Evaluation of Point of Care Testing (POCT) Abbot i-STAT

and Alere EPOC Analyzers in Ampang Hospital

HOSPITAL AMPANG SITI SUHANA ABDULLAH SOHEIMI, CHUO PECK HAM, DR. BAIZURAH MOHD HUSSAIN
Pathology Department, Ampang Hospital, Selangor Darul Ehsan

1. Introduction
The development of Point-of-Care (POC) device has resulted in many systems
that are widely used at the bedside. These simple devices have been developed
to provide improvement in convenience, patient care and faster turnaround
time. An evaluation was done in Pathology Department, Hospital Ampang to
assure that i-STAT and EPOC perform as published performance claims. A com-
parison was done versus laboratory analyzer, ABL 800 Basic Radiometer while
glucose was tested versus ABBOTT Exceed Glucometer.
The evaluation is to provide an efficient, valid test protocol to demonstrate that
i-STAT and Epoc performs in accordance with published performance claims and
typical performance data.

2. Objective
To evaluate the:
a) Precision and Correlation of the ABG of i-STAT and EPOC versus ABL
800 Basic Radiometer.
b) Glucose of i-STAT and EPOC versus ABBOTT Exceed Glucometer.
Figure 4.2 Day-to-day Precision
3. Method demonstrates the day-to-day precision for 10 working days. The day-to-day run
a) Imprecision-Two precision studies were carried out; within run and
CV for i-STAT is between 0-5.86 (level 1), 0-7.06 (level 2) and 0-4.86 (level 3)
day-to-day run. The coefficient of variation (CV) was determined.
whereas for EPOC, the CVs is between 0-10.66 (level 1), 0-21.79 (level 2) and
i-STAT control solution Level 1, Level 2 and Level 3 were used with
0-9.45 (level 3). However, the CV’s day-to-day precision couldn’t be compared
i-STAT analyzer whereas Eurotrol solution Level 1, Level 3 and Biorad
with manufacturers claim since the day-to-day run CV from the manufacturer is
ABG solution Level 2 were used with EPOC analyzer.
not available.
b) Correlation- 45 specimens containing at least 5 ml of whole blood
were selected and analyzed with i-STAT, EPOC and ABL for testing.
The parameter tested were sodium, potassium, hematocrit (except
for ABL 800 Basic), glucose, pH, PCO2 and PO2.

4. Results

Figure 4.3 Correlation and assessment of data set between two analyzers using T-Test

Figure 4.3 demonstrates correlation (R2) between the analyzers. For all
parameters with the exception of glucose and hematocrit, i-STAT demonstrate
linear correlation with the R2 more than 0.92 whereas EPOC is 0.88. However,
the glucose parameter correlates well between i-STAT and EPOC with the R2 of
0.99. The P-value less than 0.05 indicate that the different between the two data
set analyzed from different analyzers is significant. When comparing the data of
samples analyzed on different instruments using the T-test, there is no significant
different between EPOC versus i-STAT, i-STAT versus ABL 800 and EPOC versus
Figure 4.1 Within-Run Precision ABL 800.

Figure 4.1 demonstrates CVs for within-run precision. Overall CVs

demonstrate that all values were below manufacturer claimed. Within run
5. Discussion and Conclusion
Within run CVs for i-STAT and EPOC were good and below manufacturer claimed.
CV for i-STAT is between 0-2.57 for level 1, 0.06-5.24 for level 2 and
However, the CV’s day-to-day precision is better in i-STAT compared to EPOC. The
0.05-3.03 for level 3 whereas the within run CV for EPOC is between
correlation of hematocrit between i-STAT and EPOC were not done with ABL 800
0.15 - 7.52 for level 1, 0-6.28 for level 2 and 0.53-1.96 for level 3
Basic because the hematocrit is determined by conductometry in i-STAT and
(Confidence interval at 95%). Glucose couldn’t be determined in Biorad
EPOC whereas in ABL 800 Basic, the hematocrit is calculated via internal algo-
ABG solution Level 2 using EPOC. It was below the sensitivity limit of the
rithm. When comparing the data of samples analyzed on different instruments
analyzer.
using the T-Test, it showed that there is no significant between i-STAT and EPOC
analyzers. i-STAT showed better performance in term of CV when compared to
EPOC. i-STAT also demonstrate results near to the laboratory performance.

References:
1. D.S Young, Effects of Drugs on Clinical Laboratory Tests, 3rd ed. (Washington,
EPOC analyzer DC: American Association of Clinical Chemistry, 1990).
2. J.D. Bower, P.G. Ackerman and G. Toto, eds., “Evaluation of Formed Elements
ABL 800 Basic Radiometer of Blood,” in Clinical Laboratory Methods (St. Louis: The C.V. Mosby Company,
Abbot Exceed Glucometer
1974).