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DNA Methylation Detection Kit for systemic lupus erythematosus(SLE)

Systemic lupus erythematosus (SLE) is a complicated autoimmune disease with female susceptibility. It is characterized byover-activation of the immune system and deposit of autoimmune complex in multiple organs. High heterogeneity, unpredictable disease course of SLE as well as the lack of specific and sensitive biomarkers posed diagnostic challenges to clinicians.

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Systemic lupus erythematosus (SLE) is an autoimmune-mediated diffuse connective tissue disease characterized by immune inflammation, involving multiple systems and organs throughout the body, and its main clinical features are complex clinical manifestations, characterized by immune dysregulation and systemic inflammation, resulting in progressive and irreversible multi-organ damage. The clinical manifestations are extensive, including kidney, skin diseases, neuropsychiatric and cardiovascular symptoms, the ratio of men to women is 1:9-1:13, there are differences in race, gender, race, repeated recurrence and remission, the presence of a large number of autoantibodies in the body, and untimely treatment can easily cause irreversible damage to the affected organs, and even lead to the death of patients.

  The incidence of SLE ranges from 0.3 to 31.5 per 100,000, with adjusted prevalence approaching or exceeding 50 to 100 per 100,000. Unfortunately, the prevalence of SLE seems to increase over time. Medical-related costs of SLE are related to disease severity and type of organ involved. In the United States, the average annual cost of SLE patients is about $21,000-53,000, and in Europe, their average annual direct medical expenses are 2600-4800 euros.

 SLE is now an important social and public health issue because drugs and multidisciplinary approaches to treat SLE can only control symptoms and delay the progression of the disease, but they cannot completely cure it. Improving the ability to diagnose SLE early for effective treatment is critical.

Systemic lupus erythematosus (SLE) is a highly heterogeneous disease.
This can range from minor joint and skin lesions to life-threatening renal, hematologic, or central nervous system lesions. Many autoimmune, infectious, or haematological disorders can have a similar presentation to SLE, making diagnosis challenging.
Biomarkers play a crucial role in diagnosing SLE, classifying SLE complications, assessing SLE disease activity, and assessing the therapeutic effects of SLE interventions. Common biomarkers in SLE patients and their detection sites are shown in the figure:
Finding the ideal biomarker for SLE is challenging because it should have the following characteristics:
(1) reflect potential pathophysiology or therapeutic targets;
(2) It has reliability, effectiveness, high predictive value, high sensitivity and specificity;
(3) the ability to monitor the activity of systemic lupus erythematosus;
(4) measured reliably in tissues, cells, or fluids, independent of other factors or complications;
(5) Stable, reproducible, easy to detect, and readily available at a reasonable cost in most laboratories.
The existing clinical pain points of systemic lupus erythematosus are as follows:
1. The pathogenesis of systemic lupus erythematosus is complex, heterogeneous, atypical symptoms, unclear first diagnosis, delayed diagnosis, resulting in irreversible physical damage to the patient's organ system.
2. Conventional immunological detection products cannot meet high sensitivity and specificity, and there is a risk of missed diagnosis and misdiagnosis.
3. The construction of clinical rheumatology departments and talent construction lags behind, and the awareness and professional level of systemic lupus erythematosus are uneven, and misdiagnosis and missed diagnosis occur from time to time.
4. The existing diagnostic classification standards are mainly based on the scoring system, there are no diagnostic standards, the subjectivity is high, the diagnosis time process is long, the patient's long-term organ system is damaged, and timely diagnosis and treatment cannot be made.
 In order to solve the major medical problem in the field of rheumatology and immunity in the field of clinical accurate diagnosis of systemic lupus erythematosus, Xaar Biologics and the team of Central South University discovered a new potential diagnostic marker of gene methylation, and its detection effect evaluation was verified in an international multi-racial multi-center clinical trial. This index has the characteristics of high specificity and high sensitivity for the diagnosis of systemic lupus erythematosus, and can be widely used in early clinical diagnosis of systemic lupus erythematosus, differential diagnosis of autoimmune diseases, medication monitoring and efficacy evaluation, etc., which greatly improves the accuracy and timeliness of clinical screening and diagnosis of systemic lupus erythematosus! It has a wide application prospect in improving the diagnosis and treatment level of clinical systemic lupus erythematosus in China.

Features

1.early diagnosis

2.differential diagnosis

3.High sensitivity

4.High specificity

5.Medication guidance

6.Prognostic testing
7.Health economy







Specifications

96 Tests/Kit

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