulant and allow clotting. Hemolyzed samples should not be used.
  2. Venous blood was collected according to routine laboratory methods to avoid hemolysis.
  3. It is highly recommended to use fresh samples instead of keeping the samples at room temperature for a long time. After samples were collected, the detection should be completed within 4 hours at room temperature (15℃~30℃). The whole blood sample can be stored at 2℃~8℃ for 24 hours. Plasma and serum samples can be stored at 2℃~ 8℃ for 7 days, -20℃for 30 days.
  4. Before testing, the sample should return to room temperature (15℃~30℃). The frozen samples should be completely thawed, rewarming and mixed evenly before use. Repeated freeze-thaw cycles should be avoided.

 

 

【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】

  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 Lp-PLA2 concentration lower than 10.00ng/mL and higher than 900.00ng/mL, the detection results are reported as "<10.00ng/mL" and "> 900.00ng/mL", respectively.

 

 

 

WWHS Assay list     
Cardiac     
cat#.Product itemSpecimenReaction TimeMeasure RangeClinical RangeItended Use
1cTnIWB/Serum/Plasma12min.0.1-40ng/ml<0.3ng/mlseveral heart diseases including myocardial infarction and heart failure.
2MyoWB/Serum/Plasma12min.5-400ng/ml<58ng/mlacute myocardial infarction (AMI) in early stage.
3CK-MBWB/Serum/Plasma12min.1-200ng/ml<5ng/mlacute myocardial infarction (AMI) in early stage.
4NT-proBNPWB/Serum/Plasma10min.20-35000pg/mlUnder 75:0~347pg/mL,
Over 75:0~449pg/mL
heart failure .
5D-DimerWB/Plasma10min.40-10000ng/ml<500ng/mldisseminated intravascular coagulation (DIC),deep vein thrombosis (DVT),pulmonary embolism (PE), myocardial infarction, cerebral infarction, etc.
6cTnI+Myo+CKMBWB/Serum/Plasma12min.same with single itemsame with single itemTriple marker of myocardial infarction.
7ST2WB/Serum/Plasma10min.10-400ng/ml<35ng/mlheart failure .
8Lp-PLA2WB/Serum/Plasma10min.10-900ng/ml<175ng/mlRisk evaluation of ACS and atherosclerotic ischemic stroke patients.
9S100-βWB/Serum/Plasma10min.0.05-10ng/ml<0.2ng/mlCerebral infarction, cerebral injury.
Inflammation     
10CRP / hs-CRPWB/Serum/Plasma3min.0.5-200mg/LCRP<10mg/L,hs-CRP<1mg/Lnonspecficity inflammatory marker.
11SAASerum5min.1-200mg/L<10mg/Linflammation&infection.
12PCTWB/Serum/Plasma10min.0.2-100ng/ml<0.5ng/mlSepsis
13CRP+SAAWB/Serum/Plasma5min.same with single itemsame with single iteminflammation&infection.
14IL-6WB/Serum/Plasma10min.5-4000pg/ml10pg/mldiabetes,rheumatoid arthritis,etc
Thyroid Hormone     
15TSHSerum/Plasma15min.0.3-100mU/L0.35-5mU/Lhyperthyroidism and hypothyroidism
16TT3Serum/Plasma15min.0.5-10nmol/L1.3-3.1nmol/Lthyroid dysfunction
17TT4Serum/Plasma15min.5-300nmol/L66-181nmol/Lthyroid dysfunction
18FT3Serum/Plasma15min.1-100pmol/L4-10pmol/Lthyroid dysfunction
19FT4Serum/Plasma15min.5-300pmol/L19-39pmol/Lthyroid dysfunction
Tumor Marker     
20AFPSerum/Plasma15min.2.5-200ng/ml<20ng/mlpregnancy cancer
21CEASerum/Plasma15min.1-200ng/ml<5ng/mlcolon cancer, colorectal cancer,etc.
22NSESerum/Plasma15min.1-400ng/ml<16ng/mlnon-small cell lung cancer
23FOBfecal specimens10min.50-1000ng/ml<100ng/mlAbnormal recessive gastrointestinal bleeding
24PG IISerum/Plasma15min.1-100ug/LPGI/PGII>3.0gastric abnormalities
25PG ISerum/Plasma15min.2.5-200ug/L>70ng/mlgastric abnormalities
26TPSASerum/Plasma15min.0.5-40ng/ml<4ng/mlprostate cancer
27FPSASerum/Plasma15min.0.1-10ng/ml<1ng/mlprostate cancer
28CA12-5Serum/Plasma15min.20-500U/ml<35U/mlovarian cancer
29CA15-3Serum/Plasma15min.10-400U/ml< 25 U/mLbreast cancer
30HE4Serum/Plasma15min.50-2000pmol/L<140 pmol/Lovarian cancer
31CA19-9Serum/Plasma15min.10-400U/ml< 27 U/mLpancreatic cancer
32β-HCGSerum/Plasma15min.5-400mIU/ml<10 mIU/mLEarly pregrancy, ectopic HCG cancer,incomplete abortion
33CK19(Cyfra21-1)Serum/Plasma15min.0.5-50ng/ml<2.5ng/mlnon-small cell lung cancer
Fertility     
34HCG / β-HCGSerum/Plasma10min.5-20000mIU/ml<5 mIU/mLearly pregrancy.
35AMHSerum/Plasma10min.0.1-16ng/mlMale: 20-60 years old, 0.92-13.89 ng/mL
Female: 20-29 years old, 0.88-10.35 ng/mL
30-39 years old, 0.31-7.86 ng/mL 40 -50 years old, <5. 07 ng/mL
ovarian reserve level
Gastrointestinal      
36FOBfecal specimens10min.qualitativequalitativegastrointestinal hemorrhage.
37TRFfecal specimens10min.qualitativequalitativegastrointestinal hemorrhage.
38FOB+TRFfecal specimens10min.qualitativequalitativegastrointestinal hemorrhage.
Infection      
39C.PneumoniaWB/Serum/Plasma15min.qualitativequalitativeCP infection
40M.PneumoniaWB/Serum/Plasma15min.qualitativequalitativeMP infection
41Covid-19 Antigennasal swab, throat swab or nasal wash/aspirate specimens15min.qualitativequalitativerespiratory tract
42Covid-19 Ab IgG/IgMWB/Serum/Plasma15min.qualitativequalitativerespiratory tract
43FluAnasal swab, throat swab or nasal wash/aspirate specimens15min.qualitativequalitativerespiratory tract
44FluBnasal swab, throat swab or nasal wash/aspirate specimens15min.qualitativequalitativerespiratory tract
Renal Injury      
45CysCWB/Serum/Plasma5min.0.4-9mg/L0.5-1.1mg/Lrenal function
46NGALUrine10min.10-1500ng/mL<132ng/mLacute kidney injury.
Other      
47FERRSerum5min.10-500ng/mlMale:24ng/mL~335ng/mL,
Female:11ng/mL~307ng/mL
iron metabolism related diseases, such as hemochromatosis and iron deficiency anemia
48HbA1cWB10min.4%-14%4%-6%diabetes
49VDSerum/Plasma15min.8-70ng/mL19-57ng/mLfetation

 

 

 

 

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