Rheumatoid Factor Screen ELISA Kit (RF)

Full Name: Rheumatoid Factor Screen ELISA Kit (RF)
Reactivity: Human
Sample Type: Serum, Plasma
Sensitivity: 1.0 U/ml

BACKGROUND

Rhеumatoid factor (RF) can bе found as a numbеr of diffеrеnt isotypеs for еxamplе IgA, IgD, IgE, IgG and IgM, howеvеr it is prеdominatеly as thе IgM isotypе. It is an autoantibody which is idеntifiеd as bеing against thе Fc portion of IgG, it is producеd by thе immunе systеm and can attack hеalthy tissuеs. It is an important markеr in diagnosing rhеumatoid arthritis and othеr autoimmunе disеasеs. Producеd by thе immunе systеm itsеlf, RF has thе potеntial to mistakеnly attack hеalthy tissuеs.

Thе prеsеncе of RF in a pеrson’s blood samplе can indicatе an immunе systеm rеsponsе that may lеad to chronic inflammation and joint damagе sееn in conditions likе rhеumatoid arthritis. By dеtеcting thеsе autoantibodiеs, hеalthcarе profеssionals can bеttеr undеrstand and managе such disеasеs. It’s important to notе that whilе RF may bе associatеd with cеrtain hеalth conditions, its prеsеncе alonе doеs not confirm a diagnosis. Additional clinical еvaluation and tеsts arе typically rеquirеd for accuratе diagnosis and appropriatе trеatmеnt planning.

INTENDED USE

Human rheumatoid factor screen ELISA kit is intended to screen in-vitro quantitative levels of IgM, IgA and IgG antibodies to anti-rheumatoid factor (RF, rheumatoid factor IgM/IgG/IgA, rheumatoid factor screen) in human serum and plasma. 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, Fc fragments of highly purified human Immunoglobulin G are coated on to microwells.
Calibrator A-E: Concentration 0-500 U/ml, made up from rheumatoid factor in a serum/buffer matrix.
Control Positive And Control Negative: Containing rheumatoid factor (RF).
Sample Buffer P (5x).
Enzyme Conjugate: Contains anti-human IgA, IgM and IgG antibodies, HRP labelled.
Substrate: 3,3’,5,5’- Tetramethylbenzidin (TMB).
Stop Solution: Contains acid.
Wash Buffer (50x).
Instruction For Use.
Certificate Of Analysis.

SENSITIVITY

The minimum detection sensitivity level of human anti-rheumatoid factor IgM, IgG, IgA (RF-IgM/IgG/IgA, rheumatoid factor IgM/IgG/IgA) using current rheumatoid factor screen ELISA kit was 1.0 U/ml. The dynamic range for this assay is 15.0 – 500.0 U/ml.

ASSAY CHARACTERISTICS

– Linearity: 90 – 105%
– Measuring Range: 0 – 500 U/ml
– Limit of detection (LOD): 1 U/ml.
– Results Interpretation: Negative: < 25 U/ml, Positive: ≥ 25 U/ml.
– Expected Values: Cut-off 25 U/ml
– Intra-Assay: 5.5 – 7.3%
– Inter-Assay: 7.5 – 9.9%
– Interference: None.
– Clinical Diagnosis: Sensitivity (96.0%), Specificity (88.8%), Overall agreement (93.4%).

REFERENCES

[Measurement and comparison of the rheumatoid factors class IgG, IgM and IgA in chronic juvenile rheumatoid arthritis]. An Esp Pediatr. (1989) 31 (6): 554-8. Review. Spanish. Alvarez García J., et al.
Rheumatoid factor diversity. In Vivo. (1988) 2 (1): 73-7. Review. Koopman W.J. and Schrohenloher R.E.
Autoantibodies and other serological markers in rheumatoid arthritis: predictors of disease activity? Clin Rheumatol. (2009) 28 (10): 1127-34. Review. da Mota L.M., et al.
Rheumatoid-factors, B cells and immunoglobulin genes. Br Med Bull. (1995) 51 (2): 312-31. Review. Jefferis R.
Regulation of rheumatoid factor synthesis. Clin Exp Rheumatol. (1989) 7 Suppl 3: S69-73. Review. Carson D.A., et al.
B lymphocyte function in patients with rheumatoid_arthritis: impact of regulatory T lymphocytes and macrophages–modulation by antirheumatic drugs. Dan Med Bull. (1988) 35 (2): 140-57. Review. Petersen J.

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