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components of any other kit with different lot numbers. temperature 15 minutes prior to testing.  Throughout testing all test tubes, syringes and pipettes 2. Pre-warm PT reagent at 37°C for 5 minutes. should be plastic. 3. Pipette 100µl of PT reagent to each tube.  Throughout testing all test tubes, incubation time should 4. Add 50 µl of sample, controls to the tubes prepared in Prothrombin Time (PT) be kept in constant and incubation temperature at step 3, start stop watch , mix in a water bath ( 37°C ) (LIQUID REAGENT) 36.5-37.5°C. for 8 seconds , then record the time required for clot For In-Vitro diagnostic use only  If testing is delayed for more than 4 hours, plasma may formation . be stored at 2-8°C. B.Automated Method Store at: 2-8°C  Each laboratory should establish a Quality Control To perform this test, refer to the appropriate Instrument program that includes both normal and abnormal control Operator’s Manual for detailed instructions. INTENDED USE plasmas to evaluate instrument, reagent tested daily Prothrombin Time (PT) is commonly used for screening for prior to performing tests on patient plasmas. Monthly RESULTS extrinsic factor deficiency, monitoring oral quality control charts are recommended to determine Clot time of the test Prothrombin Time plasma therapy and quantitative determination of the extrinsic the mean and standard deviation of each of the daily = Ratio (PTR) Clot time of the control factors. control plasma. All assays should include controls, and if plasma any of the controls are outside the established reference INR = PTRISI PRINCIPLE ranges, then the should be considered invalid and Example: for a PTR of 2.0 and an ISI of 1.0 Tissue , in the presence of ions and no patient results should be reported. INR = 2.01.0 = 2.0 Factor VII, activates the extrinsic pathway of coagulation. When a mixture of tissue thromboplastin and calcium ions SPECIMEN COLLECTION AND PREPARATION REFERENCE VALUES is added to normal anticoagulant plasma, the clotting 1. Plasma obtained from whole blood samples that had Normal control sample: (11-16 seconds) mechanism is initiated and a clot will form within a been collected in a tube with 0.109M sodium citrate as PTR: 1.0±0.15; INR: 0.8-1.24 specified time period. If a deficiency exists within the an anticoagulant, nine parts of freshly collected whole  These values should only serve as guidelines. extrinsic pathway, the time required for clot formation will blood should be immediately added to one part of  Because differences may exist between instruments, be prolonged. The degree of prolongation is proportional to anticoagulant. Centrifuge the whole blood specimen at laboratories, and local populations, it is recommended the severity of single factor deficiency, or in a cumulative 2500xg for 15 minutes. Separate the plasma using a that each laboratory establish its own reference range of deficiency of all the factors involved. plastic pipette and place it in a plastic . Perform expected Prothrombin Time LIQUID results. the Prothrombin Time assay within 4 hours.  The results of the Prothrombin Time LIQUID tests should MATERIALS 2. Reconstitute the control plasmas (normal control plasma, be reported to the nearest tenth of a second. Results MATERIALS PROVIDED abnormal control plasma) according to the package greater than the upper limits of the range should be  PT Reagent: ISI 1.0 insert included with the control. considered abnormal and follow-up testing should be MATERIALS NEEDED BUT NOT PROVIDED: performed. PT values below the lower limits of the range  Plasma Normal and Abnormal Control. PROCEDURE may indicate a compromised sample, and a new sample STORAGE AND STABILITY A. Manual Method should be collected.  Do not mix or use the components of this kit with the 1. Bring all reagents, controls and sample to room Table for INR values for PT Ratios between (0.05 - 1.95 1.95 3.95 3.95 5.95 5.95 6.0) 2.00 2.00 4.00 4.00 6.00 6.00 ISI Value = 1.0 REFERENCES: PTR INR PTR INR PTR INR 0.05 0.05 2.05 2.05 4.05 4.05 1. Basu, D; Gallus.; Hirsh, j. N. Eng. J. Med. 287: 324,1972 0.10 0.10 2.10 2.10 4.10 4.10 2. Young, D.; Pestaner, L.; Gibberman, V. Clin. Chen. 21: 0.15 0.15 2.15 2.15 4.15 4.15 355 D, 1975 0.20 0.20 2.20 2.20 4.20 4.20 3. Quick A. J., The PARTIAL THROMBOPLASTIN TIME in 0.25 0.25 2.25 2.25 4.25 4.25 0.30 0.30 2.30 2.30 4.30 4.30 Hemophilia and in Obstructive 0.35 0.35 2.35 2.35 4.35 4.35 .J.Biol.Chem,:109,73-74:1935 0.40 0.40 2.40 2.40 4.40 4.40 4. Biggs R.ed, Human Blood Coagulation and 0.45 0.45 2.45 2.45 4.45 4.45 Second Ed.Blackwell Scientific Publications, 0.50 0.50 2.50 2.50 4.50 4.50 London 1976. 0.55 0.55 2.55 2.55 4.55 4.55 0.60 0.60 2.60 2.60 4.60 4.60 5. Peterson C.E., K waan H.C., Current Conce PTs of 0.65 0.65 2.65 2.65 4.65 4.65 Therapy, Arch Intern. Med. 146:581-584,1986. 0.70 0.70 2.70 2.70 4.70 4.70 0.75 0.75 2.75 2.75 4.75 4.75 ATLAS MEDICAL 0.80 0.80 2.80 2.80 4.80 4.80 0.85 0.85 2.85 2.85 4.85 4.85 William James House, Cowley Road, 0.90 0.90 2.90 2.90 4.90 4.90 Cambridge, CB4 0WX 0.95 0.95 2.95 2.95 4.95 4.95 Tel: ++44 (0) 1223 858 910 1.00 1.00 3.00 3.00 5.00 5.00 Fax: ++44 (0) 1223 858 524 1.05 1.05 3.05 3.05 5.05 5.05 1.10 1.10 3.10 3.10 5.10 5.10 PPI471A01 1.15 1.15 3.15 3.15 5.15 5.15 Rev D (19.05.2014) 1.20 1.20 3.20 3.20 5.20 5.20 Catalogue Number Store at 1.25 1.25 3.25 3.25 5.25 5.25 For In-Vitro Diagnostic Caution 1.30 1.30 3.30 3.30 5.30 5.30 use 1.35 1.35 3.35 3.35 5.35 5.35 Number of tests in the Read product insert 1.40 1.40 3.40 3.40 5.40 5.40 pack before use 1.45 1.45 3.45 3.45 5.45 5.45 Lot (batch) number Manufacturer 1.50 1.50 3.50 3.50 5.50 5.50 Fragile, handle with Expiry date 1.55 1.55 3.55 3.55 5.55 5.55 care 1.60 1.60 3.60 3.60 5.60 5.60 Manufacturer fax Do not use if 1.65 1.65 3.65 3.65 5.65 5.65 number package is damaged 1.70 1.70 3.70 3.70 5.70 5.70 Manufacturer 1.75 1.75 3.75 3.75 5.75 5.75 telephone number 1.80 1.80 3.80 3.80 5.80 5.80 1.85 1.85 3.85 3.85 5.85 5.85 1.90 1.90 3.90 3.90 5.90 5.90