China-PAR–based cardiovascular risk assessment in East Shenzhen using Biossays homocysteine and lipid assays: A prospective cross-sectional and retrospective study

Objective Hypertension and dyslipidemia are two well-established risk factors for cardiovascular disease. This study aimed to evaluate the analytical performance of homocysteine and lipid assays, estimate the 10-year cardiovascular disease risk among individuals with hypertension, and determine the proportions of hyperhomocysteinemia-type hypertension and dyslipidemia in a hospital-based population in East Shenzhen, China. Methods The analytical performances of the Biossays homocysteine, total cholesterol, triglycerides, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol assays were evaluated according to the Clinical and Laboratory Standards Institute documents. A cross-sectional hypertension cohort comprising 400 eligible participants was recruited from Pingshan People's Hospital between April 2024 and April 2025 to assess the risk of cardiovascular disease and prevalence of hyperhomocysteinemia-type hypertension. Additionally, a retrospective analysis was performed involving 55,575 unique individuals with complete lipid data identified from the hospital laboratory database in 2024, following the exclusion of participants with incomplete and duplicate records, to assess the proportion of participants with dyslipidemia. Results The Biossays homocysteine and lipid assays demonstrated satisfactory precision, trueness, sensitivity, and linearity. The 10-year cardiovascular disease risk, based in the Prediction for Atherosclerotic Cardiovascular Disease Risk in China, differed across ages but not across sexes. The proportions of individuals with hypertension and hyperhomocysteinemia, defined as homocysteine levels ≥10 μmol/L and ≥15 μmol/L, were 85.50% (342) and 33.75% (135), respectively, with no difference in the risk distribution between the two criteria. At least one abnormal lipid parameter was observed in 68.00% (272) of the participants in the hypertension cohort and in 62.35% (34,651) of individuals from the annual laboratory dataset. Conclusions The Biossays homocysteine and lipid assays demonstrated satisfactory analytical performance. Among individuals with hypertension, the estimated 10-year cardiovascular disease risk differed across ages but not between sexes, and hyperhomocysteinemia was frequently observed. Lipid abnormalities were also common in the hospital-based population. These findings may support cardiovascular risk assessment and preventive management in similar clinical populations.