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Prothrombin Screen ELISA Kit

INTENDED USE

Human prothrombin screen ELISA kit is useful to sceen in-vitro quantitative concentrations of IgG, IgA and IgM autoantibodies to prothrombin antibody (anti prothrombin screen) in human serum or plasma. This assay has a minimum analytical sensitivity limit of 1.0 U/ml.

BACKGROUND

Prothrombin is a carbohydrate-protein compound which is transformed to thrombin using the enzyme prothrombinase, thrombin is then responsible for transforming fibrinogen into fibrin. Platelets and fibrin can cause the formation clots, a process known as coagulation and this is important during bleeding. A deficiency in anti-prothrombin which is known as hypoprothrombinemia is defined by its prolonged tendency to bleeding.

PROTHROMBIN SCREEN ELISA KIT 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: Highly purified prothrombin is bound to microwells.
  • Calibrator A-F: Concentrations 0, 6.3, 12.5, 25, 50, 100 U/ml, made up of anti-prothrombin.
  • Control Positive And Control Negative: Containing prothrombin antibodies in a serum/buffer matrix.
  • Sample Buffer P (5x).
  • Enzyme Conjugate: Contains anti-human IgG, IgA and IgM antibodies, HRP labelled.
  • TMB Substrate: Tetramethylbenzidin.
  • Stop Solution.
  • Wash Buffer (50x).
  • Instruction for Use.
  • Certificate of Analysis.

SENSITIVITY

The minimum detection sensitivity level of human IgM, IgG and IgA antibodies against prothrombin (anti-prothrombin) using current prothrombin screen ELISA kit was 1.0 U/ml. The dynamic range for this assay is 6.3 – 100.0 U/ml.

ASSAY CHARACTERISTICS

– Prothrombin Screen (Prothrombin IgG, IgA, IgM): ELISA
– Measuring Range: 0 – 100 U/ml
– Expected Values: Cut-off 20 U/ml for samples from healthy blood donors.
– Results Interpretation: Negative: < 20 U/ml, Positive: ≥ 20 U/ml.
– Linearity: 91 – 102%
– Limit of detection (LOD): Functional sensitivity was 1 U/ml.
– Intra Assay Precision: 2.2 – 6.0%
– Inter Assay Precision: 2.0 – 9.4%
– Interference: None.
– Clinical Diagnosis: Sensitivity (36.7%), Specificity (98.0%), Overall agreement (80.5%).

REFERENCES

  1. Mixing studies for abnormal coagulation screen – the current trend. Clin Chem Lab Med. (2017) 55 (3): e54-e55. Mohammad E. and Thachil J.
  2. IgG, IgA, IgM, and IgD antiglobulins in juvenile rheumatoid arthritis. Ann Rheum Dis. (1974) 33 (1): 32-4. Florin-Christensen A., et al.
  3. Utility of antiphosphatidylserine/prothrombin and IgA antiphospholipid assays in systemic lupus erythematosus. J Rheumatol. (2013) 40 (3): 282-6. Akhter E., et al.
  4. Selected autoantibodies and normal-tension glaucoma. Med Sci Monit. (2014) 20: 1201-9. Skonieczna K., et al.

ADDITIONAL INFORMATION

  • Full Name: Prothrombin Screen ELISA Kit
  • Reactivity: Human
  • Sample Type: Plasma, Serum
  • Sensitivity: 1.0 U/ml

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