Brosur Hba1c Dxgen .pdf

\#

BRIM?X@@3GROUP

itco

f#;r"r**t:,.

HbA is the snswer for effective diqheles mqnqgement

;frocedure

*nffij** tr

ffi'

il*

4\

lncubation

Ronge

r

Dropping

"

',*ntu#

Dropplng Wl

R1

of HbAI c 15.7-6.40/o ;39-47 mmol/mol)

os 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.

Graha Cempaka Mas Blok B 15-17 Jl. Let. Jend. Suprapto No. 1 Jakarta Pusat 10540 Phone : (+6221) 42L7675,42871L60

Fax

: l+522L) 4217677, 4287L172

Ruko Puri Mos: Jl. I Gusti Nsuroh Roi Blok A1/16

Jt.

Fox ;l+62 311879

Fox

Surobovo 6b294 Phone 3'(+62 311879 1969

3656

: Permaitt/6 A

Dictrik Semarono

Gombel

Semorono 50261 Phone:

l+62241747 2OO1 ;(+62241747 2OO1

Aln,alyzlng

PRIMACO GROUP

DxGeri'ft

www.primaco.co.id

System Performance of Epithod@616 for

Point-Of-Care HbAlc Testing

Introduction Diabetes is global health emergency of the 2l't century. More and more people live with diabetes, which can result in lifechanging complications. In addition to the 415 million adults who are estimated to currently have diabetes, there are 318

million adults with impaired glucose tolerance (IGT), which puts them at high risk ofdeveloping the disease in the futuret. There has been a considerable increase in the importance of

making timely decisions about diabetes. People requires same-visit result with high precision and accuracy at small or medium sized lab and POC. DCCT (Diabetes Control and Complications Trial) showed that even a drop of I % brings with2lYo reduction in deaths, 37 o/o red:uction in microvascular complications, and 14 % reduction in heart attack related to diabetes2. Test for IIbAlc

is highly

recommended

Association).

HbAlc

by ADA

(American Diabetes

should perform when no prior data on

glycemic control is availablp and when glycemic control becomes stable for long-term monitoring of diabetes3.

System Performance Precision (lVithin-Run, Day-to-Day) Precision testing was designed by the CLSI document EP5-

A24. Within-run precision was evaluated using contol solution at two different sites within a day by two users. Testing is repeated for l0 times at each 3 different concentrations (% HbAlc) from 3 Lots of test kit on 2 test meters. Table I shows the high within-run precision of Eplthod@616, ofwhich CY (%) are less rha13%.

@-sg!u1ip4 Concentration Mean(%) STD

I 4.6 0.13

-cv(%) _2.8

2 3 5.9 9.7 0.16 0.24 __ZJ___Z;__

Day-to-day precision was evaluated using control solution for l0 days. Testing is performed at each 3 different concentrations (% HbAlc) from 1 Lot of test kit on 2 test meters. Table 2 demonshated the high dayto-day precision of Epithod@616, of which CV (%) are less than3%o. n

Concentration fltean(%) STD

CY (%)

4.6 0.13 2.7

2

5.9 15 2.5

0.

3

9.8 0.24 2.4

Linearity

rgh

Linearity testing was designed by CLSI document EP6-A5. Samples were prepared by dilution method using control

Ed

:

1

solution ranging from 2.8

!i:

% to

17.2

% of

HbAlc

concentrations. Test was performed using 2 lots of test kit 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

-

0.999 1x+0.04 52,

N

Figure

Assay Principle and Procedure Epithod@616 HbAlc Test Kit is a new application of the boronate affinity principle - the gold standard to measure 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 precipitate hemoglobin while the nanoencapsulated bluedyed boronic acid conjugate binds specifically to the cisdiols 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 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 NGSP (%), IFCC (mmol/mol), and eAG (mg/dl, mmol/L).

1.

:

of g

0.9992.

Plot of the Linerrity

20

y=0.9991x+0.0452

.'ls

R: =

0.9992

..,r

:10

0510r520 Ilel

Ctr1

UbAlc '/.

'r::#X::"r"sting was designed tiy the cLSr guidelines EP7-A26. Hemoglobin variants solutions were purchased from IFCC and NGSP. Control solutions spiked with interference substances were used. Test was performed by

DXG-DH-210-E0-00 (180320)

DxGen Corp.

PageT/2

5

!

DxGetn'=i'' kit. Interference substances and

test meters with 3 lots oftest

their concentrations are listed in Table 3.

Conclusions According

to

Epithod@616

variants

precision (CV

<

30Yo < 34.5 V.

HbAD HbAE HbF HbAS Crbamvlated Hb

< 24yo < 6.20 < 36Yo

Exo- and

Bilirubin

endo-genous substances

Triglycerides Cholesterol Glucose

< 20 mgldL < 450 mg/dl < 275 mg/dL < 120 mf/dl < 20 mgldL < 20 mgldL < 50 mgldL < 7 ms /dI.. < 500 IU/dL

No interference

Acetaminophen Ibuprofen Salicylic acid Ascorbic acid Heparin

Anti-

< 3%), linearity (3 - l5%, R2:0.99) and interference characteristics. Also, it has comparable performance in comparison with Tosoh Gll, AfinionrM ASl00, and DCAVantage@. NGSP certified Epithod@616 has lab quality performance with high accuracy and precision,

Concentrations

Substances

Hemoglobin HbAC

which is suitable for small or medium sized lab and POC.

< 3 mg/ml < 2 mglmL

coagulants Sodiumfluoride EDTA Sodium

systematic performance evaluation study, system exhibits excellent

HbAlc measuring

<

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 from 4.7 to l4.l %o of HbAlc concentrations. Due to limited numbers of hyperglycemia, diluted control solutions were used for high HbAlc level above 1l %. Testing was repeated using 3 Lots oftest kit at each level and their average values were compared with Tosoh Gl1 and other certified analyzers. Results were plotted as shown in Fig. 2.

N Engl J Med 1993;

3) Standard ofmedical care in diabetes, Diabetes care 2017;

Quantitative Measurement Methods".

I*l{0?a+0,019 Bf

insulin-dependent diabetes mellitus, 329:977-986.

4) CLSI EP5-A2 "Evaluation of Precision Performance of

10 18

IDF diabetes atlas, IDF 2015; seventh edition. intensive treatrnent of diabetes on the development and progression of long-term complications in

2) The effect of

40 (Suppl.l).

Figure 2. Plot ofAccuracy and Comparison

$16

References 1)

* 0,9984

5) CLSI EP6aA. "Evaluation of the Linearity of Quantitative Measurement Procedure: A Statistical Approach.".

e14

Err

I

G10 L

"*-"""

H8 .40

&

e?

6) CLSI EP7-A2 "Interference Testing in Clinical Chemistry". 7) CLSI EP9-A2 "Method Comparison and Bias Estimation Using Patient Samples". 8) CLSI EPI5-P "User Demonstration of Performance for Precision and Accuracy"

"f

4

t

'Iatl 4_6

I

"

I,ot2 'LqB

l0 12 14 16

18

Iqloh Gll (HbAlc ol{)

2t

l DCAYersg€o

l8

" AndonrM"4.Sl00

y-1.0r?2r-0.1411 y-

s16

Rr-0.9963

E-:

1.0?16r.0.103?

R-0.9S6?

i1{ &1?

= 1{l E8

f

F"s

s-

4

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@. Table 4. R.glults of

'Linearity Correlation

Accullcy

and!Sgp-lM!___

Accuracy Comparison Epithodo6l6 oce vanmge' ennrcni"estoo

1.007x

y= +0.019 0.9984

PRIMACO GROUP www.primaco.co.id

7-1.0172x

y=l.0236x

-0.1441 0.9963

-0.2037 0.9967

Head

Fax DXG-DH-21.0-E0-00 (180320)

DxGen Corp.

0ffice

Graha Cempaka Mas Blok B t 6-17 Jl. Let. Jend. SupraptoNo. I Jakarta Pusat 10640 Phone : (+62 21) 421 7675,42871160 :

(+6221) 421'7677,42871172

Page2/2