PT Reagent (Thromboplastin)
Catalog No.: DCP-PTR
Size:
20 mL
Sterile: Filtered 0.1-micron membrane ONCE
Storage: -20°C, protect from light
Shelf Life: 12 months
*Use before the expiry date given on the product label | Aliquoted vials are stable for up to 28 days when stored at 2–8 °C.
Description:
A reagent fully compatible (not exclusive) with the Blood Coagulation Analyzer (Catalog No.: DCBio-SACA)
[Link]
A ready-to-use, pre-calcified liquid coagulation reagent constituting the complete one-stage Prothrombin Time (PT) test reagent. Contains tissue factor (TF; Factor III) — either purified from mammalian brain/placenta or produced as recombinant human TF — incorporated into procoagulant phospholipid vesicles, combined with calcium chloride, and formulated in a stabilizing isotonic buffer. Upon addition to citrated platelet-poor plasma at 37°C, tissue factor binds plasma Factor VII/VIIa to form the extrinsic tenase complex (TF:FVIIa), which rapidly activates Factors X and IX, initiating the common coagulation pathway and generating a fibrin clot. The elapsed time from reagent addition to clot formation — the Prothrombin Time — is reported in seconds and simultaneously converted to the International Normalized Ratio (INR) using the reagent's International Sensitivity Index (ISI), enabling globally standardized results across instruments and reagent types. ISI ≤ 1.2 for optimal warfarin monitoring sensitivity.
The Prothrombin Time is a one-stage clot-based assay that specifically evaluates the extrinsic coagulation pathway (Factor VII + tissue factor) and the common pathway (Factors X, V, II, fibrinogen). The term "thromboplastin" is the historical designation for the tissue factor/phospholipid complex that triggers this pathway in vitro, directly paralleling the physiological role of tissue factor exposed at sites of vascular injury.
The test mechanism is elegantly direct:
- TF:FVIIa complex formation: Tissue factor (TF; an integral membrane glycoprotein, M_r ~47 kDa) binds circulating Factor VII and FVIIa with high affinity. The TF:FVII complex undergoes rapid autoactivation to TF:FVIIa. This extrinsic tenase complex is fully assembled on the phospholipid membrane surface of the thromboplastin vesicle.
- Common pathway activation: TF:FVIIa preferentially activates Factor X to FXa (and Factor IX to FIXa as a secondary reaction). FXa combines with FVa on the phospholipid surface to form the prothrombinase complex, which converts prothrombin (FII) to thrombin (FIIa).
- Fibrin clot formation: Thrombin cleaves fibrinogen (FI) to fibrin monomers, which polymerize and are cross-linked by FXIIIa to form the stable fibrin clot detected by the coagulometer.
- Result reporting: The elapsed time (seconds) is converted to the INR using the lot-specific ISI value. Normal PT: 11.0–12.5 seconds; INR reference range: 0.8–1.1; therapeutic INR for warfarin: typically 2.0–3.0.
* All DiagnoCine Precision Sterile filtered-sterilized with 40 nanometer. Thus, mycoplasma contamination is prevented. The smallest size mycoplasma type can be about 0.2 microns.
* This product is manufactured under ISO 13485-certified and CE-approved facilities (Suppliers of DiagnoCine Precision). All final packaging, quality assurance, and testing are done at the DiagnoCine R&D and Quality Testing Center. All specific customization requests and assembly were accomplished at DiagnoCine Precision in Totowa, New Jersey, USA
