Document No.

Page: 1 of 2
Revision Date
Department: Pathology 06 September
2023
Section: Effective Date:
Revision No. 06September 2023

Policy Title:
STANDARD OPERATING PROCEDURE IN

ARKRAY HGBA1C

1. PURPOSE AND SCOPE

This document serves as an information guide to the medical technologist who is
performing HgbA1c assay in ADAMS a1c HA-8180V instrument. The A1C test—also
known as the hemoglobin A1C or HbA1c test—is a simple blood test that measures your
average blood sugar levels over the past 3 months. It's one of the commonly used tests
to diagnose prediabetes and diabetes, and is also the main test to help you and your
health care team manage your diabetes.

HbA1c is a blood test that is used to help diagnose type 2 diabetes and monitor
blood glucose control in people who have diabetes. People with diabetes are advised to
have this test every 3 to 6 months.

2. ASSAY PRINCIPLE
The ADAMS A1c, HA-8180V is a fully automated Glycohemoglobin (HbA1c)
analyzer based on HPLC (High Performance Liquid Chromatography). Glucose in your
blood sticks to hemoglobin, a protein in your red blood cells. As your blood glucose
levels increase, more of your hemoglobin will be coated with glucose. An A1C test
measures the percentage of your red blood cells that have glucose-coated hemoglobin.
Specifically, the A1C test measures what percentage of hemoglobin proteins in your
blood are coated with sugar (glycated). Hemoglobin proteins in red blood cells transport
oxygen. The higher your A1C level is, the poorer your blood sugar control and the higher
your risk of diabetes complications.

3. CLINICAL SIGNIFICANCE

HbA1c values represents the average blood glucose level over the past 8-12 weeks
and is used for long-term glycemic control in diabetic individuals. Besides monitoring

Prepared By: Reviewed By: Noted by: Approved by:

JOBELLE C. AYALA, RMT KHRISTINE T. MORENO, RMT, MPH CARINA P. VILLAMAYOR, MD, FPSP Roy O. Arceo, MD, MHA, FPSO-HNS
Date: 06 September 2023 Date: 06 September 2023 Date Date:
 Document No. Page: 2 of 2
Revision Date
Department: Pathology 06 September
2023
Section: Effective Date:
Revision No. 06September 2023

Policy Title:
STANDARD OPERATING PROCEDURE IN

ARKRAY HGBA1C

HbA1c is also recommended by international organizations as WHO and ADA for

reliable diagnosis of diabetes.

HbA1c is an important indicator of long-term glycemic control with the ability to

reflect the cumulative glycemic history of the preceding two to three months. HbA1c not
only provides a reliable measure of chronic hyperglycemia but also correlates well with
the risk of long-term diabetes complications. If you have consistently elevated blood
glucose levels (hyperglycemia) — and an elevated A1C result — it usually indicates
diabetes. Diabetes develops when your pancreas doesn't make any insulin or enough
insulin, or your body isn't using insulin properly.

4. TEST INFORMATION
4.1 Running Day: Daily
4.2 Cut-off time: None
4.3 Result: After 2 hours
4.4 Relaying of Result: Results must be relayed once available.
4.5 Reference Range:
4.5.1 Normal: <5.5%
4.5.2 Pre-Diabetic: 5.6-6.4%
4.5.3 Diabetic: 6.5% (2 occassions)
4.6 Unit of Reporting: % percentage

5. PATIENT PREPARATION: Non-fasting

6. SPECIMEN REQUIREMENTS
6.1 Sample Volume
6.1.1 Machine required volume per run: 3.5 uL EDTA whole blood
6.1.2 Volume required for submission: At least 1 ml EDTA whole
blood

Prepared By: Reviewed By: Noted by: Approved by:

JOBELLE C. AYALA, RMT KHRISTINE T. MORENO, RMT, MPH CARINA P. VILLAMAYOR, MD, FPSP Roy O. Arceo, MD, MHA, FPSO-HNS
Date: 06 September 2023 Date: 06 September 2023 Date Date:
 Document No. Page: 3 of 2
Revision Date
Department: Pathology 06 September
2023
Section: Effective Date:
Revision No. 06September 2023

Policy Title:
STANDARD OPERATING PROCEDURE IN

ARKRAY HGBA1C

6.2 Acceptable Sample Type:

6.2.1 Capillary whole blood/venous
6.3 Acceptable Collection Tube or Container:
6.3.1 Ethylenediamine tetra acetic acid (EDTA)
6.4 Sample Storage and Stability:
6.4.1 24 hours at room temperature or for 3-4 days refrigerated (2
to 8 degrees Celsius).
6.5 Sample Transport Requirement
6.5.1 Whole blood sample from EDTA tube
6.5.2 Transport bag must have a temperature of 2 – 8 ◦C.

6.6 Rejection Criteria and Action to be taken: It is recommended not to use

plasma and whole blood that are clearly clotted insufficient and unlabeled it
is suggested to collect a new sample.

7. REAGENTS

7.1 Storage conditions, Stability and Labeling:

7.1.1 Store the VIDAS kit at 2-8°C (both the used or unused kit.)
7.1.2 Do not freeze reagents.
7.1.3 After opening the kit, check that the SPR pouch is correctly
sealed and undamaged. If not, do not use the SPRs.
7.1.4 Carefully reseal the pouch with the desiccant inside after use
to maintain stability of the SPRs and return the complete kit
to 2-8°C.

Prepared By: Reviewed By: Noted by: Approved by:

JOBELLE C. AYALA, RMT KHRISTINE T. MORENO, RMT, MPH CARINA P. VILLAMAYOR, MD, FPSP Roy O. Arceo, MD, MHA, FPSO-HNS
Date: 06 September 2023 Date: 06 September 2023 Date Date:
 Document No. Page: 4 of 2
Revision Date
Department: Pathology 06 September
2023
Section: Effective Date:
Revision No. 06September 2023

Policy Title:
STANDARD OPERATING PROCEDURE IN

ARKRAY HGBA1C

7.1.5 Label the reagent box with the date opened and user’s
initials.
7.1.6 If stored according to the recommended conditions, all
components are stable until the expiration date indicated on
the label.

8. SAMPLE RACKS
8.1 Normal rack - normal measurements, HbA1c reproducibility test (whole blood
sample) *normally use this rack to measure samples.
Object: whole blood sample
Adapter: adapters are not attached at the time of shipment. Attach
adapters if needed according to the type of sample containers to be used.
Sample container: sample tube
8.2 Start Rack - normal measurement, HbA1c control measurement, HbA1c control
calibration (if sample rack transportation is set to “loop transportation). Set this
rack as the first rack to be measured on the loading side of the sampler.
Measurement operation will stop automatically after all samples have been
measured and start rack has returned to its initial position. Example: For normal
measurements, set the start rack in the first position, followed by normal racks in
the 2nd to 10th positions.
Object: whole blood sample
Adapter: spinning unit adapter (transparent)
Sample container: sample tube
8.3 Whole blood pair rack - normal measurement. Use this rack to measure whole
blood sample cups. IDs are read from the barcode labels attached to sample
tubes.
Object: whole blood samples
Adapter: odd-numbered ports - spinning unit adapter (transparent)

Prepared By: Reviewed By: Noted by: Approved by:

JOBELLE C. AYALA, RMT KHRISTINE T. MORENO, RMT, MPH CARINA P. VILLAMAYOR, MD, FPSP Roy O. Arceo, MD, MHA, FPSO-HNS
Date: 06 September 2023 Date: 06 September 2023 Date Date:
 Document No. Page: 5 of 2
Revision Date
Department: Pathology 06 September
2023
Section: Effective Date:
Revision No. 06September 2023

Policy Title:
STANDARD OPERATING PROCEDURE IN

ARKRAY HGBA1C

Even-numbered ports - conventional adapter (gray)

Sample container: Odd-numbered ports - sample tubes (for barcode
labels)
Even-numbered ports - sample cups (sample)
8.4 Hemolysis pair rack - normal measurement of hemolysis samples. Use sample
cups with sample. IDs are read from the barcode labels attached to sample
tubes.
Object: hemolysis sample
Adapter: Odd-numbered ports - spinning unit adapter (transparent)
Even-numbered ports - conventional adapter (gray)
Sample container: Odd-numbered ports - sample tube (for barcode labels)
Even-numbered ports - sample cup (sample)
NOTE: Do not set whole blood samples in the even-numbered ports of the
hemolysis pair rack to avoid seriously degrading the column. If whole blood is measured
in these ports, it is recommended to replace the column with a new one.
8.5 Anemia rack - normal measurement of anemia samples (whole blood)
Object: whole blood sample
Adapter: spinning unit adapter (transparent)
Sample container: sample tube
NOTE: Use the anemia rack foir whole blood samples from patients previously
diagnosed as anemic. Measuring non-anemia samples with the anemia rack may cause
inaccurate measurement result.
8.6 Hemolysis control rack - HbA1c control measurement, HbA1c reproducibility test
(hemolysis sample)
Object: controls for HbA1c measurement
Adapter: Odd-numbered ports - spinning unit adapter (transparent)
Even-numbered ports - conventional adapter (gray)
Sample container: Sample tubes with controls

Prepared By: Reviewed By: Noted by: Approved by:

JOBELLE C. AYALA, RMT KHRISTINE T. MORENO, RMT, MPH CARINA P. VILLAMAYOR, MD, FPSP Roy O. Arceo, MD, MHA, FPSO-HNS
Date: 06 September 2023 Date: 06 September 2023 Date Date:
 Document No. Page: 6 of 2
Revision Date
Department: Pathology 06 September
2023
Section: Effective Date:
Revision No. 06September 2023

Policy Title:
STANDARD OPERATING PROCEDURE IN

ARKRAY HGBA1C

Odd-numbered ports - sample tube (control)

Even-numbered ports - empty
Sample cups with controls
Odd-numbered ports - sample tube (attach barcode
labels to empty sample tubes and set in these ports
when using the internal barcode reader.)
Even-numbered ports - sample cup (control)
NOTE: Do not set whole blood samples in the hemolysis control rack to avoid
seriously degrading the column. If whole blood is measured with this rack, it is
recommended to replace the column with a new one.

8.7 Calibraton rack - HbA1c automatic calibration

Object: dummy samples (whole blood), standard solutions
Adapter: ports 1 to 3 - conventional adapter (blue)
Ports 4 to 8 - spinning unit adapter (transparent)
Ports 9 and 10 - conventional adapter (orange)
Sample container: ports 1 to 3: sample tube (for calibration information
barcode label)
Ports 4 to 8: sample tube (dummy sample)
Port 9 - sample cup (low solution)
Port 10 - sample cup (high solution)
NOTE: Do not set whole blood samples in ports 9 and 10 of the calibration rack to
avoid seriously degrading the column. If whole blood is measured in these ports, it is
recommended to replace the column with a new one.
8.8 Washing rack - tube wash
Object: washing solution for tubes
Adapter: conventional adapter (blue)

Prepared By: Reviewed By: Noted by: Approved by:

JOBELLE C. AYALA, RMT KHRISTINE T. MORENO, RMT, MPH CARINA P. VILLAMAYOR, MD, FPSP Roy O. Arceo, MD, MHA, FPSO-HNS
Date: 06 September 2023 Date: 06 September 2023 Date Date:
 Document No. Page: 7 of 2
Revision Date
Department: Pathology 06 September
2023
Section: Effective Date:
Revision No. 06September 2023

Policy Title:
STANDARD OPERATING PROCEDURE IN

ARKRAY HGBA1C

Sample container: sample tube

9. CALIBRATION AND CONTROLS

10. PERFORMING A CALIBRATION AND CONTROL

Prepare: dummy sample (whole blood), samples containers for dummy sample
(sample tubes, x1 to 5), calibrator that is specified by your distributor, sample cups (for
standard solutions, x2), calibration rack (CAL) and protective gloves
*[when reading calibration information from barcodes] Calibration information barcode
labels (come with the calibrator) and sample tubes (x2)
*[when diluents are not included in the calibrator] CONTROL DILUTION SET 80

10.1 Prepare dummy samples

10.1.1 Add dummy sample (whole blood) to sample tubes.
10.1.1.1 Prepare 1 to 5 tubes with sample tube
10.1.1.2 See “2.5.1. preparing samples” on page 2-11
10.1.2 Set dummy samples in ports 4 to 8 of the calibration rack
10.1.2.1 Use any of the ports 4 to 8
10.1.2.2 [12.3 mm diameter] Use the adapters on the rack.
[15mm diameter] Remove the adapters.
10.2 Prepare the standard solutions
10.2.1 Dissolve and dilute the low and high solutions included in the calibrator
10.2.2 Add low and high solution to separate sample cups (each sample cup
requires a minimun of 400uL of solution.
10.2.3 Set the standard solutins in the calibration rack. (Low solution: Port 9;
High solution: Port 10)
10.3 Label the sample tubes with calibration information barcode labels

Prepared By: Reviewed By: Noted by: Approved by:

JOBELLE C. AYALA, RMT KHRISTINE T. MORENO, RMT, MPH CARINA P. VILLAMAYOR, MD, FPSP Roy O. Arceo, MD, MHA, FPSO-HNS
Date: 06 September 2023 Date: 06 September 2023 Date Date:
 Document No. Page: 8 of 2
Revision Date
Department: Pathology 06 September
2023
Section: Effective Date:
Revision No. 06September 2023

Policy Title:
STANDARD OPERATING PROCEDURE IN

ARKRAY HGBA1C

10.3.1 Attach the calibration information barcode labels to each of two empty
sample tubes
10.3.2 Set the sample tubes in port 1 to 3 of the calibration rack
-use any of the ports 1 to 3
-set barcodes in any order
10.4 Load the calibration rack onto the sampler
10.4.1 Load the calibration rack onto the sampler
10.5 Check the measurement mode (Variant or Fast)
10.5.1 On the standby screen, check the [measurement mode] setting.
10.6 Set the calibration information. [For the numeric button operation]
10.6.1 On the standby screen, press Cal
10.6.2 Set the HbA1c calibration conditions.
10.6.3 Press OK
10.6.4 Below <CODE>, check the current reagent code.
10.6.5 To change the reagent code, enter the 10-digit code that is written on
the standard value list.

10.7 Start calibration

10.7.1 Start calibration
- For the barcode operation: Press START
- For the numeric button operation: Press START
- the message “Preparing for measurement” will appear and the rack
will be transported to the aspiration position
10.8 Check the measurement results
10.8.1 “Measuring…”
- dummy samples, Low solution and High solution will be measured in
that order
10.8.2 “Results”

Prepared By: Reviewed By: Noted by: Approved by:

JOBELLE C. AYALA, RMT KHRISTINE T. MORENO, RMT, MPH CARINA P. VILLAMAYOR, MD, FPSP Roy O. Arceo, MD, MHA, FPSO-HNS
Date: 06 September 2023 Date: 06 September 2023 Date Date:
 Document No. Page: 9 of 2
Revision Date
Department: Pathology 06 September
2023
Section: Effective Date:
Revision No. 06September 2023

Policy Title:
STANDARD OPERATING PROCEDURE IN

ARKRAY HGBA1C

- The obtained measurement results will be displayed on the screen

and printed out
10.9 Once the calibration is complete
10.9.1 Check that the calibration rack is not moving, and remove the rack
from the rack unloading side of the sampler.

11. RESULTS AND INTERPRETATION

12. TAKING CORRECTIVE ACTIONS/BASIC TROUBLESHOOTING

12.1 If trouble occurs
12.1.1 From warning/error/trouble occurrence to remedy - if a warning (W:001 to
W:095), an error (E:100 to E:122) or trouble (T:200 to T:999) occurs, follow
the instructions described below to clear it.
12.1.1.1 An alarm sounds for about 10 seconds, and a warning/ error/trouble
code and message appear on the display.
- W:001 to W:050 even if the warning occurs during measurement,
measurement continues without interruption.
- W:051 to W:095, E:100 to E:122, T:200 to T:999
if the warning/error/ trouble occurs during measurement,
measurement stops.

12.1.1.2 Check the code and message, and Press OK

- the alarm is silenced
- in the case of an error or trouble, initialization starts. If it occurs
during measurement, initialization starts when measurement is
complete for the aspirated sample.
12.1.1.3 Take the necessary action to remove the cause

Prepared By: Reviewed By: Noted by: Approved by:

JOBELLE C. AYALA, RMT KHRISTINE T. MORENO, RMT, MPH CARINA P. VILLAMAYOR, MD, FPSP Roy O. Arceo, MD, MHA, FPSO-HNS
Date: 06 September 2023 Date: 06 September 2023 Date Date:
 Document No. Page: 10 of 2
Revision Date
Department: Pathology 06 September
2023
Section: Effective Date:
Revision No. 06September 2023

Policy Title:
STANDARD OPERATING PROCEDURE IN

ARKRAY HGBA1C

- if measurement results were not obtained for samples due to the

warning/error/trouble, load those samples onto the sampler again
and press START. Measurement will start.
- if the warning/error/trouble persists, turn off the power and contact
your distributor.
12.1.1.4 Abnormal result messages - the instrument displays a message as
shown below if inaccurate measurement results are obtained.
Measurements will continue.
12.2 If the Instrument Does Not Start Up (Replacing Fuses)
12.2.1 If the instrument does not start up after turning on both the main power
switch and standby switch, there is a possibility that a fuse has blown. The
instrument has a pair of fuses and they can be replaced from the rear panel.
Replace whichever is blown.
12.2.2 Turn off the main power
12.2.2.1 Press the standby switch to turn off the power
- press the standby switch two or three times. The power is ON
when the switch remains slightly depressed. Then, press the switch
one more time to turn off the power.
12.2.2.2 Press the main power switch on the rear panel to turn off the main
power.
12.2.2.3 Press the side of the main power switch.
12.2.2.4 Unplug the power cord from the outlet
12.2.2.5 Unplug the power cord from the power input terminal on the rear
panel

12.2.3Remove the fuse holder

12.2.3.1 Pop open the fuse holder cover by working a flat-head screwdriver
under the tab (dotted area in the figure).

Prepared By: Reviewed By: Noted by: Approved by:

JOBELLE C. AYALA, RMT KHRISTINE T. MORENO, RMT, MPH CARINA P. VILLAMAYOR, MD, FPSP Roy O. Arceo, MD, MHA, FPSO-HNS
Date: 06 September 2023 Date: 06 September 2023 Date Date:
 Document No. Page: 11 of 2
Revision Date
Department: Pathology 06 September
2023
Section: Effective Date:
Revision No. 06September 2023

Policy Title:
STANDARD OPERATING PROCEDURE IN

ARKRAY HGBA1C

12.2.3.2 Pull the fuse holder straight to the front.

12.2.4 Replace the fuse
12.2.4.1 Remove the blown fuse from the fuse holder and set a new fuse
12.2.5 Store the fuse holder.
12.2.5.1 Insert the holder into its original position.
NOTE: Align the arrows on the fuse holder and cover, and insert the holder
into place
12.2.5.2 Close the fuse holder cover.
12.2.6 Turn on the power.
12.2.6.1 Plug the power cord into the power input terminal on the rear panel.
12.2.6.2 Plug the power cord into an outlet.
12.2.6.3 Press the main power switch on the rear panel to turn on the main
power
12.2.6.4 Press the standby switch to turn on the power. The standby switch
will light up.

Prepared By: Reviewed By: Noted by: Approved by:

JOBELLE C. AYALA, RMT KHRISTINE T. MORENO, RMT, MPH CARINA P. VILLAMAYOR, MD, FPSP Roy O. Arceo, MD, MHA, FPSO-HNS
Date: 06 September 2023 Date: 06 September 2023 Date Date: