Comparison of VACUETTE Heparin Gel Tubes for Common Chemistry Analytes Background: Greiner-Bio-One, Austria has been selling plastic evacuated tubes (VACUETTE ) for venous blood collection since 9. The anticoagulant heparin activates antithrombins, thus blocking the coagulation cascade and producing a whole blood/ plasma sample making it ideal for rapid analysis and analysis of blood from patients under anticoagulant therapy. VACUETTE Lithium Heparin separator tubes contain a barrier gel in the tube. The specific gravity of this material lies between the blood cells and plasma. During centrifugation the gel moves upwards providing a stable barrier separating the plasma from cells. Plasma may be aspirated directly from the collection tube, eliminating the need for manual transfer to another container for analysis. [] Study Objective: The aim of this study was to demonstrate comparable performance of two different gel polymers used in VACUETTE Lithium Heparin Separator tubes when assessed for biochemistry parameters. Study design and procedure: Two types of tubes were evaluated in this study: Sample Description Draw Volume Size Sample A (US P-Gel) VACUETTE Lithium Heparin Separator Tube ml x Sample B (European Gel) VACUETTE Lithium Heparin Separator Tube ml x Venous blood collection was performed on or up to healthy and pathological donors using two VACUETTE Lithium Heparin Tubes with a VACUETTE Standard tube holder. The order of collection was randomized. Directly after blood collection all tubes were inverted times to mix the blood and the chemical additive. Samples were centrifuged in a cooled swing-out bucket centrifuge ( C- C) at g for minutes to separate plasma from cellular components. All sample tubes were analyzed for the components listed below at the initial time point within hours of blood collection and after hours on the Roche Cobas Integra and Elecsys using accompanying reagents from the corresponding instrument manufacturers. Between measurements, the samples were stored in the refrigerator at - C. After hours the tubes were taken out of the refrigerator and inverted gently before the second analysis to avoid any concentration gradients. The following parameters were measured: Alanine Aminotransferase (ALT) Alkaline Phosphatase (ALP) Aspartate Aminotransferase (AST) Blood Urea Nitrogen (BUN) Calcium Carcinoembryonic Antigen (CEA) Chloride Cholesterol Creatine Kinase Creatinine Ferritin Free Thyroxin (ft ) Free Triiodothyronine (ft ) Gamma Glutamyltransferase (GGT) Glucose Iron Lactate Dehydrogenase (LDH) Magnesium Phosphate Potassium Prostate Specific Antigen (PSA) Sodium Total Bilirubin Total Protein page /9
Triglyceride Thyroid stimulating hormone (TSH) Troponin T-hs Uric acid Results: Comparison analysis was performed at the initial time point and at hours for both gel types. Statistical evaluation was performed with the T-test (α =.) using StatSoft Software, Version 9. One Sample B was found to be hemolyzed (Donor ). Pathological and normal donors were evaluated separately for statistical analysis, wherever applicable. Outlier testing was performed and wherever applicable considered for interpreting the results. Statistical significant differences could be observed for some parameters, but those were not considered to be clinically significant. Clinical evaluation was based on the allowed recommendation by the German Medical Association (RILIBÄK). [, ] Both gel types showed equivalent results. Conclusion: The test showed that both gel types (P-Gel and European Gel) showed comparable test results at the initial time point and after hours when centrifuged at g for minutes. Differences in results were not clinically significant. References: [] Instructions for Use. Evacuated Blood Collection System. For in vitro Diagnostic Use. Rev. [] Thomas L., Laboratory and Diagnosis. Indication and Evaluation of Laboratory Results for Medical Diagnosis. th edition. TH-Books. [] Guideline from the medical association in Germany for quality assurance of laboratory tests. German Medical Journal. Vol., Issue.. page /9
Alanine Aminotransferase (ALT, GPT) Reference range: - U/l GPT h GPT A (h) GPT B (h) GPT h GPT A (h) GPT B (h) 9 9 9 9 99 Alkaline Phosphatase Reference range: -9 U/l Alkaline Phosphatase h AP A (h) AP B (h) Alkaline Phosphatase h AP A (h) AP B (h) 9 9 9 9 9 9 Aspartate Aminotransferase (AST, GOT) Reference range male: - U/l GOT h GOT A (h) GOT B (h) GOT h GOT A (h) GOT B (h) 9 9 9 9 9 9 Blood Urea Nitrogen (BUN) Reference range:.- mg/dl BUN h BUN A (h) BUN B (h) BUN h BUN A (h) BUN B (h) 9 9 9 9 9 9 FRE page /9
Calcium Reference range:.-. mmol/l, Calcium h Ca A (h) Ca B (h), Calcium h Ca A (h) Ca B (h),,,,,,,,,,, 9 9 9, 9 9 9 Carcinoembryonic Antigen (CEA) Reference range:.-. ng/ml CEA h CEA A (h) CEA B (h) CEA h CEA A (h) CEA B (h) 9 9 9 9 9 9 Chloride Reference range: 9- mmol/l Chloride h Cl A (h) Cl B (h) Chloride h Cl A (h) Cl B (h) 9 9 9 9 9 9 Cholesterol Reference range: - mg/dl Cholesterol h Chol A (h) Chol B (h) Cholesterol h Chol A (h) Chol B (h) 9 9 9 9 9 9 FRE page /9
Creatine Kinase Reference range: - U/l 9 Creatinine Kinase h CK A (h) CK B (h) 9 Creatinine Kinase h CK A (h) CK B (h) 9 9 9 9 9 9 Creatinine Reference range:.-. mg/dl Creatinine h Crea A (h) Crea B (h) Creatinine h Crea A (h) Crea B (h) 9 9 9 9 9 9 Ferritin Reference range: - ng/ml Ferritin h Ferr A (h) Ferr B (h) Ferritin h Ferr A (h) Ferr B (h) 9 9 9 9 9 9 ft Reference range:.-. pg/ml,, ft h ft A (h) ft B (h),, ft h ft A (h) ft B (h),,,, [pg/ml],, [pg/ml],,,,,,,,, 9 9 9, 9 9 9 FRE page /9
ft Reference range:.9-. ng/dl,, ft h ft A (h) ft B (h),, ft h ft A (h) ft B (h),,,, [ng/dl], [ng/dl],,,,,,,, 9 9 9, 9 9 9 Gamma Glutamyltransferase (GGT) Reference range male: - U/l GGT h GGT A (h) GGT B (h) GGT h GGT A (h) GGT B (h) 9 9 9 9 9 9 Glucose Reference range: - mg/dl Glucose h Gluc A (h) Gluc B (h) Glucose h Gluc A (h) Gluc B (h) 9 9 9 9 9 9 Iron Reference range: 9- µg/dl Iron h Fe A (h) Fe B (h) Iron h Fe A (h) Fe B (h) [μg/dl] [μg/dl] 9 9 9 9 9 9 FRE page /9
Lactate Dehydrogenase (LDH) Reference range: - U/l LDH h LDH A (h) LDH B (h) LDH h LDH A (h) LDH B (h) 9 9 9 9 9 9 Magnesium Reference range:.-. mmol/l,, Magnesium h Mg A (h) Mg B (h),, Magnesium h Mg A (h) Mg B (h),,,,,,,,,,, 9 9 9, 9 9 9 Phosphate Reference range:.-. mmol/l,, Phosphate h P A (h) P B (h),, Phophate h P A (h) P B (h),,,,,,,,,,,,,,,,, 9 9 9, 9 9 9 Potassium Reference range:.-. mmol/l Potassium h K A (h) K B (h) Potassium h K A (h) K B (h) 9 9 9 9 9 9 FRE page /9
Prostate Specific Antigen (PSA ECLIA) Reference range:.-. ng/ml PSA h PSA A (h) PSA B (h) PSA h PSA A (h) PSA B (h) 9 9 9 9 9 9 Sodium Reference range: - mmol/l Sodium h Sodium h Na A (h) Na B (h) Na A (h) Na B (h) 9 9 9 9 9 9 Total Bilirubin Reference range:.-. mg/dl Total Bilirubin h TBili A (h) TBili B (h) Total Bilirubin h TBili A (h) TBili B (h) 9 9 9 9 9 9 Total Protein Reference range:.-. g/dl 9 Total Protein h TP A (h) TP B (h) 9 Total Protein h TP A (h) TP B (h) [g/dl] [g/dl] 9 9 9 9 9 9 FRE page /9
Triglyceride Reference range: - mg/dl Triglyceride h Tri A (h) Tri B (h) Triglyceride h Tri A (h) Tri B (h) 9 9 9 9 9 9 Thyroid stimulating hormone (TSH) Reference range:.-. µu/ml TSH h TSH A (h) TSH B (h) TSH h TSH A (h) TSH B (h) [μu/ml] [μu/ml] 9 9 9 9 9 9 Troponin T-hs Reference range:.-. ng/l Troponin T-hs h Trop A (h) Trop B (h) Troponin T-hs h Trop A (h) Trop B (h) [ng/l] [ng/l] 9 9 9 9 9 9 Uric acid Reference range:.-. mg/dl 9 Uric Acid h UA A (h) UA B (h) 9 Uric Acid h UA A (h) UA B (h) 9 9 9 9 99 FRE page 9/9