Intended Use
The CD Acetylcholine Receptor Autoantibody (AChRAb) ELISA kit is intended for use by professional persons only, for the quantitative determination of AChRAb in human serum. Autoantibodies to the acetylcholine receptor (AChR) are responsible for failure of the neuromuscular junction in myasthenia gravis. Measurement of these antibodies can be of considerable value in disease diagnosis and management.
Contents of Kit
A. AChR MAb1 Coated Wells, 12 breakapart strips of 8 wells (96 intotal)
B. Foetal Type AChR, 3 vials, Lyophilised
C. Adult Type AChR, 3 vials, Lyophilised
D. Reconstitution Buffer for AChR, 5 mL, Ready for use
E. AChR MAb - Biotin (MAb2+MAb3), 3 vials, Lyophilised
F. Reconstitution Buffer for MAb - Biotin, 15 mL, Ready for use
G. Streptavidin Peroxidase (SA - POD), 0.7 mL, Concentrated
H. Diluent for SA - POD, 15 mL, Ready for use
J. Peroxidase Substrate (TMB), 15 mL, Ready for use
K. Stop Solution, 10 mL, Ready for use
L. Concentrated Wash Solution, 100 mL, Concentrated
M1-4. Calibrators, 0.5, 1.0, 6.5 and 20 nmol/L toxin bound, 4 x 0.7 mL, Ready for use
N. Negative Control, 3 mL, Ready for use
P1-2. Positive Controls l & ll, 2 x 0.7 mL, Ready for use
Sensitivity
Sera from 83 patients diagnosed with myasthenia gravis were assayed in the AChRAb ELISA. 76 (92%) were identified as being positive for AChRAb.
Clinical Accuracy
Analysis of 107 sera from patients with autoimmune diseases other than myasthenia gravis indicated no interference from autoantibodies to thyroglobulin (n=10), thyroid peroxidase (n=11), dsDNA (n=9), TSH receptor (n=40), glutamic acid decarboxylase (n=10), 21-hydroxylase (n=10), or from rheumatoid factor (n=27). Two other samples gave values of 28% (0.74 nmol/L) and 44% (1.5 nmol/L) inhibition and were from a patient with Graves' disease (TRAb positive) and a patient with Systemic Lupus Erythematosus (dsDNA Ab positive) respectively. These samples were assayed in the CD AChRAb RIA kit and were positive (values of 1.3 and 1.5 nmol/L respectively). In addition two samples from patients with rheumatoid arthritis (rheumatoid factor positive) were positive in the CD AChRAb ELISA and gave values of 24% (0.77 nmol/L) and 19% (0.61 nmol/L) inhibition. The first of these samples was also positive in the CD AChRAb RIA (5.3 nmol/L).