RNP/Sm Ab ELISA Kit (Ribonucleoprotein/Anti-Smith)

Full Name: RNP/Sm Ab ELISA Kit (Ribonucleoprotein/Anti-Smith)
Reactivity: Human
Sample Type: Plasma, Serum
Sensitivity: 1.0 U/ml

BACKGROUND

A sеlеction of antinuclеar antibodiеs such as ribonuclеoprotеin antibodiеs (RNP), anti-smith (anti-Sm) and anti-doublе-strandеd dеoxyribonuclеic acid (dsDNA) arе known to bе highly spеcific in aiding thе diagnosis of systеmic lupus еrythеmatosus (SLE). In thе casе of antibodiеs against U1 ribonuclеoprotеin (RNP) complеx, thеsе arе vital markеrs for mixеd connеctivе tissuе disеasе (MCTD), can also bе found in patiеnts having SLE and numеrous othеr disеasеs such as sclеrodеrma, polymyositis and Sjögrеn’s syndromе. Elеvatеd lеvеls of antibodiеs to RNP can bе found in MCTD patiеnts whеrеas in SLE patiеnts RNP antibodiеs havе bееn linkеd to rеlativеly bеnign disеasе that havе lowеr incidеncе of cеntral nеrvous systеm and rеnal involvеmеnt. Patiеnts arе gеnеrally considеrеd positivе for RNP antibodiеs RNP antibody rеsult is significantly grеatеr than that of thе Sm antibody rеsult.

INTENDED USE

Human RNP/Sm Ab ELISA kit can be used for detecting in-vitro quantitative amounts of IgG autoantibodies to ribonucleoprotein and Anti-Smith (RNP/Sm antibody, anti-RNP/Sm, RNP/Sm Ab) in human plasma and serum. This assay has a minimum analytical sensitivity limit of 1.0 U/ml.

CONTENT

All reagents supplied need to be stored at 2 °C – 8 °C, unopened reagents will retain reactivity until expiration date. Do not use reagents beyond this date.

Divisible Microplate: Consisting of 12 modules of 8 wells, highly purified RNP/Sm antibodies bound to microwells.
Calibrators (A-F): Concentrations 0, 12.5, 25, 50, 100, 200 U/ml, made up from anti-RNP/Sm in a serum/buffer matrix.
Controls Positive and Control Negative: Containing human anti-RNP/Sm antibodies.
Sample Buffer P.
Enzyme Conjugate: Contains anti-human IgG antibodies, HRP labelled.
TMB Substrate.
Stop Solution: Contains acid.
Wash Buffer (50x Concentrated).
Instruction Manual.
Certificate of Analysis.

SENSITIVITY

The minimum detection sensitivity level of human ribonucleoprotein and Anti-Smith IgG auto-antibodies (RNP/Sm Ab, anti-RNP/Sm, RNP/Sm antibody) using current RNP/Sm Ab ELISA kit was 1.0 U/ml. The dynamic range for this assay is 12.5 – 200.0 U/ml.

ASSAY CHARACTERISTICS

– Measuring Range: 0 – 200 U/ml
– Limit Of Detection (LOD): 1 U/ml.
– Results Interpretation: Negative: < 25 U/ml, Borderline 15-25 U/ml, Positive: ≥ 25 U/ml.
– Expected Values: Cut-off 25 U/ml.
– Linearity: 97 – 100%
– Intra Assay Precision: 1.8 – 5.9%
– Inter Assay Precision: 2.9 – 4.2%
– Interference: None.
– Clinical Diagnosis: Sensitivity (66.0%), Specificity (95.8%), Overall agreement (82.3%).

REFERENCES

An immunoassay differentiating sera with antibodies to Sm alone, antibodies to Sm/RNP complex, and antibodies to RNP alone. Arthritis Rheum. (1987) 30 (4): 389-96. Tsay G.J., et al.
The relationship between Sm and RNP antigens. Clin Immunol Immunopathol. (1986) 41 (1): 91-107. Fronek Z., et al.
Anti-Sm and anti-RNP antibodies. Autoimmunity. (2005) 38 (1): 47-54. Review. Migliorini P., et al.
Two major autoantibody clusters in systemic lupus erythematosus. PLoS One. (2012) 7 (2): e32001. Ching K.H., et al.
Contrasting molecular patterns of MHC class II alleles associated with the anti-Sm and anti-RNP precipitin autoantibodies in systemic lupus erythematosus. Arthritis Rheum. (1993) 36 (1): 94-104. Olsen M.L., et al.
Antibodies to Sm and RNP. Prognosticators of disease involvement. Arthritis Rheum. (1983) 26 (7): 848-53. Munves E.F. and Schur P.H.

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