Recently, Hybribio ApoE and SLCO1B1 Gene MCA Real-time PCR Kit (Fluorescence PCR melting curve method) has been approved by the National Medical Products Administration (NMPA) and obtained a Class III medical device registration certificate (registration number: National Equipment Registration 20233401275).

Abnormal blood lipids are one of the important risk factors for cardiovascular disease ^[1]. The overall prevalence of abnormal blood lipids in Chinese adults is as high as 40.4%, and the prevalence of hypercholesterolemia in children and adolescents in China also witnesses an increasing trend.

At present, statins are the most widely used lipid-lowering drugs in the world, which can reduce the risk of cardiovascular and cerebrovascular diseases by lowering low-density lipoprotein cholesterol (LDL-C) levels; it can also reduce blood lipids by competitively inhibiting HMG-CoA (3-hydroxy-3-methylglutaryl-coenzyme A) reductase activity to reduce the biosynthesis of cholesterol ^[3,4]. However, there are individual differences in the clinical efficacy and adverse reactions of statins. Some patients do not have obvious lipid-lowering effects after using statins, and they also experience adverse reactions such as liver dysfunction, rhabdomyolysis.

Pharmacogenomics research has shown that the liver metabolism and transport of statins vary due to individual genetic characteristics. In particular, the genetic polymorphisms of key transport proteins involved in the liver metabolism of statins, such as organic anion transporting polypeptide (OATP1B1) (encoded by the SLCO1B1 gene) and apolipoprotein E (ApoE), can affect the plasma and liver concentrations of statins, thereby affecting the efficacy and safety of statins ^[5-7].

Hybribio independently developed ApoE and SLCO1B1 Gene MCA Real-time PCR Kit has passed the NMPA Class III registration review. It covers the ApoE and SLCO1B1 gene polymorphism analysis sites recommended in the "Expert consensus on detection of SLCO1B1 and ApoE gene polymorphisms and clinical application of statins". Based on fluorescence PCR melting curve technology, it can qualitatively detect the polymorphisms of the SLCO1B1*1b 388A>G, SLCO1B1*5 521T>C, ApoE2 526C>T, and ApoE4 388T>C sites in human venous whole blood samples, thereby assisting doctors in providing personalized medication guidance and health management guidance for patients with abnormal blood lipids.

Hybribio ApoE and SLCO1B1 Gene MCA Real-time PCR Kit

 (Fluorescence PCR Melting Curve Method)

Product features and advantages

- The application of fluorescence PCR melting curve technology, which is easy to operate and efficient.

- Detection of four sites of two genes in a single tube.

- Meet the needs of medication guidance and health management guidance simultaneously.

- Widely compatible with common fluorescent PCR instruments.

- High sensitivity and anti-contamination owing to its closed-tube operation.

Innovation

- This is the first time that fluorescent PCR melting curve technology is used in a gene polymorphism detection kit.

- This is the first time that qualitative detection of multiple colors, multiple channels, and multiple sites has been achieved in a single tube amplification.

Intended use

The kit is intended for use in the in vitro qualitative detection of polymorphisms at the 388 (c.388T>C), 526 (c.526C>T) sites of the apolipoprotein E (ApoE) gene and the 388 (c.388A>G), 521 (c.521T>C) sites of the organic anion transporting polypeptide 1B1 encoding gene (SLCO1B1) in human venous whole blood samples. This kit is used for medication guidance for statins.

Target population group

- People who are currently taking or plan to take statins (to help doctors assess the safety and effectiveness of statin use).

- People with high blood lipids (to assess the risk of cardiovascular disease related to hyperlipidemia).

- People with a family history of cardiovascular or cerebrovascular diseases or diabetes (to assess their risk of developing these diseases).

- People with a family history of Alzheimer's disease (the ApoE gene is an early screening indicator for Alzheimer's disease).

- Health management for healthy people (to assess the impact of fish oil, alcohol consumption, low-fat diet, etc. on individuals).

References

[1] Hu Shengshou, Gao Runlin, Liu Lisheng, et al. Summary of "China Cardiovascular Disease Report 2018"[J]. Chinese Circulation Journal, 2019, 34(3):209-220.

[2] Zhu Junren, Gao Runlin, Zhao Shuiping, et al. Guidelines for the Prevention and Treatment of Dyslipidemia in Chinese Adults (Revised Edition 2016) [J]. Chinese Circulation Journal, 2016,31(10): 937-953.

[3] Li Qiwen. The role and mechanism of HMG-CoA reductase inhibitors-statins[J]. Modern Drug Application in China, 2014,(17):228-229.

[4] Postmus I, Trompet S, Deshmukh HA, et al. Pharmacogenetic meta-analysis of genome-wide association studies of LDL cholesterol response to statins[J].Nat Commun,2014,5:5068.

[5] In 2015, the "Guidelines for the Detection of Drug Metabolizing Enzymes and Drug Target Genes (Trial)" by the National Health Commission of China.

[6] The Clinical Pharmacogenetics Implementation Consortium (CPIC) guideline for SLCO1B1, ABCG2, and CYP2C9 and statin-associated musculoskeletal symptoms[J]. Clinical Pharmacology & Therapeutics, 2022.

[7] Statin-associated muscle symptoms: impact on statin therapy—European Atherosclerosis Society Consensus Panel Statement on Assessment, Aetiology and Management[J]. European Heart Journal, 2015(17):1012-1022.

[8] Chinese Association of Integrative Medicine Laboratory Medicine Professional Committee, Zhejiang Immunology Association Clinical Immunodiagnostic Professional Committee, Zhejiang Pharmacological Society Therapeutic Drug Monitoring Research Professional Committee. Expert consensus on SLCO1B1 and ApoE gene polymorphism detection and clinical application of statins[J]. Chinese Journal of Laboratory Medicine, 2023, 46(7): 672-680.