2797

LIQUID TUMOUR MARKER CONTROL - LEVEL 1

(TMR LIQ CONTROL 1)
CAT. NO. TU 5085 LOT NO. 249TU
SIZE: 6 x 3 ml EXPIRY: 2021-10-28
GTIN: 05055273207354

INTENDED USE
This product is intended for in vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems. The
Liquid Tumor Marker Controls are for the control of accuracy and reproducibility for tumour marker analysis of Alpha-fetoprotein,
CA15-3, CA 19-9, CA 125, CA 27-29, CA 72-4, Cyfra 21-1, Carcinoembryonic Antigen, Neuron Specific Enolase, Total Prostate
Specific Antigen, Free Prostate Specific Antigen and Thyroglobulin and serum protein analysis of Beta-2-microglobulin, Ferritin and
Human Chorionic Gonadotropin (Total Beta hCG).

DEVICE DESCRIPTION
The Liquid Tumour Marker Controls are supplied at 3 levels, level 1, 2 and 3. Target values and ranges are supplied for 15 tumour
markers. The Liquid Tumour Marker Control is prepared from Human Serum and proteins.

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

UNOPENED: Store at +2ºC to +8ºC. Stable to expiration date printed on individual vials.

OPENED: Store refrigerated (+2ºC to +8ºC). The Liquid Tumour Marker Controls are stable for 30 days at +2ºC to +8ºC, if
kept capped in original container and free from contamination. Only the required amount of product should be
removed. After use, any residual product should NOT BE RETURNED to the original vial.

LIMITATIONS
No claim is made for the stability of CA 27-29, CA 72-4, Cyfra 21-1 and Neuron Specific Enolase (NSE).

PREPARATION FOR USE

The Liquid Tumour Marker controls are supplied ready to use.

MATERIALS PROVIDED
Liquid Tumour Marker Control - Level 1 6 x 3 ml

MATERIALS REQUIRED BUT NOT PROVIDED

Not applicable.

ASSIGNED VALUES
Each batch of Liquid Tumour Marker Controls 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 methods.

Rev. 21 Nov ’19 ne

PAGE 1 OF 3

LIQUID TUMOUR MARKER CONTROL - LEVEL 1 (TMR LIQ CONTROL 1)
Cat. No. TU5085 Lot No. 249TU
Size: 6 x 3 ml Expiry: 2021-10-28 Range
Analyte unit Target low high methods
Alpha-fetoprotein KIU/l = lU/ml 9.75 7.80 11.7 Beckman Access
ng/ml 11.8 9.44 14.2
KIU/l = lU/ml 8.00 6.40 9.60 Beckman DxI 600/800
ng/ml 9.68 7.74 11.6
KIU/l = lU/ml 7.47 5.98 8.96 Roche Cobas e series
ng/ml 9.04 7.24 10.8
KIU/l = lU/ml 9.17 7.34 11.0 Siemens Centaur XP/XPT/Classic
ng/ml 11.1 8.88 13.3
KIU/l = lU/ml 8.12 6.49 9.74 Siemens Immulite Series
ng/ml 9.82 7.85 11.8
KIU/l = lU/ml 8.10 6.48 9.72 Tosoh Series
ng/ml 9.80 7.84 11.8
Beta-2-microglobulin µg/ml = mg/l 6.00 4.80 7.20 Siemens BNII
µg/ml = mg/l 4.83 3.86 5.80 Siemens Immulite Series
µg/ml = mg/l 4.65 3.72 5.58 Tosoh Series
CA 15-3 U/ml 16.6 13.3 19.9 Beckman Access
U/ml 30.3 24.2 36.4 Roche Cobas e series
U/ml 33.3 26.6 40.0 Siemens Centaur XP/XPT/Classic
U/ml 35.2 28.2 42.2 Siemens Immulite Series
CA 19-9 U/ml 35.4 28.3 42.5 Beckman Access
U/ml 31.8 25.4 38.2 Beckman DxI 600/800
U/ml 26.1 20.9 31.3 Roche Cobas e series
U/ml 116 92.8 139 Siemens Centaur XP/XPT/Classic
U/ml 23.3 18.6 28.0 Tosoh Series
CA 72-4 U/ml 5.95 4.46 7.44 Roche Cobas e series
CA125 U/ml 23.5 18.8 28.2 Beckman Access
U/ml 46.9 37.5 56.3 Beckman DxI 600/800
U/ml 36.0 28.8 43.2 Roche Cobas e series
U/ml 35.9 28.7 43.1 Siemens Centaur XP/XPT/Classic
U/ml 25.8 20.6 31.0 Siemens Immulite Series
U/ml 52.4 41.9 62.9 Tosoh Series
CA27-29 U/ml 38.2 30.6 45.8 Siemens Centaur XP/XPT/Classic
U/ml 31.3 25.1 37.6 Tosoh Series
Carcinoembryonic Antigen (CEA) ng/ml = µg/l 4.51 3.61 5.41 Beckman Access
ng/ml = µg/l 3.82 3.06 4.58 Beckman DxI 600/800
ng/ml = µg/l 4.16 3.33 4.99 Roche Cobas e series
ng/ml = µg/l 3.87 3.10 4.64 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 4.79 3.83 5.75 Siemens Immulite Series
ng/ml = µg/l 5.90 4.72 7.08 Tosoh Series
Cyfra 21-1 ng/ml 4.83 3.62 6.04 Roche Cobas e series

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 2 OF 3
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com

LIQUID TUMOUR MARKER CONTROL - LEVEL 1 (TMR LIQ CONTROL 1)
Cat. No. TU5085 Lot No. 249TU
Size: 6 x 3 ml Expiry: 2021-10-28 Range
Analyte unit Target low high methods
Ferritin ng/ml = µg/l 20.1 16.1 24.1 Beckman Access
ng/ml = µg/l 18.9 15.1 22.7 Beckman DxI 600/800
ng/ml = µg/l 29.2 23.4 35.0 Roche Cobas e series
ng/ml = µg/l 24.2 19.4 29.0 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 22.3 17.8 26.8 Siemens BNII
ng/ml = µg/l 28.0 22.4 33.6 Siemens Dimension EXL
ng/ml = µg/l 25.7 20.6 30.8 Siemens Immulite Series
ng/ml = µg/l 18.2 14.6 21.8 Tosoh Series
Neuron Specific Enolase (NSE) ng/ml 0.95 0.71 1.19 Roche Cobas e series
PSA Free ng/ml = µg/l 0.56 0.42 0.70 Beckman Access
ng/ml = µg/l 0.47 0.35 0.58 Beckman DxI 600/800
ng/ml = µg/l 0.32 0.24 0.40 Roche Cobas e series
ng/ml = µg/l 0.34 0.26 0.43 Siemens Immulite Series
PSA Total ng/ml = µg/l 2.31 1.73 2.89 Beckman Access
ng/ml = µg/l 2.15 1.61 2.69 Beckman DxI 600/800
ng/ml = µg/l 1.96 1.47 2.45 Roche Cobas e series
ng/ml = µg/l 1.74 1.31 2.18 Siemens Centaur XP/XPT/Classic
ng/ml = µg/l 2.04 1.53 2.55 Siemens Dimension EXL
ng/ml = µg/l 1.59 1.19 1.99 Siemens Immulite Series
ng/ml = µg/l 1.91 1.43 2.39 Tosoh Series
Thyroglobulin ng/ml 4.79 3.59 5.99 Beckman Access
ng/ml 1.10 0.83 1.38 Beckman DxI 600/800
ng/ml 1.22 0.92 1.53 Siemens Immulite Series
Total Beta hCG mU/ml=IU/l 5.95 4.76 7.14 Beckman Access
IU/ml 0.006 0.005 0.007
mU/ml=IU/l 5.49 4.39 6.59 Beckman DxI 600/800
IU/ml 0.005 0.004 0.007
mU/ml=IU/l 6.18 4.94 7.42 BioMerieux Vidas
IU/ml 0.006 0.005 0.007
mU/ml=IU/l 5.26 4.21 6.31 Roche Cobas e series
IU/ml 0.005 0.004 0.006
mU/ml=IU/l 7.91 6.33 9.49 Siemens Centaur XP/XPT/Classic
IU/ml 0.008 0.006 0.009
mU/ml=IU/l 7.00 5.60 8.40 Siemens Dimension EXL
IU/ml 0.007 0.006 0.008
mU/ml=IU/l 13.8 11.0 16.6 Siemens Immulite Series
IU/ml 0.014 0.011 0.017
mU/ml=IU/l 9.20 7.36 11.0 Tosoh Series
IU/ml 0.009 0.007 0.011

___________________________________________________________________________________________________

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 3 OF 3
Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: applications@randox.com Website: www.randox.com