hs-cTn-related technology has been upgraded again!
发布日期：
2024-07-12
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According to 《Report on Cardiovascular Health and Diseases in China 2022》, cardiovascular disease is the leading cause of death among urban and rural residents in China, and has become a major public health problem. And cardiac markers play a very important role in the diagnosis and prognosis of cardiovascular diseases, including prevention and efficacy judgment. The following cardiac markers are commonly used in clinical practice: troponin associated with myocardial injury, BNP and NT-proBNP associated with heart failure, D-dimer associated with embolism, and C-reactive protein associated with inflammation, which are widely recognized and recommended by the guidelines[1].



Key Points in Cardiac Marker Testing







Key point 1: Interference problems with cTn


The structural properties of cTn itself can introduce potential confounding factors that can lead to false positive or false negative results. For example, restriction enzyme cutting sites, phosphorylation and glycosylation sites, autoantibody binding sites, and so on. To address this point, Diagreat has upgraded its R&D process and technology again, and has made a breakthrough by adopting a proprietary technology to obtain the (Fab)2 fragment of the antibody and ligating the alkaline phosphatase enzyme directionally to the neck-loop region of the antibody.

✓ Fc fragment free: with cTnT Cap03 antibody, very low HAMA interference.

✓ High homogeneity: SEC-HPLC single peak 95%+, brings homogeneity of reagent process, excellent CV, very low Between-Run Precision:.

✓ Directed coupling: good preservation of Fab activity, better reactivity.

hs-cTn-related technology has been upgraded again!

Preparation process of cTnT Det Fab-ALP



Key point 2: Difficulty in meeting patients' needs for different options for myocardial testing


For myocardial testing, some clinics choose hs-cTnT or hs-cTnI, and hs-cTnT and hs-cTnI are rarely developed and marketed at the same time due to the patent restriction of hs-cTnT. With the localization of hs-cTnT, Diagreat has made a breakthrough in upgrading the technology of hs-cTnT and hs-cTnI to meet the needs of different patients for high-sensitivity troponin I/T testing! Diagreat has a more complete myocardial test catalog and better production quality to meet the multi-dimensional testing needs of patients.



Diagreat high sensitive troponin test kit performance verification data




hs-cTn-related technology has been upgraded again!

Validated Item: High Sensitive Troponin I


Validation protocol: validate Diagreat hs-cTnI against an imported brand hs-cTnI reagent

Testing platform: Automatic chemiluminescence immunoassay analyzer DF200i versus an imported brand analyzer.


Test samples: 47 clinical samples were tested

Result: R2=0.9777, meets the laboratory requirements



hs-cTn-related technology has been upgraded again!


Correlation analysis of high-sensitivity troponin I performance validation






Advantages of the clinical application of hs-cTn


1. Help to detect the small myocardial injuries that were easily missed in the past

2. Earlier diagnosis of acute myocardial infarction (AMI)

3. Rational screening of patients with high risk of cardiovascular disease

4. Optimize clinical treatment decisions and prognosis assessment






What is the difference between high-sensitivity troponin (hs-cTn) and normal troponin (con-cTn)?


Traditional cTn detection methods are relatively insensitive and imprecise, and it is difficult to detect cTn at low concentrations in the blood circulation, and it is basically impossible to detect cTn in apparently healthy populations. cTn may lead to delayed diagnosis or even misdiagnosis when the symptoms of ischemia or electrocardiographic changes are atypical, which is not conducive to early diagnosis, risk assessment, and prognosis judgment. With the continuous development of cardiac biomarker technology, high-sensitivity troponin with high sensitivity and precision has emerged. According to the proportion of cTn below the 99th percentile detected by the assay in the healthy population, it is divided into four levels: detection rate <50% for the traditional method; detection rate of 50% to 75% for the first-generation high-sensitivity method; detection rate of 75% to 95% for the second-generation high-sensitivity method; and detection rate of >95% for the third-generation high-sensitivity method. hs-cTnT assay can be detected at a minimum threshold of 0.003 μg/L, which fully meets the requirements of the ESC for myocardial infarction markers[2]. Therefore hs-cTn realizes a sensitive detection of mild or minor cardiac injury and has a very high diagnostic and prognostic value in clinical applications.


hs-cTn-related technology has been upgraded again!


Sensitivity levels of different cTn assays





A study on the clinical application of high-sensitivity troponin


Research methodology

1. Participants included patients who received an emergency department visit (April 30, 2018 to April 23, 2019) and underwent troponin testing in 21 Queensland Health hospitals (QH).

2. Pre-implementation phase (prior to the use of hs-cTn): 63,335 cases using the AccuTnI+3 assay with a 99th percentile Upper Reference Limit (URL) of 40 ng/L, with a recommended cTn sampling interval of 6 to 8 hours for most patients (after an office visit for initial testing), and an IMPACT process (which allows for 0 h and 2/3 h sampling in moderate- and low-risk patients) for some patients.

3. post-intervention phase (after hs-cTn use): 61,022 cases using the Access hs-cTnI assay (from October 25, 2018 onwards. Data within two weeks of hs-cTnI use were not used because some hospitals used AccuTnI+3 and hs-cTnI in parallel during this period) using a gender-specific upper reference limit of 10 ng/L for women and 20 ng/L for men.Sampling intervals of 0 h and 2/3 h were used for all patients.

Findings

Result 1: Median hospital LOS was 11.1 h (IQR 5.0–45.4) in the pre-intervention and 9.1 h (IQR = 5.1 to
43.7 h) in the post-intervention period; a reduction of 1.9 h (95% CI: 2.9 to 1.0 h).

Result 2: Death from a CV cause (up to 90 days after presentation) occurred in 513/54,600 (0.9%)pre-implementation patients and 333/52,310 (0.6%) post-implementation patients; a reduction of0.3% (95% Cl: -0.4 to -0.2). Death from a CV cause occurred in 219(0.8%) females pre- and 140 (0.5%) post-implementation. For males, CV deaths occurred in 294 (1.1%)
patients pre- and 193 (0.7%) patient's post-implementation.


hs-cTn-related technology has been upgraded again!


Discussion

In patients with suspected ACS, the use of more accurate hs-cTnI reduced hospital LOS without an increase in cardiovascular hospitalizations, invasive treatments, or diagnosis of AMI. Current research supports the growing popularity of hs-cTnI testing worldwide. Highly sensitive cTnI assays allow for more rapid evaluation protocols within the emergency department, resulting in medical diagnostic and societal value[3].




References:

[1]《中国心血管健康与疾病报告2022》要点解读[J].中国心血管杂志,2023,28(04):297-312.

[2]李萌辉,胡志东.高敏心肌肌钙蛋白的临床研究进展[J].国际检验医学杂志,2013,34(12):1561-1562+1577.

[3]Greenslade J H, Parsonage W, Foran L, et al. Widespread introduction of a high-sensitivity troponin assay: Assessing the impact on patients and health services [J]. J Clin Med, 2020, 9(6). DOI:10.3390/jcm9061883



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