COMPARISON STUDY BETWEEN THE STATSPIN EXPRESS 4 HORIZONTAL CENTRIFUGE AND THE HERAEUS LABOFUGE 400 CENTRIFUGE WITH BD TUBES

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Candice Harrison
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Iris Sample Processing Toll-Free (8) 782-8774 6 Glacier Drive Phone (781) 551-1 Westwood,

com COMPARISON STUDY BETWEEN THE STATSPIN EXPRESS 4 HORIZONTAL CENTRIFUGE AND THE HERAEUS

1 Iris Sample Processing Toll-Free (8) Glacier Drive Phone (781) Westwood, MA 29 Fax (781) info@proiris.com COMPARISON STUDY BETWEEN THE STATSPIN EXPRESS 4 HORIZONTAL CENTRIFUGE AND THE HERAEUS LABOFUGE 4 CENTRIFUGE WITH BD TUBES Sponsored At: Henry Ford Hospital, Detroit, Michigan COPYRIGHT 27 DOCUMENT # REV. A

2 Comparison Study Between the StatSpin Horizontal Centrifuge and the Heraeus 4 Centrifuge With BD Tubes Purpose The StatSpin is a high-speed horizontal bench top centrifuge used to rapidly produce plasma and serum from whole blood contained in original collection tubes. The horizontal rotor holds 8 tubes up to 1 ml and provides a flat gel barrier for rapid separation of gel tubes. The has pre-set cycle times of 3, 5, and 1 minutes. This study examined chemistry and coagulation testing for 35 analytes on whole blood samples centrifuged in as compared to a traditional horizontal centrifuge, the Heraeus 4. Materials and Methods Two serum gel tubes (BD #367988, 16 x 1 mm, 8.5 ml, plastic) were collected from 27 individuals and centrifuged in the (3 minutes, 51 rpm, 4 g) and the Heraeus 4 (1 minutes, 25 rpm, 1215 g). The serum was tested for glucose, BUN, creatinine, albumin, total protein, calcium, uric acid, total bilirubin, direct bilirubin, LDH, CK, alkaline phosphatase, ALT, AST, GGT, amylase, Na, K, Cl, CO 2, phosphorus, cholesterol, HDL, triglycerides, iron, and magnesium on the Dade Vista analyzer. TSH, T 4, CK-MB, troponin, and myoglobin were tested on the Bayer Centaur analyzer. Two sodium citrate tubes (BD #36383, 13 x 75 mm, 2.7 ml, glass) were collected from 27 individuals and centrifuged in (5 minutes, 51 rpm, 4 g) and the Heraeus 4 (15 minutes, 45 rpm, 2558 g). The plasma was tested for PT, PTT, and D-dimer on the Diagnostica Stago STA-R Evolution analyzer. Residual platelets were measured using the Beckman Coulter Act 8 analyzer. Results Tables 1, 2, and 3 present results of the statistical analysis. Original data are listed in Table 4. Chart 1 includes scatter plots for each analyte. For direct bilirubin, AST, TSH, CK-MB, and troponin, results below the detectable limit were not included in the data analysis. For potassium and platelets, repeated results are indicated in parentheses. Data Analysis Results for and the Heraeus 4 were analyzed to assess clinical equivalence between the two centrifuges. The mean and standard deviation (SD) for each analyte were calculated for both centrifuges. The mean bias and 95% confidence limits for the mean bias were calculated for each analyte and compared to the established clinical acceptance limit (CAL), an estimate of the maximum allowable difference in test results between the two centrifuges. Residual platelet results were evaluated per recommendations of the Clinical and Laboratory Standards Institute (CLSI) for platelet poor plasma. Interpretation BD gel tubes spun in for only 3 minutes exhibited complete separation of serum and cells with a flat gel separation. Results indicate both the mean bias and 95% confidence limits are contained within ± CAL for all analytes except iron. (For iron, the upper 95% confidence limit (1.5 %) is just outside the CAL (± 1 %). COPYRIGHT 27 PAGE 1

3 Although a clinical acceptance limit is not available for D-dimer, the means for the and (327 and 324 ng/ml, respectively) are comparable, with a mean bias between the two centrifuges of only.3 %. Residual platelet counts meet the recommendations of the Clinical and Laboratory Standards Institute for platelet poor plasma. The percent of results with a platelet count less than 1,/ L is 89 % for as compared to 1 % for the Heraeus 4. Discussion Results indicate clinical equivalence between the StatSpin and a traditional horizontal centrifuge, the Heraeus 4. The unique horizontal rotor produces a flat gel separation in BD tubes in just 3 minutes, ideal for chemistry labs. provides faster turnaround times and greater productivity for a lean laboratory. COPYRIGHT 27 PAGE 2

4 Table 1 Statistical Analysis Units Study Range LaboFuge Mean ± SD Mean ± SD Glucose mg/dl ± ± 14.9 BUN mg/dl ± ± 4.9 Creatinine mg/dl ±.2.9 ±.2 Albumin g/dl ± ±.26 Total Protein g/dl ± ±.49 Calcium mg/dl ± ±.31 Uric Acid mg/dl ± ± 1.14 Total Bilirubin mg/dl ±.15.5 ±.16 Direct Bilirubin mg/dl ±.4.1 ±.4 LDH U/L ± ± 29.5 CK U/L ± ± 38.1 Alkaline Phosphatase U/L ± ± 33.6 ALT U/L ± ± 9.5 AST U/L ± ± 6.2 GGT U/L ± ± 22.3 Amylase U/L ± ± 23.9 Na mmol/l ± ± 2.3 K mmol/l ± ±.26 Cl mmol/l ± ± 2.1 CO2 mmol/l ± ± 2. TSH U/mL ± ± 1.1 T4 g/dl ± ± 1.76 CK-MB U/L ± ±.77 Troponin ng/ml n/a n/a n/a Phosphorus mg/dl ± ±.44 Cholesterol mg/dl ± ± 34. HDL mg/dl ± ± 15.3 Triglycerides mg/dl ± ± 87.3 Iron g/dl ± ± 27.7 Magnesium mg/dl ± ±.22 Myoglobin g/l ± ± 16.1 PT sec ± ±.47 PTT sec ± ± 2.7 D-dimer ng/ml ± ± 23.8 COPYRIGHT 27 PAGE 2

5 Table 2 Statistical Analysis Mean Bias, units or % (95% Confidence Limits) CAL, units or % Clinical Equivalence Glucose -.7 (-1.8,.3) 1 % Yes BUN -.1 (-.5,.3) 3 mg/dl Yes Creatinine -.4 (-.8,.1).3 mg/dl Yes Albumin -1.3 (-2.2, -.3) 5 % Yes Total Protein.2 (-.9, 1.2) 5 % Yes Calcium -.3 (-.12,.5).4 mg/dl Yes Uric Acid -.1 (-1.4, 1.2) 1 % Yes Total Bilirubin. (-.2,.3).1 mg/dl Yes Direct Bilirubin. (-.1,.1).5 mg/dl Yes LDH 3.7 (2., 5.4) 2 % Yes CK 2.1 (.7, 3.4) 15 % Yes Alkaline Phosphatase.2 (-2.2, 2.6) 1 % Yes ALT -2.3 (-5.8, 1.2) 1 % Yes AST 3.4 (-1.3, 8.1) 1 % Yes GGT 2.8 (-1.2, 6.8) 1 % Yes Amylase -.1 (-1.4, 1.2) 1 % Yes Na -.8 (-1.3, -.3) 3 mmol/l Yes K -.3 (-.14,.9).3 mmol/l Yes Cl -.3 (-.8,.2) 3 mmol/l Yes CO2 2.8 (-.9, 6.5) 1 % Yes TSH.3 (-.29,.88).5 U/mL Yes T4-1.2 (-2.9,.5) 1 % Yes CK-MB -.6 (-.14,.2) 1 U/L Yes Troponin n/a.2 ng/ml n/a Phosphorus -.1 (-.11,.9).4 mg/dl Yes Cholesterol -.3 (-1.5,.8) 5 % Yes HDL -.3 (-1.9, 1.4) 5% Yes Triglycerides -.9 (-3.4, 1.6) 5 % Yes Iron 4.4 (-1.6, 1.5) 1 % No Magnesium.3 (-.3,.9).3 mg/dl Yes Myoglobin -1.4 (-3.4,.7) 15 % Yes PT -.1 (-1.2,.9) 1% Yes PTT -.3 (-1.8, 1.3) 1% Yes D-dimer -.3 (-7.4, 6.8) n/a n/a Table 3 Statistical Analysis Platelet Counts, x 1 3 / L % < COPYRIGHT 27 PAGE 3

6 Table 4 Data Glucose BUN Creatinine Albumin Sample Total Protein Calcium Uric Acid Total Bilirubin Sample COPYRIGHT 27 PAGE 4

7 Direct Bilirubin LDH CK Alkaline Phosphatase Sample < COPYRIGHT 27 PAGE 5

8 ALT AST GGT Amylase Sample < < NA K Cl CO2 Sample (4.9) (5.7) COPYRIGHT 27 PAGE 6

9 (4.8) TSH T4 CK-MB Troponin Sample <.4 < <.4 < <.4 < <.4 < <.4 < <.4 < <.4 < <.4 <.4 <.4 < <.4 < <.4 <.4 <.4 11 <.4 < <.4 <.4 <.4 < <.4 < <.4 <.4 <.4 < <.4 <.4 <.4 < <.4 <.4 <.4 < <.4 <.4 <.4 < <.4 < <.4 < <.4 < <.4 < <.4 < <.4 < <.4 < <.4 <.4 <.4 < <.4 < <.4 <.4 Phosphorus Cholesterol HDL Triglycerides Sample COPYRIGHT 27 PAGE 7

10 Iron Magnesium Myoglobin Sample COPYRIGHT 27 PAGE 8

11 PT PTT D-Dimer Platelets Sample (12) (1) (14) COPYRIGHT 27 PAGE 9

12 Linda Martin, MT (ASCP) Chart 1 Glucose BUN Creatinine Albumin Total Protein Calcium COPYRIGHT 27 PAGE 1

13 Linda Martin, MT (ASCP) Uric Acid Total Bilirubin Direct Bilirubin LDH CK Alkaline Phosphatase COPYRIGHT 27 PAGE 11

14 Linda Martin, MT (ASCP) ALT AST GGT Amylase Na K COPYRIGHT 27 PAGE 12

15 Linda Martin, MT (ASCP) Chloride CO TSH T CK-MB Phosphorus COPYRIGHT 27 PAGE 13

16 Linda Martin, MT (ASCP) Cholesterol HDL Triglycerides Iron Magnesium Myoglobin COPYRIGHT 27 PAGE 14

17 Linda Martin, MT (ASCP) PT PTT D-Dimer COPYRIGHT 27 PAGE 15

COMPARISON STUDY BETWEEN THE STATSPIN EXPRESS 3 CENTRIFUGE AND THE STATSPIN EXPRESS 2 CENTRIFUGE

Iris Sample Processing Toll-Free (8) 782-8774 6 Glacier Drive Phone (781) 551-1 Westwood, MA 29 Fax (781) 551-36 www.proiris.com info@proiris.com COMPARISON STUDY BETWEEN THE STATSPIN EXPRESS 3 CENTRIFUGE