It‘s here …

Finally …
25th Jan. 2015
Arab Health Distributor Meeting
Dubai
Kees Heije
ARKRAY EUROPE B.V.

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 ...the smaller
brother
of the ADAMS
HA-8180
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… it is smaller !
… it is lower price !
… but it has same
precision as HA-8180(V) !

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ADAMS A1c Lite (HA-8380V)

SMALLER FOOTPRINT:
- 30% less in size than HA-8180
- 10% less in size than Bio-Rad D-10
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ADAMS A1c Lite (HA-8380V)

*
The compact and light
solution for HbA1c testing

*final reagent design not yet decided.

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Contents

1. Main features of ADAMS A1c Lite

2. Measurement Data & Chromatograms
3. Comparison to the Bio-Rad D-10
4. Comparison to Tosoh benchtop analyzer
5. Other POC A1c analyzers

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ADAMS A1c Lite (HA-8380V)
*Same Precision as HA-8180V
*Small Footprint
Main features 30% less than HA-8180
10% less than the BioRad D-10
*2.7min/test with HbS,C separated & HbE,D detection in V-mode.
*Fast/Variant modes (switch using keypad)
No need to change eluents/ column
*Long column life
Same column as HA-8180V,
1 year expiry (>2.500 tests)
*Uninterrupted measurement using 5-sample racks.
Or set 10 samples (2 racks) at a time.
*Timer built in
Device will start up at preset time
*80B/LiteH have 3 months on board stability.
*80A/80C have 1 month on board stability.
*No need to match reagent and column lots
(=reagent info and expiry date management)

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Outline of ADAMS A1c Lite

(Appearance)
Reagents

Printer

Display & operation

panel

Sample rack(s)

Sampling part

Position BCR

February 19, 2019 8

Details – Small Sample rack

blood collection tube Sample cup

5-sample rack
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Measurement Data

&

Chromatograms

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ADAMS A1c Lite (HA-8380V)

Outline
Accuracy Equivalent to the HA-8180V
Meas. Time 1.7 min/ test (Fast mode) (100sec)
2.7 min/ test (Variant mode) (160sec)
First Report 3 min (Fast mode)
4 min (Variant mode)
Column & reagent Same as HA-8180V (except 80H)
Sampling nozzle Piercing nozzle
Number of settable samples 10 samples
(5 samples/rack x 2 racks)
Sample volume of whole blood 10 μL
Footprint About 70% of HA-8180V
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ADAMS A1c Lite (HA-8380V)

Outline
Lite H

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ADAMS A1c Lite (HA-8380V)

Outline

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Measurement time

Meas. start Approx 4.0 min

3.0min (first report)
Individual meas. Fast Mode
Clean priming Start priming Meas. End priming
Sample prep 48 sec. 60 sec.
1.7min 1.7min
Consecutive
meas. Start priming Meas. Start priming Meas. ---
Sample prep 48 sec. Sample prep 48 sec.

Variant Mode
Meas. start Approx 5.0 min
4.0min (first report)
Individual meas.
Clean priming Start priming Meas. End priming
Sample prep 90 sec. 60 sec.
2.7min 2.7mins
Consecutive
meas. Start priming Meas. Start priming Meas. ---
Sample prep 90 sec. Sample prep 90 sec.

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Correlation (ADAMS A1c Lite vs. HA-8180)

NGSP (%)
HbA1c n = 393
(in-house data)
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y = 0.9857x + 0.0495
R2 = 0.9987
ADAMS A1c Lite　HA-8380

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10

0
0 5 10 15 20 NGSP (%)
HA-8180
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ADAMS A1c Lite Chromatogram
(same as HA-8180V)

(Fast mode) (Variant mode)

HbA0
HbA0

HbA1c HbS

48sec 1.5min
100 sec 160 sec
(1.7min) (2.7min)
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ADAMS A1c Lite Chromatogram
(same as HA-8180V)

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ADAMS A1c Lite Chromatogram
(same as HA-8180V)

If you don‘t want to have the chromatogram printed,

HbA1c results can be reported in 3 ways:

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Chromatogram (HbS sample)

ADAMS A1c Lite ADAMS A1c

HA-8380V HA-8180V

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Chromatogram (HbC sample)

ADAMS A1c Lite ADAMS A1c

HA-8380V HA-8180V

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Chromatogram (HbD sample)

ADAMS A1c Lite ADAMS A1c

HA-8380V HA-8180V

*detection
*detection

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More ADAMS A1c Lite Chromatograms

HbD (het.) HbE (het.)

*detection

*detection

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 Evaluation at Jin’nouchi Hospital,
Kumamoto City, Kumamoto Prefecture,
Japan

(Q1 2014)

 It has been confirmed, that ADAMS A1c Lite meets

the needed performance specifications.
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Evaluation at Dr. Cas Weykamp’s
Laboratory, Winterswijk, NL

(July 2014)

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Evaluation at Dr. Weykamp’s lab
(ISO13485 certified lab, July 2014)

ADAMS A1c Lite was evaluated at the Queen Beatrix Hospital,

MCA Laboratory, Beatrixpark 1, NL-7101 BN Winterswijk, The
Netherlands

Dr. Cas Weykamp, Clin. Chemist, is Director of MCA Laboratory, Network Coordinator IFCC Working Group for
Standardization of HbA1c as well as EQA organiser (proficiency tests) in NL.
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Evaluation at Dr. Weykamp’s lab
(ISO13485 certified lab, July 2014)

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Evaluation at Dr. Weykamp’s lab
(ISO13485 certified lab, July 2014)

Conclusions:
 The ADAMS A1c Lite measured all 130 samples without any trouble
(in 2 days).
 The ARKRAY/Canterbury controls and the IFCC reference controls and calibrators
gave daily equal results to the ADAMS HA-8180V and the Trinity Premier Hb-9210.
 All HbS and HbC variants were successfully separated and correct HbA1c
outputted.
 All HbD and HbE variants were successfully detected and HbA1c result outputted*
(*new improved correction factors were set by R&D based on these comparison results).

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Comparison with Bio-Rad D-10

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ADAMS A1c Lite
Comparison with BioRad D-10
Manufacturer ARKRAY BioRad
Product Compact ADAMS D-10
Mode Fast mode Variant mode A1c Program Dual Program
A1c Test ○ ○ ○ ○

Interferences for A1c yes none none none

HbS, HbC Not measured Measured Measured Measured

HbD, HbE Not measured Detected Detected Measured
HbA2 Not measured Not Detected Not Detected Measured
Min. Meas. Time 1.7 2.7 3.0 6.5
Column Lifetime >2,500 >2,500 400 200
Column/Reagent
Not Need Not Need Need Need
Lot match

37×52×49cm 35 40.2×53.4×47.6cm 40.2×53.4×47.6cm

Product size 37×52×49cm kg 35 kg 35 kg

*Advantage D-10: Dual program recognizes HbA2. 29

ADAMS A1c Lite

Comparison with Bio-Rad D-10(HPLC)

or ?

Advantages of ADAMS A1c Lite

+ smaller,
+ faster,
+ more precise (CV),
+ longer column life,
+ ease of use & maintenance
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Comparison with Tosoh GX
Benchtop Analyzer

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ADAMS A1c Lite
Comparison with Tosoh HLC-723 GX (HPLC)
Manufacturer ARKRAY Tosoh
Product Compact ADAMS HLC-723GX
Method HPLC HPLC
Mode Fast mode Variant mode A1c Program
A1c Test ○ ○ ○ (and other tests)
Whole Blood, Anemia, Whole Blood, Anemia, Whole Blood, diluted samples (Anemia only
Sample
Hemolysis Hemolysis after special prep.)
A1c CV (%) <1% <1% <1%
Interferences for A1c yes (variants) none yes (HbE)
HbF Measured Measured Measured
Measured (HbS:H-V1, HbC:H-V2, HbD:H-
HbS, HbC Not measured Measured
V0)
HbD measured (H-V0), HbE not
HbD, HbE Not measured Detected
measured
HbA2 Not measured Not Detected Not measured
Min. Meas. Time 1.7 min 2.7 min 2.2 min
2 racks or continous 2 racks or continous
Sampler 10 samples / batch
loading/removing loading/removing
Walk away time 10 samples, 80sec+10x100sec = 18 min 10 samples, 80sec+10x160sec = 28 min Turntable: 10 samples
Continuous loading yes yes ? (likely not possible)
First report ? ? 6.6 min
Tube: 10 mm away from bottom, Tube: 10 mm away from bottom,
Min.Volume Tube: 1 ml, Cup: 200 µl
Cup: 400-500 µl Cup: 400-500 µl
WB: 4 µl, Anemia: 8 µl, WB: 4 µl, Anemia: 8 µl,
Aspirated Volume WB: 3 µl, Diluted Samples/Cups: 120 µl
Hemolysis: 350 µl Hemolysis: 350 µl
Column Lifetime >2,500 (1 year) >2,500 (1 year) 1500 (prefilter: every 350 tests)
Column/Reagent
Not Needed, reagents with barcode Not Needed, reagents with barcode reagent logging
Lot match
ARKRAY A1c: 18 months at 2-8°C, ARKRAY A1c: 18 months at 2-8°C,
Calibrator reconstituted: 8 hrs at 2-8°C reconstituted: 8 hrs at 2-8°C recommend weekly
Memory 300 300 800 (1GB-USB stick for 250.000 tests)

LIS / communication yes / one-way & two-way yes / one-way & two-way yes / two-way
37×52×49cm 37×52×49cm 37x52.5x48.2cm
Product size
35 kg 35 kg 25 kg

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ADAMS A1c Lite

Comparison with Tosoh HLC-723 GX (HPLC)

or ?

ADAMS A1c Lite will be serious threat for HLC-723GX :

1. As it can measure HbA1c correctly in presence of HbE!
2. It can measure anemia and hemolysis samples (=> more flexibility)!
3. Easier maintenance: longer column stability, no pre-filter change,
no weekly calibration
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Comparable with small A1c
POC-Analyzers ?

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Point-of-Care HbA1c instruments

In2it (Bio-Rad) Nycocard (Alere/Axis-Shield)

DCA Vantage (Siemens) Afinion (Alere/Axis-Shield) 10 min, 10 µl 3 min, 5 µl
6 min, 1 µl 3 min, 1.5 µl

Clover (Infopia) A1c Now+ (Bayer) Banalyst (Rohm)

InnovaStar (Diasys-Greiner)
5 min, 4 µl
InnovaStar A1CNOW
6.5 min, 10 µl 5 min, 5 µl
7.5 min, 4 µl 35
Conclusions

ADAMS A1c Lite

- might not compete with small POC A1c analyzers in terms of
sample volume, size, weight and prize.

But
+ is superior due to HPLC technology (high precision).
+ has the needed precision and accuracy for Diabetes
diagnosis.
+ allows even testing of new patients as it detects the
main 4 variants (HbS, HbC, HbD, HbE).
+ With <3 min/test ADAMS A1c Lite is faster than any of
the above POC tests.
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 Compact size – affordable price

… ideal for small or medium labs as well as a backup to

HA-8180 analyzers.

ARKRAY HbA1c devices will

continue to evolve

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Speed you can feel,
quality you can trust

ARKRAY HbA1c devices will

continue to evolve

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THANK YOU VERY MUCH !

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