BİYOKİMYASAL TIBBİ ANALİZ SONUÇLARININ GEÇERLİLİĞİ ÜZERİNDEKİ KRİTİK MÜDAHALE NOKTALARI VE OLASI ETKİLERİ: İSTATİSTİKSEL YAKLAŞIM

Öz

Amaç: Manipülatör, çeşitli biyokimyasal analiz yöntemleriyle elde edilen bazı sonuçların hatalı olabileceğinin ve gerçeği temsil etmediğinin farkında olmalıdır. Bunun için, biyokimyacıdan elde edilen sonuçların sapmasından sorumlu kritik noktaları belirlemesi istenir ve elde edilen sonuçların değişmesine neden olabilecek tüm faktörlerin farkında olması zorunludur. Listelenen etkileyici faktörler, bir biyokimyasal analiz laboratuvarındaki uzun pratik deneyimin sonuçları olup, bir rehber şeklinde bir eğitim belgesinde bir araya getirdiğimiz ve istatistiksel çalışması bu çalışma tarafından rapor edilen bibliyografik araştırmalarla desteklenmiştir. Gereç ve Yöntem: Bu çalışmada, bir biyokimyasal tıbbi analizin sonuçları üzerindeki tüm etki faktörlerini ve olası girişimleri listelemek ve düzenlemek için Tehlike Analizi Kritik Kontrol Noktasının Ichikawa diyagramını kullandık, ardından her bir faktörün etki oranlarını ve bununla bağlantılı tüm faktörleri belirledik. Yürütülen istatistiksel çalışma, bir biyokimyasal analizin analiz öncesi, analitik ve analitik sonrası aşamalarıyla ilgilidir. Elde edilen oranlar, belirlenen tüm faktörlerle ilişkili olarak izole bir faktörün veya ortak bir faktör kümesinin etkisini temsil etmektedir. Sonuç ve Tartışma: Elde edilen sonuçların geçerliliği üzerindeki kritik müdahale ve etki noktaları, biyokimyasal bir analizin tüm aşamaları boyunca %60.26, %28.75 ve %07.84 gibi değişken oranlarla listelenmiştir. En yüksek oran analitik öncesi aşamada %35.29 ile hastaya ait faktörlerde, analitik aşamada kullanılan malzemeler %11.11 oranında, analiz sonrası aşama için ölçümü etkileyebilecek faktörler %05.58 oranında ortaya çıkmıştır.

Anahtar Kelimeler

• Analiz
• biyokimyasal
• HACCP
• girişim
• etki

CRITICAL POINTS OF INTERFERENCE AND PROBABLE INFLUENCE ON THE VALIDITY OF RESULTS OF A BIOCHEMICAL MEDICAL ANALYSIS: STATISTICAL APPROACH

Öz

Objective: The manipulator must be aware that some results obtained by the various biochemical analysis methods may be erroneous and don’t represent reality. For this, the biochemist is asked to identify the critical points responsible for the aberration of the results obtained and it is imperative that he be aware of all the factors that can induce the modification of the results obtained. The influencing factors listed are the results of long practical experience within a biochemical analysis laboratory supplemented by bibliographic research that we have brought together in an educational document in the form of a guide and of which the statistical study is reported by the present study. Material and Method: Through this study, we used the Ichikawa diagram of Hazard Analysis Critical Control Point to list and organize all the factors of influence and probable interference on the results of a biochemical medical analysis, subsequently, we determined the influence rates of each factor as well as all the factors linked to it. The statistical study carried out relates to the pre-analytical, analytical and post-analytical stages of a biochemical analysis. The rates obtained represent the influence of an isolated factor or a common set of factors in relation to all the factors determined. Result and Discussion: The critical points of interference and influence on the validity of the results obtained have been listed through all the steps of a biochemical analysis with variable rates of 60.26%, 28.75% and 07.84% respectively for the pre- analytical stage, analytical and post analytical stage; The highest rate for the pre--analytical stage was represented by factors related to patient with a rate of 35.29%,concerning the analytical stage, the materials used presented a rate of 11.11% for the post-analytical stage, factors that could interfere with the measurement presented a rate of 05.58%.

Anahtar Kelimeler

• Analysis
• biochemical
• HACCP
• influence
• interference

Destekleyen Kurum

University of Tahri Mohammed of Bechar Algéria

Teşekkür

The authors of this investigation would like to thank anyone who has contributed directly or indirectly to providing useful information, including: Mr Gherdine Ali, Dr Absi Bachir, Dr Benchaib, Dr Talbi Abderrahmane, Mrs Yachir aicha, Mrs Berrached farida, Mrs bouziane djamila, Mrs mehdadi fatiha, Mrs hamida djemaa, Mr Boungabi Ahmed, Mr Zaalan Abd elmadjid, Mr Mamouni aissa, Mr Seddiki hashemi, Mr Zoui abdelwahab, Mr Tasfaout AbdALLAH without forgetting the sampler Mr Moumni Abdeljallil and Miss Hidjazi Daouia; Without forgetting the members of the ENERGARID laboratory of the Tahri Mohamed University of Bechar Algeria. honest thanks to every person who contributed to the enrichment of information related to the present study.

Kaynakça

1. 1. Berbaoui, H. (2022). Guide de pratique Points critiques d’interférence et probable influence sur la validité des résultats d’une analyse médicale biochimique, Polycopié pédagogique Ref (n° 65), Université Tahri Mohamed, Bechar, Algérie, p.58.
2. 2. Vaubourdolle, M. (2010). Recommandations pour l’accréditation des laboratoires de biologie médicale. Société Française de Biologie Clinique, Paris, 1-312.
3. 3. Laboratoire Orbio conditions-pre-analytiques Web site (2004). Retrieved from https://www.orbio.fr/le-laboratoire-orbio/conditions-pre-analytiques/. Accessed date: 03.03.2024.
4. 4. Dailymed Web Site. (2021). Retrieved from https://dailymed.nlm.nih.gov/dailymed/. Accessed date: 03.03.2024.
5. 5. Ordre professionnel des technologistes médicaux du Québec et Ordre des chimistes du Québec. Guide de Collecte de Transport de Conservation et D’analyse des Urines Web site. (2024). Retrieved from https://www.optmq.org/. Accessed date: 03.03.2024.
6. 6. World Health Organization. Diagnostic Imaging and Laboratory & Stability of blood, plasma and serum samples. Use of anticoagulants in diagnostic laboratory investigations. Web site (2024). Retrieved from https://iris.who.int/bitstream/handle/10665/65957/;jsessionid=309A516243D7A5468631D29F0C7D02D1?sequence=1. Accessed date: 03.03.2024.
7. 7. Clark, S., Youngman, L.D., Palmer, A., Parish, S., Peto, R., Collins, R. (2003). Stability of plasma analytes after delayed separation of whole blood implications for epidemiological studies. International Journal of Epidemiology, 32(1), 125-130. [CrossRef]
8. 8. D'Orazio, P., Toffaletti, J.G., Wandrup, J.H. (2001). C31-A2: Ionized calcium determinations: Precollection variables specimen choice, collection, and handling. Clinical and Laboratory Standards Institute, 15(20), from https://clsi.org/media/1363/c31a2¬-sample.pdf. Accessed date: 03.03.2024.

9. 9. Barbier, F., Berkane Z., Dehorne, J., Desch, G., Dhondt, J., Drouillard, I. (2010). Recommandations pour la maîtrise de l'étape de prélèvement des échantillons biologiques. Annales de Biologie Clinique, 68(1), 69-104.
10. 10. LeBlanc, R.M. (2007). Comment maîtriser les interférences des médicaments sur l’immuno-analyse, Option Bio, 0389, 15-16.
11. 11. Ben Jdidia, I., Zribi, K., Boubeker, M., Brahem, A., Sayadi, M., Tlijavani, M., Cherif, Z.S.A. (2021). Les médicaments qui interfèrent avec les bilans biologiques. Revue de la littérature. Canadian Journal of Hospital Pharmacy, 74(4), 378-385. [CrossRef]
12. 12. Simundic, A.M., Filipi, P., Vrtaric, A., Miler, M., Gabaj, N.N., Kocsis, A., Avram, S., Barhanovic, N.G., Bulo, A., Cadamuro, J., Dongen-Lases, E., Eker, P., Vital-e-Silva, A., Homsak, E., Ibarz, M., Labudovic, D., Nybo, M., Plvovarniková, H., Shmidt, I., Siodmiak, J., Sumarac, Z., Vitkus, D. (2019). Patient’s knowledge and awareness about the effect of the over-the-counter (OTC) drugs and dietary supplements on laboratory test results a survey in 18 European countries. Clinical Chemistry and Laboratory Medicine, 57(2), 183-194. [CrossRef]
13. 13. Damien, A. (2015). PhD Thesis. Interférence de l’hémolyse, de la lipémie et de l’ictère sur les dosages des principaux paramètres biochimiques. Faculté de Pharmacie, Université Angers, Angers, France. 14. Metais, P. (2000). Biochimie clinique, édlavoisier, p.356.
14. 15. Bakerman, S., Bakerman, P., Strausbauch, P. (2002). ABC’s of Interpretive Laboratory Data, 4th edition, Interpretive Laboratory Data Inc., Bloomington, Indiana, USA, p.580.
15. 16. Mayo Medical Laboratory Website (1995). Retrieved from https://www.mayocliniclabs.com/. Accessed date: 03.03.2024.
16. 17. Wu, A.H.B. (2006). Clinical guide to laboratory tests. 4th edition, Saunders Elsevier, p.1798.
17. 18. D'Orazio, P., Ehrmeyer, S.S., Jacobs, E., Toffaletti, J.G., Wandrup, J.H. (2009). C46-A2: Approved Blood Gas and pH Analysis and Related Measurements. Clinical and Laboratory Standards Institute, 29(8), from https://clsi.org/media/1355/c46a2_sample.pdf. Accessed date: 03.03.2024.