(492 days)
The assay is to be used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid in the diagnosis of Systemic Lupus Erythematosus (SLE). FOR IN VITRO DIAGNOSTIC USE.
The Ribosomal P ELISA test is an enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG antibodies to Ribosomal P in human sera. The Ribosomal P ELISA test is an enzyme linked immunosorbent assay to detect IgG, M, A, antibodies to Ribosomal P. Purified Ribosomal P antigen is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled antihuman IgG, M. A is added to each well. If antibody is present it will bind to the antibody attached to the antigen on well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.
Here's an analysis of the provided information regarding the acceptance criteria and study for the Ribosomal P ELISA Test Kit:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Sensitivity | Acceptable relative sensitivity to Ouchterlony method. While no specific numeric target is given, the high value suggests an expectation of strong agreement. | Relative Sensitivity = 100% (95% CI: 93.5%-100%) (46/46 samples positive by Ouchterlony were positive by the device). |
| Specificity | Acceptable relative specificity to Ouchterlony method. While no specific numeric target is given, the high value suggests an expectation of strong agreement. | Relative Specificity = 99.3% (95% CI: 97.8%-100%) (136/137 samples negative by Ouchterlony were negative by the device). |
| Agreement | Acceptable overall agreement with the Ouchterlony method. | Relative Agreement = 99.5% (95% CI: 98.4%-100%) (182/183 samples showed agreement). |
| Precision (C.V.) | Coefficient of Variation (C.V.) should be less than 15% with proper technique. | Intra-Assay and Inter-Assay C.V.s: Most reported C.V.s for Sera 1-4 are well below 15%. Serum 5 has an inter-assay C.V. of 25.6% and some individual assay C.V.'s of 19.6%. Serum 6 has even higher C.V.s (46.3%-48.0%). This suggests the device meets the criteria for some serum concentrations but not others, particularly at low values. |
| Linearity | The assay should be semi-quantitative, meaning there should be a strong correlation between index values and log2 of dilution. | Linearity (r-value): 0.991 to 0.997 for five positive sera when comparing the Ribosomal P Index Value to log2 of dilution. This indicates excellent linearity and confirms its semi-quantitative nature. |
| Cross-Reactivity | Antibodies to alternate autoimmune antigens (Ro, La, Scl-70, Jo-1, Sm, RNP, DNA) should not cross-react with the Ribosomal P ELISA kit. | Zero cross-reactivity observed: All 19 sera tested with high levels of antibodies to other autoimmune antigens produced negative interpretations (Immunoprobe Index Value |
§ 866.5100 Antinuclear antibody immunological test system.
(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).