Der Inhalt dieses Dokuments dient lediglich als Beispiel, die aktuellste Version senden wir gerne zu: [email protected]. The content of this document is an example only. You may request the latest version at: [email protected] R • • • • • WARNINGS AND PRECAUT (LMWH) (UFH Unfractionated sensitivity high a offer to order in lot each for adjusted is and lot to lot from The Contains andBSA stabilizers. REAGENTS: measuredin seconds. citrated of amount constant and (CT) time clotting the measures It (TT). Time kit (T.T.)TimeThrombin HEMOCLOT™ The PRINCIPLE: TheThrombin Timeisnormal presencein of a Factor XIII deficiency. • • • prolonged A Time ca Intravascular Disseminated (DIC)and liver disease. of evaluation the for useful be can It fibrin. or thrombin against inhibitors detect to and The to Clinical: time the measuring assay coagulation convertfibrinogen to fibrin a is Time Thrombin The Technical: SUMMARY AND EXPLANAT plasma vitro HEMOCLOT™ INTENDEDUSE: whenopening vial.the freeze the remove Gently

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3. Introduce into a reaction cuvette, silicon glass or plastic • Interferences: incubated at 37°C: No interference, on the analyzer Sysmex CS-5100 was observed Reagents Volume with the molecules and up to following concentrations: Specimens and controls non-diluted 100 µL Intralipids Bilirubin (F/C) Incubate at 37°C for 1 minute, then introduce (starting the stop-watch) : 1000 mg/dL 1000 mg/dL F : 30 / C : 60 mg/dL R Bovine Thrombin, preincubated at 37°C 100 µL Apixaban Rivaroxaban Edoxaban Record the exact clotting time (CT, sec). 400 ng/mL 400 ng/mL 400 ng/mL

Also refer to the specific application guide of the analyzer used. If a reaction volume other than that specified above is required for the method used, the ratio of volumes must be strictly observed to guarantee assay performance. The user is responsible for validating REFERENCES: any changes and their impact on all results. 1. Appel I.M. et al. Age dependency of coagulation parameters during childhood and puberty. Journal of Thrombosis and Haemostasis. 2012. 2. CLSI Document H21-A5: “Collection, transport, and processing of QUALITY CONTROL: blood specimens for testing plasma -based coagulation assays and The use of quality controls serves to validate method compliance, molecular hemostasis assays; approved guideline”. 2008 along with between-test assay homogeneity for a given batch of 3. Woodhams B. et al. Stability of coagulation proteins in frozen plasma. reagents. Blood coagulation and Fibrinolysis. 2001. Include the quality controls with each series, as per good laboratory practice, in order to validate the test. Each laboratory must define its SYMBOLS: acceptable ranges and verify the expected performance in its Symbols used and signs listed in the ISO 15223-1 standard, see analytical system. Symbol definitions document.

RESULTS: • The obtained CT for the sample must be compared with that of the reference normal range for the laboratory (refer to current local recommendations). • Results can be reported as a ratio: TT ratio = Sample (CT, sec) / Mean of normals (CT, sec). • The results should be interpreted according to the patient's clinical and biological condition.

LIMITATIONS: • To ensure optimum test performance and to meet the specifications, the technical instructions validated by HYPHEN BioMed should be followed carefully. • Any reagent presenting an unusual appearance or showing signs of contamination must be rejected. • Any suspicious samples or those showing signs of activation must be rejected. • Various drugs or treatments can affect TT results. An additional investigation should be realized to determine the origin of each unexpected abnormal result. • The obtained CT for a same sample and a same reagent lot can vary according to the instrument used and the clot detection mode. In the same way, many variables (eg: different sources of heparin) can affect the obtained results: each laboratory should consequently establish its own heparin therapeutic range. • The assay is sensitive to low concentrations of heparin provided the tested plasma is collected without activation and release of alpha granules, which contain PF4, a heparin inhibitor.1,2

EXPECTED VALUES: Thrombin Time is usually expected < 25 sec. As an example, for one lot, the mean value from healthy adults (n=120) on Sysmex CS-5100 was 18.5 seconds with SD = 0.8 seconds. Each laboratory should determine its own usual ranges (normal range, heparin sensitivity…) for each combination of lot and instrument used.

PERFORMANCES: • The reagent assay is sensitive to low concentrations of plasmatic heparin (from 0.05 to 0.10 IU/mL of UFH, and from > 0.20 IU/mL LMWH in plasma). • Performance studies were conducted internally on Sysmex CS-5100. Performance was assessed using laboratory controls over a 5-day period, 2 series per day and 3 repetitions within each series for a control level. The following results were obtained: Intra assay Inter assays Control n Mean CV% SD n Mean CV% SD Control 1 40 23.9 2.2 0.5 30 23.9 1.7 0.4 Control 2 40 39.4 1.1 0.4 30 40.0 1.2 0.5 • Correlation with reference method (Test Thrombin Reagent (Siemens) on Sysmex CS-5100, on T.T. seconds) : n = 104 y = 1.64x -11.64 r = 0.883

HYPHEN BioMed 155 rue d’Eragny, 95000 Neuville-sur-Oise, France D750-02/CK/011K-011L/v1