Product name           

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】

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.