Systemic lupus erythematosus (SLE), characterised by the presence of autoantibodies, is a multifactorial autoimmune disease with diverse clinical mani-festation and can involve one or more organs. The substantial morbidity, chronic disease course and over-reliance on corticosteroid therapy all contribute to long-term organ damage, even leading to life-threatening systemic organ damage.

For the overall population, the global SLE incidence and newly diagnosed population were estimated to be 5.14 (1.4 to 15.13) per 100000 person-years and 0.40million annually, respectively.

However, the complexity of the clinical manifestations and challenge brought by diagnosis make SLE epidemiological studies difficult to conduct. Although anti-dsDNA and anti-Sm antibodies are highly specific for SLE, and the 2019 European Alliance of Associations for Rheumatology/American College of Rheumatology (EULAR/ACR) classification criteria for SLE include positive antinuclear antibody as an entry criterion, the risk of false positives resulting in diagnosis of SLE still relies on classification criteria instead of a singular diagnostic test.

In recent years, the promotor methylation of Interferon-induced protein 44-like(IFI44L) gene has been proved as a high sensitive and high special marker for SLE diagnostic. Lower methylation (＜25%) within whole disease progression of SLE, IFI44L promotor lower methylation can be clarified in any disease stage.

This marker is brilliance than any others in SLE clinic diagnostic. IFI44L promotor methylation test can be used for SLE identify/ Evaluation of treatment efficacy/ Pre-clinic clarify/ Recurrence prediction.

We provide the methylation diagnostic kit based on Methylation-sensitive-high-resolution melting-PCR (MS-HRM-PCR). MS-HRM-PCR is the highest sensitive method for DNA testing. Extremely, lower to just one drop of blood is needed for sample casting.