(28 days)
This enzyme-linked immunosorbent assay (ELISA) is indicated for the detection and measurement of antimitochondrial antibodies in human serum. The presence of mitochondrial antibodies, in combination with clinical observations and other serological tests, can aid in the diagnosis of primary biliary cirrhosis(PBC)
An enzyme-linked immunosorbent assay (ELISA) designed for the detection and measurement of antibodies to mitochondrial antigen in human serum. The ELISA methodology is commonly used for serum antibody evaluations. Purified mitochondrial antigen has been attached to the inner surfaces of the microwell plate. During the initial incubation step, antibodies in patient serum bind specifically to the immobilized antigen and remain in place after a wash step. A second antibody which is conjugated to horseradish peroxidase (HRP) is used to recognize the "heavy + light" chain regions of the patient's antibodies remaining after the wash step. In the wells where the second antibody remains bound, the conjugated HRP catalyzes a color change in the substrate, tetramethyl benzidine (TMB). After the reaction is stopped, the color is read in an EIA Plate reader.
The provided document describes the VIRGO® AMA ELISA KIT, an enzyme-linked immunosorbent assay designed for the detection and measurement of antimitochondrial antibodies in human serum. This device is intended to aid in the diagnosis of primary biliary cirrhosis (PBC) when used in combination with clinical observations and other serological tests.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria with numerical targets. However, based on the comparative testing and precision studies, the implied criteria are:
| Acceptance Criteria Category | Implied Acceptance Criteria (Based on context) | Reported Device Performance (VIRGO® AMA ELISA KIT) |
|---|---|---|
| Precision (Inter-assay) | Demonstrates consistency across different assays | Mean % CV for positive samples (OD): 4.9 - 11.0% |
| Mean % CV for positive samples (Units): 9.9 - 15.9% | ||
| Negative samples: N/A due to low OD values. | ||
| Precision (Intra-assay) | Demonstrates consistency within a single assay run | Mean % CV for positive samples (OD): 2.7 - 8.5% |
| Mean % CV for positive samples (Units): 9.1 - 13.7% | ||
| Negative samples: N/A due to low OD values. | ||
| Comparative Testing (Sensitivity) | High agreement with predicate device for positive samples from individuals with known or suspected liver disease. | Relative Sensitivity = 100.0% (61/61) with 94.1% to 100% confidence interval. |
| Comparative Testing (Specificity) | High agreement with predicate device for negative samples from apparently healthy donors. | 86 out of 86 normal samples were negative, indicating 100% agreement with the predicate device for this cohort. |
| Interfering Substances | No significant effect ( |
§ 866.5090 Antimitochondrial antibody immunological test system.
(a)
Identification. An antimitochondrial antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the antimitochondrial antibodies in human serum. The measurements aid in the diagnosis of diseases that produce a spectrum of autoantibodies (antibodies produced against the body's own tissue), such as primary biliary cirrhosis (degeneration of liver tissue) and chronic active hepatitis (inflammation of the liver).(b)
Classification. Class II (performance standards).