Intended Use
Rheumatoid Factor IgM is an ELISA test system for the quantitative measurement of IgM class rheumatoid factor in human serum or plasma samples. The test is used as an aid in the differential diagnosis of rheumatoid arthritis (RA), and presence of rheumatoid factors (RF) is an integral part of the current ACR criteria for classification of RA. In established RA, high titres of serum IgG and especially IgM RF indicate poor prognosis. The presence of either IgG or IgA RF in patients with long-standing RA may be a prognostic indicator of systemic manifestations. Evaluation of a test result should always take into account all clinical and laboratory findings.
Contents of Kit
1. SORB MT 1 divisible microplate consisting of 12 modules of 8 wells each. Ready to use.
2. CAL A-E 5x 1.5 ml Calibrator A-E (0, 15, 50, 150, 500 IU/ml), containing rheumatoid factor in a serum/buffer matrix (PBS, BSA, detergent, NaN3 0.09%), yellow. Ready to use.
3. CONTROL 1 & 2 2x 1.5 ml Control positive (1) and negative (2), containing rheumatoid factor in a serum/buffer matrix (PBS, BSA, detergent, NaN3 0.09%), yellow. Ready to use. The concentration is specified on the certificate of analysis.
4. SAM DIL 5x 20 ml Sample Buffer, containing PBS, BSA, detergent, preservative NaN3 0.09%, yellow, 5x conc.
5. ENZ CONJ 15 ml Enzyme Conjugate containing anti-human IgM antibodies, HRP labelled; PBS, BSA, detergent, preservative ProClin 300 0.05%, light red. Ready to use.
6. SUB TMB 15 ml TMB Substrate; containing 3,3', 5,5'- Tetramethylbenzidin, colorless. Ready to use.
7. STOP SOLN 15 ml Stop solution; contains acid. Ready to use.
8. WASH SOLN 50x 20 ml Wash Buffer, containing Tris, detergent, preservative NaN3 0.09%; 50x conc.
9. 1 Instruction for Use
10. 1 Certificate of Analysis
Storage
1. Store test kit at 2-8°C in the dark.
2. Do not expose reagents to heat, sun, or strong light during storage and usage.
3. Store microplate sealed and desiccated in the clip bag provided.
4. Unopened reagents are stable until expiration of the kit. See labels for individual batch.
5. Diluted Wash Solution and Sample Buffer are stable for at least 30 days when stored at 2-8°C. We recommend consumption on the same day.
Performance Characteristics
Calibration
The assay system is calibrated against the international reference preparation 1st British Standard Preparation 64/2 for Rheumatoid Factor IgM as 100 IU/ml.
Measuring range
The calculation range of this ELISA assay is 0 - 500 IU/ml
Expected values
In a normal range study with samples from healthy blood donors the following ranges have been established with this ELISA assay: Cut-off 20 IU/ml
Interpretation of results
Negative: < 20 IU/ml
Positive: ≥ 20 IU/ml
Sensitivity: 91.4 %
Specificity: 93.5 %
Overall agreement: 92.1 %
General Notes
Rheumatoid Factor IgM is an ELISA test system for the quantitative measurement of IgM class rheumatoid factor in human serum or plasma samples. The test is used as an aid in the differential diagnosis of rheumatoid arthritis (RA), and presence of rheumatoid factors (RF) is an integral part of the current ACR criteria for classification of RA. In established RA, high titres of serum IgG and especially IgM RF indicate poor prognosis. The presence of either IgG or IgA RF in patients with long-standing RA may be a prognostic indicator of systemic manifestations. Evaluation of a test result should always take into account all clinical and laboratory findings.
COA
Publication 
Loading ......
