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】
| 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.
【Sample requirements】
- 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.
- Venous blood was collected according to routine laboratory methods to avoid hemolysis.
- 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.
- 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】
- 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.
- 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 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. |
| 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. |
| Inflammation | | | | | |
| 10 | CRP / hs-CRP | WB/Serum/Plasma | 3min. | 0.5-200mg/L | CRP<10mg/L,hs-CRP<1mg/L | nonspecficity inflammatory marker. |
| 11 | SAA | Serum | 5min. | 1-200mg/L | <10mg/L | inflammation&infection. |
| 12 | PCT | WB/Serum/Plasma | 10min. | 0.2-100ng/ml | <0.5ng/ml | Sepsis |
| 13 | CRP+SAA | WB/Serum/Plasma | 5min. | same with single item | same with single item | inflammation&infection. |
| 14 | IL-6 | WB/Serum/Plasma | 10min. | 5-4000pg/ml | 10pg/ml | diabetes,rheumatoid arthritis,etc |
| Thyroid Hormone | | | | | |
| 15 | TSH | Serum/Plasma | 15min. | 0.3-100mU/L | 0.35-5mU/L | hyperthyroidism and hypothyroidism |
| 16 | TT3 | Serum/Plasma | 15min. | 0.5-10nmol/L | 1.3-3.1nmol/L | thyroid dysfunction |
| 17 | TT4 | Serum/Plasma | 15min. | 5-300nmol/L | 66-181nmol/L | thyroid dysfunction |
| 18 | FT3 | Serum/Plasma | 15min. | 1-100pmol/L | 4-10pmol/L | thyroid dysfunction |
| 19 | FT4 | Serum/Plasma | 15min. | 5-300pmol/L | 19-39pmol/L | thyroid dysfunction |
| Tumor Marker | | | | | |
| 20 | AFP | Serum/Plasma | 15min. | 2.5-200ng/ml | <20ng/ml | pregnancy cancer |
| 21 | CEA | Serum/Plasma | 15min. | 1-200ng/ml | <5ng/ml | colon cancer, colorectal cancer,etc. |
| 22 | NSE | Serum/Plasma | 15min. | 1-400ng/ml | <16ng/ml | non-small cell lung cancer |
| 23 | FOB | fecal specimens | 10min. | 50-1000ng/ml | <100ng/ml | Abnormal recessive gastrointestinal bleeding |
| 24 | PG II | Serum/Plasma | 15min. | 1-100ug/L | PGI/PGII>3.0 | gastric abnormalities |
| 25 | PG I | Serum/Plasma | 15min. | 2.5-200ug/L | >70ng/ml | gastric abnormalities |
| 26 | TPSA | Serum/Plasma | 15min. | 0.5-40ng/ml | <4ng/ml | prostate cancer |
| 27 | FPSA | Serum/Plasma | 15min. | 0.1-10ng/ml | <1ng/ml | prostate cancer |
| 28 | CA12-5 | Serum/Plasma | 15min. | 20-500U/ml | <35U/ml | ovarian cancer |
| 29 | CA15-3 | Serum/Plasma | 15min. | 10-400U/ml | < 25 U/mL | breast cancer |
| 30 | HE4 | Serum/Plasma | 15min. | 50-2000pmol/L | <140 pmol/L | ovarian cancer |
| 31 | CA19-9 | Serum/Plasma | 15min. | 10-400U/ml | < 27 U/mL | pancreatic cancer |
| 32 | β-HCG | Serum/Plasma | 15min. | 5-400mIU/ml | <10 mIU/mL | Early pregrancy, ectopic HCG cancer,incomplete abortion |
| 33 | CK19(Cyfra21-1) | Serum/Plasma | 15min. | 0.5-50ng/ml | <2.5ng/ml | non-small cell lung cancer |
| Fertility | | | | | |
| 34 | HCG / β-HCG | Serum/Plasma | 10min. | 5-20000mIU/ml | <5 mIU/mL | early pregrancy. |
| 35 | AMH | Serum/Plasma | 10min. | 0.1-16ng/ml | Male: 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 | | | | | | |
| 36 | FOB | fecal specimens | 10min. | qualitative | qualitative | gastrointestinal hemorrhage. |
| 37 | TRF | fecal specimens | 10min. | qualitative | qualitative | gastrointestinal hemorrhage. |
| 38 | FOB+TRF | fecal specimens | 10min. | qualitative | qualitative | gastrointestinal hemorrhage. |
| Infection | | | | | | |
| 39 | C.Pneumonia | WB/Serum/Plasma | 15min. | qualitative | qualitative | CP infection |
| 40 | M.Pneumonia | WB/Serum/Plasma | 15min. | qualitative | qualitative | MP infection |
| 41 | Covid-19 Antigen | nasal swab, throat swab or nasal wash/aspirate specimens | 15min. | qualitative | qualitative | respiratory tract |
| 42 | Covid-19 Ab IgG/IgM | WB/Serum/Plasma | 15min. | qualitative | qualitative | respiratory tract |
| 43 | FluA | nasal swab, throat swab or nasal wash/aspirate specimens | 15min. | qualitative | qualitative | respiratory tract |
| 44 | FluB | nasal swab, throat swab or nasal wash/aspirate specimens | 15min. | qualitative | qualitative | respiratory tract |
| Renal Injury | | | | | | |
| 45 | CysC | WB/Serum/Plasma | 5min. | 0.4-9mg/L | 0.5-1.1mg/L | renal function |
| 46 | NGAL | Urine | 10min. | 10-1500ng/mL | <132ng/mL | acute kidney injury. |
| Other | | | | | | |
| 47 | FERR | Serum | 5min. | 10-500ng/ml | Male:24ng/mL~335ng/mL,
Female:11ng/mL~307ng/mL | iron metabolism related diseases, such as hemochromatosis and iron deficiency anemia |
| 48 | HbA1c | WB | 10min. | 4%-14% | 4%-6% | diabetes |
| 49 | VD | Serum/Plasma | 15min. | 8-70ng/mL | 19-57ng/mL | fetation |
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Lipoprotein-Associated Phospholipase A2 Lp-PLA2 Rapid Test Kit 5000 Tests/Day Images
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