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identifying individuols with pre-diobetes. The test wos
performed in o loborotory using o method thot is NGSP
certified ond stondordized to the DCCT ossoy.

Permaitt/6 A
Graha Cempaka Mas Blok B 15-17 Ruko Puri Mos: Dictrik Semarono :
Jl. Let. Jend. Suprapto No. 1 Jl. I Gusti Nsuroh Roi Blok A1/16 Jt. Gombel
Jakarta Pusat 10540 Surobovo 6b294 Semorono 50261
Phone : (+6221) 42L7675,42871L60 Phone 3'(+62 311879 1969 Phone: l+62241747 2OO1
Fax : l+522L) 4217677, 4287L172 Fox ;l+62 311879 3656 Fox ;(+62241747 2OO1
 PRIMACO GROUP
www.primaco.co.id DxGeri'ft

System Performance of Epithod@616 for

Point-Of-Care HbAlc Testing

Introduction System Performance

Diabetes is global health emergency of the 2l't century. More Precision (lVithin-Run, Day-to-Day)
and more people live with diabetes, which can result in life- Precision testing was designed by the CLSI document EP5-
changing complications. In addition to the 415 million adults A24. Within-run precision was evaluated using contol
who are estimated to currently have diabetes, there are 318 solution at two different sites within a day by two users.
million adults with impaired glucose tolerance (IGT), which Testing is repeated for l0 times at each 3 different
puts them at high risk ofdeveloping the disease in the futuret. concentrations (% HbAlc) from 3 Lots of test kit on 2 test
There has been a considerable increase in the importance of meters. Table I shows the high within-run precision of
making timely decisions about diabetes. People requires Eplthod@616, ofwhich CY (%) are less rha13%.
same-visit result with high precision and accuracy at small or
medium sized lab and POC. @-sg!u1ip4
Concentration I 2 3
DCCT (Diabetes Control and Complications Trial) showed Mean(%) 4.6 5.9 9.7
that even a drop of I % brings with2lYo reduction in deaths, STD 0.13 0.16 0.24
37 o/o red:uction in microvascular complications, and 14 % -cv(%) _2.8 __ZJ___Z;__
reduction in heart attack related to diabetes2. Test for IIbAlc
Day-to-day precision was evaluated using control solution
is highly recommended by ADA (American Diabetes
for l0 days. Testing is performed at each 3 different
Association). HbAlc should perform when no prior data on
concentrations (% HbAlc) from 1 Lot of test kit on 2 test
glycemic control is availablp and when glycemic control
meters. Table 2 demonshated the high dayto-day precision
becomes stable for long-term monitoring of diabetes3.
of Epithod@616, of which CV (%) are less than3%o.
n
Concentration 1 2 3
fltean(%) 4.6 5.9 9.8
STD 0.13 0. 15 0.24
CY (%) 2.7 2.5 2.4

rgh Linearity
Linearity testing was designed by CLSI document EP6-A5.
Ed
: !i:
Samples were prepared by dilution method using control
solution ranging from 2.8 % to
concentrations. Test was performed using 2 lots of test kit
17.2 % of HbAlc

and repeated for 5 times. The result shows that Epithod@616

is perfectly calibrated to Tosoh Gll and is strictly linear
between 3.0 - 15.0 Yo with linear regression of g !
0.999 1x+0.04 52, N : 0.9992.
Figure 1. Plot of the Linerrity
Assay Principle and Procedure 20
Epithod@616 HbAlc Test Kit is a new application of the y=0.9991x+0.0452
R: = 0.9992 ..,r
boronate affinity principle - the gold standard to measure .'ls
IIbAlc.The whole blood from either capillary or venous is
mixed with Rl reagent and the mixture is incubated for 2
minutes. The Rl reagent lysis red blood cells (RBCs) and :10
precipitate hemoglobin while the nanoencapsulated blue-
dyed boronic acid conjugate binds specifically to the cis-
diols of HbAlc. Both precipitated glycated and non-glycated
Hemoglobin are collected on a filter membrane by dropping
Rl mixture on carhidge and the excess boronic acid 0510r520
Ilel Ctr1 UbAlc '/.
conjugates are removed by dropping Wl on carhidge. The
analyzer measures the reflectance intensities oftotal llb (red)
and HbAlc (blue) and the result is reported as values of 'r::#X::"r"sting was designed tiy the cLSr guidelines
NGSP (%), IFCC (mmol/mol), and eAG (mg/dl, mmol/L).
EP7-A26. Hemoglobin variants solutions were purchased
from IFCC and NGSP. Control solutions spiked with
interference substances were used. Test was performed by 5

DXG-DH-210-E0-00 (180320) DxGen Corp. PageT/2

 DxGetn'=i''
test meters with 3 lots oftest kit. Interference substances and Conclusions
their concentrations are listed in Table 3. According to systematic performance evaluation study,
Epithod@616 HbAlc measuring system exhibits excellent
Substances Concentrations precision (CV < 3%), linearity (3 - l5%, R2:0.99) and
Hemoglobin HbAC < 30Yo interference characteristics. Also, it has comparable
variants HbAD < 34.5 V.
HbAE < 24yo performance in comparison with Tosoh Gll, AfinionrM
HbF < 6.20 ASl00, and DCAVantage@. NGSP certified Epithod@616 has
HbAS < 36Yo lab quality performance with high accuracy and precision,
Crbamvlated Hb No interference
Exo- and Bilirubin < 20 mgldL which is suitable for small or medium sized lab and POC.
endo-genous Triglycerides < 450 mg/dl
substances Cholesterol < 275 mg/dL
Glucose < 120 mf/dl
Acetaminophen < 20 mgldL
Ibuprofen < 20 mgldL
Salicylic acid < 50 mgldL
Ascorbic acid < 7 ms /dI..
Anti- Heparin < 500 IU/dL
coagulants Sodiumfluoride < 3 mg/ml
EDTA < 2 mglmL
Sodium citrate < 3.5 me/ml,
Each of samples was compared to control (normal) sample
and the bias (%) with respect to reference value was derived.
No significant interference was observed and a1l the % bias
were within r l0 o . Substances not listed may possible to
interfere with result.

Accuraqt
Accuracy testing was designed by CLSI document FP9-A27
EPl5-P8. Total 50 whole blood samples were tested ranging References
from 4.7 to l4.l %o of HbAlc concentrations. Due to limited 1)IDF diabetes atlas, IDF 2015; seventh edition.
numbers of hyperglycemia, diluted control solutions were 2) The effect of intensive treatrnent of diabetes on the
used for high HbAlc level above 1l %. Testing was repeated development and progression of long-term complications in
using 3 Lots oftest kit at each level and their average values insulin-dependent diabetes mellitus, N Engl J Med 1993;
were compared with Tosoh Gl1 and other certified analyzers. 329:977-986.
Results were plotted as shown in Fig. 2. 3) Standard ofmedical care in diabetes, Diabetes care 2017;
Figure 2. Plot ofAccuracy and Comparison 40 (Suppl.l).
10
4) CLSI EP5-A2 "Evaluation of Precision Performance of
18 I*l{0?a+0,019 Quantitative Measurement Methods".
Bf * 0,9984
$16 5) CLSI EP6aA. "Evaluation of the Linearity of Quantitative
e14 Measurement Procedure: A Statistical Approach.".
e?
Err I 6) CLSI EP7-A2 "Interference Testing in Clinical Chemistry".
G10 7) CLSI EP9-A2 "Method Comparison and Bias Estimation
L
H8 "*-"""
& Using Patient Samples".
.40 "f 8) CLSI EPI5-P "User Demonstration of Performance for
4
Precision and Accuracy"
t 'Iatl " I,ot2 'LqB
4_6 I l0 12 14 16 18
Iqloh Gll (HbAlc ol{)

2t
l DCAYersg€o " AndonrM"4.Sl00
l8 y-1.0r?2r-0.1411 y- E-:
1.0?16r.0.103?
s16 Rr-0.9963 R-0.9S6?

i1{
&1?
= 1{l
E8 F"s
4
s-f
0
0 2 4 6 I 10121,1161820
Certifiad analyarr (gb"Uc %)

Table 4 summarizes the correlation results of Epithod@616

compare to Tosoh Gl l, AfinionrM AS100, and DCAvantage@. PRIMACO GROUP
Table 4. R.glults of Accullcy and!Sgp-lM!___ www.primaco.co.id
'- Accuracy Comparison Head 0ffice
Epithodo6l6 oce vanmge' ennrcni"estoo Graha Cempaka Mas Blok B t 6-17
Linearity y= 1.007x 7-1.0172x y=l.0236x Jl. Let. Jend. SupraptoNo. I
+0.019 -0.1441 -0.2037 Jakarta Pusat 10640
Correlation 0.9984 0.9963 0.9967 Phone : (+62 21) 421 7675,42871160
Fax : (+6221) 421'7677,42871172

DXG-DH-21.0-E0-00 (180320) DxGen Corp. Page2/2