The new high-sensitivity troponin I/T upgraded again!
发布日期：
2024-01-04
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Cardiac Markers



According to China Cardiovascular Health and Disease Report 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].

The new high-sensitivity troponin I/T upgraded again!



Cardiac Markers

Pain Points in Cardiac Marker Testing

Pain Point 1: Interference with cTn

The structural properties of cTn can cause potential interferences that can lead to false positive or false negative results. For example, enzymatic cleavage sites, phosphorylation and glycosylation sites, autoantibody binding sites and so on. To address this pain point, Diagreat Biotech R&D process technology has been upgraded again, with the breakthrough of using a proprietary technology to obtain the (Fab)2 fragment of the antibody and ligating alkaline phosphatase directionally to the neck loop region of the antibody.

✓ Fc-free fragment: extremely low HAMA, complement interference with cTnT Cap03 antibody.

✓ Highly homogeneous: SEC-HPLC single peaks 95%+, brings reagent process homogeneity, excellent CV, very low lot-to-lot variation.

✓ Directed coupling: well preserved Fab activity, better reactivity.


The new high-sensitivity troponin I/T upgraded again!

cTnTDet Fab-ALP preparation process


Pain point 2: Difficult to meet patients' needs for different choices of myocardial testing

For clinical myocardial testing, some choose hs-cTnT or hs-cTn I, and due to the restriction of hs-cTnT patent, it is rare to develop and market hs-cTnT and hs-cTn I at the same time. With the breakthrough of the localization of hs-cTnT, Diagreat Biotech breakthroughs to realize the technical upgrading of hs-cTnT and hs-cTn I, which can satisfy the needs of different patients for high-sensitivity troponin I/T testing! Diagreat Biotech has a more complete myocardial testing catalog and better production process quality, which greatly meets the multi-dimensional patient testing needs.


Validation data for Diagreat’s High Sensitive Troponin I/T kit

Validation Program: High Sensitive Troponin I

Validation program: Validation of Diagreat High Sensitive Troponin I and an imported brand of High Sensitive Troponin I 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.



The new high-sensitivity troponin I/T upgraded again!


Correlation analysis of high-sensitivity troponin I performance validation


Advantages of clinical application of high-sensitivity troponin (hs-cTn)

1、Help to detect 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


Troponin



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="" detection="" rate="" of="" to="" first-generation="" high-sensitivity="" second-generation="" and="">95% for the third-generation high-sensitivity method. hs-cTnT assay can be detected at a minimum threshold of 0.003 μg/L, which is fully compatible with the ESRT method. g/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.

The new high-sensitivity troponin I/T upgraded again!


Sensitivity levels of different cTn assays



hs-cTn

A study on the clinical application of high-sensitivity troponin

01

Research Methods

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

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

  • 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.

02

Research Findings

Outcome 1: Reduction in hospital length of stay: median in-hospital LOS was 11.1 h (IQR = 5.0 to 45.4 h) before hs-cTn use and 9.1 h (IQR = 5.1 to 43.7 h) after hs-cTn use, a reduction of 1.9 h (95% CI: -2.9 to -1.0 h).

The new high-sensitivity troponin I/T upgraded again!

Outcome 2: Reduction in cardiovascular deaths: The proportion of cardiovascular deaths before and after hs-cTn use decreased from 0.9% (513 / 54,600) to 0.6% (333 / 52,310), a reduction of 0.3% (95% CI: -0.4 to -0.2 h). For women, the proportion of cardiovascular deaths in patients before and after hs-cTn decreased from 0.8% (219) to 0.5% (140); for men, the proportion of cardiovascular deaths in patients before and after hs-cTn decreased from 1.1% (294) to 0.7% (193).

03

 Discussion Exploration

In patients with suspected ACS, the use of more accurate hs-cTnI reduces hospital LOS with no increase in cardiovascular hospitalization, invasive therapy, 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].


Ordering Information


The new high-sensitivity troponin I/T upgraded again!The new high-sensitivity troponin I/T upgraded again!The new high-sensitivity troponin I/T upgraded again!

References:

[1] Interpretation of the key points of the China Cardiovascular Health and Disease Report 2022[J]. Chinese Cardiovascular Journal,2023,28(04):297-312.

[2]LI Menghui,HU Zhidong. Progress of clinical research on high-sensitivity cardiac troponin[J]. International Journal of Laboratory Medicine,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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