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ASCA IgG/IgA ELISA Kit (Anti-Saccharomyces Cerevisiae Antibodies)

INTENDED USE

Human ASCA IgG/IgA ELISA kit is intended for analysing in vitro quantitative levels of IgA and IgG anti-saccharomyces cerevisiae antibodies (ASCA IgG or IgA) using human plasma or serum samples. This assay has a minimum analytical sensitivity limit of 0.5 U/ml.

BACKGROUND

Anti-saccharomyces cerevisiae antibodies (ASCAs) is present in people having inflammatory bowel disease (IBD). It is a useful tool that is used to distinguishing between ulcerative colitis and Crohn disease, both of these are the common types of IBD. The tests that are carried out involve detecting two classes of ASCA in blood, notably IgA and IgG.

Studies have identified 7% positive IgA and 5% IgG class in ulcerative colitis, in comparison to Crohn’s disease where a sensitivity of 60% for IgA and 75% for IgG can be observed. ASCAs and pANCAs are two vital biomarkers which are used for colitis discrimination, where pANCA tend to recognize ulcerative colitis and ASCA recognizes Crohn’s disease more frequently. It has been identified include Celiac disease, Crohn’s disease, Colitis and Behçet’s disease.

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: Consisting of 12 modules of 8 wells, highly purified mannan from Saccharomyces cerevisiae (ASCA) is bound to microwells.
  • Calibrator A-F: Concentration 0-100 U/ml.
  • Control Positive and Control negative.
  • Sample Buffer (5x).
  • Enzyme Conjugate: Contains anti-human IgG antibodies, HRP labelled.
  • Enzyme Conjugate: Contains anti-human IgA antibodies, HRP labelled.
  • TMB Substrate
  • Wash Buffer (50x).
  • Instruction for Use.
  • Certificate of Analysis.

SENSITIVITY

The minimum detection sensitivity level of human anti saccharomyces cerevisiae antibodies (ASCA IgG and IgA) using current ASCA IgG or IgA ELISA kit was 0.5 U/ml. The dynamic range for this assay is 6.3 – 100.0 U/ml.

ASSAY CHARACTERISTICS

– Measuring Range: For IgG and IgA it is 0 – 100 U/ml.
– Expected Values: Samples from healthy blood donors display a cut-off 10 U/ml for IgA and IgG
– Results Interpretation: IgG or IgA Negative: < 10 U/ml, Positive: ≥ 10 U/ml.
– Linearity: IgA or IgG was 95 – 113%
– Limit Of Detection (LOD): Functional sensitivity for IgA and IgA was 0.5 U/ml.
– Intra Assay: For IgG 3 – 8.8%, for IgA 5.2 – 6.1%.
– Inter Assay: For IgG 3.8 – 7.5%, for IgA 6.0 – 6.6%.
– Interfering Substances: None
– Clinical Diagnosis: Sensitivity (IgG 75.0% and IgA 62.5%), Specificity (IgG 96.9% and IgA 97.7%), Overall agreement (IgG 89.1% and IgA 85.1%).

REFERENCES

  1. ASCA, ANCA, ALCA and Many More: Are They Useful in the Diagnosis of Inflammatory Bowel Disease? Dig Dis. (2016) 34 (1-2): 90-7. Review. Zhou G., et al.
  2. IBD serological panels: facts and perspectives. Inflamm Bowel Dis. (2007) 13 (12): 1561-6. Review. Peyrin-Biroulet L., et al.
  3. Inflammatory bowel diseases: from pathogenesis to laboratory testing. Clin Chem Lab Med. (2014) 52 (4): 471-81. Review. Basso D., et al.
  4. Diagnostic approach to IBD. Hepatogastroenterology. (2000) 47 (31): 44-8. Review. Vermeire S., et al.
  5. Biomarkers of inflammatory bowel disease. Dis Markers. (2014) 2014: 710915. Review. Fengming Y. and Jianbing W.

ADDITIONAL INFORMATION

  • Full Name: ASCA IgG/IgA ELISA Kit (Anti-Saccharomyces Cerevisiae Antibodies)
  • Reactivity: Human
  • Sample Type: Serum, Plasma
  • Sensitivity: 0.5 U/ml

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