Superiority of DiaSys Lp‑PLA2 confirmed by Chinese study

Cardiovascular disease (CVD) has become the most common cause of death in both developed and developing countries worldwide and represents a large economic burden. Although several biomarkers for predicting cardiovascular disease exist, CVD is far from being accurately diagnosed and assessed. Lipoprotein-associated phospholipase A2 (Lp-PLA2) is a vascular inflammatory factor that has been demonstrated to be positively correlated with CVD and ischemic stroke.

Lp-PLA2 FS from DiaSys was the first reagent registered by the China Food and Drug Administration. Several studies using the DiaSys reagent have revealed a relation between CVD and Lp-PLAactivity but no studies have been conducted to compare the available Lp-PLA2 activity assays in the Chinese population.

In 2019, results of a Chinese study, published in the Journal of Clinical Laboratory Analysis, showed that DiaSys Lp-PLA2 FS is superior to activity assays provided by Diazyme (US) as well as to those produced by Evermed, Hengxiao and Zybio (all based in P.R. of China). The basic principle for all enzymatic Lp-PLA2 activity assays is the same; formation rate of 4 nitro-phenol is measured photometrically, and Lp-PLA2 activity is calculated from the rate of change in the absorbance.

Due to the lack of reference material, the assays were recalibrated with fresh serum prior to comparison. Results have shown excellent linear correlation between Evermed and DiaSys (Corr. Coeff. 0.999). Assay precision in the study varied from 0.8% - 2.9%. In addition, the study proves that the quality of the sample material is important for measuring Lp-PLA2 activity; fresh serum improved comparability of the assays used in the study. For further information please refer to the publication.(1)

DiaSys Lp-PLA2 FS, which determines the activity of the enzyme Lp-PLA2 in serum and plasma, has been introduced in 2013. The superiority of the test has been confirmed in several studies in recent years. A large scale introduction of Lp-PLA2 measurement has so far been hampered by the lack of reference materials and methods, leading to the use of different calibration methods and lack of comparability of results. Due to the lack of a reference method or reference material for Lp-PLA2, DiaSys standardized their Lp-PLA2 FS test system to the reagent specific molar extinction coefficient of 4 nitrophenol, thus implementing a scientifically proven traceability for the Lp-PLA2 FS reagent.

For further information on the DiaSys test, please refer to the DiaSys microsite.

References

1. Wang D, Guo X, Hou L, et al. Measuring lipoprotein-associated phospholipase A2 activity in China: Protocol comparison and recalibration. J Clin Lab Anal. 2019;33:e22628. doi.org/10.1002/jcla.22628