LIPID CONTROL - LEVEL 1 (LPD CONTROL 1)
Cat. No. LE2661 Lot No. 3097CH
Size: 5 x 3 ml Expiry: 2026-10-28
GTIN: 05055273204155
INTENDED USE
This product is intended for in vitro use in the quality control of Direct HDL, Direct LDL, Lipoprotein (a),
Apolipoprotein A-1, Apolipoprotein B, Cholesterol and Triglyceride methods on clinical chemistry systems.
SAFETY PRECAUTIONS AND WARNINGS
Human source material, from which this product has been derived, has been tested at donor level for the Human
Immunodeficiency Virus (HIV1 & HIV2) antibody, Hepatitis B surface antigen (HbsAg) and the 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 disease. For in vitro diagnostic use only.
STORAGE AND STABILITY
Unopened Lipid Control is stable until the expiry date printed on the product label when stored between +2ºC and
+8ºC. Once reconstituted, the components of the serum are stable for 7 days at +2ºC to +8ºC, and 4 weeks at –20ºC
when frozen once. The following exceptions apply: LP(a) is stable for 16 weeks at –20ºC when frozen once. Values may
drop by up to 10% for Direct LDL Cholesterol when stored for 4 weeks at –20ºC.
PREPARATION FOR USE
Open the vial carefully, avoiding any loss of the material and reconstitute with 3 ml of distilled water. Replace the rubber
stopper, close the vial and leave to stand for 30 minutes before use. Ensure that all traces of dry material are dissolved
by swirling gently.
MATERIALS PROVIDED
Lipid Control - Level 1 5 x 3 ml
MATERIALS REQUIRED BUT NOT PROVIDED
Distilled water
Volumetric pipette
VALUE ASSIGNMENT
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 Lipid 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.
If a method is unavailable, contact Randox Laboratories - Technical Services, Northern Ireland, tel: +44 (0) 28 9445 1070
or email [email protected].
Randox Teoranta, Meenmore,
Dungloe, Donegal,
F94 TV06, Ireland
17 Jun ’24 me
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LIPID CONTROL - LEVEL 1 (LPD CONTROL 1)
Lot. No. 3097CH Cat. No. LE2661
Size 5 x 3 ml Expiry 2026-10-28 Range
Analyte unit Target low high methods
Apolipoprotein A-1 g/l 1.03 0.85 1.22 Immunoturbidimetric
mg/dl 103 84.5 122
g/l 1.04 0.85 1.23 Nephelometric
mg/dl 104 85.3 123
Apolipoprotein B g/l 0.84 0.69 0.99 Immunoturbidimetric
mg/dl 84.0 68.9 99.0
g/l 0.84 0.69 0.99 Nephelometric
mg/dl 84.0 68.9 99.0
Cholesterol mmol/l 4.09 3.56 4.62 Cholesterol Oxidase - Abell Kendall
mg/dl 158 137 179
mmol/l 4.07 3.54 4.60 Siemens Dimension
mg/dl 157 137 177
mmol/l 4.12 3.58 4.66 Cholesterol Oxidase - IDMS
mg/dl 159 138 180
HDL - Cholesterol mmol/l 1.03 0.88 1.18 Direct Clearance Method
mg/dl 39.8 33.8 45.8
mmol/l 0.97 0.83 1.12 Direct HDL Immunoseparation
mg/dl 37.4 31.8 43.0
mmol/l 1.04 0.88 1.20 Direct HDL PEGME
mg/dl 40.1 34.1 46.1
mmol/l 1.07 0.91 1.23 Direct HDL PPD
mg/dl 41.3 35.1 47.5
mmol/l 0.90 0.77 1.04 Direct HDL Roche 4th Generation
mg/dl 34.7 29.5 39.9
LDL - Cholesterol mmol/l 2.74 2.33 3.15 Direct Clearance Method
mg/dl 106 89.9 122
mmol/l 2.37 2.01 2.73 Calculated
mg/dl 91.5 77.6 105
mmol/l 2.40 2.04 2.76 Selective detergent methods
mg/dl 92.6 78.7 107
Lipoprotein (a) mg/dl 16.4 13.1 19.7 Immunoturbidimetric
nmol/l 30.5 24.4 36.6
Triglycerides mmol/l 1.39 1.17 1.61 Lipase/GPO-PAP no correction
mg/dl 123 104 142
mmol/l 1.40 1.18 1.62 Lipase/GPO-PAP 0.11mmol/l correction
mg/dl 124 104 144
mmol/l 1.42 1.19 1.65 Lipase/GK UV no correction
mg/dl 126 105 147
mmol/l 1.44 1.21 1.67 Lipase/Glycerol Dehydrogenase
mg/dl 127 107 147
___________________________________________________________________________________________________
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 PAGE 2 OF 2
Email: [email protected] Website: www.randox.com
