Sample
Serum, plasma, tissue homogenates and other biological fluids.
Intended Use
For quantitative detection of ANA in serum, plasma, tissue homogenates and other biological fluids.
Contents of Kit
| No. | Components | Size | Storage Conditions |
| 1 | ELISA Microplate(Dismountable) | 8×12 | 2-8°C/-20°C |
| 2 | Lyophilized Standard | 2vial | 2-8°C/-20°C |
| 3 | Sample Dilution Buffer | 20ml | 2-8°C |
| 4 | Biotin-labeled Antigen (Concentrated) | 120μl | 2-8°C(Avoid Direct Light) |
| 5 | Antigen Dilution Buffer | 10ml | 2-8°C |
| 6 | HRP-Streptavidin Conjugate(SABC) | 120μl | 2-8°C(Avoid Direct Light) |
| 7 | SABC Dilution Buffer | 10ml | 2-8°C |
| 8 | TMB Substrate | 10ml | 2-8°C(Avoid Direct Light) |
| 9 | Stop Solution | 10ml | 2-8°C |
| 10 | Wash Buffer(25×) | 30ml | 2-8°C |
| 11 | Plate Sealer | 5pieces | |
| 12 | Product Description | 1copy | |
Performance Characteristics
The stability of ELISA kit is determined by the loss rate of activity. The loss rate of this kit is less than 10% within the expiration date under appropriate storage condition.
To minimize extra influence on performance, operation procedures and lab conditions, especially room temperature, air humidity, incubator temperature should be strictly controlled. It is strongly suggested that the same operator performs the whole assay from the beginning to the end.
Precision
Intra-Assay: CV<8%
Inter-Assay: CV<10%
Detection Range
0.469-30ng/ml
Standard Curve
Results of a typical standard operation of a ANA ELISA Kit are listed below. This standard curve was generated at our lab for demonstration purpose only. Users shall obtain standard curve as per experiment by themselves. (N/A=not applicable)
Citations
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Anti-nuclear antibodies (ANA) are a diverse group of antibodies that target various nuclear and cytoplasmic antigens. These antibodies were initially found to be associated with systemic lupus erythematosus (SLE) and have now been associated with a wider range of rheumatic diseases. For example, anti-SSA/Ro and anti-SSB/La antibodies are linked to SLE and Sjögren's Syndrome (SS), while anti-dsDNA and anti-Sm antibodies are associated with SLE. Anti-histone antibodies are found in SLE and Drug-Induced Lupus, anti-RNP antibodies in mixed connective tissue disease (MCTD) and SLE, anti-Scl-70 antibodies in scleroderma (progressive systemic sclerosis), anti-Jo1 in polymyositis and dermatomyositis, and anti-centromere antibodies in CREST syndrome.
ANA testing is an essential tool in clinical immunology and rheumatology. It aids in the identification and classification of autoimmune disorders, as well as monitoring disease activity and assessing treatment response. Traditionally, ANA detection has been performed using indirect immunofluorescence (IFA) on HEp-2 cells. However, IFA has certain limitations, and ANA ELISA testing has emerged as a more robust alternative. The ANA ELISA test offers several advantages, including ease of operation and reduced reliance on the expertise required for IFA. It enables efficient screening of large numbers of patient samples and minimizes human error. The ANA ELISA test collectively detects various ANAs, including those against double-stranded DNA (dsDNA), histones, SS-A/Ro, SS-B/La, Sm, Sm/RNP, Scl-70, Jo-1, and centromeric antigens. It is important to note that a positive ANA result is not diagnostic of a specific disease but serves as an important screening tool. Further clinical evaluation, including the patient's symptoms, medical history, and additional laboratory tests, is necessary for a definitive diagnosis.
Alternative Names
Mouse Anti-nuclear Antibody ELISA
Mouse Antinuclear Antibody ELISA
Mouse ANA ELISA
Mouse Anti-nuclear Antibody ELISA Kit
Mouse Antinuclear Antibody ELISA Kit
Mouse ANA ELISA Kit
New insights into the role of antinuclear antibodies in systemic lupus erythematosus
Nature Reviews Rheumatology
Authors: Pisetsky D S, Lipsky P E.
Abstract
Systemic lupus erythematosus (SLE) is a prototypic autoimmune disease characterized by antinuclear antibodies (ANAs) that form immune complexes that mediate pathogenesis by tissue deposition or cytokine induction. Some ANAs bind DNA or associated nucleosome proteins, whereas other ANAs bind protein components of complexes of RNA and RNA-binding proteins (RBPs). Levels of anti-DNA antibodies can fluctuate widely, unlike those of anti-RBP antibodies, which tend to be stable. Because anti-DNA antibody levels can reflect disease activity, repeat testing is common; by contrast, a single anti-RBP antibody determination is thought to suffice for clinical purposes. Experience from clinical trials of novel therapies has provided a new perspective on ANA expression during disease, as many patients with SLE are ANA negative at screening despite previously testing positive. Because trial results suggest that patients who are ANA negative might not respond to certain agents, screening strategies now involve ANA and anti-DNA antibody testing to identify patients with so-called 'active, autoantibody-positive SLE'. Evidence suggests that ANA responses can decrease over time because of the natural history of disease or the effects of therapy. Together, these findings suggest that, during established disease, more regular serological testing could illuminate changes relevant to pathogenesis and disease status.
The Clinical Utility of a Positive Antinuclear Antibody Test Result
The American Journal of Medicine
Authors: Abeles A M, Abeles M.
Abstract
Background
This retrospective study investigated the clinical utility of a positive antinuclear antibody (ANA) test performed outside of the rheumatology setting. Prior studies have investigated the frequency of ANA positivity within the general population. The purpose of this investigation was to evaluate the clinical utility of a positive ANA test result in a real-world setting by reviewing the final diagnoses of patients who were referred to a tertiary rheumatology clinic for evaluation of a positive ANA test result.
Methods
We reviewed the records of patients presenting to the authors between July 2007 and July 2009. Patients were included in the evaluation if they were referred for a positive ANA test result. All relevant descriptive and laboratory data were collated, as were the initial reasons for ordering ANA testing and the ultimate diagnoses reached. Positive predictive values for a "positive ANA test result" were calculated for all antinuclear antibody-associated rheumatic diseases and for lupus specifically.
Results
A total of 232 patients were referred for a positive ANA test result. The positive predictive value of a positive ANA test result in this cohort was 2.1% for lupus and 9.1% for any antinuclear antibody-associated rheumatic disease. No antinuclear antibody-associated rheumatic disease was identified in patients with an ANA < 1:160. The most common reason for ordering ANA testing was widespread pain (54/232, 23.2%).
Conclusions
In this retrospective study, more than 90% of patients who were referred to a tertiary rheumatology clinic for a positive ANA test result had no evidence for an ANA-associated rheumatic disease. The poor predictive value of a positive ANA in this cohort was largely attributable to unnecessary testing in patients with low pretest probabilities for ANA-associated rheumatic disease.
COA
Certificate of Analysis