Intended Use
Human RNP/Sm IgG is an indirect ELISA for the detection and quantitation of IgG class of antibodies against RNP/Sm antigen in human serum or plasma. This kit is for in vitro research use only (RUO), and not for therapeutic use.
Contents of Kit
Purified RNP/Sm coated microwell strips (96 wells), Readyto-use, 1 Plate
Anti-RNP/Sm Standard A ( 0 U/ml) 1.5 ml, 1 vial
Anti-RNP/Sm Standard B ( 12.5 U/ml) 1.5 ml, 1 vial
Anti-RNP/Sm Standard C ( 25 U/ml) 1.5 ml, 1 vial
Anti-RNP/Sm Standard D ( 50 U/ml) 1.5ml, 1 vial
Anti-RNP/Sm Standard E ( 100 U/ml) 1.5 ml, 1 vial
Anti-RNP/Sm Standard F ( 200 U/ml) 1.5 ml, 1 vial
Anti-RNP/Sm Postive control, 1.5 ml, 1 vial
Anti-RNP/Sm Negative control, 1.5 ml, 1 vial
Anti-RNP/Sm Sample Buffer (5×), 20 ml, 1 bottle
Anti-hIgG HRP Conjugate, 15 ml, 1 bottle
Wash buffer (50×), 20 ml, dilute 1:50 with distilled water, 1 bottle
HRP Substrate Solution, 15 ml, 1 bottle
Stop solution, 15 ml,1 bottle
Complete Instruction Manual; 1
Storage
The microtiter well plate and all other reagents are stable at 2-8°C until the expiration date printed on the label. The whole kit stability is usually 6 months from the date of shipping under appropriate storage conditions.
Precision
Intra-assay precision:

Inter-assay precision:

Sensitivity
The lower detection limit for the Anti-RNP/Sm test was determined at 1 U/ml.
General Description
Rheumatoid autoimmune diseases are often associated with the occurrence of autoantibodies against several nuclear or cytoplasmatic antigens. These so-called anti nuclear antigens (ANA) can be divided into three groups:
1. true anti nuclear antigens (ANA): dsDNA, ssDNA, histones, nucleolic RNA and DNP
2. extractable nuclears antigens: Sm (Smith), n-RNP, Scl 70 and PM-1
3. cytoplasmatic antigens: SS-A (Ro)*, SS-B (La)* and Jo-1 SS-A (Ro) and SS-B (La) are co-localized in cytoplasm and nucleus
Inflammatory connective tissue diseases are characterized by idiopathic genesis along with disturbances in terms of cellular and humoral immunity, systemic organ failure and a chronic course of disease. Additionally, connective tissue diseases exhibit overlapping symptomatic features that render an accurate diagnosis difficult. Considering the diversity of mixed connective tissue diseases, such disorders exhibit a common serological characteristic; the presence of anti-nuclear antibodies. These antibodies are directed against parts of the cell nucleus and the cytoplasm, and many rheumatic diseases are characterized by the presence of one or more of these ANAs. Antibodies to doublestranded DNA (dsDNA), single-stranded DNA (ssDNA), histone, nuclear ribonucleoprotein (RNP) and Smith antigen (Sm) are associated with SLE, while antibodies to Sjogren´s Syndrome A (SSA/Ro) and Sjogren´s Syndrome B (SSB/La) can occur in both SLE and Sjogren´s Syndrome (SS). Antibodies to Jo-1 may be observed in polymyositis and dermatomyositis, while antibodies to scleroderma- associated antigen (Scl-70) and centromere can occur in patients with progressive systemic sclerosis (PSS). Anti-histone antibodies are associated with SLE and druginduced lupus, while anti-RNP antibodies are linked with mixed connective tissue disease (MCTD) and with SLE. Antibodies directed against centromere are associated with CREST syndrome. Although IFA technology was traditionally used to detect autoantibodies in conjunction with HEp2 cells, it is now widely acknowledged that ELISA technology offers an excellent alternative.
Anti-Nuclear Antibodies (ANA) are autoantibodies which binds to cellular nuclear antigens including ds-DNA, ss-DNA, histones, ribonucleoproteins (RNP) and the SS-A, SS-B, and Sm antigens. ANA ELISA, a sandwich ELISA, provides a rapid semi-quantitative measurement of ANA in serum to further investigate the presence of specific autoantibodies
Standard Curve
These data are for demonstration purpose only.

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