Comparison of VACUETTE Serum Gel Tubes for Common Chemistry Analytes

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1 Comparison of VACUETTE Serum Gel Tubes for Common Chemistry Analytes Background: Greiner-Bio-One, Austria has been selling plastic evacuated tubes (VACUETTE ) for venous blood collection since 9. Serum Tubes with and without gel separator are coated with micronised silica particles which activate clotting when the tubes are gently inverted. VACUETTE Serum Separator Clot Activator tubes contain a barrier gel that is present in the bottom of the tube. The specific gravity of this material lies between the blood clot and the serum. During centrifugation, the gel moves upwards to the serum-cell interface where it forms a stable barrier separating the serum from the fibrin clot. This improves the serum yield and enables serum to be left in the primary tube for analysis. It further allows greater stability of certain analytes when kept under specified conditions. [] Study Objective: The aim of this study was to show the comparable performance of two different gel polymers used in VACUETTE Serum 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 VACUETTE Serum ml x US P-Gel Clot Activator Separator Sample B European Gel VACUETTE Serum Clot Activator Separator ml x Venous blood collection was performed on or up to healthy and pathological donors using two VACUETTE Serum Separator Tubes with a VACUETTE Standard tube holder. The order of collection was randomized. Directly after blood collection all tubes were inverted times for proper mixing. Tubes were allowed to clot for at least minutes in an upright position at room temperature and then centrifuged in a cooled swing-out bucket centrifuge ( C- C) at g for minutes. All samples were analyzed for the constituents listed below at the initial time point within hours of blood collection and after hours on a Dimension Vista from Siemens using accompanying reagents from the instrument manufacturer. 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 second analyses to avoid any concentration gradients. The following parameters were measured: Alanine Aminotransferase (ALT) Alkaline Phosphatase (ALP) Alpha Fetoprotein (AFP) Aspartate Aminotransferase (AST) Albumin Blood Urea Nitrogen (BUN) Calcium Carcinoembryonic Antigen (CEA) Chloride Cholesterol Creatine Kinase Creatinine Ferritin Free Thyroxin (ft ) Free Triiodothyronine (ft ) Folic Acid Gamma Glutamyltransferase (GGT) Glucose Iron Lactate Dehydrogenase (LDH) Magnesium Phosphate Potassium Prostate Specific Antigen (PSA) page /

2 Sodium Total Bilirubin Total Protein Triglyceride Thyroid stimulating hormone (TSH) Troponin I Uric acid Vitamin B (Cobalamin) 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. Pathological and normal donors were evaluated separately for statistical analysis, wherever applicable. Clinical evaluation was based on the allowed recommendation by the German Medical Association (RILIBÄK). [,] Further, the quality control data were taken into consideration for interpretation of results. One Sample A was found to be hemolyzed (Sample ). To increase the number of pathological values for some parameters, specific donors were selected for blood collection and only a limited parameter profile was measured which can be seen in the bar charts as missing values. For the parameter Phosphate, higher deviations of the values were seen due to presumably instrument error detected by the laboratory. Quality control data were checked and showed higher coefficient of variation (CV) within the testing period. Based on outlier testing, some Phosphate values were excluded from statistical analysis. Statistically significant differences were observed for some parameters, but were not considered to be clinically significant. Both gel types showed comparable 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 /

3 Results in Detail: Alanine Aminotransferase (ALT, GPT) Reference range: - U/l Alanine Aminotransferase (ALT, GPT) h GPT A (h) GPT B (h) 9 9 Alanine Aminotransferase (ALT, GPT) h GPT A (h) GPT B (h) 9 9 Alkaline Phosphatase Reference range: - U/l Alkaline Phosphatase h AP A (h) AP B (h) Alkaline Phosphatase h AP A (h) AP B (h) [IU/l] Alpha-Fetoprotein (AFP) Reference range: -. IU/ml Alpha-Fetoprotein (AFP) h AFP A (h) AFP B (h) Alpha-Fetoprotein h AFP A (h) AFP B (h) [IU/ml] [IU/ml] Aspartate Aminotransferase (AST, GOT) Reference range male: - U/l 9 Aspartate Aminotransferase (AST, GOT) h GOT A (h) GOT B (h) 9 Aspartate Aminotransferase (AST, GOT) h GOT A (h) GOT B (h) page /

4 Albumin Reference range:.-. ng/ml Albumin h ALB A (h) ALB B (h) Albumin h ALB A (h) ALB B (h) Blood Urea Nitrogen (BUN) Reference range: - mg/dl Blood Urea Nitrogen (BUN) h BUN A (h) BUN B (h) Blood Urea Nitrogen (BUN) h BUN A (h) BUN B (h) Calcium Reference range:.-. mmol/l Calcium h, Ca A (h), Ca B (h),,,,,,,,,,,,,, 9 9,,,,,,,,,,,,,,,, Calcium h Ca A (h) Ca B (h) 9 9 CEA Reference range:.- ng/ml CEA h CEA A (h) CEA B (h) CEA h CEA A (h) CEA B (h) page /

5 Chloride Reference range: 9- mmol/l Chloride h Chloride h Cl A (h) Cl B (h) Cl A (h) Cl B (h) Cholesterol Reference range: - mg/dl Cholesterol h Chol A (h) Chol B (h) Cholesterol h Chol A (h) Chol B (h) Creatine Kinase Reference range: - U/l 9 CK h CK A (h) CK B (h) 9 Creatine Kinase h CK A (h) CK B (h) Creatinine Reference range:.-. mg/dl Creatinine h Crea A (h) Crea B (h) Creatinine h Crea A (h) Crea B (h) page /

6 Ferritin Reference range: -9 ng/ml Ferritin h Ferr A (h) Ferr B (h) Ferritin h Ferr A (h) Ferr B (h) 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 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 Folic Acid Reference range:.-. ng/ml Folic Acid h Fol A (h) Fol B (h) Folic Acid h Fol A (h) Fol B (h) page /

7 Gamma Glutamyltransferase (GGT) Reference range male: - U/l 9 GGT h GGT A (h) GGT B (h) 9 Gamma Glutamyltransferase (GGT) h GGT A (h) GGT B (h) Glucose Reference range: -99 mg/dl Glucose h Gluc A (h) Gluc B (h) Glucose h Gluc A (h) Gluc B (h) Iron Reference range: - µg/dl Iron h Fe A (h) Fe B (h) Iron h Fe A (h) Fe B (h) [µg/dl] [µg/dl] LDH Reference range: - U/l LDH h LDH A (h) LDH B (h) LDH h LDH A (h) LDH B (h) page /

8 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 Phosphate Reference range:.-. mmol/l Phosphate h, P A (h), P B (h),,,,,,,,,,,,,, 9 9,,,,,,,,,,,,,,,, Phosphate h P A (h) P B (h) 9 9 Potassium Reference range:.-. mmol/l Potassium h K A (h) K B (h) Potassium h K A (h) K B (h) PSA Reference range:.-. ng/ml PSA h PSA A (h) PSA B (h) PSA h PSA A (h) PSA B (h) page /

9 Sodium Reference range: - mmol/l Sodium h Sodium h Na A (h) Na B (h) Na A (h) Na B (h) Total Bilirubin Reference range:.-. mg/dl 9 Total Bilirubin h TBili A (h) TBili B (h) 9 Total Bilirubin h TBili A (h) TBili B (h) Total Protein Reference range: - g/dl Total Protein h TP A (h) TP B (h) 9 Total Protein h TP A(h) TP B (h) [g/dl] [g/dl] Triglyceride Reference range: - mg/dl Triglyceride h Tri A (h) Tri B (h) Triglyceride h Tri A (h) Tri B (h) page 9/

10 TSH Reference range:.-. mu/l TSH h TSH A (h) TSH B (h) TSH h TSH A (h) TSH B (h) [mu/l] Troponin I Reference range:.-. ng/ml,9, Troponin I h Trop A (h) Trop B (h),9, Troponin I h Trop A (h) Trop B (h),,,,,,,,,,,,,,, 9 9, 9 9 Uric acid Reference range:.-. mg/dl Uric Acid h UA A (h) UA B (h) Uric Acid h UA A (h) UA B (h) Vitamin B (Cobalamin) Reference range: - pg/ml Vitamin B h Vit B A (h) Vit B B (h) Vitamin B h Vit B A (h) Vit B B (h) [pg/ml] [pg/ml] KHS page /