Novel diagnostic marker, a diagnostic kit and a method for diagnosis of rheumatoid arthritis

A method for the diagnosis of rheumatoid arthritis in the human subject, wherein the said method comprising the steps of:

• a) Screening of normal control individuals and rheumatoid arthritis patients for the diagnostic marker as claimed in claim 1 by quantifying the level of autoantibodies to MBL by ELISA in the blood of a human subject.
• b) Statistically comparing the levels of autoantibodies to MBL in the rhematoid arthritis (RA) patients with that of the normal healthy individuals obtained from step (a) to establish association of rheumatoid arthritis disease with the elevated MBL auto antibodies.
• c) Estimating the isotypes of rheumatoid factors (IgM RF and IgG RF) by the ELISA test followed by computing their association with rheumatoid arthritis disease.
• d) Comparing the values of auto antibodies to MBL and the RF isotypes (IgM RF and IgG RF) obtained from step (c) for the diagnosis of RA, wherein the presence of anti MBL autoantibodies indicates the possibility of the rhematoid arthritis.
• e) A method as claimed in claim 4, wherein the blood of normal control individuals are collected from Guru Teg Bahadur Hospital, Delhi, India.

A diagnostic kit for diagnosis of Rheumatoid arthritis comprising:

• a purified or recombinant Mannose binding protein;
• b anti-MBL auto antibody serum standard;
• c requisite reconstituable coating, washing and dilution buffers;
• d micro titre plates;
• e secondary enzyme conjugated antibodies;
• f appropriate substrate reagent, stop solution.