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MRX Thrombin Time

Two different lyophilised reagents for detection of fibrinogen abnormalities, and the presence of heparin and other thrombin inhibitors in human citrated plasma.

Thrombin Time (TT) is a common clotting test used to detect fibrinogen abnormalities, and the presence of heparin and other thrombin inhibitors in human citrated plasma. MediRox has developed two different TT reagents in order to meet different instrument performances and different market requirements.

High precision: Total CV ≤2,5 % 

High stability: Up to 8 days reconstituted 2-8 °C and for MRX945 2 days 25 °C 

High flexibility: multiple reconstitution volumes and sample:reagent ratio

 

General Description

Thrombin Time is a clotting test, measuring the ability of exogenous thrombin to convert fibrinogen to fibrin, followed by fibrin polymerisation and clot detection. The time taken from addition of thrombin to citrated plasma, to fibrin clot formation is recorded as the thrombin time and presented in seconds.

Performance Characteristics

Plasma fibrinogen is cleaved by thrombin to form fibrin, which polymerises to form a fibrin clot. Fibrinogen present in the sample is converted to fibrin by the addition of purified bovine thrombin and the time (measured in seconds) to form a clot is reported as the thrombin time. The Thrombin Time assay is commonly used to detect functional abnormalities of fibrinogen, i.e. detection of an impaired fibrin polymerisation process, observed in most patientx with 

hereditary dysfibrinogenemia and to detect the presence of heparin and/or thrombin inhibitors in human citrated plasma. Several conditions will result in a prolonged thrombin time, including low fibrinogen concentrations (hypofibrinogenemia), malfunction of fibrinogen (hereditary dysfibrinogenemia), fibrinogen degradation products, direct and indirect thrombin inhibitors such as heparin, hirudin, dabigatran (Pradaxa®) etc.

Sensitivity & Specificity

Details & typical data

Parameters MRX941-5 MRX941-5 MRX945-2
Available volumes: 2 mL reconstituted 5 mL reconstituted 2 mL reconstituted
Product form: Lyophilised Lyophilised Lyophilised
Origin: Bovine thrombin and bovine albumin Bovine thrombin and bovine albumin Bovine thrombin and bovine albumin
Additional products needed: • Diluent (GHI154) or CLSI CLRW type water or equivalent
• Eximius Control Basic or Plus (L1) (MRX170, MRX180)
• No calibration required
• Diluent (GHI154) or CLSI CLRW type water or equivalent
• Eximius Control Basic or Plus (L1) (MRX170, MRX180)
• No calibration required
• Diluent (GHI154) or CLSI CLRW type water or equivalent
• Eximius Control Basic or Plus (L1) (MRX170, MRX180)
• No calibration required
Expected values: 7,8-8,3 sec 15,4-18,8 sec 10,0-15,2 sec
Heparin sensitivity: 0,03‑0,25 IU/mL N/A 0,03‑2 IU/mL
No interferences with: Triglycerides <0,625 g/L Bilirubin* Hemoglobin Triglycerides <3,75 g/L Bilirubin* Hemoglobin* Triglycerides <1,25 g/L Bilirubin <500 mg/L Hemoglobin <2,5 g/L
*Haemolysed or Icteric plasma should not be assayed

Stability & storage

Parameters MRX941-5 (2mL) MRX941-5 (5mL) MRX945-2
Storage: 2-8 ºC 2-8 ºC 2-8 ºC
Shelf-life: 24 months at 2-8 ºC 24 months at 2-8 ºC 24 months at 2-8 ºC
Reconstituted solution: 8 days at 2-8 °C 8 days at 2-8 °C 7 days at 2-8 °C / 2 days at 25 °C

Ordering information

Reference number Product description Pack size
MRX941-5 MRX Thrombin Time 10x5mL
MRX945-2 MRX Thrombin Time Plus 10x2 mL
MRX171 Eximius Control Basic Level 1 10x1 mL
MRX181 Eximius Control Plus Level 1 10x1 mL
GHI154 Diluent (CLSI CLRW type water) 10x5 mL

MRX Thrombin Time product line

 
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