COAGULATION CONTROL - LEVEL 2

(COAG CONTROL 2)
CAT. NO. CG5022 LOT NO. 405CG
SIZE: 12 x 1 ml EXPIRY: 2025-09-28
GTIN: 05055273207637

INTENDED USE
This product is intended for in vitro diagnostic use, and in the quality control of coagulation systems. The Coagulation Controls are for
the control of accuracy and precision.

DEVICE DESCRIPTION
The Coagulation Controls are supplied at 3 levels, level 1, 2 and 3. Target values and ranges are supplied for the analytes listed in the
values section.

SAFETY PRECAUTIONS AND WARNINGS

The controls are intended for in vitro diagnostic use only. Do not pipette by mouth. Exercise the normal precautions required for
handling laboratory reagents and controls.

Human source material, which has been added, 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 was 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.

Health and Safety Data sheets are available on request.

STORAGE AND STABILITY

OPENED: Store refrigerated (+2°C to +8°C). APTT, TT, PT, Fibrinogen and Antithrombin III in reconstituted control are stable for 24
hours at +2°C to +8°C if kept capped in original container and free from contamination. Protein C, Protein S, Plasminogen, and
Factors II, V, VII, VIII, IX, X, XI, XII are stable for 8 hours at +2°C to +8°C. Only the required amount of product should be removed.
After use, any residual product should NOT BE RETURNED to the original vial.

UNOPENED: Store refrigerated (+2°C to +8°C). Stable to expiration date printed on individual vials.

PREPARATION FOR USE

The Coagulation Controls are supplied lyophilised.

1. Carefully reconstitute each vial of lyophilised control with exactly 1 ml of distilled water at +15°C to +25°C. Close the bottle and
allow to stand for 30 minutes before use. Ensure contents are completely dissolved by swirling gently. Avoid the formation of
foam. Do not shake the vial.

2. Refer to the Control section of the individual analyser application.

3. Refrigerate any unused material. Prior to reuse, mix the contents of the vial thoroughly.

MATERIALS PROVIDED
Coagulation Control - Level 2 12 x 1 ml

MATERIALS REQUIRED BUT NOT PROVIDED

Volumetric pipette

ASSIGNED 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 Coagulation Control is submitted to a number of external laboratories. Values are assigned from a consensus of results
obtained by these laboratories and internal testing conducted at Randox Laboratories Ltd. The expected range of the mean is provided
to aid laboratory until it has established its own mean and SD for its test methods.

Randox Teoranta, Meenmore,

Dungloe, Donegal,
F94 TV06, Ireland

07 May ’24 me

PAGE 1 OF 1
Table of Content
Method 2
Sunbio UP1500 13

Page 1 of 13 07/05/2024

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
All enzyme values are quoted to a temperature of 37°C, unless otherwise stated
Method COAGULATION CONTROL - LEVEL 2 (COAG CONTROL 2)

Lot. No: 405CG Cat. No: CG5022 Expiry: 2025-09-28

Size: 12 x 1 ml Range
Analyte Unit Target Low High 1SD 2SD Method
Activated Partial seconds 47.9 38.3 57.5 4.80 9.60 Beijing Succeeder aPTT
Thromboplastin Time
seconds 46.4 37.1 55.7 4.65 9.30 Bio-Ksel System APTTs
(APTT)
seconds 53.3 42.6 64.0 5.35 10.7 Biolabo Bio-CK APTT
seconds 73.5 58.8 88.2 7.35 14.7 Cobas aPTT MedS
seconds 57.9 46.3 69.5 5.80 11.6 DG Lab APTT
seconds 49.3 39.4 59.2 4.95 9.90 Diagon Dia-PTT Liquid
seconds 59.2 47.4 71.0 5.90 11.8 Diagon Dia-PTT Lyophilised
seconds 47.9 38.3 57.5 4.80 9.60 DIRUI aPTT
seconds 57.2 45.8 68.6 5.70 11.4 Erba Actime APTT
seconds 45.7 36.6 54.8 4.55 9.10 Fortress Diagnostics aPTT
seconds 57.8 46.2 69.4 5.80 11.6 Helena aPTT Si L Minus
seconds 64.8 51.8 77.8 6.50 13.0 HemosIL aPTT Lyophilised Silica
seconds 41.4 33.1 49.7 4.15 8.30 HemosIL APTT-SP liquid
seconds 61.1 48.9 73.3 6.10 12.2 HemosIL Synthasil
seconds 48.8 39.0 58.6 4.90 9.80 Human Hemostat APTT
seconds 54.0 43.2 64.8 5.40 10.8 Labitec aPTT
seconds 50.1 40.1 60.1 5.00 10.0 Media IVD aPTT
seconds 48.5 38.8 58.2 4.85 9.70 Mindray/Longisland APTT
seconds 48.4 38.7 58.1 4.85 9.70 MTI Diagnostics APTT

Page 2 of 13 07/05/2024

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
All enzyme values are quoted to a temperature of 37°C, unless otherwise stated
Method COAGULATION CONTROL - LEVEL 2 (COAG CONTROL 2)

Lot. No: 405CG Cat. No: CG5022 Expiry: 2025-09-28

Size: 12 x 1 ml Range
Analyte Unit Target Low High 1SD 2SD Method
Activated Partial seconds 38.0 30.4 45.6 3.80 7.60 Renam APTT
Thromboplastin Time
seconds 62.0 49.6 74.4 6.20 12.4 Roche Cobas APTT
(APTT)
seconds 64.6 51.7 77.5 6.45 12.9 Roche Cobas APTT Screen
seconds 58.9 47.1 70.7 5.90 11.8 Sclavo APTT-S
seconds 46.2 37.0 55.4 4.60 9.20 Siemens/Dade Actin
seconds 47.5 38.0 57.0 4.75 9.50 Siemens/Dade Actin Cephaloplastin
seconds 46.2 37.0 55.4 4.60 9.20 Siemens/Dade Actin FS
seconds 41.2 33.0 49.4 4.10 8.20 Siemens/Dade Actin FSL
seconds 68.2 54.6 81.8 6.80 13.6 Siemens/Dade Actin SL
seconds 74.4 59.5 89.3 7.45 14.9 Siemens/Dade Pathromtin SL
seconds 59.5 47.6 71.4 5.95 11.9 Spinreact APTT
seconds 57.5 46.0 69.0 5.75 11.5 Stago aPTT
seconds 55.0 44.0 66.0 5.50 11.0 Stago Cephascreen
seconds 54.8 43.8 65.8 5.50 11.0 Stago CK Prest
seconds 56.8 45.4 68.2 5.70 11.4 Stago PTT Automate
seconds 58.6 46.9 70.3 5.85 11.7 Tcoag TriniCLOT aPTT S
seconds 46.6 37.3 55.9 4.65 9.30 Technoclone Siron aPTT
seconds 61.4 49.1 73.7 6.15 12.3 Teco TEClot APTT
seconds 50.8 40.6 61.0 5.10 10.2 Thalys APTT-EA

Page 3 of 13 07/05/2024

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
All enzyme values are quoted to a temperature of 37°C, unless otherwise stated
Method COAGULATION CONTROL - LEVEL 2 (COAG CONTROL 2)

Lot. No: 405CG Cat. No: CG5022 Expiry: 2025-09-28

Size: 12 x 1 ml Range
Analyte Unit Target Low High 1SD 2SD Method
Activated Partial seconds 40.3 32.2 48.4 4.05 8.10 Wiener Lab APTT
Thromboplastin Time
seconds 45.5 36.4 54.6 4.55 9.10 Yumizen G APTT Liq
(APTT)
Activated Partial RATIO 1.34 1.07 1.61 0.135 0.270 Bio-Ksel System APTTs
Thromboplastin Time
RATIO 1.81 1.45 2.17 0.180 0.360 Biolabo Bio-CK APTT
(APTT) Ratio
RATIO 1.72 1.38 2.06 0.170 0.340 Diagon Dia-PTT Lyophilised
RATIO 1.92 1.54 2.30 0.190 0.380 Erba Actime APTT
RATIO 2.09 1.67 2.51 0.210 0.420 Helena aPTT Si L Minus
RATIO 1.38 1.10 1.66 0.140 0.280 HemosIL APTT-SP liquid
RATIO 2.00 1.60 2.40 0.200 0.400 HemosIL Synthasil
RATIO 1.56 1.25 1.87 0.155 0.310 Human Hemostat APTT
RATIO 1.91 1.53 2.29 0.190 0.380 Labitec aPTT
RATIO 1.66 1.33 1.99 0.165 0.330 Media IVD aPTT
RATIO 1.63 1.30 1.96 0.165 0.330 MTI Diagnostics APTT
RATIO 2.14 1.71 2.57 0.215 0.430 Sclavo APTT-S
RATIO 1.85 1.48 2.22 0.185 0.370 Siemens/Dade Actin FS
RATIO 1.54 1.23 1.85 0.155 0.310 Siemens/Dade Actin FSL
RATIO 2.28 1.82 2.74 0.230 0.460 Siemens/Dade Pathromtin SL
RATIO 1.79 1.43 2.15 0.180 0.360 Stago aPTT
RATIO 1.78 1.42 2.14 0.180 0.360 Stago Cephascreen
RATIO 1.78 1.42 2.14 0.180 0.360 Stago CK Prest
RATIO 1.66 1.33 1.99 0.165 0.330 Stago PTT Automate
RATIO 2.00 1.60 2.40 0.200 0.400 Tcoag TriniCLOT aPTT S
RATIO 2.31 1.85 2.77 0.230 0.460 Teco TEClot APTT
RATIO 1.90 1.52 2.28 0.190 0.380 Thalys APTT-EA
RATIO 1.47 1.18 1.76 0.145 0.290 Yumizen G APTT Liq
Antithrombin III activity % 66.6 53.3 79.9 6.65 13.3 HemosIL Liquid Antithrombin
% 72.7 58.2 87.2 7.25 14.5 Roche Antithrombin
% 70.1 56.1 84.1 7.00 14.0 Roche Chromogenic Thrombin
% 68.5 54.8 82.2 6.85 13.7 Sclavo ATIII
% 72.5 58.0 87.0 7.25 14.5 Siemens Innovance Antithrombin III
% 73.6 58.9 88.3 7.35 14.7 Siemens/Dade Antithrombin III
% 71.1 56.9 85.3 7.10 14.2 Siemens/Dade Berichrom ATIII
% 75.4 60.3 90.5 7.55 15.1 STAChrom ATIII
% 73.3 55.0 91.6 9.15 18.3 Thalys Antithrombin III
Factor II activity % 66.0 52.8 79.2 6.60 13.2 HemosIL Factor II deficient plasma
% 64.9 51.9 77.9 6.50 13.0 HemosIL RecombiPlasTin 2G
% 77.9 62.3 93.5 7.80 15.6 Siemens Factor II Deficient Plasma

Page 4 of 13 07/05/2024

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
All enzyme values are quoted to a temperature of 37°C, unless otherwise stated
Method COAGULATION CONTROL - LEVEL 2 (COAG CONTROL 2)

Lot. No: 405CG Cat. No: CG5022 Expiry: 2025-09-28

Size: 12 x 1 ml Range
Analyte Unit Target Low High 1SD 2SD Method
Factor II activity % 74.7 59.8 89.6 7.45 14.9 Siemens/Dade Innovin
% 83.5 66.8 100 8.25 16.5 Siemens/Dade Thromborel S
% 65.6 52.5 78.7 6.55 13.1 Stago STA-NeoPTimal
Factor IX activity % 83.1 66.5 99.7 8.30 16.6 HemosIL APTT-SP liquid
% 61.3 49.0 73.6 6.15 12.3 HemosIL Factor IX deficient plasma
% 65.6 52.5 78.7 6.55 13.1 HemosIL Synthasil
% 64.1 51.3 76.9 6.40 12.8 Siemens Factor IX Deficeint Plasma
% 63.5 50.8 76.2 6.35 12.7 Siemens/Dade Actin FS
% 65.6 52.5 78.7 6.55 13.1 Siemens/Dade Actin FSL
% 70.2 56.2 84.2 7.00 14.0 Siemens/Dade Pathromtin SL
% 66.1 52.9 79.3 6.60 13.2 Stago Deficient / ImmunoDef IX
Factor V activity % 52.7 42.2 63.2 5.25 10.5 HemosIL Factor V deficient plasma
% 55.7 44.6 66.8 5.55 11.1 HemosIL RecombiPlasTin 2G
% 61.5 49.2 73.8 6.15 12.3 Siemens Factor V Deficient Plasma
% 50.1 40.1 60.1 5.00 10.0 Siemens/Dade Innovin
% 70.7 56.6 84.8 7.05 14.1 Siemens/Dade Thromborel S
% 54.2 43.4 65.0 5.40 10.8 Stago STA-NeoPTimal
Factor VII activity % 94.4 75.5 113 9.30 18.6 HemosIL Factor VII deficient plasma
% 93.1 74.5 112 9.45 18.9 HemosIL RecombiPlasTin 2G
% 92.1 73.7 111 9.45 18.9 Siemens Factor VII Deficient Plasma
% 89.4 71.5 107 8.80 17.6 Siemens/Dade Innovin
% 95.2 76.2 114 9.40 18.8 Siemens/Dade Thromborel S
% 82.7 66.2 99.2 8.25 16.5 Stago Deficient Factor VII
Factor VIII activity % 41.3 33.0 49.6 4.15 8.30 HemosIL Factor VIII deficient plasma
% 43.7 35.0 52.4 4.35 8.70 HemosIL Synthasil
% 42.4 33.9 50.9 4.25 8.50 Siemens Factor VIII Deficient Plasma
% 41.8 33.4 50.2 4.20 8.40 Siemens/Dade Actin FS
% 42.1 33.7 50.5 4.20 8.40 Siemens/Dade Actin FSL
% 44.0 35.2 52.8 4.40 8.80 Siemens/Dade Pathromtin SL
% 44.0 35.2 52.8 4.40 8.80 Stago CK Prest
% 40.9 32.7 49.1 4.10 8.20 Stago Deficient VIII
% 40.3 32.2 48.4 4.05 8.10 Stago STA Factor VIII
% 40.3 32.2 48.4 4.05 8.10 Stago Deficient / ImmunoDef VIII
Factor X activity % 75.8 60.6 91.0 7.60 15.2 HemosIL Factor X deficient plasma
% 72.4 57.9 86.9 7.25 14.5 HemosIL RecombiPlasTin 2G
% 86.4 69.1 104 8.80 17.6 Siemens Factor X Deficient Plasma
% 80.4 64.3 96.5 8.05 16.1 Siemens/Dade Innovin
% 88.8 71.0 107 9.10 18.2 Siemens/Dade Thromborel S
% 71.0 56.8 85.2 7.10 14.2 Stago Deficient Factor X
% 70.5 56.4 84.6 7.05 14.1 Stago STA-NeoPTimal

Page 5 of 13 16/10/2024

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
All enzyme values are quoted to a temperature of 37°C, unless otherwise stated
Method COAGULATION CONTROL - LEVEL 2 (COAG CONTROL 2)

Lot. No: 405CG Cat. No: CG5022 Expiry: 2025-09-28

Size: 12 x 1 ml Range
Analyte Unit Target Low High 1SD 2SD Method
Factor XI activity % 36.5 29.2 43.8 3.65 7.30 HemosIL Factor XI deficient plasma
% 35.5 28.4 42.6 3.55 7.10 HemosIL Synthasil
% 31.5 25.2 37.8 3.15 6.30 Siemens/Dade Actin FSL
Factor XII activity % 68.5 54.8 82.2 6.85 13.7 HemosIL Factor XII deficient plasma
% 62.7 50.2 75.2 6.25 12.5 HemosIL Synthasil
% 68.4 54.7 82.1 6.85 13.7 Siemens Factor XII Deficient Plasma
% 68.7 55.0 82.4 6.85 13.7 Siemens/Dade Actin FS
% 69.4 55.5 83.3 6.95 13.9 Siemens/Dade Actin FSL
% 74.9 59.9 89.9 7.50 15.0 Siemens/Dade Pathromtin SL
Fibrinogen g/l 2.04 1.63 2.45 0.205 0.410 Bio-Ksel Fibrinogen
mg/dl 204 163 245 20.5 41.0
g/l 2.01 1.61 2.41 0.200 0.400 Biolabo Bio-Fibri
mg/dl 201 161 241 20.0 40.0
g/l 1.96 1.57 2.35 0.195 0.390 Cobas Fibrinogen
mg/dl 196 157 235 19.5 39.0
g/l 1.61 1.29 1.93 0.160 0.320 Diagon Dia-F
mg/dl 161 129 193 16.0 32.0
g/l 1.69 1.35 2.03 0.170 0.340 DIRUI Fibrinogen
mg/dl 169 135 203 17.0 34.0
g/l 1.64 1.31 1.97 0.165 0.330 Erba Thrombin Reagent
mg/dl 164 131 197 16.5 33.0
g/l 2.06 1.65 2.47 0.205 0.410 HaemoDiagnostics Fibrinogen
mg/dl 206 165 247 20.5 41.0
g/l 2.13 1.70 2.56 0.215 0.430 Helena Clauss Fibrinogen 100
mg/dl 213 170 256 21.5 43.0
g/l 1.87 1.50 2.24 0.185 0.370 HemosIL Fibrinogen C
mg/dl 187 150 224 18.5 37.0
g/l 2.06 1.65 2.47 0.205 0.410 HemosIL PT-Fibrinogen
mg/dl 206 165 247 20.5 41.0
g/l 1.83 1.46 2.20 0.185 0.370 HemosIL PT-Fibrinogen HS Plus
mg/dl 183 146 220 18.5 37.0
g/l 1.77 1.42 2.12 0.175 0.350 HemosIL QFA (bovine thrombin)
mg/dl 177 142 212 17.5 35.0
g/l 1.33 1.06 1.60 0.135 0.270 HemosIL RecombiPlasTin 2G
mg/dl 133 106 160 13.5 27.0
g/l 2.06 1.65 2.47 0.205 0.410 Human Fibrinogen
mg/dl 206 165 247 20.5 41.0
g/l 1.98 1.58 2.38 0.200 0.400 Labitec Fibrinogen
mg/dl 198 158 238 20.0 40.0

Page 6 of 13 07/05/2024

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
All enzyme values are quoted to a temperature of 37°C, unless otherwise stated
Method COAGULATION CONTROL - LEVEL 2 (COAG CONTROL 2)

Lot. No: 405CG Cat. No: CG5022 Expiry: 2025-09-28

Size: 12 x 1 ml Range
Analyte Unit Target Low High 1SD 2SD Method
Fibrinogen g/l 2.00 1.60 2.40 0.200 0.400 Media IVD Fibrinogen
mg/dl 200 160 240 20.0 40.0
g/l 1.90 1.52 2.28 0.190 0.380 Mindray/Longisland Fibrinogen
mg/dl 190 152 228 19.0 38.0
g/l 1.79 1.43 2.15 0.180 0.360 MTI Diagnostics Fibrinogen
mg/dl 179 143 215 18.0 36.0
g/l 1.62 1.30 1.94 0.160 0.320 Renam Fibrinogen
mg/dl 162 130 194 16.0 32.0
g/l 2.02 1.62 2.42 0.200 0.400 Roche Cobas t411 Fibrinogen
mg/dl 202 162 242 20.0 40.0
g/l 2.14 1.71 2.57 0.215 0.430 Roche Cobas t511/t711 Fibrinogen
mg/dl 214 171 257 21.5 43.0
g/l 2.11 1.69 2.53 0.210 0.420 Sclavo Fibrinogen
mg/dl 211 169 253 21.0 42.0
g/l 1.52 1.22 1.82 0.150 0.300 Siem/DadeThromboplastin deriv.Fibrinogen
mg/dl 152 122 182 15.0 30.0
g/l 1.48 1.18 1.78 0.150 0.300 Siemens/Dade Innovin derived Fibrinogen
mg/dl 148 118 178 15.0 30.0
g/l 1.91 1.53 2.29 0.190 0.380 Siemens/Dade Multifibren U
mg/dl 191 153 229 19.0 38.0
g/l 1.73 1.38 2.08 0.175 0.350 Siemens/Dade Thrombin
mg/dl 173 138 208 17.5 35.0
g/l 2.05 1.64 2.46 0.205 0.410 Stago Fibrinogen/ Liquid-Fib
mg/dl 205 164 246 20.5 41.0
g/l 1.99 1.59 2.39 0.200 0.400 Stago STA Fibri-Prest Automate
mg/dl 199 159 239 20.0 40.0
g/l 2.08 1.66 2.50 0.210 0.420 Tcoag TriniCLOT Fibrinogen
mg/dl 208 166 250 21.0 42.0
g/l 2.39 1.91 2.87 0.240 0.480 Technoclone Fibrinogen
mg/dl 239 191 287 24.0 48.0
g/l 1.80 1.44 2.16 0.180 0.360 Teco Teclot Fibrinogen
mg/dl 180 144 216 18.0 36.0
g/l 1.96 1.57 2.35 0.195 0.390 Thalys Fibrinogen
mg/dl 196 157 235 19.5 39.0
g/l 1.69 1.35 2.03 0.170 0.340 Yumizen G Fibrinogen
mg/dl 169 135 203 17.0 34.0
Plasminogen activity % 67.6 54.1 81.1 6.75 13.5 Hemosil Plasminogen
% 78.9 63.1 94.7 7.90 15.8 Siemens/Dade Berichrom Plasminogen
Protein C activity % 65.5 52.4 78.6 6.55 13.1 IL HemosIL Protein C

Page 7 of 13 07/05/2024

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
All enzyme values are quoted to a temperature of 37°C, unless otherwise stated
Method COAGULATION CONTROL - LEVEL 2 (COAG CONTROL 2)

Lot. No: 405CG Cat. No: CG5022 Expiry: 2025-09-28

Size: 12 x 1 ml Range
Analyte Unit Target Low High 1SD 2SD Method
Protein C activity % 69.5 55.6 83.4 6.95 13.9 Siemens/Dade Berichrom Protein C
% 82.3 65.8 98.8 8.25 16.5 Siemens/Dade Protein C Clotting
% 74.6 59.7 89.5 7.45 14.9 STAChrom Protein C
% 74.8 59.8 89.8 7.50 15.0 Stago StaClot
Protein S activity % 71.2 49.8 92.6 10.7 21.4 IL HemosIL Free Protein S
% 76.5 53.6 99.4 11.5 22.9 IL HemosIL ProS
% 68.1 47.7 88.5 10.2 20.4 IL HemosIL Protein S Activity
% 70.9 49.6 92.2 10.7 21.3 Siemens Innovance Free PS Ag
% 57.1 40.0 74.2 8.55 17.1 Siemens/Dade Protein S Ac
% 75.1 52.6 97.6 11.3 22.5 STA Liatest
% 71.1 49.8 92.4 10.7 21.3 Stago StaClot
Prothrombin Time (PT) seconds 15.9 12.7 19.1 1.60 3.20 Beijing Succeeder PT
seconds 12.9 10.3 15.5 1.30 2.60 Bio-Ksel PT Plus
seconds 13.1 10.5 15.7 1.30 2.60 Bio-Ksel System PT
seconds 21.1 16.9 25.3 2.10 4.20 Biolabo Bio-TP
seconds 22.4 17.9 26.9 2.25 4.50 Biolabo Bio-TP (Low ISI)
seconds 19.7 15.8 23.6 1.95 3.90 Biomedica QuikCoag PT-HS
seconds 17.9 14.3 21.5 1.80 3.60 DG Lab APTT
seconds 17.9 14.3 21.5 1.80 3.60 Diagon, Dia-PT
seconds 15.8 12.6 19.0 1.60 3.20 Diagon, Dia-PT R
seconds 12.5 10.0 15.0 1.25 2.50 DIRUI PT
seconds 18.9 15.1 22.7 1.90 3.80 Dutch Diagnostics PT
seconds 18.1 14.5 21.7 1.80 3.60 Erba Protime PT
seconds 13.2 10.6 15.8 1.30 2.60 Fortress Diagnostics PT with Calcium
seconds 18.9 15.1 22.7 1.90 3.80 Helena Thromboplastin

Page 8 of 13 07/05/2024

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
All enzyme values are quoted to a temperature of 37°C, unless otherwise stated
Method COAGULATION CONTROL - LEVEL 2 (COAG CONTROL 2)

Lot. No: 405CG Cat. No: CG5022 Expiry: 2025-09-28

Size: 12 x 1 ml Range
Analyte Unit Target Low High 1SD 2SD Method
Prothrombin Time (PT) seconds 20.2 16.2 24.2 2.00 4.00 HemosIL PT-Fibrinogen HS Plus
seconds 13.5 10.8 16.2 1.35 2.70 HemosIL ReadiPlasTin
seconds 13.6 10.9 16.3 1.35 2.70 HemosIL RecombiPlasTin 2G
seconds 18.6 14.9 22.3 1.85 3.70 Human Thromboplastin
seconds 17.9 14.3 21.5 1.80 3.60 Labitec PT
seconds 18.9 15.1 22.7 1.90 3.80 Media IVD PT
seconds 16.9 13.5 20.3 1.70 3.40 Mindray/Longisland PT
seconds 17.9 14.3 21.5 1.80 3.60 MTI Diagnostics Prothrombin Time
seconds 20.1 16.1 24.1 2.00 4.00 Roche Cobas PT Rec
seconds 14.3 11.4 17.2 1.45 2.90 Roche Cobas PT Screen
seconds 17.5 14.0 21.0 1.75 3.50 Sclavo PT
seconds 17.5 14.0 21.0 1.75 3.50 Siemens/Dade Innovin
seconds 13.8 11.0 16.6 1.40 2.80 Siemens/Dade Thromborel IS
seconds 13.6 10.9 16.3 1.35 2.70 Siemens/Dade Thromborel S
seconds 21.1 16.9 25.3 2.10 4.20 Stago Neoplastine CI
seconds 15.8 12.6 19.0 1.60 3.20 Stago Neoplastine R
seconds 19.8 15.8 23.8 2.00 4.00 Stago STA Neoplastine CI Plus
seconds 23.1 18.5 27.7 2.30 4.60 Stago STA-NeoPTimal
seconds 25.5 20.4 30.6 2.55 5.10 Tcoag TriniCLOT PT Excel S

Page 9 of 13 07/05/2024

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
All enzyme values are quoted to a temperature of 37°C, unless otherwise stated
Method COAGULATION CONTROL - LEVEL 2 (COAG CONTROL 2)

Lot. No: 405CG Cat. No: CG5022 Expiry: 2025-09-28

Size: 12 x 1 ml Range
Analyte Unit Target Low High 1SD 2SD Method
Prothrombin Time (PT) seconds 19.8 15.8 23.8 2.00 4.00 Technoclone Technoplastin HIS
seconds 17.3 13.8 20.8 1.75 3.50 Teco TEClot PT-S
seconds 18.2 14.6 21.8 1.80 3.60 Thalys PT-HIS
seconds 17.4 13.9 20.9 1.75 3.50 Yumizen G PT
seconds 20.1 16.1 24.1 2.00 4.00 Yumizen G PT Liq
Prothrombin Time (PT) % 85.8 68.6 103 8.60 17.2 Bio-Ksel PT Plus
activity
% 49.3 39.4 59.2 4.95 9.90 Biolabo Bio-TP (Low ISI)
% 46.1 36.9 55.3 4.60 9.20 Diagon, Dia-PT
% 51.6 41.3 61.9 5.15 10.3 HemosIL PT-Fibrinogen HS Plus
% 75.5 60.4 90.6 7.55 15.1 HemosIL ReadiPlasTin
% 75.5 60.4 90.6 7.55 15.1 HemosIL RecombiPlasTin 2G
% 45.0 36.0 54.0 4.50 9.00 Human Thromboplastin
% 55.6 44.5 66.7 5.55 11.1 Media IVD PT
% 30.3 24.2 36.4 3.05 6.10 Roche Cobas PT Rec
% 65.4 52.3 78.5 6.55 13.1 Roche Cobas PT Screen
% 64.8 51.8 77.8 6.50 13.0 Sclavo PT
% 39.0 31.2 46.8 3.90 7.80 Siemens/Dade Innovin
% 72.7 58.2 87.2 7.25 14.5 Siemens/Dade Thromborel S
% 51.0 40.8 61.2 5.10 10.2 Stago Neoplastine CI
% 57.2 45.8 68.6 5.70 11.4 Stago Neoplastine CL Plus -Etaloquick
% 72.4 57.9 86.9 7.25 14.5 Stago Neoplastine R
% 85.6 68.5 103 8.70 17.4 Stago SPA
% 52.7 42.2 63.2 5.25 10.5 Stago STA Neoplastine CI Plus
% 44.8 35.8 53.8 4.50 9.00 Stago STA-NeoPTimal
% 31.5 25.2 37.8 3.15 6.30 Tcoag TriniCLOT PT Excel S
% 71.6 57.3 85.9 7.15 14.3 Technoclone Technoplastin HIS
% 50.0 40.0 60.0 5.00 10.0 Teco TEClot PT-S
% 39.6 31.7 47.5 3.95 7.90 Thalys PT-HIS
% 46.6 37.3 55.9 4.65 9.30 Yumizen G PT
% 34.5 27.6 41.4 3.45 6.90 Yumizen G PT Liq
Prothrombin Time (PT) INR 1.27 1.02 1.52 0.125 0.250 Beijing Succeeder PT
INR
INR 1.19 0.952 1.43 0.120 0.240 Bio-Ksel PT Plus
INR 1.77 1.42 2.12 0.175 0.350 Biolabo Bio-TP
INR 1.83 1.46 2.20 0.185 0.370 Biolabo Bio-TP (Low ISI)

Page 10 of 13 07/05/2024

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
All enzyme values are quoted to a temperature of 37°C, unless otherwise stated
Method COAGULATION CONTROL - LEVEL 2 (COAG CONTROL 2)

Lot. No: 405CG Cat. No: CG5022 Expiry: 2025-09-28

Size: 12 x 1 ml Range
Analyte Unit Target Low High 1SD 2SD Method
Prothrombin Time (PT) INR 1.70 1.36 2.04 0.170 0.340 Biomedica QuikCoag PT-HS
INR
INR 1.54 1.23 1.85 0.155 0.310 DG Lab APTT
INR 1.49 1.19 1.79 0.150 0.300 Diagon, Dia-PT
INR 1.47 1.18 1.76 0.145 0.290 Diagon, Dia-PT R
INR 1.07 0.856 1.28 0.105 0.210 DIRUI PT
INR 1.62 1.30 1.94 0.160 0.320 Dutch Diagnostics PT
INR 1.52 1.22 1.82 0.150 0.300 Erba Protime PT
INR 1.42 1.14 1.70 0.140 0.280 Helena Thromboplastin
INR 1.31 1.05 1.57 0.130 0.260 HemosIL PT-Fibrinogen
INR 1.51 1.21 1.81 0.150 0.300 HemosIL PT-Fibrinogen HS Plus
INR 1.21 0.968 1.45 0.120 0.240 HemosIL ReadiPlasTin
INR 1.20 0.960 1.44 0.120 0.240 HemosIL RecombiPlasTin 2G
INR 1.57 1.26 1.88 0.155 0.310 Human Thromboplastin
INR 1.47 1.18 1.76 0.145 0.290 Labitec PT
INR 1.45 1.16 1.74 0.145 0.290 Media IVD PT
INR 1.34 1.07 1.61 0.135 0.270 Mindray/Longisland PT
INR 1.66 1.33 1.99 0.165 0.330 MTI Diagnostics Prothrombin Time
INR 1.38 1.10 1.66 0.140 0.280 Pacific Thromboplastin DS
INR 2.08 1.66 2.50 0.210 0.420 Roche Cobas PT Rec
INR 1.37 1.10 1.64 0.135 0.270 Roche Cobas PT Screen
INR 1.42 1.14 1.70 0.140 0.280 Sclavo PT
INR 1.74 1.39 2.09 0.175 0.350 Siemens/Dade Innovin
INR 1.19 0.952 1.43 0.120 0.240 Siemens/Dade Thromborel S
INR 1.56 1.25 1.87 0.155 0.310 Spinreact PT
INR 1.80 1.44 2.16 0.180 0.360 Stago Neoplastine CI
INR 1.52 1.22 1.82 0.150 0.300 Stago Neoplastine CL Plus -Etaloquick
INR 1.17 0.936 1.40 0.115 0.230 Stago Neoplastine R
INR 1.07 0.856 1.28 0.105 0.210 Stago SPA
INR 1.61 1.29 1.93 0.160 0.320 Stago STA Neoplastine CI Plus
INR 1.80 1.44 2.16 0.180 0.360 Stago STA-NeoPTimal
INR 1.22 0.976 1.46 0.120 0.240 Technoclone Technoplastin HIS
INR 1.33 1.06 1.60 0.135 0.270 Teco TEClot PT-S
INR 1.60 1.28 1.92 0.160 0.320 Thalys PT-HIS
INR 3.20 2.56 3.84 0.320 0.640 Wiener Lab Soluplastin
INR 1.49 1.19 1.79 0.150 0.300 Yumizen G PT
INR 1.87 1.50 2.24 0.185 0.370 Yumizen G PT Liq
INR 1.73 1.38 2.08 0.175 0.350 Yumizen G PT Reco
Prothrombin Time (PT) RATIO 1.18 0.944 1.42 0.120 0.240 HemosIL RecombiPlasTin 2G
ratio
RATIO 1.53 1.22 1.84 0.155 0.310 Human Thromboplastin

Page 11 of 13 07/05/2024

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
All enzyme values are quoted to a temperature of 37°C, unless otherwise stated
Method COAGULATION CONTROL - LEVEL 2 (COAG CONTROL 2)

Lot. No: 405CG Cat. No: CG5022 Expiry: 2025-09-28

Size: 12 x 1 ml Range
Analyte Unit Target Low High 1SD 2SD Method
Prothrombin Time (PT) RATIO 1.31 1.05 1.57 0.130 0.260 Sclavo PT
ratio
RATIO 1.77 1.42 2.12 0.175 0.350 Siemens/Dade Innovin
RATIO 1.18 0.944 1.42 0.120 0.240 Siemens/Dade Thromborel S
RATIO 1.58 1.26 1.90 0.160 0.320 Stago STA Neoplastine CI Plus
RATIO 1.76 1.41 2.11 0.175 0.350 Stago STA-NeoPTimal
RATIO 1.60 1.28 1.92 0.160 0.320 Thalys PT-HIS
Thrombin Time (TT) seconds 25.9 20.7 31.1 2.60 5.20 Biolabo Bio-TT
seconds 19.6 15.7 23.5 1.95 3.90 Erba Thrombin Time
seconds 17.8 14.2 21.4 1.80 3.60 Helena Thrombin Clotting Time rgt
seconds 23.6 18.9 28.3 2.35 4.70 HemosIL Thrombin Time 5ml
seconds 17.4 13.9 20.9 1.75 3.50 Mindray/Longisland TT
seconds 30.6 24.5 36.7 3.05 6.10 Renam TT
seconds 35.4 28.3 42.5 3.55 7.10 Siemens BC Thrombin
seconds 27.8 22.2 33.4 2.80 5.60 Siemens Test Thrombin
seconds 28.4 22.7 34.1 2.85 5.70 Siemens/Dade Thrombin
seconds 23.4 18.7 28.1 2.35 4.70 Siemens/Dade Thromboclotin
seconds 29.9 23.9 35.9 3.00 6.00 Stago Thrombin
seconds 27.1 21.7 32.5 2.70 5.40 Sysmex Thrombin Time
seconds 16.4 13.1 19.7 1.65 3.30 Thalys TT

Page 12 of 13 07/05/2024

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com
All enzyme values are quoted to a temperature of 37°C, unless otherwise stated
Sunbio UP1500 Coagulation Control - Level 2 (Coag Control 2)
Lot. No: 405CG Cat. No: CG5022 Expiry: 2025-09-28
Size: 12 x 1 ml Range
Analyte Unit Target Low High 1SD 2SD Method
Activated Partial Seconds 46.1 36.9 55.3 4.60 9.20 SUNBIO APTT (ELLAGIC ACID)
Thromboplastin Time
(APTT)
Activated Partial RATIO 1.75 1.40 2.10 0.175 0.350 SUNBIO APTT (ELLAGIC ACID)
Thromboplastin Time
(APTT) Ratio
Antithrombin III activity % 72.2 57.8 86.6 7.20 14.4 SUNBIO AT III
Fibrinogen g/l 1.98 1.58 2.38 0.200 0.400 SUNBIO Fibrinogen
mg/dl 198 158 238 20.0 40.0
Prothrombin Time (PT) Seconds 15.6 12.5 18.7 1.55 3.10 SUNBIO PT
Prothrombin Time (PT) % 52.3 41.8 62.8 5.25 10.5 SUNBIO PT
activity
PT as a ratio RATIO 1.30 1.04 1.56 0.130 0.260 SUNBIO PT
PT as an INR INR 1.34 1.07 1.61 0.135 0.270 SUNBIO PT
Thrombin Time (TT) Seconds 20.9 16.7 25.1 2.10 4.20 SUNBIO TT

Page 13 of 13 2025/03/13

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: Email: applications@randox.com Website: www.randox.com
All enzyme values are quoted to a temperature of 37°C, unless otherwise stated
COAGULATION CONTROL - LEVEL 2
(COAG CONTROL 2)
CAT. NO. CG5022 LOT NO. 405CG
SIZE: 12 x 1 ml EXPIRY: 2025-09-28
GTIN: 05055273207637

INTENDED USE
This product is intended for in vitro diagnostic use, and in the quality control of coagulation systems. The Coagulation Controls are for
the control of accuracy and precision.

DEVICE DESCRIPTION
The Coagulation Controls are supplied at 3 levels, level 1, 2 and 3. Target values and ranges are supplied for the analytes listed in the
values section.

SAFETY PRECAUTIONS AND WARNINGS

The controls are intended for in vitro diagnostic use only. Do not pipette by mouth. Exercise the normal precautions required for
handling laboratory reagents and controls.

Human source material, which has been added, 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 was 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.

Health and Safety Data sheets are available on request.

STORAGE AND STABILITY

OPENED: Store refrigerated (+2°C to +8°C). APTT, TT, PT, Fibrinogen and Antithrombin III in reconstituted control are stable for 24
hours at +2°C to +8°C if kept capped in original container and free from contamination. Protein C, Protein S, Plasminogen, and
Factors II, V, VII, VIII, IX, X, XI, XII are stable for 8 hours at +2°C to +8°C. Only the required amount of product should be removed.
After use, any residual product should NOT BE RETURNED to the original vial.

UNOPENED: Store refrigerated (+2°C to +8°C). Stable to expiration date printed on individual vials.

PREPARATION FOR USE

The Coagulation Controls are supplied lyophilised.

1. Carefully reconstitute each vial of lyophilised control with exactly 1 ml of distilled water at +15°C to +25°C. Close the bottle and
allow to stand for 30 minutes before use. Ensure contents are completely dissolved by swirling gently. Avoid the formation of
foam. Do not shake the vial.

2. Refer to the Control section of the individual analyser application.

3. Refrigerate any unused material. Prior to reuse, mix the contents of the vial thoroughly.

MATERIALS PROVIDED
Coagulation Control - Level 2 12 x 1 ml

MATERIALS REQUIRED BUT NOT PROVIDED

Volumetric pipette

ASSIGNED 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 Coagulation Control is submitted to a number of external laboratories. Values are assigned from a consensus of results
obtained by these laboratories and internal testing conducted at Randox Laboratories Ltd. The expected range of the mean is provided
to aid laboratory until it has established its own mean and SD for its test methods.

Randox Teoranta, Meenmore,

Dungloe, Donegal,
F94 TV06, Ireland

(S). 01 Apr ’25 me

PAGE 1 OF 2
COAGULATION CONTROL - LEVEL 2 (COAG CONTROL 2)
Lot. No: 405CG Cat. No: CG5022 Expiry: 2025-09-28
Size: 12 x 1 ml Range
Analyte Unit Target Low High 1SD 2SD Method
Activated Partial Thromboplastin Time (APTT) seconds 46.3 37.0 55.5 3.09 6.18 Mindray/CX Series APTT
Antithrombin III activity % 72.4 57.9 86.9 4.80 9.60 Mindray/CX Series ATIII
Fibrinogen g/l 1.87 1.50 2.24 0.13 0.25 Mindray/CX Series FIB
mg/dl 187 150 224 12.5 25.0
Thrombin Time (TT) seconds 17.5 14.0 20.9 1.16 2.32 Mindray/CX Series TT

PAGE 2 OF 2