Lipoprotein(a) assay cartridge kit

This product is meticulously crafted for the precise quantification of lipoprotein(a) in human whole blood and is intended to be utilized alongside an iProtin reader. In clinical scenarios, Lp(a) assessment values emerge as a highly sensitive indicator in the development of coronary artery disease. When evaluating the comprehensive risk of atherosclerosis, Lp(a) measurements should be complemented by assessments of cholesterol, HDL, LDL, and TG.

Furthermore, it is recommended to measure Lp(a) values in individuals with dyslipoproteinemia, diabetes mellitus, renal failure, cardiovascular or cerebrovascular disease, and early atherosclerosis. Given that Lp(a) levels are genetically determined and impervious to dietary or lifestyle modifications, screening for diagnosis becomes imperative. Identifying high-risk individuals through screening provides a crucial window for proactive measures to eliminate or manage other risk factors promptly.

Product Performance Properties
(1) Linearity range
ApoB concentration 8.0 2 02.2 mg/dL, conducted in accordance with CLSI EP6 A guidelines
(2) Accuracy
The limit of detection (LoB) for the blank is 5.47 mg/dL, while the limit of detection (LoD) is 8.01mg/dL, conducted in accordance with CLSI EP17-A guidelines, 60 replicate tests were performed on low concentration samples.
(3) Precision
Intra-study Conducted according to CLSI EP5 A2 guidelines, Please contact manufacturer for more information.

Storage conditions: Ambient temperature: 2~24 ℃; Relative humidity:< 85%

Expiration date: One year under standard storage conditions.

Approved - CE, FDA, TFDA listing