Roche CoaguChek XS Plus, Training Manual

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76 CoaguChek Professional Monitoring Systems
Training Manual
COAGUCHEK and BECAUSE IT’S MY LIFE
are trademarks of Roche.
©2014 Roche
Roche Diagnostics International Ltd
CH-6343 Rotkreuz
Switzerland
www.coaguchek.com
References
1 Van Geest-Daalderop, J.H., Pequeriaux, N.C., & van den Besselaar, A.M. (2009). Variability of INR in patients on stable long-term treatment with
phenprocoumon and acenocoumarol and implications for analytical quality requirements. Thromb Haemost 102, 588-592.
2 Tripodi, A., Breukink-Engbers, W.G., & van den Besselaar, A.M. (2003). Oral anticoagulant monitoring by laboratory or near-patient testing: what
a clinician should be aware of. Semin Vasc Med 3, 243-254.
3 Roche Diagnostics GmbH. (2006). CoaguChek® XS Evaluation Study (internal reference).
4 Van den Besselaar, A.M., Poller, L., & Tripodi, A. (1999). WHO Expert Committee on Biological Standardization. Forty-eighth report. Guidelines
for thromboplastins and plasmas used to control anticoagulant therapy. WHO Technical Report Series 64-93. Available at: http://www.who.int/
bloodproducts/publications/WHO_TRS_889_A3.pdf (last accessed April 2014).
5 You, J.J., Singer, D.E., Howard, P.A., Lane, D.A., Eckman, M.H. et al. (2012). Antithrombotic therapy for atrial fibrillation: Antithrombotic Therapy
and Prevention of Thrombosis, 9
th
ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 141, e531S-e575S.
6 Tripodi, A. (2013). Monitoring oral anticoagulant therapy with vitamin K antagonists. In: Olson J.D., Kitchen, S., Preston, F.E., ed. Quality in
laboratory hemostasis and thrombosis, 2
nd
ed. Sheffield, UK: Blackwell Publishing Ltd: 253-263.
7 Smith, S.A., Comp, P.C., & Morrissey, J.H. (2006). Phospholipid composition controls thromboplastin sensitivity to individual clotting factors.
J Thromb Haemost 4, 820-827.
8 Amukele, T.K., Ferrell, C., & Chandler, W.L. (2010). Comparison of plasma with whole blood prothrombin time and fibrinogen on the same
instrument. Am J Clin Pathol 133, 550-556.
9 Adcock, D. (2013). Sample integrity and preanalytical variables. In: Olson J.D., Kitchen, S., Preston, F.E., ed. Quality in laboratory hemostasis and
thrombosis, 2
nd
ed. Sheffield, UK: Blackwell Publishing Ltd: 45-56.
10 Kitchen, D.P., Kitchen, S., Jennings, I., Woods, T.A., Fitzmaurice, D.A. et al. (2012). Point of Care INR testing devices: performance of the Roche
CoaguChek XS and XS Plus in the UK NEQAS BC external quality assessment programme for healthcare professionals: four years' experience. J Clin
Pathol 65, 1119-1123.
11 Bernardo, A., & Halhuber, C. (2006). Gerinnungs-Selbstmanagement leicht gemacht. Stuttgart, Germany: TRIAS-Verlag in MVS.
12 Holbrook, A., Schulman, S., Witt, D.M., Vandvik, P.O., Fish, J. et al. (2012). Evidence-based management of anticoagulant therapy: Antithrombotic
Therapy and Prevention of Thrombosis, 9
th
ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 141,
e152S-e184S.
13 Plesch, W., Wolf, T., Breitenbeck, N., Dikkeschei, L.D., Cervero, A. et al. (2008). Results of the performance verification of the CoaguChek XS system.
Thromb Res 123, 381-389.
14 International Organization for Standardization. (2007). ISO 17593: Clinical laboratory testing and in vitro medical devices – Requirements for in
vitro monitoring systems for self-testing of oral anticoagulation therapy.
15 Leichsenring, I., Plesch, W., Unkrig, V., Kitchen, S., Kitchen, D.P. et al. (2007). Multicentre ISI assignment and calibration of the INR measuring
range of a new point-of-care system designed for home monitoring of oral anticoagulation therapy. Thromb Haemost 97, 856-861.
16 Plesch, W., & van den Besselaar, A.M. (2009). Validation of the international normalized ratio (INR) in a new point-of-care system designed for
home monitoring of oral anticoagulation therapy. Int J Lab Hematol 31, 20-25.
17 Poller, L. (1998). The prothrombin time (synonymous with thromboplastin time or Quick test). World Health Organization, Geneva, WHO/
LAB/98.3. Available at: http://whqlibdoc.who.int/hq/1998/WHO_LAB_98.3.pdf (last accessed April 2014).
18 Plesch, W., & Schwab, M. (2006). Evaluation of the CoaguChek XS System – International Evaluation Workshop, 25 November 2005, Heidelberg,
Germany: Workshop Report (1 st edition).
19 Plesch, W., & Wolf, T. (2006). Performance evaluation of the CoaguChek XS Plus System (Study LB 157-2005), evaluation report, evaluation Roche
near patient, Mannheim, March 16, 2006 (available upon request).
20 Roche Professional Diagnostics. (2013). CoaguChek XS Pro launch book (internal reference).
21 Roche Professional Diagnostics. (2010). CoaguChek XS PT Test package insert.
12 1/20/2015 8:50:10 AM
©2015 Roche
COAGUCHEK and BECAUSE IT’S MY LIFE
are trademarks of Roche.
©2014 Roche
Roche Diagnostics International Ltd
CH-6343 Rotkreuz
Switzerland
www.coaguchek.com
References
1 Van Geest-Daalderop, J.H., Pequeriaux, N.C., & van den Besselaar, A.M. (2009). Variability of INR in patients on stable long-term treatment with
phenprocoumon and acenocoumarol and implications for analytical quality requirements. Thromb Haemost 102, 588-592.
2 Tripodi, A., Breukink-Engbers, W.G., & van den Besselaar, A.M. (2003). Oral anticoagulant monitoring by laboratory or near-patient testing: what
a clinician should be aware of. Semin Vasc Med 3, 243-254.
3 Roche Diagnostics GmbH. (2006). CoaguChek® XS Evaluation Study (internal reference).
4 Van den Besselaar, A.M., Poller, L., & Tripodi, A. (1999). WHO Expert Committee on Biological Standardization. Forty-eighth report. Guidelines
for thromboplastins and plasmas used to control anticoagulant therapy. WHO Technical Report Series 64-93. Available at: http://www.who.int/
bloodproducts/publications/WHO_TRS_889_A3.pdf (last accessed April 2014).
5 You, J.J., Singer, D.E., Howard, P.A., Lane, D.A., Eckman, M.H. et al. (2012). Antithrombotic therapy for atrial fibrillation: Antithrombotic Therapy
and Prevention of Thrombosis, 9
th
ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 141, e531S-e575S.
6 Tripodi, A. (2013). Monitoring oral anticoagulant therapy with vitamin K antagonists. In: Olson J.D., Kitchen, S., Preston, F.E., ed. Quality in
laboratory hemostasis and thrombosis, 2
nd
ed. Sheffield, UK: Blackwell Publishing Ltd: 253-263.
7 Smith, S.A., Comp, P.C., & Morrissey, J.H. (2006). Phospholipid composition controls thromboplastin sensitivity to individual clotting factors.
J Thromb Haemost 4, 820-827.
8 Amukele, T.K., Ferrell, C., & Chandler, W.L. (2010). Comparison of plasma with whole blood prothrombin time and fibrinogen on the same
instrument. Am J Clin Pathol 133, 550-556.
9 Adcock, D. (2013). Sample integrity and preanalytical variables. In: Olson J.D., Kitchen, S., Preston, F.E., ed. Quality in laboratory hemostasis and
thrombosis, 2
nd
ed. Sheffield, UK: Blackwell Publishing Ltd: 45-56.
10 Kitchen, D.P., Kitchen, S., Jennings, I., Woods, T.A., Fitzmaurice, D.A. et al. (2012). Point of Care INR testing devices: performance of the Roche
CoaguChek XS and XS Plus in the UK NEQAS BC external quality assessment programme for healthcare professionals: four years' experience. J Clin
Pathol 65, 1119-1123.
11 Bernardo, A., & Halhuber, C. (2006). Gerinnungs-Selbstmanagement leicht gemacht. Stuttgart, Germany: TRIAS-Verlag in MVS.
12 Holbrook, A., Schulman, S., Witt, D.M., Vandvik, P.O., Fish, J. et al. (2012). Evidence-based management of anticoagulant therapy: Antithrombotic
Therapy and Prevention of Thrombosis, 9
th
ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 141,
e152S-e184S.
13 Plesch, W., Wolf, T., Breitenbeck, N., Dikkeschei, L.D., Cervero, A. et al. (2008). Results of the performance verification of the CoaguChek XS system.
Thromb Res 123, 381-389.
14 International Organization for Standardization. (2007). ISO 17593: Clinical laboratory testing and in vitro medical devices – Requirements for in
vitro monitoring systems for self-testing of oral anticoagulation therapy.
15 Leichsenring, I., Plesch, W., Unkrig, V., Kitchen, S., Kitchen, D.P. et al. (2007). Multicentre ISI assignment and calibration of the INR measuring
range of a new point-of-care system designed for home monitoring of oral anticoagulation therapy. Thromb Haemost 97, 856-861.
16 Plesch, W., & van den Besselaar, A.M. (2009). Validation of the international normalized ratio (INR) in a new point-of-care system designed for
home monitoring of oral anticoagulation therapy. Int J Lab Hematol 31, 20-25.
17 Poller, L. (1998). The prothrombin time (synonymous with thromboplastin time or Quick test). World Health Organization, Geneva, WHO/
LAB/98.3. Available at: http://whqlibdoc.who.int/hq/1998/WHO_LAB_98.3.pdf (last accessed April 2014).
18 Plesch, W., & Schwab, M. (2006). Evaluation of the CoaguChek XS System – International Evaluation Workshop, 25 November 2005, Heidelberg,
Germany: Workshop Report (1 st edition).
19 Plesch, W., & Wolf, T. (2006). Performance evaluation of the CoaguChek XS Plus System (Study LB 157-2005), evaluation report, evaluation Roche
near patient, Mannheim, March 16, 2006 (available upon request).
20 Roche Professional Diagnostics. (2013). CoaguChek XS Pro launch book (internal reference).
21 Roche Professional Diagnostics. (2010). CoaguChek XS PT Test package insert.
12 1/20/2015 8:50:10 AM
COAGUCHEK and BECAUSE IT’S MY LIFE
are trademarks of Roche.
©2014 Roche
Roche Diagnostics International Ltd
CH-6343 Rotkreuz
Switzerland
www.coaguchek.com
References
1 Van Geest-Daalderop, J.H., Pequeriaux, N.C., & van den Besselaar, A.M. (2009). Variability of INR in patients on stable long-term treatment with
phenprocoumon and acenocoumarol and implications for analytical quality requirements. Thromb Haemost 102, 588-592.
2 Tripodi, A., Breukink-Engbers, W.G., & van den Besselaar, A.M. (2003). Oral anticoagulant monitoring by laboratory or near-patient testing: what
a clinician should be aware of. Semin Vasc Med 3, 243-254.
3 Roche Diagnostics GmbH. (2006). CoaguChek® XS Evaluation Study (internal reference).
4 Van den Besselaar, A.M., Poller, L., & Tripodi, A. (1999). WHO Expert Committee on Biological Standardization. Forty-eighth report. Guidelines
for thromboplastins and plasmas used to control anticoagulant therapy. WHO Technical Report Series 64-93. Available at: http://www.who.int/
bloodproducts/publications/WHO_TRS_889_A3.pdf (last accessed April 2014).
5 You, J.J., Singer, D.E., Howard, P.A., Lane, D.A., Eckman, M.H. et al. (2012). Antithrombotic therapy for atrial fibrillation: Antithrombotic Therapy
and Prevention of Thrombosis, 9
th
ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 141, e531S-e575S.
6 Tripodi, A. (2013). Monitoring oral anticoagulant therapy with vitamin K antagonists. In: Olson J.D., Kitchen, S., Preston, F.E., ed. Quality in
laboratory hemostasis and thrombosis, 2
nd
ed. Sheffield, UK: Blackwell Publishing Ltd: 253-263.
7 Smith, S.A., Comp, P.C., & Morrissey, J.H. (2006). Phospholipid composition controls thromboplastin sensitivity to individual clotting factors.
J Thromb Haemost 4, 820-827.
8 Amukele, T.K., Ferrell, C., & Chandler, W.L. (2010). Comparison of plasma with whole blood prothrombin time and fibrinogen on the same
instrument. Am J Clin Pathol 133, 550-556.
9 Adcock, D. (2013). Sample integrity and preanalytical variables. In: Olson J.D., Kitchen, S., Preston, F.E., ed. Quality in laboratory hemostasis and
thrombosis, 2
nd
ed. Sheffield, UK: Blackwell Publishing Ltd: 45-56.
10 Kitchen, D.P., Kitchen, S., Jennings, I., Woods, T.A., Fitzmaurice, D.A. et al. (2012). Point of Care INR testing devices: performance of the Roche
CoaguChek XS and XS Plus in the UK NEQAS BC external quality assessment programme for healthcare professionals: four years' experience. J Clin
Pathol 65, 1119-1123.
11 Bernardo, A., & Halhuber, C. (2006). Gerinnungs-Selbstmanagement leicht gemacht. Stuttgart, Germany: TRIAS-Verlag in MVS.
12 Holbrook, A., Schulman, S., Witt, D.M., Vandvik, P.O., Fish, J. et al. (2012). Evidence-based management of anticoagulant therapy: Antithrombotic
Therapy and Prevention of Thrombosis, 9
th
ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 141,
e152S-e184S.
13 Plesch, W., Wolf, T., Breitenbeck, N., Dikkeschei, L.D., Cervero, A. et al. (2008). Results of the performance verification of the CoaguChek XS system.
Thromb Res 123, 381-389.
14 International Organization for Standardization. (2007). ISO 17593: Clinical laboratory testing and in vitro medical devices – Requirements for in
vitro monitoring systems for self-testing of oral anticoagulation therapy.
15 Leichsenring, I., Plesch, W., Unkrig, V., Kitchen, S., Kitchen, D.P. et al. (2007). Multicentre ISI assignment and calibration of the INR measuring
range of a new point-of-care system designed for home monitoring of oral anticoagulation therapy. Thromb Haemost 97, 856-861.
16 Plesch, W., & van den Besselaar, A.M. (2009). Validation of the international normalized ratio (INR) in a new point-of-care system designed for
home monitoring of oral anticoagulation therapy. Int J Lab Hematol 31, 20-25.
17 Poller, L. (1998). The prothrombin time (synonymous with thromboplastin time or Quick test). World Health Organization, Geneva, WHO/
LAB/98.3. Available at: http://whqlibdoc.who.int/hq/1998/WHO_LAB_98.3.pdf (last accessed April 2014).
18 Plesch, W., & Schwab, M. (2006). Evaluation of the CoaguChek XS System – International Evaluation Workshop, 25 November 2005, Heidelberg,
Germany: Workshop Report (1 st edition).
19 Plesch, W., & Wolf, T. (2006). Performance evaluation of the CoaguChek XS Plus System (Study LB 157-2005), evaluation report, evaluation Roche
near patient, Mannheim, March 16, 2006 (available upon request).
20 Roche Professional Diagnostics. (2013). CoaguChek XS Pro launch book (internal reference).
21 Roche Professional Diagnostics. (2010). CoaguChek XS PT Test package insert.
12 1/20/2015 8:50:10 AM
COAGUCHEK and BECAUSE IT’S MY LIFE
are trademarks of Roche.
©2014 Roche
Roche Diagnostics International Ltd
CH-6343 Rotkreuz
Switzerland
www.coaguchek.com
References
1 Van Geest-Daalderop, J.H., Pequeriaux, N.C., & van den Besselaar, A.M. (2009). Variability of INR in patients on stable long-term treatment with
phenprocoumon and acenocoumarol and implications for analytical quality requirements. Thromb Haemost 102, 588-592.
2 Tripodi, A., Breukink-Engbers, W.G., & van den Besselaar, A.M. (2003). Oral anticoagulant monitoring by laboratory or near-patient testing: what
a clinician should be aware of. Semin Vasc Med 3, 243-254.
3 Roche Diagnostics GmbH. (2006). CoaguChek® XS Evaluation Study (internal reference).
4 Van den Besselaar, A.M., Poller, L., & Tripodi, A. (1999). WHO Expert Committee on Biological Standardization. Forty-eighth report. Guidelines
for thromboplastins and plasmas used to control anticoagulant therapy. WHO Technical Report Series 64-93. Available at: http://www.who.int/
bloodproducts/publications/WHO_TRS_889_A3.pdf (last accessed April 2014).
5 You, J.J., Singer, D.E., Howard, P.A., Lane, D.A., Eckman, M.H. et al. (2012). Antithrombotic therapy for atrial fibrillation: Antithrombotic Therapy
and Prevention of Thrombosis, 9
th
ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 141, e531S-e575S.
6 Tripodi, A. (2013). Monitoring oral anticoagulant therapy with vitamin K antagonists. In: Olson J.D., Kitchen, S., Preston, F.E., ed. Quality in
laboratory hemostasis and thrombosis, 2
nd
ed. Sheffield, UK: Blackwell Publishing Ltd: 253-263.
7 Smith, S.A., Comp, P.C., & Morrissey, J.H. (2006). Phospholipid composition controls thromboplastin sensitivity to individual clotting factors.
J Thromb Haemost 4, 820-827.
8 Amukele, T.K., Ferrell, C., & Chandler, W.L. (2010). Comparison of plasma with whole blood prothrombin time and fibrinogen on the same
instrument. Am J Clin Pathol 133, 550-556.
9 Adcock, D. (2013). Sample integrity and preanalytical variables. In: Olson J.D., Kitchen, S., Preston, F.E., ed. Quality in laboratory hemostasis and
thrombosis, 2
nd
ed. Sheffield, UK: Blackwell Publishing Ltd: 45-56.
10 Kitchen, D.P., Kitchen, S., Jennings, I., Woods, T.A., Fitzmaurice, D.A. et al. (2012). Point of Care INR testing devices: performance of the Roche
CoaguChek XS and XS Plus in the UK NEQAS BC external quality assessment programme for healthcare professionals: four years' experience. J Clin
Pathol 65, 1119-1123.
11 Bernardo, A., & Halhuber, C. (2006). Gerinnungs-Selbstmanagement leicht gemacht. Stuttgart, Germany: TRIAS-Verlag in MVS.
12 Holbrook, A., Schulman, S., Witt, D.M., Vandvik, P.O., Fish, J. et al. (2012). Evidence-based management of anticoagulant therapy: Antithrombotic
Therapy and Prevention of Thrombosis, 9
th
ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 141,
e152S-e184S.
13 Plesch, W., Wolf, T., Breitenbeck, N., Dikkeschei, L.D., Cervero, A. et al. (2008). Results of the performance verification of the CoaguChek XS system.
Thromb Res 123, 381-389.
14 International Organization for Standardization. (2007). ISO 17593: Clinical laboratory testing and in vitro medical devices – Requirements for in
vitro monitoring systems for self-testing of oral anticoagulation therapy.
15 Leichsenring, I., Plesch, W., Unkrig, V., Kitchen, S., Kitchen, D.P. et al. (2007). Multicentre ISI assignment and calibration of the INR measuring
range of a new point-of-care system designed for home monitoring of oral anticoagulation therapy. Thromb Haemost 97, 856-861.
16 Plesch, W., & van den Besselaar, A.M. (2009). Validation of the international normalized ratio (INR) in a new point-of-care system designed for
home monitoring of oral anticoagulation therapy. Int J Lab Hematol 31, 20-25.
17 Poller, L. (1998). The prothrombin time (synonymous with thromboplastin time or Quick test). World Health Organization, Geneva, WHO/
LAB/98.3. Available at: http://whqlibdoc.who.int/hq/1998/WHO_LAB_98.3.pdf (last accessed April 2014).
18 Plesch, W., & Schwab, M. (2006). Evaluation of the CoaguChek XS System – International Evaluation Workshop, 25 November 2005, Heidelberg,
Germany: Workshop Report (1
st
edition).
19 Plesch, W., & Wolf, T. (2006). Performance evaluation of the CoaguChek XS Plus System (Study LB 157-2005), evaluation report, evaluation Roche
near patient, Mannheim, March 16, 2006 (available upon request).
20 Roche Professional Diagnostics. (2013). CoaguChek XS Pro launch book (internal reference).
21 Roche Professional Diagnostics. (2010). CoaguChek XS PT Test package insert.
12 1/20/2015 8:50:10 AM
COAGUCHEK and BECAUSE IT’S MY LIFE
are trademarks of Roche.
©2014 Roche
Roche Diagnostics International Ltd
CH-6343 Rotkreuz
Switzerland
www.coaguchek.com
References
1 Van Geest-Daalderop, J.H., Pequeriaux, N.C., & van den Besselaar, A.M. (2009). Variability of INR in patients on stable long-term treatment with
phenprocoumon and acenocoumarol and implications for analytical quality requirements. Thromb Haemost 102, 588-592.
2 Tripodi, A., Breukink-Engbers, W.G., & van den Besselaar, A.M. (2003). Oral anticoagulant monitoring by laboratory or near-patient testing: what
a clinician should be aware of. Semin Vasc Med 3, 243-254.
3 Roche Diagnostics GmbH. (2006). CoaguChek® XS Evaluation Study (internal reference).
4 Van den Besselaar, A.M., Poller, L., & Tripodi, A. (1999). WHO Expert Committee on Biological Standardization. Forty-eighth report. Guidelines
for thromboplastins and plasmas used to control anticoagulant therapy. WHO Technical Report Series 64-93. Available at: http://www.who.int/
bloodproducts/publications/WHO_TRS_889_A3.pdf (last accessed April 2014).
5 You, J.J., Singer, D.E., Howard, P.A., Lane, D.A., Eckman, M.H. et al. (2012). Antithrombotic therapy for atrial fibrillation: Antithrombotic Therapy
and Prevention of Thrombosis, 9
th
ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 141, e531S-e575S.
6 Tripodi, A. (2013). Monitoring oral anticoagulant therapy with vitamin K antagonists. In: Olson J.D., Kitchen, S., Preston, F.E., ed. Quality in
laboratory hemostasis and thrombosis, 2
nd
ed. Sheffield, UK: Blackwell Publishing Ltd: 253-263.
7 Smith, S.A., Comp, P.C., & Morrissey, J.H. (2006). Phospholipid composition controls thromboplastin sensitivity to individual clotting factors.
J Thromb Haemost 4, 820-827.
8 Amukele, T.K., Ferrell, C., & Chandler, W.L. (2010). Comparison of plasma with whole blood prothrombin time and fibrinogen on the same
instrument. Am J Clin Pathol 133, 550-556.
9 Adcock, D. (2013). Sample integrity and preanalytical variables. In: Olson J.D., Kitchen, S., Preston, F.E., ed. Quality in laboratory hemostasis and
thrombosis, 2
nd
ed. Sheffield, UK: Blackwell Publishing Ltd: 45-56.
10 Kitchen, D.P., Kitchen, S., Jennings, I., Woods, T.A., Fitzmaurice, D.A. et al. (2012). Point of Care INR testing devices: performance of the Roche
CoaguChek XS and XS Plus in the UK NEQAS BC external quality assessment programme for healthcare professionals: four years' experience. J Clin
Pathol 65, 1119-1123.
11 Bernardo, A., & Halhuber, C. (2006). Gerinnungs-Selbstmanagement leicht gemacht. Stuttgart, Germany: TRIAS-Verlag in MVS.
12 Holbrook, A., Schulman, S., Witt, D.M., Vandvik, P.O., Fish, J. et al. (2012). Evidence-based management of anticoagulant therapy: Antithrombotic
Therapy and Prevention of Thrombosis, 9
th
ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 141,
e152S-e184S.
13 Plesch, W., Wolf, T., Breitenbeck, N., Dikkeschei, L.D., Cervero, A. et al. (2008). Results of the performance verification of the CoaguChek XS system.
Thromb Res 123, 381-389.
14 International Organization for Standardization. (2007). ISO 17593: Clinical laboratory testing and in vitro medical devices – Requirements for in
vitro monitoring systems for self-testing of oral anticoagulation therapy.
15 Leichsenring, I., Plesch, W., Unkrig, V., Kitchen, S., Kitchen, D.P. et al. (2007). Multicentre ISI assignment and calibration of the INR measuring
range of a new point-of-care system designed for home monitoring of oral anticoagulation therapy. Thromb Haemost 97, 856-861.
16 Plesch, W., & van den Besselaar, A.M. (2009). Validation of the international normalized ratio (INR) in a new point-of-care system designed for
home monitoring of oral anticoagulation therapy. Int J Lab Hematol 31, 20-25.
17 Poller, L. (1998). The prothrombin time (synonymous with thromboplastin time or Quick test). World Health Organization, Geneva, WHO/
LAB/98.3. Available at: http://whqlibdoc.who.int/hq/1998/WHO_LAB_98.3.pdf (last accessed April 2014).
18 Plesch, W., & Schwab, M. (2006). Evaluation of the CoaguChek XS System – International Evaluation Workshop, 25 November 2005, Heidelberg,
Germany: Workshop Report (1 st edition).
19 Plesch, W., & Wolf, T. (2006). Performance evaluation of the CoaguChek XS Plus System (Study LB 157-2005), evaluation report, evaluation Roche
near patient, Mannheim, March 16, 2006 (available upon request).
20 Roche Professional Diagnostics. (2013). CoaguChek XS Pro launch book (internal reference).
21 Roche Professional Diagnostics. (2010). CoaguChek XS PT Test package insert.
12 1/20/2015 8:50:10 AM
11
12
13
14
15
16
17
18
19
20
Roche Diagnostics Ltd.
Charles Avenue,
Burgess Hill
RH15 9RY
United Kingdom
www.coaguchek.co.uk
Company registration no: 571546
© Copyright 2015. Roche Diagnostics Limited. All rights reserved.
COAGUCHEK and ‘BECAUSE IT’S MY LIFE’ are registered trademarks of Roche.
COAGUCHEK and BECAUSE IT’S MY LIFE
are trademarks of Roche.
©2014 Roche
Roche Diagnostics International Ltd
CH-6343 Rotkreuz
Switzerland
www.coaguchek.com
References
1 Van Geest-Daalderop, J.H., Pequeriaux, N.C., & van den Besselaar, A.M. (2009). Variability of INR in patients on stable long-term treatment with
phenprocoumon and acenocoumarol and implications for analytical quality requirements. Thromb Haemost 102, 588-592.
2 Tripodi, A., Breukink-Engbers, W.G., & van den Besselaar, A.M. (2003). Oral anticoagulant monitoring by laboratory or near-patient testing: what
a clinician should be aware of. Semin Vasc Med 3, 243-254.
3 Roche Diagnostics GmbH. (2006). CoaguChek® XS Evaluation Study (internal reference).
4 Van den Besselaar, A.M., Poller, L., & Tripodi, A. (1999). WHO Expert Committee on Biological Standardization. Forty-eighth report. Guidelines
for thromboplastins and plasmas used to control anticoagulant therapy. WHO Technical Report Series 64-93. Available at: http://www.who.int/
bloodproducts/publications/WHO_TRS_889_A3.pdf (last accessed April 2014).
5 You, J.J., Singer, D.E., Howard, P.A., Lane, D.A., Eckman, M.H. et al. (2012). Antithrombotic therapy for atrial fibrillation: Antithrombotic Therapy
and Prevention of Thrombosis, 9
th
ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 141, e531S-e575S.
6 Tripodi, A. (2013). Monitoring oral anticoagulant therapy with vitamin K antagonists. In: Olson J.D., Kitchen, S., Preston, F.E., ed. Quality in
laboratory hemostasis and thrombosis, 2
nd
ed. Sheffield, UK: Blackwell Publishing Ltd: 253-263.
7 Smith, S.A., Comp, P.C., & Morrissey, J.H. (2006). Phospholipid composition controls thromboplastin sensitivity to individual clotting factors.
J Thromb Haemost 4, 820-827.
8 Amukele, T.K., Ferrell, C., & Chandler, W.L. (2010). Comparison of plasma with whole blood prothrombin time and fibrinogen on the same
instrument. Am J Clin Pathol 133, 550-556.
9 Adcock, D. (2013). Sample integrity and preanalytical variables. In: Olson J.D., Kitchen, S., Preston, F.E., ed. Quality in laboratory hemostasis and
thrombosis, 2
nd
ed. Sheffield, UK: Blackwell Publishing Ltd: 45-56.
10 Kitchen, D.P., Kitchen, S., Jennings, I., Woods, T.A., Fitzmaurice, D.A. et al. (2012). Point of Care INR testing devices: performance of the Roche
CoaguChek XS and XS Plus in the UK NEQAS BC external quality assessment programme for healthcare professionals: four years' experience. J Clin
Pathol 65, 1119-1123.
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