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2435ha 241003 144411

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689 views6 pages

2435ha 241003 144411

Uploaded by

Penelope Kalicharan
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

PRODUCT INFORMATION

HA5072

2435HA

Please note that HbA1c control Level 2, Lot number 2435HA, will recover high above the level 6
calibrator concentration for indirect HbA1c on RX Instruments when converted to units g/dl or
µmol/l.

Contact [Link]@[Link] if you require further assistance

CCS INC1103

Page 1 of 1 FORM NO. 8373-GP


REVISION (2)
2 Aug 2019
HAEMOGLOBIN A1c CONTROL SET
(HbA1c CONTROL)
CAT. NO: HA5072 LOT NO: 2433HA & 2435HA
SIZE: 2 x 2 x 0.5 ml EXPIRY: 2026-06-28
GTIN: 05055273208818
INTENDED USE
This product is intended for in vitro diagnostic use, in the quality control of HbA1c on clinical chemistry systems.
SAFETY PRECAUTIONS AND WARNINGS
The level 1 & level 2 controls contain human blood.
Warning: Potentially Biohazardous Material.
Human source material, from which this product has been derived, has been tested at donor level for the Human Immunodeficiency
Virus (HIV 1, HIV 2) antibody, Hepatitis B Surface Antigen (HbsAg), and Hepatitis C Virus (HCV) antibody and found to be NON-
REACTIVE. FDA approved methods have been used to conduct these tests.
However, since no method can offer complete assurance as to the absence of infectious agents, this material and all patient samples
should be handled as though capable of transmitting infectious diseases and disposed of accordingly.
For in vitro diagnostic use only, do not pipette by mouth, exercise the normal precautions required for handling laboratory reagents.
STORAGE AND STABILITY
The level 1 & level 2 controls are stable up to expiry as supplied.

The reconstituted control is stable for 1 month when stored refrigerated at +2°C to +8°C. This stability claim is based on data
obtained using immunoturbidimetric methodology.
N.B. Do not freeze the reconstituted controls.
PREPARATION FOR USE/RECONSTITUTION
1. Remove the cap from the control bottle.
2. Add 0.5 ml of double deionised water to the control.
3. Replace control bottle cap. Swirl the bottle several times and leave to stand at room temperature for 15 minutes.
4. After 15 minutes, coat all surfaces of the bottle by rotating and inverting the bottle.
Continue mixing until the solution is homogeneous and all lyophilised material is reconstituted.
N.B. Once reconstituted, these controls should be treated in the same way as samples and in accordance with kit or reagent being
used. When used with Randox Haemoglobin A1c reagent, catalogue numbers HA3830 or HA8321, the controls should be
pre-treated by mixing 10 µl of the reconstituted control with 400 µl of Haemoglobin denaturant reagent (1:41 dilution), prior to
analysis for HbA1c & Total Haemoglobin.
When used with Randox Haemoglobin A1c ll reagent, catalogue numbers HA4068, HA8123 or HA8379, no pre-
treatment is required prior to analysis.
MATERIALS PROVIDED
Level 1 Control: 2 x 0.5 ml
(HbA1c CONTROL 1)
Level 2 Control: 2 x 0.5 ml
(HbA1c CONTROL 2)
MATERIALS REQUIRED BUT NOT PROVIDED
Double deionised water
Volumetric pipette
ASSIGNED % HbA1c VALUES
Due to the variation caused by test equipment, test reagents and laboratory technique, the quoted ranges are provided for
guidance. It is recommended that these ranges are used until each laboratory has established its own ranges, based on individual
laboratory requirements.

Each batch of HbA1c control is submitted to a number of external laboratories and values are assigned from a consensus of results
obtained by these laboratories.
If a method is unavailable, contact Randox Laboratories - Technical Services, Northern Ireland, tel: +44 (0) 28 9445 1070 or email
[Link]@[Link].

PAGE 1 OF 5
LOT NOS. 2433HA & 2435HA

LEVEL 1
Method Units Target Range
Abbott Architect c / Alinity c (DCCT/NGSP) %HBA1C 5.35 4.28 - 6.42
Abbott Architect c / Alinity c (IFCC) mmol/mol 35.0 28.0 – 42.0
Abbott Architect c(Direct Turbidimetric) (DCCT/NGSP) %HBA1C 5.52 4.42 - 6.62
Abbott Architect c(Direct Turbidimetric) (IFCC) mmol/mol 36.8 29.4 - 44.2
Arkray/Adams/Menarini A1c HA-8000 Series (DCCT/NGSP) %HBA1C 5.60 4.48 - 6.72
Arkray/Adams/Menarini A1c HA-8000 Series (IFCC) mmol/mol 37.7 30.2 - 45.2
Arkray Pocket Chem A1c Advanced (DCCT / NGSP) %HBA1C 6.40 5.12 – 7.68
Arkray Pocket Chem A1c Advanced (IFCC) mmol/mol 46.4 37.1 – 55.7
Beckman AU Instruments (DCCT/NGSP) %HBA1C 5.80 4.64 - 6.96
Beckman AU Instruments (IFCC) mmol/mol 39.9 31.9 - 47.9
Beckman DxC600/DxC800 (DCCT/NGSP) %HBA1C 5.78 4.62 - 6.94
Beckman DxC600/DxC800 (IFCC) mmol/mol 39.7 31.8 - 47.6
BioHermes Hb A1c (DCCT/NGSP) %HBA1C 5.55 4.44 - 6.66
BioHermes Hb A1c (IFCC) mmol/mol 37.2 29.8 - 44.6
Biorad D-10 (DCCT/NGSP) %HBA1C 5.72 4.58 - 6.86
Biorad D-10 (IFCC) mmol/mol 39.0 31.2 - 46.8
Biorad D-100 (DCCT/NGSP) %HBA1C 5.68 4.54 - 6.82
Biorad D-100 (IFCC) mmol/mol 38.6 30.9 - 46.3
Biorad Variant II (ion exchange) (DCCT/NGSP) %HBA1C 5.68 4.54 - 6.82
Biorad Variant II (ion exchange) (IFCC) mmol/mol 38.6 30.9 - 46.3
BioSystems BA400 (DCCT/NGSP) %HBA1C 5.62 4.50 - 6.74
BioSystems BA400 (IFCC) mmol/mol 37.9 30.3 - 45.5
Boditech Med Inc i-CHROMA (DCCT/NGSP) %HBA1C 5.43 4.34 - 6.52
Boditech Med Inc i-CHROMA (IFCC) mmol/mol 35.8 28.6 – 43.0
Centronic HbA1c (DCCT/NGSP) %HBA1C 5.77 4.62 - 6.92
Centronic HbA1c (IFCC) mmol/mol 39.6 31.7 - 47.5
Ceragem/Green Cross M.S. Labona Check (DCCT/NGSP) %HBA1C 6.04 4.83 - 7.25
Ceragem/Green Cross M.S. Labona Check (IFCC) mmol/mol 42.5 34.0 – 51.0
Clover A1c (DCCT/NGSP) %HBA1C 6.09 4.87 - 7.31
Clover A1c (IFCC) mmol/mol 43.1 34.5 - 51.7
DiaSys QDx Alc Advance (DCCT / NGSP) %HBA1C 6.43 5.14 – 7.72
DiaSys QDx Alc Advance (IFCC) mmol/mol 46.8 37.4 – 56.2
DiaSys respons A1c (DCCT / NGSP) %HBA1C 6.45 5.16 – 7.74
DiaSys respons(IFCC) mmol/mol 47.0 37.6 – 56.4
EKF Quotient Quo-Lab A1c Test (DCCT/NGSP) %HBA1C 6.79 5.43 - 8.15
EKF Quotient Quo-Lab A1c Test (IFCC) mmol/mol 50.7 40.6 - 60.8
Erba XL Series (DCCT/NGSP) %HBA1C 5.72 4.58 - 6.86
Erba XL Series (IFCC) mmol/mol 39.0 31.2 - 46.8
Fortress Diagnostics Electalyte-500 (DCCT/NGSP) %HBA1C 5.38 4.30 - 6.46
Fortress Diagnostics Electalyte-500 (IFCC) mmol/mol 35.3 28.2 - 42.4
GCMS Greencare A1c (DCCT / NGSP) %HBA1C 6.41 5.13 – 7.69
GCMS Greencare A1c (IFCC) mmol/mol 46.6 37.3 – 55.9
Human Diagnostics HumaNex A1c (DCCT/NGSP) %HBA1C 5.69 4.55 - 6.83
Human Diagnostics HumaNex A1c (IFCC) mmol/mol 38.7 31.0 - 46.4
Labnovation LD-500 (DCCT/NGSP) %HBA1C 6.17 4.94 - 7.40
Labnovation LD-500 (IFCC) mmol/mol 43.9 35.1 - 52.7
MediSys Hemo G Smart (DCCT / NGSP) %HBA1C 6.47 5.18 – 7.76
MediSys Hemo G Smart (IFCC) mmol/mol 47.2 37.8 – 56.6
Menarini HB Next (DCCT/NGSP) %HBA1C 5.68 4.54 - 6.82
Menarini HB Next (IFCC) mmol/mol 38.6 30.9 - 46.3
Mindray BS200/300/400/800 (DCCT/NGSP) %HBA1C 5.69 4.55 - 6.83
Mindray BS200/300/400/800 (IFCC) mmol/mol 38.7 31.0 - 46.4
Mindray H50/ H50P (DCCT/NGSP) %HBA1C 5.76 4.61 - 6.91
Mindray H50/ H50P (IFCC) mmol/mol 39.5 31.6 - 47.4
MTI Diagnostics HA-1500 (DCCT/NGSP) %HBA1C 6.19 4.95 - 7.43
MTI Diagnostics HA-1500 (IFCC) mmol/mol 44.2 35.4 – 53.0
Nycocard Reader (DCCT/NGSP) %HBA1C 5.68 4.54 - 6.82
Nycocard Reader (IFCC) mmol/mol 38.6 30.9 - 46.3
Ortho Vitros A1C1 (Enzymatic) (DCCT/NGSP) %HBA1C 6.35 5.08 - 7.62
Ortho Vitros A1C1 (Enzymatic) (IFCC) mmol/mol 45.9 36.7 - 55.1
Ortho Vitros d%A1c (DCCT/NGSP) %HBA1C 5.60 4.48 - 6.72
Ortho Vitros d%A1c (IFCC) mmol/mol 37.7 30.2 - 45.2
Randox Rx HbA1c (DCCT/NGSP) %HBA1C 6.13 4.90 - 7.36
Randox Rx HbA1c (IFCC) mmol/mol 43.5 34.8 - 52.2
Randox Rx HbA1c II (DCCT/NGSP) %HBA1C 6.05 4.84 - 7.26
Randox Rx HbA1c II (IFCC) mmol/mol 42.6 34.1 - 51.1
Roche Cobas 4000/c311 (DCCT/NGSP) %HBA1C 5.60 4.48 - 6.72
Roche Cobas 4000/c311 (IFCC) mmol/mol 37.7 30.2 - 45.2
Roche Cobas 6000/8000 (DCCT/NGSP) %HBA1C 5.69 4.55 - 6.83

PAGE 2 OF 5
LOT NOS. 2433HA & 2435HA

LEVEL 1 (continued)
Method Units Target Range
Roche Cobas 6000/8000 (IFCC) mmol/mol 38.7 31.0 - 46.4
Roche Cobas c303/c503 (DCCT/NGSP) %HBA1C 5.82 4.66 - 6.98
Roche Cobas c303/c503 (IFCC) mmol/mol 40.1 32.1 - 48.1
Roche Cobas c513 (DCCT/NGSP) %HBA1C 5.77 4.62 - 6.92
Roche Cobas c513 (IFCC) mmol/mol 39.6 31.7 - 47.5
Roche Integra (DCCT/NGSP) %HBA1C 5.74 4.59 - 6.89
Roche Integra (IFCC) mmol/mol 39.2 31.4 – 47.0
Roche Modular P/Cobas c111 (DCCT/NGSP) %HBA1C 5.80 4.64 - 6.96
Roche Modular P/Cobas c111 (IFCC) mmol/mol 39.9 31.9 - 47.9
Sebia Capillarys / Minicap (DCCT/NGSP) %HBA1C 5.52 4.42 - 6.62
Sebia Capillarys / Minicap (IFCC) mmol/mol 36.8 29.4 - 44.2
Siemens Advia CH A1c_E (DCCT/NGSP) %HBA1C 5.19 4.15 - 6.23
Siemens Advia CH A1c_E (IFCC) mmol/mol 33.2 26.6 - 39.8
Siemens Atellica CH A1c_3 (DCCT/NGSP) %HBA1C 5.28 4.22 - 6.34
Siemens Atellica CH A1c_3 (IFCC) mmol/mol 34.2 27.4 – 41.0
Siemens Atellica CH A1c_E (DCCT/NGSP) %HBA1C 5.36 4.29 - 6.43
Siemens Atellica CH A1c_E (IFCC) mmol/mol 35.1 28.1 - 42.1
Siemens DCA2000/Vantage (DCCT/NGSP) %HBA1C 6.10 4.88 - 7.32
Siemens DCA2000/Vantage (IFCC) mmol/mol 43.2 34.6 - 51.8
Siemens/Dade Dimension (DCCT/NGSP) %HBA1C 5.77 4.62 - 6.92
Siemens/Dade Dimension (IFCC) mmol/mol 39.6 31.7 - 47.5
Tokyo Boeki/Prestige 24i (DCCT/NGSP) %HBA1C 5.87 4.70 - 7.04
Tokyo Boeki/Prestige 24i (IFCC) mmol/mol 40.7 32.6 - 48.8
TOSOH G8 Automated HPLC Analyser (DCCT/NGSP) %HBA1C 5.74 5.28 - 6.14
TOSOH G8 Automated HPLC Analyser (IFCC) mmol/mol 39.2 36.1 - 42.4
TOSOH GX Automated HPLC Analyser (DCCT/NGSP) %HBA1C 5.69 5.23 - 6.09
TOSOH GX Automated HPLC Analyser (IFCC) mmol/mol 38.7 35.6 - 41.8
TOSOH G11 Automated HPLC Analyser (DCCT/NGSP) %HBA1C 5.67 5.22 - 6.07
TOSOH G11 Automated HPLC Analyser (IFCC) mmol/mol 38.5 35.4 - 41.6
Wondfo Finecare Meter (DCCT/NGSP) %HBA1C 5.79 4.63 - 6.95
Wondfo Finecare Meter (IFCC) mmol/mol 39.8 31.8 - 47.8

Total Haemoglobin Target Range


Beckman AU Instruments g/dl 13.0 10.5 – 15.6
Roche Cobas 6000/8000 g/dl 17.7 14.2 – 21.2
Roche Cobas c303/c503 g/dl 11.9 9.52 – 14.3
Randox RX Series g/dl 15.8 12.6 – 18.9

PAGE 3 OF 5
LOT NOS. 2433HA & 2435HA

LEVEL 2
Method Units Target Range
Abbott Architect c / Alinity c (DCCT/NGSP) %HBA1C 10.2 8.16 - 12.2
Abbott Architect c / Alinity c (IFCC) mmol/mol 88.0 70.4 - 106
Abbott Architect c(Direct Turbidimetric) (DCCT/NGSP) %HBA1C 11.0 8.80 - 13.2
Abbott Architect c(Direct Turbidimetric) (IFCC) mmol/mol 96.7 77.4 - 116
Arkray/Adams/Menarini A1c HA-8000 Series (DCCT/NGSP) %HBA1C 10.6 8.48 - 12.7
Arkray/Adams/Menarini A1c HA-8000 Series (IFCC) mmol/mol 92.4 73.9 - 111
Arkray Pocket Chem A1c Advanced (DCCT / NGSP) %HBA1C 10.4 8.32 – 12.5
Arkray Pocket Chem A1c Advanced (IFCC) mmol/mol 90.2 72.2 – 108
Beckman AU Instruments (DCCT/NGSP) %HBA1C 11.0 8.80 - 13.2
Beckman AU Instruments (IFCC) mmol/mol 96.7 77.4 - 116
Beckman DxC600/DxC800 (DCCT/NGSP) %HBA1C 11.0 8.8 - 13.2
Beckman DxC600/DxC800 (IFCC) mmol/mol 96.7 77.4 - 116
BioHermes Hb A1c (DCCT/NGSP) %HBA1C 10.9 8.72 - 13.1
BioHermes Hb A1c (IFCC) mmol/mol 95.6 76.5 - 115
Biorad D-10 (DCCT/NGSP) %HBA1C 11.2 8.96 - 13.4
Biorad D-10 (IFCC) mmol/mol 98.9 79.1 - 119
Biorad D-100 (DCCT/NGSP) %HBA1C 11.0 8.80 - 13.2
Biorad D-100 (IFCC) mmol/mol 96.7 77.4 - 116
Biorad Variant II (ion exchange) (DCCT/NGSP) %HBA1C 10.9 8.72 - 13.1
Biorad Variant II (ion exchange) (IFCC) mmol/mol 95.6 76.5 - 115
BioSystems BA400 (DCCT/NGSP) %HBA1C 10.4 8.32 - 12.5
BioSystems BA400 (IFCC) mmol/mol 90.2 72.2 - 108
Boditech Med Inc i-CHROMA (DCCT/NGSP) %HBA1C 8.70 6.98 - 10.5
Boditech Med Inc i-CHROMA (IFCC) mmol/mol 71.9 57.5 – 86.0
Centronic HbA1c (DCCT/NGSP) %HBA1C 10.9 8.72 - 13.1
Centronic HbA1c (IFCC) mmol/mol 95.6 76.5 - 115
Ceragem/Green Cross M.S. Labona Check (DCCT/NGSP) %HBA1C 11.5 9.20 - 13.8
Ceragem/Green Cross M.S. Labona Check (IFCC) mmol/mol 102 81.6 - 122
Clover A1c (DCCT/NGSP) %HBA1C 10.7 8.56 - 12.8
Clover A1c (IFCC) mmol/mol 93.4 74.7 - 112
DiaSys QDx Alc Advance (DCCT / NGSP) %HBA1C 10.4 8.32 – 12.5
DiaSys QDx Alc Advance (IFCC) mmol/mol 90.2 72.2 – 108
DiaSys respons A1c (DCCT / NGSP) %HBA1C 10.5 8.40 – 12.6
DiaSys respons(IFCC) mmol/mol 91.3 73.0 – 110
EKF Quotient Quo-Lab A1c Test (DCCT/NGSP) %HBA1C 11.2 8.96 - 13.4
EKF Quotient Quo-Lab A1c Test (IFCC) mmol/mol 98.9 79.1 - 119
Erba XL Series (DCCT/NGSP) %HBA1C 11.0 8.8 - 13.2
Erba XL Series (IFCC) mmol/mol 96.7 77.4 - 116
Fortress Diagnostics Electalyte-500 (DCCT/NGSP) %HBA1C 10.7 8.56 - 12.8
Fortress Diagnostics Electalyte-500 (IFCC) mmol/mol 93.4 74.7 - 112
GCMS Greencare A1c (DCCT / NGSP) %HBA1C 10.4 8.32 – 12.5
GCMS Greencare A1c (IFCC) mmol/mol 90.2 72.2 - 108
Human Diagnostics HumaNex A1c (DCCT/NGSP) %HBA1C 11.1 8.88 - 13.3
Human Diagnostics HumaNex A1c (IFCC) mmol/mol 97.8 78.2 - 117
Labnovation LD-500 (DCCT/NGSP) %HBA1C 10.1 8.08 - 12.1
Labnovation LD-500 (IFCC) mmol/mol 86.9 69.5 - 104
MediSys Hemo G Smart (DCCT / NGSP) %HBA1C 10.5 8.40 – 12.6
MediSys Hemo G Smart (IFCC) mmol/mol 91.3 73.0 - 110
Menarini HB Next (DCCT/NGSP) %HBA1C 11.0 8.8 - 13.2
Menarini HB Next (IFCC) mmol/mol 96.7 77.4 - 116
Mindray BS200/300/400/800 (DCCT/NGSP) %HBA1C 11.1 8.88 - 13.3
Mindray BS200/300/400/800 (IFCC) mmol/mol 97.8 78.2 - 117
Mindray H50/ H50P (DCCT/NGSP) %HBA1C 10.9 8.72 - 13.1
Mindray H50/ H50P (IFCC) mmol/mol 95.6 76.5 - 115
MTI Diagnostics HA-1500 (DCCT/NGSP) %HBA1C 10.6 8.48 - 12.7
MTI Diagnostics HA-1500 (IFCC) mmol/mol 92.4 73.9 - 111
Nycocard Reader (DCCT/NGSP) %HBA1C 10.8 8.64 – 13.0
Nycocard Reader (IFCC) mmol/mol 94.5 75.6 - 113
Ortho Vitros A1C1 (Enzymatic) (DCCT/NGSP) %HBA1C 12.4 9.92 - 14.9
Ortho Vitros A1C1 (Enzymatic) (IFCC) mmol/mol 112 89.6 - 134
Ortho Vitros d%A1c (DCCT/NGSP) %HBA1C 11.2 8.96 - 13.4
Ortho Vitros d%A1c (IFCC) mmol/mol 98.9 79.1 - 119

PAGE 4 OF 5
LOT NOS. 2433HA & 2435HA

LEVEL 2 (continued)
Method Units Target Range
Randox Rx HbA1c (DCCT/NGSP) %HBA1C 13.8 11.0 - 16.6
Randox Rx HbA1c (IFCC) mmol/mol 127 102 - 152
Randox Rx HbA1c II (DCCT/NGSP) %HBA1C 11.5 9.20 - 13.8
Randox Rx HbA1c II (IFCC) mmol/mol 102 81.6 - 122
Roche Cobas 4000/c311 (DCCT/NGSP) %HBA1C 11.1 8.88 - 13.3
Roche Cobas 4000/c311 (IFCC) mmol/mol 97.8 78.2 - 117
Roche Cobas 6000/8000 (DCCT/NGSP) %HBA1C 11.0 8.8 - 13.2
Roche Cobas 6000/8000 (IFCC) mmol/mol 96.7 77.4 - 116
Roche Cobas c303/c503 (DCCT/NGSP) %HBA1C 11.2 8.96 - 13.4
Roche Cobas c303/c503 (IFCC) mmol/mol 98.9 79.1 - 119
Roche Cobas c513 (DCCT/NGSP) %HBA1C 11.3 9.04 - 13.6
Roche Cobas c513 (IFCC) mmol/mol 100 80.0 - 120
Roche Integra (DCCT/NGSP) %HBA1C 11.1 8.88 - 13.3
Roche Integra (IFCC) mmol/mol 97.8 78.2 - 117
Roche Modular P/Cobas c111 (DCCT/NGSP) %HBA1C 11.2 8.96 - 13.4
Roche Modular P/Cobas c111 (IFCC) mmol/mol 98.9 79.1 - 119
Sebia Capillarys / Minicap (DCCT/NGSP) %HBA1C 10.6 8.48 - 12.7
Sebia Capillarys / Minicap (IFCC) mmol/mol 92.4 73.9 - 111
Siemens Advia CH A1c_E (DCCT/NGSP) %HBA1C 10.0 8.00 – 12.0
Siemens Advia CH A1c_E (IFCC) mmol/mol 85.8 68.6 - 103
Siemens Atellica CH A1c_3 (DCCT/NGSP) %HBA1C 10.3 8.24 - 12.4
Siemens Atellica CH A1c_3 (IFCC) mmol/mol 89.1 71.3 - 107
Siemens Atellica CH A1c_E (DCCT/NGSP) %HBA1C 10.3 8.24 - 12.4
Siemens Atellica CH A1c_E (IFCC) mmol/mol 89.1 71.3 - 107
Siemens DCA2000/Vantage (DCCT/NGSP) %HBA1C 11.7 9.36 – 14.0
Siemens DCA2000/Vantage (IFCC) mmol/mol 104 83.2 - 125
Siemens/Dade Dimension (DCCT/NGSP) %HBA1C 11.0 8.80 - 13.2
Siemens/Dade Dimension (IFCC) mmol/mol 96.7 77.4 - 116
Tokyo Boeki/Prestige 24i (DCCT/NGSP) %HBA1C 10.7 8.56 - 12.8
Tokyo Boeki/Prestige 24i (IFCC) mmol/mol 93.4 74.7 - 112
TOSOH G8 Automated HPLC Analyser (DCCT/NGSP) %HBA1C 10.8 9.97 - 11.6
TOSOH G8 Automated HPLC Analyser (IFCC) mmol/mol 94.9 87.3 - 103
TOSOH GX Automated HPLC Analyser (DCCT/NGSP) %HBA1C 10.7 9.88 - 11.5
TOSOH GX Automated HPLC Analyser (IFCC) mmol/mol 93.8 86.3 - 101
TOSOH G11 Automated HPLC Analyser (DCCT/NGSP) %HBA1C 10.7 9.85 - 11.5
TOSOH G11 Automated HPLC Analyser (IFCC) mmol/mol 93.6 86.1 - 101
Wondfo Finecare Meter (DCCT/NGSP) %HBA1C 11.0 8.8 - 13.2
Wondfo Finecare Meter (IFCC) mmol/mol 96.7 77.4 - 116

Total Haemoglobin Target Range


Beckman AU Instruments g/dl 12.9 10.3 – 15.5
Roche Cobas 6000/8000 g/dl 14.7 11.8 – 17.6
Roche Integra g/dl 13.5 10.8 – 16.2
Randox RX Series g/dl 14.4 11.5 - 17.3

Randox Teoranta, Meenmore,


Dungloe, Donegal,
F94 TV06, Ireland

14 Aug ’24 me

PAGE 5 OF 5

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