Determination of Coagulation Tests Reference Ranges from Konya City Hospital Central Laboratory Data by Indirect Method and Investigation of Age-Dependent Changes
Abstract
This study aimed to establish age- and gender-specific reference ranges for activated partial thromboplastin time (aPTT), prothrombin time (PT), and the international normalized ratio (INR) using data from the Central Laboratory of Konya City Hospital. The study retrospectively analyzed PT, aPTT, and INR results from patients aged 0-95 years who underwent preoperative evaluations for minor elective surgeries between August 2020 and March 2023. Patients with genetic or acquired bleeding disorders or who were on regular anticoagulant therapy (e.g., warfarin, LMWH, ASA) were excluded. PT and aPTT measurements were conducted using the Sysmex CS 5100 coagulation analyzer with an optical detection method. A total of 1,253 individuals (708 males and 545 females) were divided into 12 age groups. The results indicated an INR reference range of 0.93-1.29 for all patients. The PT reference ranges were determined as 10.70-14.50 seconds, while aPTT reference ranges varied by age. For instance, for patients aged 0-5 months, the lower and upper limits were 20.63 and 35.45 seconds, respectively; for patients aged six months and over, these limits were 19.7 and 29.6 seconds. Our study revealed differences with the reference ranges provided by manufacturers and emphasized the need for specific aPTT reference ranges for some pediatric age groups compared to adults.
Keywords
References
- Arzideh, F., Wosniok, W., & Haeckel, R. (2011). Indirect reference intervals of plasma and serum thyrotropin (TSH) concentrations from intra-laboratory data bases from several German and Italian medical centres. Clinical Chemistry and Laboratory Medicine, 49(4), 659-664. https://doi.org/doi:10.1515/CCLM.2011.114
- Castellone, D. D. (2017). Establishing reference intervals in the coagulation laboratory. Int J Lab Hematol, 39 Suppl 1, 121-127. https://doi.org/10.1111/ijlh.12661
- Concordet, D., Geffré, A., Braun, J. P., & Trumel, C. (2009). A new approach for the determination of reference intervals from hospital-based data. Clin Chim Acta, 405(1-2), 43-48. https://doi.org/10.1016/j.cca.2009.03.057.
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- Devreese, K. M. J., de Groot, P. G., de Laat, B., Erkan, D., Favaloro, E. J., Mackie, I. … Cohen, H. (2020). Guidance from the Scientific and Standardization Committee for lupus anticoagulant/antiphospholipid antibodies of the International Society on Thrombosis and Haemostasis: Update of the guidelines for lupus anticoagulant detection and interpretation. J Thromb Haemost, 18(11), 2828-2839. https://doi.org/10.1111/jth.15047
- Fuentes-Arderiu, X., Mas-Serra, R., Alumà-Trullàs, A., Martí-Marcet, M. I., & Dot-Bach, D. (2004). Guideline for the production of multicentre physiological reference values using the same measurement system. A proposal of the Catalan Association for Clinical Laboratory Sciences. Clinical Chemistry and Laboratory Medicine (CCLM), 42(7), 778-782. https://doi.org/doi:10.1515/CCLM.2004.130
- Fuentes-Arderiu, X., Mas-Serra, R., Alumà-Trullàs, A., Martí-Marcet, M. I., & Dot-Bach, D. (2004). Guideline for the production of multicentre physiological reference values using the same measurement system. A proposal of the Catalan Association for Clinical Laboratory Sciences. Clin Chem Lab Med, 42(7), 778-782. https://doi.org/10.1515/cclm.2004.130
- Horowitz, G. (2006). Establishment and use of reference values (D. E. B. Carl A. Burtis, Ed. 7th ed ed.). Elsevier Saunders.
- Jones, G. R. D., Haeckel, R., Loh, T. P., Sikaris, K., Streichert, T., Katayev, A. … Limits, D. (2019). Indirect methods for reference interval determination – review and recommendations. Clinical Chemistry and Laboratory Medicine (CCLM), 57(1), 20-29. https://doi.org/doi:10.1515/cclm-2018-0073
- Kartekin, A., Tire, Y., & Aydoğan, E. (2020). Comparison of Liver Function in Terms of Different Parameters in Patients Receiving Imipenem Therapy in the Intensive Care Unit; Retrospective study. Dünya Sağlık ve Tabiat Bilimleri Dergisi, 3(2), 111-116.
- Katayev, A., Balciza, C., & Seccombe, D. W. (2010). Establishing reference intervals for clinical laboratory test results: is there a better way? Am J Clin Pathol, 133(2), 180-186. https://doi.org/10.1309/ajcpn5bmtsf1cdyp
- Lippi, G., Franchini, M., Montagnana, M., & Guidi, G. C. (2007). Coagulation testing in pediatric patients: the young are not just miniature adults. Semin Thromb Hemost, 33(8), 816-820. https://doi.org/10.1055/s-2007-1000373
- Rizzo, F., Papasouliotis, K., Crawford, E., Dodkin, S., & Cue, S. (2008). Measurement of prothrombin time (PT) and activated partial thromboplastin time (APTT) on canine citrated plasma samples following different storage conditions. Res Vet Sci, 85(1), 166-170. https://doi.org/10.1016/j.rvsc.2007.10.001
- Rosendaal, F. R., Cannegieter, S. C., van der Meer, F. J., & Briët, E. (1993). A method to determine the optimal intensity of oral anticoagulant therapy. Thromb Haemost, 69(3), 236-239.
- Solberg, H. E., & PetitClerc, C. (1988). Approved recommendation (1988) on the theory of reference values. Part 3. Preparation of individuals and collection of specimens for the production of reference values. Clin Chim Acta, 177(3), S3-11. https://doi.org/10.1016/0009-8981(88)90074-5
- Toulon, P., Berruyer, M., Brionne-François, M., Grand, F., Lasne, D., Telion, C. … De Pooter, N. (2016). Age dependency for coagulation parameters in paediatric populations. Results of a multicentre study aimed at defining the age-specific reference ranges. Thromb Haemost, 116(1), 9-16. https://doi.org/10.1160/th15-12-0964
- Tripodi, A., & Mannucci, P. M. (2011). The coagulopathy of chronic liver disease. N Engl J Med, 365(2), 147-156. https://doi.org/10.1056/NEJMra1011170
- Weidhofer, C., Meyer, E., Ristl, R., Wiedemann, H., Cadamuro, J., Kipman, U. … Einwallner, E. (2018). Dynamic reference intervals for coagulation parameters from infancy to adolescence. Clin Chim Acta, 482, 124-135. https://doi.org/10.1016/j.cca.2018.04.003
- Winter, W. E., Flax, S. D., & Harris, N. S. (2017). Coagulation Testing in the Core Laboratory. Laboratory Medicine, 48(4), 295-313. https://doi.org/10.1093/labmed/lmx050
Konya Şehir Hastanesi Merkezi Laboratuvar Verilerinden Koagülasyon Testleri Referans Aralıklarının İndirekt Yöntemle Belirlenmesi ve Yaşa Bağımlı Değişiminin İncelenmesi
Abstract
Konya Şehir Hastanesi Merkezi Laboratuvar verilerinden elde edilen bilgilerle hastane popülasyonunda kullanılmak üzere parsiyel tromboplastin zamanı (aPTT), protrombin zamanı (PT) ve uluslararası normalize edilmiş oranın (INR) yaş ve cinsiyete özgü referans değerlerinin belirlenmesi amaçlanmıştır. Ağustos 2020-Mart 2023 tarihleri arasında Konya Şehir Hastanesine minör elektif cerrahi öncesi preoperatif değerlendirme kapsamında başvuran 0-95 yaş arasındaki hastaların PT, aPTT ve INR test sonuçları retrospektif olarak incelenmiştir. Çalışmaya genetik veya edinilmiş kanama bozukluğu olan, kanama bozukluğu tedavisi (varfarin, DMAH, ASA) için düzenli ilaç kullanan hastalar dahil edilmemiştir. PT ve aPTT ölçümleri, otomatik pıhtılaşma analiz cihazı olan Sysmex CS 5100’de optik algılama yöntemiyle gerçekleştirilmiştir. Toplam 1253 kişi (708 erkek ve 545 kadın) yaşlarına göre 12 gruba ayrılmıştır. Sonuçlar, INR alt sınır değerinin tüm hastalarda 0,93; üst sınır değerinin ise 1,29 olduğunu göstermiştir. PT alt sınır değeri tüm hastalar için 10,70 saniye, üst sınır değeri ise 14,50 saniye olarak belirlenmiştir. aPTT referans aralıkları yaş gruplarına göre değişiklik göstermiştir; örneğin, 0-5 ay grubunda alt sınır 20,63 ve üst sınır 35,45 saniye iken, 6 ay ve üzeri hastalarda alt sınır 19,7 ve üst sınır 29,6 saniye olarak bulunmuştur. Çalışmamız sonucunda, üreticiler tarafından sağlanan referans aralıkları ile farklılıklar olduğu ortaya konmuş ve yetişkinlere kıyasla bazı pediatrik yaş grupları için spesifik aPTT referans aralıklarının gerekliliği vurgulanmıştır.
Keywords
References
- Arzideh, F., Wosniok, W., & Haeckel, R. (2011). Indirect reference intervals of plasma and serum thyrotropin (TSH) concentrations from intra-laboratory data bases from several German and Italian medical centres. Clinical Chemistry and Laboratory Medicine, 49(4), 659-664. https://doi.org/doi:10.1515/CCLM.2011.114
- Castellone, D. D. (2017). Establishing reference intervals in the coagulation laboratory. Int J Lab Hematol, 39 Suppl 1, 121-127. https://doi.org/10.1111/ijlh.12661
- Concordet, D., Geffré, A., Braun, J. P., & Trumel, C. (2009). A new approach for the determination of reference intervals from hospital-based data. Clin Chim Acta, 405(1-2), 43-48. https://doi.org/10.1016/j.cca.2009.03.057.
- Deniz, Ç. D., Yıldız, M., İyisoy, M. S., Erdem, S. S., Yıldırım, H. B., Kozanhan, B. … Ünlü, B. (2021). Konya Şehir Hastanesi’nde PT, aPTT ve INR Referans Aralıklarının Belirlenmesi. Türk Klinik Biyokimya Dergisi, 19(3): 235-240.
- Devreese, K. M. J., de Groot, P. G., de Laat, B., Erkan, D., Favaloro, E. J., Mackie, I. … Cohen, H. (2020). Guidance from the Scientific and Standardization Committee for lupus anticoagulant/antiphospholipid antibodies of the International Society on Thrombosis and Haemostasis: Update of the guidelines for lupus anticoagulant detection and interpretation. J Thromb Haemost, 18(11), 2828-2839. https://doi.org/10.1111/jth.15047
- Fuentes-Arderiu, X., Mas-Serra, R., Alumà-Trullàs, A., Martí-Marcet, M. I., & Dot-Bach, D. (2004). Guideline for the production of multicentre physiological reference values using the same measurement system. A proposal of the Catalan Association for Clinical Laboratory Sciences. Clinical Chemistry and Laboratory Medicine (CCLM), 42(7), 778-782. https://doi.org/doi:10.1515/CCLM.2004.130
- Fuentes-Arderiu, X., Mas-Serra, R., Alumà-Trullàs, A., Martí-Marcet, M. I., & Dot-Bach, D. (2004). Guideline for the production of multicentre physiological reference values using the same measurement system. A proposal of the Catalan Association for Clinical Laboratory Sciences. Clin Chem Lab Med, 42(7), 778-782. https://doi.org/10.1515/cclm.2004.130
- Horowitz, G. (2006). Establishment and use of reference values (D. E. B. Carl A. Burtis, Ed. 7th ed ed.). Elsevier Saunders.
- Jones, G. R. D., Haeckel, R., Loh, T. P., Sikaris, K., Streichert, T., Katayev, A. … Limits, D. (2019). Indirect methods for reference interval determination – review and recommendations. Clinical Chemistry and Laboratory Medicine (CCLM), 57(1), 20-29. https://doi.org/doi:10.1515/cclm-2018-0073
- Kartekin, A., Tire, Y., & Aydoğan, E. (2020). Comparison of Liver Function in Terms of Different Parameters in Patients Receiving Imipenem Therapy in the Intensive Care Unit; Retrospective study. Dünya Sağlık ve Tabiat Bilimleri Dergisi, 3(2), 111-116.
- Katayev, A., Balciza, C., & Seccombe, D. W. (2010). Establishing reference intervals for clinical laboratory test results: is there a better way? Am J Clin Pathol, 133(2), 180-186. https://doi.org/10.1309/ajcpn5bmtsf1cdyp
- Lippi, G., Franchini, M., Montagnana, M., & Guidi, G. C. (2007). Coagulation testing in pediatric patients: the young are not just miniature adults. Semin Thromb Hemost, 33(8), 816-820. https://doi.org/10.1055/s-2007-1000373
- Rizzo, F., Papasouliotis, K., Crawford, E., Dodkin, S., & Cue, S. (2008). Measurement of prothrombin time (PT) and activated partial thromboplastin time (APTT) on canine citrated plasma samples following different storage conditions. Res Vet Sci, 85(1), 166-170. https://doi.org/10.1016/j.rvsc.2007.10.001
- Rosendaal, F. R., Cannegieter, S. C., van der Meer, F. J., & Briët, E. (1993). A method to determine the optimal intensity of oral anticoagulant therapy. Thromb Haemost, 69(3), 236-239.
- Solberg, H. E., & PetitClerc, C. (1988). Approved recommendation (1988) on the theory of reference values. Part 3. Preparation of individuals and collection of specimens for the production of reference values. Clin Chim Acta, 177(3), S3-11. https://doi.org/10.1016/0009-8981(88)90074-5
- Toulon, P., Berruyer, M., Brionne-François, M., Grand, F., Lasne, D., Telion, C. … De Pooter, N. (2016). Age dependency for coagulation parameters in paediatric populations. Results of a multicentre study aimed at defining the age-specific reference ranges. Thromb Haemost, 116(1), 9-16. https://doi.org/10.1160/th15-12-0964
- Tripodi, A., & Mannucci, P. M. (2011). The coagulopathy of chronic liver disease. N Engl J Med, 365(2), 147-156. https://doi.org/10.1056/NEJMra1011170
- Weidhofer, C., Meyer, E., Ristl, R., Wiedemann, H., Cadamuro, J., Kipman, U. … Einwallner, E. (2018). Dynamic reference intervals for coagulation parameters from infancy to adolescence. Clin Chim Acta, 482, 124-135. https://doi.org/10.1016/j.cca.2018.04.003
- Winter, W. E., Flax, S. D., & Harris, N. S. (2017). Coagulation Testing in the Core Laboratory. Laboratory Medicine, 48(4), 295-313. https://doi.org/10.1093/labmed/lmx050
Details
| Primary Language | Turkish |
|---|---|
| Subjects | Clinical Chemistry |
| Journal Section | Articles |
| Authors | |
| Publication Date | June 26, 2025 |
| Submission Date | January 16, 2025 |
| Acceptance Date | May 9, 2025 |
| Published in Issue | Year 2025 Volume: 8 Issue: 1 |
