ANCA Screen ELISA Kit (Anti-Neutrophil Cytoplasmic Antibodies)
INTENDED USE
Human ANCA Screen ELISA kit is a method intended for screening in vitro quantitative determination of IgG class autoantibodies directed against PR3 and MPO (ANCA screen) in human serum and plasma samples. This assay has a minimum analytical sensitivity limit of diagn. 95.1%.
A mixture of purified antigens PR3 and MPO is coated on to microwells.
BACKGROUND
Antinuclear antibodies (ANA) can be found in the blood of patients that display a group of autoimmune disorders usually referred to as connective tissue diseases (CTD). They are various specific classes of autoantibodies that are able bind and destroy certain structures within the nucleus of the cells, this in many cases includes histones, single and double stranded DNA.
Initially, screening can be undertaken as a form of a generic assay that is able to detect human ANA of a broad specificity or indirect immunofluorescence tests. More specific tests will need to be carried out following a positive result being obtained. These more specific antigen can react with single autoantigens for example: Sm/RNP, SS-B/La, dsDNA, Scl-70, Sm, SS-A/Ro etc.
A positive result for ANA can help healthcare providers to diagnose the autoimmune disease at an early onset. Following further complementary tests such as more specific ELISAs and indirect immunofluorescence (IF) assays, it may even be possible to establish the specific type to autoimmunity disease that is affecting the individual. Whereas, if a negative result is obtained, this will indicate to healthcare providers a reduced risk of the patient developing an autoimmune disease. There are even cases where an ANA test is found to be abnormal even normal healthy individuals. Some conditions that are identified to lead to false positive results being obtained include: having caner, a viral infection, being old age (above 65) and taking certain prescriptions/medicines.
CONTENT
All reagents supplied need to be stored at 2 °C – 8 °C, unopened reagents will retain reactivity until expiration date. Do not use reagents beyond this date.
- Divisible Microplate: Anti-neutrophil cytoplasmic antibodies are bound to microwells.
- Control A (Negative), Control B (Cut-Off), Control C (Positive).
- Sample Buffer (5x Conc.).
- Enzyme Conjugate.
- Substrate: Tetramethylbenzidin (TMB).
- Stop Solution.
- Wash Buffer (50x).
- Instruction For Use.
- Certificate Of Analysis.
SENSITIVITY
The minimum detection sensitivity level of human class autoantibodies directed against PR3 or MPO using current ANCA ELISA kit was diagn. 95.1%.The dynamic range for this assay is cut-off index 1.0.
ASSAY CHARACTERISTICS
– Expected Values: In a normal range = Cut-off Index 1.0, Positive: Index ≥ 1.0, Negative: Index < 1.0.
– Intra Assay Precision: 3.3 – 5.4%
– Inter Assay Precision: 4.5 – 11.9%
– Clinical Diagnosis: Sensitivity (95.1%), Specificity (97.7%), Overall agreement (96.5%).
REFERENCES
- Incidence of PR3- and MPO-ANCA autoantibody specificity changes in ANCA-associated vasculitis. Ann Clin Biochem. (2015) 52 (Pt 2): 297-301. Holding S., et al.
- How are antineutrophil cytoplasmic autoantibodies detected? Am J Kidney Dis. (1991) 18 (2): 154-8. Wieslander J.
- What do antineutrophil cytoplasmic antibodies (ANCA) tell us? Best Pract Res Clin Rheumatol. (2005) 19 (2): 263-76. Review. Savige J., et al.
- Audit of the clinical usefulness of a rapid qualitative ELISA screen for antimyeloperoxidase and antiproteinase 3 antibodies in the assessment of patients with suspected vasculitis. J Clin Pathol. (2003) 56 (10): 775-7. Aslam A., et al.
- Autoantibody detection using multiplex technologies. Lupus. (2006) 15 (7): 412-21. Review. Binder S.R.
ADDITIONAL INFORMATION
- Full Name: ANCA Screen ELISA Kit (Anti-Neutrophil Cytoplasmic Antibodies)
- Reactivity: Human
- Sample Type: Serum, Plasma
- Sensitivity: 95.1%
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