Intended Use
The Mitochondrial IgG ELISA Kit is intended for the detection of IgG antibody to Mitochondrial (M2) in human serum or plasma.
Contents of Kit
1. Microwells coated with Mitochondrial antigen 12×8×1
2. Sample Buffer: 1 bottle (ready to use) 100 ml
3. Calibrator 1-3: 2.0mL×3vial. 200 RU/ml, 20 RU/ml, 2 RU/ml
4. Positive Control: 1 vial (ready to use) 2.0 ml
5. Negative Control: 1 vial (ready to use) 2.0 ml
6. Enzyme conjugate: 1 bottle (ready to use) 12 ml
7. TMB Substrate: 1 bottle (ready to use) 12 ml
8. Stop Solution: 1 bottle (ready to use) 12 ml
9. Wash concentrate 10×: 1 bottle 100 ml
Storage
The test kit has to be stored at a temperature between +2°C to +8°C. Do not freeze. Unopened, all test kit components are stable until the indicated expiry date.
Detection Limit
The limit of blank is defined as a value of three times the standard deviation of an analyte-free sample and is the smallest detectable antibody titer. The limit of blank is 1.1 RU/ml.
General Description
Mitochondrial Antibodies (MA) are directed against the E2 subunit of the pyruvate dehydrogenase enzyme complex located at the inner mitochondrial membrane (PDC-E2), the E2 subunit of the branched chain 2-oxo acid dehydrogenase complex (BCOADC-E2), the E2 subunit of the 2-oxo-glutarate dehydrogenase complex (OGDC-E2), protein X, and PDC-Ela and PDCE1. MA are found in ~95% of patients with primary biliary cirrhosis (PBC). MA in low titers are common in chronic active hepatitis and their presence does not preclude response to corticosteroids. MA disappear in about one month after orthotopic liver ransplantation (OLT) and decrease with cyclosporine treatment which might be useful in PBC. MA are found in <1% of apparently healthy Caucasoid adults. Approximately 3% of patients with PBC have scleroderma, usually of the CREST syndrome variety. In addition, MA reactive with the PDC-E2 complex are found in some patients with CREST or diffuse scleroderma, sometimes in the absence of overt liver disease. Scleroderma typically precedes PBC in those patients with both diseases.
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