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Guide for HbA1c Test Kit

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Guide for HbA1c Test Kit


with Epithod®616 Analyzer

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Guide for HbA1c Test Kit

Epithod® 616 Analyzer & Test Kit

2
1

Contents (25 Test / Kit) Specifications


1 R1 (reagents 1) 25 tubes
Principle Boronate affinity chromatography
2 W1 (washing solution) 1 vial
Sample Whole blood (5 𝛍L)
3 Cartridge 25 ea
Test range 3 – 15 % (NGSP)
Item card (NFC) 1 ea
Precision <3%
Insert paper 1 ea
Test Time < 2 minutes (Detection time : 5 sec)
Auxiliaries
Reference Tosoh G11 (HPLC)
Capillary tube (5 uL)
Pipette & tips
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Guide for HbA1c Test Kit

Materials of HbA1c Test Kit

Storage & In-use condition


• Always storage at 2 - 10 °C
• Equilibrate to 15 - 35 °C before use for 10 minutes

Specification
R1
• Prefilled tubes with colorless solution (0.2 mL)
• Single-use only
W1
• Vial with washing solution (1.5 mL)
• 1 vial for 25 tests
Warning & Precaution
• Do not mix with other Lot No. of test kit
R1 W1 • Do not freeze and avoid direct sunlight
• Avoid contamination

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Guide for HbA1c Test Kit

Specimens and Storage

Capillary blood
: Blood form finger prick is recommended.
: Do not use stored capillary blood.

Venous blood with anticoagulants


: EDTA, heparin, Na-citrate, Na-fluoride can be used.
: Venous blood can be stored refrigerated (2-8°C) for 3 days or at 15-30°C for 3 hours.
*Test is recommended right after drawing blood to avoid hemolysis.
: Venous blood must refrigerate immediately after use.

Cause of hemolysis
: Shaking the tube too vigorously after blood collection
: Freezing or thawing of blood
: Contact with air (opening the lid or using small gauge needles to collect blood)

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Guide for HbA1c Test Kit

HbA1c Test Procedure – Overview

1
Binding reaction specifically with HbA1c
Take 5 𝛍L whole blood to the R1/Reagent 1. Mix well. Incubate for 2 minutes.
Note : Equilibrate the R1 & W1 to 20 – 35°C before use.

2 Dropping R1 with blood to cartridge


Invert to obtain a homogenous solution. Drop 25 𝛍L of the R1 mixture to membrane of
cartridge. Wait to absorb completely.

3 Dropping W1/washing buffer to cartridge


Drop 25 𝛍L of the W1 to membrane of cartridge. Wait to absorb completely.

4 Reading the result


After 5 seconds to analyze, result is reported as values of NGSP (%), IFCC (mmol/mol),
and eAG.

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Guide for HbA1c Test Kit

Starting up the HbA1c Test

1. Touch ‘TEST’ on HOME screen.


2. Select ‘HbA1c’ by inserting HbA1c item card.
3. Touch ‘WB (whole blood)’ on Test Information screen.
4. Touch ‘Single’ mode.
5. Touch ‘NEXT’.

1 3 5

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Guide for HbA1c Test Kit

Method 1 - Sampling & Mixing (Capillary)

1 2 1. Clean finger using alcohol swap and air dry.

2. Prick finger using safety lancet (28 G).

3. Squeeze finger smoothly from the palm.

4. Wipe 1 - 2 drop of blood to avoid mixing with body fluid.

3 4

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Guide for HbA1c Test Kit

Sampling & Mixing (Capillary)

5 5. Fill completely the capillary tube with blood (5 𝛍L).


6. Wipe-out the extra blood at the exterior using tissue paper.

Cautions
6

Fill completely

Remove

Fill capillary tube completely and wipe out excessive blood.


: Insufficient blood (avoid air bubble) & Excessive blood can lead non-
precise results.

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Guide for HbA1c Test Kit

Sampling & Mixing (Capillary)

7 7. Peel off the end of foil.

8. Put the capillary tube with blood into R1 tube.


- Close the capillary tube tightly.

9
9. Mix well at least 5-10 times.

Cautions

Check

Check the blood completely come out from capillary tube.

Copyrights 2019. DxGen Corp. all rights reserved.


Guide for HbA1c Test Kit

Method 2 - Sampling & Mixing (venous)

1
1.Mix the blood collection tube gently but thoroughly.

2.Take venous blood using pipette with a tip.

3. Drop a blood on a clean plate.

4. Fill completely using a capillary tube (5 𝛍L).


2 3 - Avoid air-bubble.

5. Wipe-out the extra blood at the exterior using tissue paper.

6. Put into R1 tube and shake well.

4 5 Cautions

*Do not take the blood directly from the lid.


*Do not use hemolysis or frozen sample.

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Guide for HbA1c Test Kit

Incubating R1 with Blood for 2 Minutes

1 • Touch Incubation on the screen of analyzer.

1. Wait incubation for 2 minutes.


- Complete incubation (00:00).

2. Invert R1 tube gently 3 times.

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Guide for HbA1c Test Kit

Effects of temperature (R1) & Incubation time


• Prepare reagents R1 & W1 at room temperature (15 ~ 35 °C) for 10 minutes or grab R1 for 30 seconds.
• Recommended incubation time is 2 minutes.

9.8 9.8
% %

HbA1c (%)
HbA1c (%)

4.8 4.8
% %

60 90 120 150 180 210 240


Temperature of R1 Time (sec)

Low temperature of R1 (below 25 °C) : low test result Short or long incubation time leads unreliable results.
* High temperature of R1 (above 40 °C) may affect to test result. - Incomplete reaction (less than 2 min) : low test result
- Over-reaction (more than 3 min): high test result

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Guide for HbA1c Test Kit

Applying R1 and W1 to Test Cartridge

1 1. Prepare pipette and pipette tip.


- Tip is single use only.

2. Drop 25 𝛍L of R1 onto cartridge and wait to absorb (~ 10 sec).

3. Drop 25 𝛍L of W1 onto cartridge and wait to absorb (~ 10 sec).

* Make sure reagents are absorbed completely.

2
Cautions

Air bubble, Over flow Touching membrane Air bubble


around membrane Drop from the edge

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Guide for HbA1c Test Kit

Effect of volume (R1 and W1)


• Recommended volume is 25 𝛍L using constant volume pipette.

9.8 %

HbA1c (%)

1-step : Constant volume


4.8 %

15 20 25 30
Volume of R1 & W1 (𝛍L)

Non-precise volume of R1 and W1 lead to unreliable results. 2-step : Over volume


Insufficient volume (below 25 𝛍L) : low or high test result
Excessive volume (over 25 𝛍L) : high test result

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Guide for HbA1c Test Kit

Effect of absorbing time


• Recommended time is 10-15 seconds for absorbing reagents.

9.8 % 9.8 %
HbA1c (%)

HbA1c (%)
4.8 % 4.8 %

10 15 20 25 30 10 20 30 40 50 60
Absorbing time of R1 (sec) Absorbing time of W1 (sec)

Long absorbing time for R1 or W1 lead to unreliable results.


After dropping reagent, wait for 10- 15 seconds.

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Guide for HbA1c Test Kit

Reading the Results

1. Insert the cartridge in the right direction.

2. Touch Analyze on the screen.


- Detection time is 5 seconds.

3. Test results are displayed.


DCCT %
IFCC mmol/mol
eAG mg/dL
mmol/L

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Guide for HbA1c Test Kit

Test Mode (Single and multiple test)


High throughput is possible using multiple test mode (skip mode)

Single test N Multiple test

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Q&A