LipoClear Testing. Don Newton, MS, MT Brockton Hospital Laboratory, Brockton, Massachusetts

Transcription

1 StatSpin, Inc. Toll-Free (8) Morse Street Phone (781) Norwood, MA 262 Fax (781) LipoClear Testing Don Newton, MS, MT Brockton Hospital Laboratory, Brockton, Massachusetts COPYRIGHT 24 DOCUMENT # REV. A

2 Various Analytes Tested Before and After Treatment with LipoClear, StatSpin s Lipemic Clearing Agent Jessica Thibeault, MT (ASCP) Purpose To confirm that LipoClear, lipemic clearing agent does not interfere with the methodology used for determination of the most common chemistry analytes tested in the clinical laboratory. Materials and Methods Thirty volunteers each provided a Lithium Heparin plasma sample that was split into two aliquots. One aliquot was treated with LipoClear and the other was tested straight. These samples were all nonlipemic to maintain an accurate baseline. The tubes were separated using a StatSpin MP, which spins for 95 seconds at 15,8 rpm. Each sample was tested for the following chemistries: Glucose (Glu), BUN, Creatinine (Creat), Albumin (Alb), Total Protein (T. Prot), Calcium (Ca++), Uric Acid, Total Bilirubin (T. Bili), LDH, CPK, Alkaline Phosphatase (Alk. Phos.), SGPT, SGOT, GGPT, Amylase (Amy), Sodium (Na+), Potassium (K+), Chloride (Cl-), CO 2, TSH, T4, Troponin I, and CKMB. Various methodologies were used in the testing of the above analytes. TSH, T4, Troponin I, and CKMB were all tested on a Bayer Centaur. Electrolytes were performed via indirect ISE methodology and the remaining analytes were all determined with an Olympus AU 4. The samples were processed and treated according to the LipoClear Product Insert Sheet. Upon obtaining results, the values obtained on the treated samples were subsequently multiplied by a 1.2 dilution factor to account for the dilution of the actual reagent. Interpretation Most analytes tested presented acceptable correlation coefficients ranging from These analytes included Glu, BUN, Creat, Alb, Ca++, Uric Acid, T. Bili, LDH, CPK, Alk. Phos., SGPT, SGOT, GGPT, Amy, Na+, K+, Cl-, CO 2, TSH, T4 and CKMB. The p-values were mostly low however good correlation was noted and accepted based on the comparative values. Total protein was slightly decreased which has been noted in previous studies and was incorporated into the product insert. Troponin I was not calculated given that all samples analyzed were below detectable levels. Refer to Table 2.1 for all descriptive statistics Discussion The data reveals that Total Protein values are slightly decreased when treated with LipoClear however this data confirms previous studies. This error may be due to the binding of high density proteins. With exception to the above stated analyte, all other LipoClear treated samples tested produced acceptable correlation when compared to the untreated aliquots. COPYRIGHT 24 PAGE 1

3 Table 2.1 Statistical Summary Mean STD. Dev. Corr Coef P value Glucose BUN Creatinine Albumin Total Protein Calcium Uric Acid Total Bilirubin LDH CPK Alkaline Phosphatase SGPT SGOT GGPT Amylase Sodium Potassium Chloride CO TSH T Troponin I NA NA NA NA CKMB COPYRIGHT 24 PAGE 2

4 Table 3.1 Data Pat. No. Glu Glu BUN BUN Creat Creat Alb Alb T. Prot T. Prot. Cal Cal UrAc UrAc T. Bili T. Bili LDH LDH COPYRIGHT 24 PAGE 3

5 Table 4.1 Data (cont.) Pat. No. CPK CPK Alk Phos Alk Phos SGPT SGPT SGOT SGOT GGPT GGPT Amy Amy Na Na K K CL CL COPYRIGHT 24 PAGE 4

6 Table 5.1 Data (cont.) Pat. No. CO2 CO2 T4 T4 TSH TSH Trop I Trop I CKMB CKMB COPYRIGHT 24 PAGE 5

7 Glucose Table 6.1 Table 6.2 Patient# Glu Glu Gluc Gluc Mean Variance Pearson Correlation t Stat P(T<=t) one-tail P(T<=t) two-tail Table Glucose COPYRIGHT 24 PAGE 6

8 BUN Table 7.1 Table 7.2 Patient# BUN BUN Bun Bun Mean Variance Pearson Correlation.9971 t Stat P(T<=t) one-tail.8394 P(T<=t) two-tail Table BUN COPYRIGHT 24 PAGE 7

9 Creatinine Table 8.1 Table 8.2 Patient# Creat Creat Creat Creat Mean Variance Pearson Correlation.9538 t Stat P(T<=t) one-tail.2679 P(T<=t) two-tail Table 8.3 Creatinine COPYRIGHT 24 PAGE 8

10 Albumin Table 9.1 Table 9.2 Patient# Alb Alb Alb Alb Mean Variance Pearson Correlation t Stat 9 P(T<=t) one-tail P(T<=t) two-tail Table Albumin COPYRIGHT 24 PAGE 9

11 Total Protein Table 1.1 Table 1.2 Patient# T. Prot T. Prot T. Prot T. Prot Mean Variance Pearson Correlation t Stat P(T<=t) one-tail P(T<=t) two-tail Table Total Protein COPYRIGHT 24 PAGE 1

12 Calcium Table 11.1 Table 11.2 Patient# Ca++ Ca Ca++ Ca++ Mean Variance Pearson Correlation t Stat P(T<=t) one-tail P(T<=t) two-tail Table Calcium COPYRIGHT 24 PAGE 11

13 Uric Acid Table 12.1 Table 12.2 Patient# UrAc UrAc Uric Acid Uric Acid Mean Variance Pearson Correlation t Stat P(T<=t) one-tail.578 P(T<=t) two-tail Table Uric Acid COPYRIGHT 24 PAGE 12

14 Total Bilirubin Table 13.1 Table 13.2 Patient# T. Bili T. Bili T Bili T Bili Mean Variance Pearson Correlation Df 29 t Stat P(T<=t) one-tail.1 P(T<=t) two-tail Table T. Bilirubin COPYRIGHT 24 PAGE 13

15 LDH Table 14.1 Table 14.2 Patient# LDH LDH LDH LDH Mean Variance Pearson Correlation t Stat P(T<=t) one-tail P(T<=t) two-tail Table LDH COPYRIGHT 24 PAGE 14

16 CPK Table 15.1 Table 15.2 Patient# CPK CPK CPK CPK Mean Variance Pearson Correlation t Stat P(T<=t) one-tail P(T<=t) two-tail Table CPK COPYRIGHT 24 PAGE 15

17 Alkaline Phosphatase Table 16.1 Table 16.2 Patient# Alk Phos Alk Phos Alk Phos Alk Phos Mean Variance Pearson Correlation t Stat P(T<=t) one-tail.248 P(T<=t) two-tail Table Alkaline Phosphatase COPYRIGHT 24 PAGE 16

18 SGPT Table 17.1 Table 17.2 Patient# SGPT SGPT SGPT SGPT Mean Variance Pearson Correlation t Stat P(T<=t) one-tail.9582 P(T<=t) two-tail Table SGPT COPYRIGHT 24 PAGE 17

19 SGOT Table 18.1 Table 18.2 Patient# SGOT SGOT SGOT SGOT Mean Variance Pearson Correlation t Stat P(T<=t) one-tail.7751 P(T<=t) two-tail Table SGOT COPYRIGHT 24 PAGE 18

20 GGPT Table 19.1 Table 19.2 Patient# GGPT GGPT GGPT GGPT Mean Variance Pearson Correlation t Stat P(T<=t) one-tail.536 P(T<=t) two-tail Table GGPT COPYRIGHT 24 PAGE 19

21 Amylase Table 2.1 Table 2.2 Patient# Amy Amy Amy Amy Mean Variance Pearson Correlation t Stat P(T<=t) one-tail P(T<=t) two-tail Table Amylase COPYRIGHT 24 PAGE 2

22 Sodium Table 21.1 Table 21.2 Patient# Na+ Na Na+ Na+ Mean Variance Pearson Correlation Df 29 t Stat P(T<=t) one-tail P(T<=t) two-tail Table Sodium COPYRIGHT 24 PAGE 21

23 Potassium Table 22.1 Table 22.2 Patient# K+ K K+ K+ Mean Variance Pearson Correlation t Stat P(T<=t) one-tail.3859 P(T<=t) two-tail Table Potassium COPYRIGHT 24 PAGE 22

24 Chloride Table 23.1 Table 23.2 Patient# Cl Cl Cl Cl Mean Variance Pearson Correlation t Stat P(T<=t) one-tail P(T<=t) two-tail Table Chloride COPYRIGHT 24 PAGE 23

25 CO2 Table 24.1 Table 24.2 Patient# CO2 CO CO2 CO2 Mean Variance Pearson Correlation t Stat P(T<=t) one-tail P(T<=t) two-tail Table CO COPYRIGHT 24 PAGE 24

26 Thyroid Stimulating Hormone Table 25.1 Table 25.2 Patient# TSH TSH TSH TSH Mean Variance Pearson Correlation t Stat P(T<=t) one-tail P(T<=t) two-tail Table TSH COPYRIGHT 24 PAGE 25

27 T4 Table 26.1 Table 26.2 Patient# T4 T T4 T4 Mean Variance Pearson Correlation t Stat P(T<=t) one-tail P(T<=t) two-tail Table T COPYRIGHT 24 PAGE 26

28 CKMB Table 27.1 Table 27.2 Patient# CKMB CKMB CKMB CKMB Mean Variance Pearson Correlation t Stat P(T<=t) one-tail P(T<=t) two-tail Table CKMB COPYRIGHT 24 PAGE 27