PRODUCT INFORMATION

HE1532

1375UE

Please note that the concentration of Bile Acids and Vitamin B12 are higher in lot 1375UE
compared with previous elevated controls. The targets and ranges should be reviewed in line
with your assay range. For any queries regarding this, please contact
[email protected]

CCS INC1146

Page 1 of 1 FORM NO. 8373-GP

REVISION (2)
2 Aug 2019
 2797

HUMAN ASSAYED MULTI-SERA - LEVEL 3

(HUM ASY CONTROL 3)
CAT. NO. HE1532 GTIN: 05055273203608 SIZE: 20 x 5ml
CAT. NO. HS2611 GTIN: 05055273203813 SIZE: 5 x 5ml
LOT NO. 1375UE EXPIRY: 2028-08-28
INTENDED USE
This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Human Assayed Multi-
sera is for the control of accuracy.

DEVICE DESCRIPTION
The Human Assayed Multi-sera is supplied at 2 levels, level 2 and 3. Target values and ranges are supplied for the analytes
listed in the values section at both levels.

SAFETY PRECAUTIONS AND WARNINGS

For in vitro diagnostic use only. Do not pipette by mouth. Exercise the normal precautions required for handling
laboratory reagents.

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.

Health and Safety Data Sheets are available on request.

STORAGE AND STABILITY

OPENED: Store refrigerated (+2°C to +8°C). Reconstituted serum is stable for 8 hours at +15°C to +25°C or 7 days
at +2°C to +8°C, and 28 days when frozen once at –18°C to –24°C. (See Limitations)

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

LIMITATIONS
For Total & Prostatic Acid Phosphatase, the material should be stabilised by adding 1 drop (25µl - 30µl) of 0.7M Acetic
acid solution to 1ml of the serum exactly 30 minutes after reconstitution. After stabilisation Total and Prostatic Acid
Phosphatase is stable for 2 hours at +15°C to +25°C, 2 days at +2°C to +8°C, and 28 days when frozen once at –18°C to
–24°C. Alkaline Phosphatase levels in the reconstituted serum will rise over the stability period. It is recommended that
the reconstituted serum is allowed to stand for 1 hour at +15°C to +25°C before measurement.
Bilirubin in the serum is light sensitive and it is recommended that the serum is stored in the dark. Stored in the dark, it is
stable for 4 days at +2°C to +8°C. Do not store at +15°C to +25°C. Do not freeze.
GLDH is stable for 2 days at +2°C to +8°C.
NEFA is stable for 1 day at +2°C to +8°C.
Total PSA is stable for 4 days at +2°C to +8°C, or 28 days in aliquots frozen at –18°C to –24°C.
Bacterial contamination of the reconstituted serum will cause reductions in the stability of many components.
Different lot numbers of this control should not be interchanged, as the values assigned to the controls vary from lot to
lot. The control should not be used as a calibration material.

Due to the zinc content in some batches of rubber stoppers, the QC and calibrator material should be aliquoted into
polypropylene tubes and stored at +2°C to +8°C to ensure stable zinc levels throughout the stability period.

PAGE 1 OF 2
 HE1532 - Lot No. 1375UE 2797

PREPARATION FOR USE

The Human Assayed Multi-sera is supplied lyophilised.

1. Carefully reconstitute each vial of lyophilised serum with exactly 5ml 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 formation of foam. Do not shake.

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

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

MATERIALS PROVIDED
Human Assayed Multi-sera - Level 3 20 x 5ml / 5 x 5ml

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 Assayed Human Serum Control is assigned at Randox Laboratories and a number of external laboratories.
Values are assigned from a consensus of results obtained by these laboratories.

With each batch, a control range is provided for individual parameters and each parameter method. The control range is
equivalent to the assigned mean ±2S.D.

If an instrument specific value is not available, refer to the Method section. If necessary, contact Randox Laboratories -
Technical Services, Northern Ireland, tel: +44 (0) 28 9445 1070 or email [email protected].

NOTES
® All trademarks recognised.

(1) Applies only in Germany. Ranges established according to the Guidelines of the Federal Chamber of Physicians in
Germany.
(2) Values established by reference laboratories officially recognised by the Federal Chamber of Physicians in
Germany.
(3) DGKC: German Society for Clinical Chemistry.
(4) IFCC: International Federation of Clinical Chemistry.
(5) SCE: Scandinavian Committee on Enzymes.

Randox Teoranta, Meenmore,

Dungloe, Donegal,
F94 TV06, Ireland

Rev. 25 Sep ’24 me

PAGE 2 OF 2
Table of Content
Method 2

Page 1 of 4 2025/03/12

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: [email protected] Website: www.randox.com
All enzyme values are quoted to a temperature of 37°C, unless otherwise stated
Method Human Assayed Multi-Sera - Level 3
Lot. No: 1375UE Cat. No: HE1532 Expiry: 2028-08-28
Size: 20 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Albumin g/dl 3.08 2.62 3.54 0.230 0.460 Bromocresol Green
g/l 30.8 26.2 35.4 2.30 4.60
Alkaline Phosphatase U/l 371 315 427 28.0 56.0 AMP optimised to IFCC
U/l 559 475 643 42.0 84.0 Diethanolamine buffer, DEA
alpha - HBDH U/l 398 314 482 42.0 84.0 Oxobutyrate < 10 mmol/l
ALT (GPT) U/l 151 121 181 15.0 30.0 Tris Buffer Without P5P
Amylase Pancreatic U/l 306 260 352 23.0 46.0 Randox Liquid Ethylidene pNPG7
Amylase Total U/l 308 262 354 23.0 46.0 Randox Liquid Ethylidene pNPG7
Apolipoprotein A1 g/l 0.931 0.763 1.10 0.085 0.169 Immunoturbidimetric
mg/dl 93.1 76.3 110 8.45 16.9
Apolipoprotein B g/l 0.632 0.518 0.746 0.057 0.114 Immunoturbidimetric
mg/dl 63.2 51.8 74.6 5.70 11.4
AST (GOT) U/l 152 122 182 15.0 30.0 Tris Buffer Without P5P
Bicarbonate mmol/l 13.3 10.5 16.1 1.40 2.80 Enzymatic
Bile Acids µmol/l 92.0 73.6 110 9.00 18.0 5th Generation Colorimetric
Bilirubin Direct mg/dl 1.95 1.54 2.36 0.205 0.410 Modified Jendrassik
µmol/l 33.3 26.3 40.3 3.50 7.00
mg/dl 2.01 1.59 2.43 0.210 0.420 Diazo With Sulphanilic Acid
µmol/l 34.4 27.2 41.6 3.60 7.20
Bilirubin Total mg/dl 5.80 4.58 7.02 0.610 1.22 Modified Jendrassik
µmol/l 99.1 78.3 120 10.5 20.9
mg/dl 5.11 4.04 6.18 0.535 1.07 Diazo With Sulphanilic Acid
µmol/l 87.3 69.0 106 9.35 18.7
Calcium mg/dl 12.7 11.4 14.0 0.650 1.30 Arsenazo III
mmol/l 3.18 2.86 3.50 0.160 0.320
Chloride mmol/l 113 104 122 4.50 9.00 ISE Direct
Cholesterol mg/dl 322 280 364 21.0 42.0 Cholesterol Oxidase - Abell Kendall
mmol/l 8.33 7.25 9.41 0.540 1.08
Cholinesterase U/l 5393 4314 6472 540 1079 Colorimetric - Butyrylthiocholine
CK Total U/l 556 456 656 50.0 100 CK-NAC (IFCC)
Copper µg/dl 179 143 215 18.0 36.0 Colorimetric
µmol/l 28.2 22.6 33.8 2.80 5.60
Cortisol nmol/l 1004 753 1255 126 251 Roche Cobas e402/e801
µg/dl 36.1 27.1 45.1 4.50 9.00
Creatinine mg/dl 3.70 2.96 4.44 0.370 0.740 Alkaline picrate no deproteinisation
µmol/l 327 262 392 32.5 65.0
mg/dl 4.72 3.78 5.66 0.470 0.940 Enzymatic UV method
µmol/l 418 334 502 42.0 84.0
D-3-Hydroxybutyrate mmol/l 1.13 0.961 1.30 0.085 0.170 Tris buffer 100mmol pH 8.5

Page 2 of 4 2025/03/12

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: [email protected] Website: www.randox.com
All enzyme values are quoted to a temperature of 37°C, unless otherwise stated
Method Human Assayed Multi-Sera - Level 3
Lot. No: 1375UE Cat. No: HE1532 Expiry: 2028-08-28
Size: 20 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
Digoxin ng/ml 2.82 2.26 3.38 0.280 0.560 Immunoturbidimetric
nmol/l 3.61 2.89 4.33 0.360 0.720
Folate ng/ml 2.56 1.95 3.17 0.305 0.610 Roche Cobas e402/e801
nmol/l 5.80 4.41 7.19 0.695 1.39
Free T4 ng/dl 5.76 4.32 7.20 0.720 1.44 Roche Cobas e402/e801
pg/ml 57.6 43.2 72.0 7.20 14.4
pmol/l 73.8 55.4 92.2 9.20 18.4
gamma-GT U/l 170 145 195 12.5 25.0 Gamma glut.-3-carb.-4-nitro.
Gentamicin µg/ml 9.08 7.26 10.9 0.910 1.82 Gravimetric
µmol/l 19.0 15.2 22.8 1.90 3.80
GLDH U/l 25 20 30 2.50 5.00 Triethanolamine buffer
Glucose mg/dl 292 248 336 22.0 44.0 Glucose Oxidase
mmol/l 16.2 13.8 18.6 1.20 2.40
mg/dl 279 237 321 21.0 42.0 Hexokinase
mmol/l 15.5 13.2 17.8 1.15 2.30
Immunoglobulin A g/l 1.91 1.43 2.39 0.240 0.480 Turbidimetric (IFCC Cal.)
mg/dl 191 143 239 24.0 48.0
Immunoglobulin G g/l 7.61 6.24 8.98 0.685 1.37 Turbidimetric (IFCC Cal.)
mg/dl 761 624 898 68.5 137
Immunoglobulin M g/l 0.887 0.710 1.06 0.087 0.173 Turbidimetric (IFCC Cal.)
mg/dl 88.7 71.0 106 8.65 17.3
Iron µg/dl 217 178 256 19.5 39.0 Colorimetric without ppt.
µmol/l 38.9 31.9 45.9 3.50 7.00
Lactate mg/dl 49.8 40.8 58.8 4.50 9.00 Colorimetric - Lactate oxidase
mmol/l 5.53 4.53 6.53 0.500 1.00
LD (LDH) U/l 370 315 425 27.5 55.0 L to P, IFCC
U/l 788 670 906 59.0 118 P to L, German methods
Lipase U/l 101 81 121 10.0 20.0 Colorimetric Randox
Magnesium mg/dl 4.42 3.89 4.95 0.265 0.530 Xylidyl Blue
mmol/l 1.82 1.60 2.04 0.110 0.220
NEFA mmol/l 0.420 0.336 0.504 0.042 0.084 Colorimetric
Paracetamol (Acetamin) mg/l 90.9 72.7 109 9.05 18.1 Gravimetric
mmol/l 0.600 0.480 0.720 0.060 0.120
Phosphate Inorganic mg/dl 7.38 6.27 8.49 0.555 1.11 Phosphomolybdate UV
mmol/l 2.38 2.02 2.74 0.180 0.360
Potassium mmol/l 6.43 5.92 6.94 0.255 0.510 Enzymatic
mmol/l 6.18 5.69 6.67 0.245 0.490 ISE Direct
Protein Total g/dl 4.83 3.86 5.80 0.485 0.970 Biuret reaction, end point
g/l 48.3 38.6 58.0 4.85 9.70

Page 3 of 4 2025/03/12

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: [email protected] Website: www.randox.com
All enzyme values are quoted to a temperature of 37°C, unless otherwise stated
Method Human Assayed Multi-Sera - Level 3
Lot. No: 1375UE Cat. No: HE1532 Expiry: 2028-08-28
Size: 20 x 5ml Range
Analyte Unit Target Low High 1SD 2SD Method
PSA Total ng/ml = 19.8 14.9 24.7 2.45 4.90 Roche Cobas e402/e801
µg/l
Salicylate mg/dl 12.0 9.60 14.4 1.20 2.40 Gravimetric
mmol/l 0.870 0.696 1.04 0.085 0.170
Sodium mmol/l 159 151 167 4.00 8.00 Enzymatic
mmol/l 160 152 168 4.00 8.00 ISE Direct
Theophylline µg/ml 25.0 20.0 30.0 2.50 5.00 Gravimetric
µmol/l 139 111 167 14.0 28.0
Thyroid Stimulating µU/ml = 1.33 1.06 1.60 0.135 0.270 Roche Cobas e402/e801
Hormone mlU/l
TIBC µg/dl 293 231 355 31.0 62.0 Direct Colorimetric
µmol/l 52.5 41.5 63.5 5.50 11.0
Tobramycin µg/ml 7.30 5.84 8.76 0.730 1.46 Gravimetric
µmol/l 15.6 12.5 18.7 1.55 3.10
Total T3 ng/dl 262 197 327 32.5 65.0 Roche Cobas e402/e801
ng/ml 2.63 1.97 3.29 0.330 0.660
nmol/l 4.04 3.03 5.05 0.505 1.01
Total T4 ng/ml 179 134 224 22.5 45.0 Roche Cobas e402/e801
nmol/l 230 173 287 28.5 57.0
µg/dl 17.9 13.4 22.4 2.25 4.50
Triglycerides mg/dl 261 219 303 21.0 42.0 Lipase/GPO-PAP No Correction
mmol/l 2.95 2.48 3.42 0.235 0.470
Urea mg/dl 123 105 141 9.00 18.0 Urease, kinetic
mg/dl 57.1 48.5 65.7 4.30 8.60
(BUN)
mmol/l 20.4 17.3 23.5 1.55 3.10
Uric Acid (Urate) mg/dl 10.0 8.70 11.3 0.650 1.30 Uricase perox. no ascorb. ox.
mmol/l 0.596 0.519 0.673 0.039 0.077
mg/dl 9.33 8.12 10.5 0.585 1.17 Uricase Perox. with ascorb. ox @ 546nm
mmol/l 0.555 0.483 0.627 0.036 0.072
Vitamin B12 pg/ml 496 397 595 49.5 99.0 Roche Cobas e402/e801
pmol/l 366 293 439 36.5 73.0
Zinc µg/dl 235 188 282 23.5 47.0 Colorimetric with deprot.
µmol/l 36.0 28.8 43.2 3.60 7.20

Page 4 of 4 2025/03/12

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: [email protected] Website: www.randox.com
All enzyme values are quoted to a temperature of 37°C, unless otherwise stated