Prothrombin Screen ELISA Kit

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

BACKGROUND

Prothrombin plays a role in maintaining hemostasis and preventing excessive bleeding. Structurally, prothrombin is a glycoprotein synthesized in the liver, and it consists of 622 amino acids. It is synthesized as an inactive precursor and undergoes several enzymatic reactions to be converted into its active form, thrombin.

The primary function of prothrombin is to facilitate the conversion of soluble fibrinogen into insoluble fibrin strands, which form a stable blood clot. This conversion is catalyzed by thrombin, the active form of prothrombin. Thrombin also activates other clotting factors, amplifying the clotting process and promoting hemostasis.

The prothrombin time (PT) test measures the time it takes for blood to clot, while the international normalized ratio (INR) provides a standardized measurement of clotting time.

It is important to note that aberrant prothrombin levels can occur from genetic mutations or acquired diseases. This can increase the risk of blood clot formation or cause bleeding disorders. Prothrombin deficiency, or hypoprothrombinemia, can cause protracted bleeding, whereas prothrombin excess, or hyperprothrombinemia, might raise the risk of blood clots.

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.

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

– 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 anti-phospholipid 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.

OTHER RELATED ELISA KITS

• Prothrombin IgA ELISA Kit
• Prothrombin IgG/IgM ELISA Kit
• Phosphatidyl Serine ELISA Kit