Lipotrol Control

Instructions for Use

Queensway South, Team Valley Trading Estate,

5069 Gateshead, Tyne and Wear, NE11 0SD,
United Kingdom
Tel: +44 (0)191 482 8440 Fax: +44 (0)191 482 8442
Email: info@helena-biosciences.com
Web: www.helena-biosciences.com
Helena Biosciences Europe
© 2019 Helena Laboratories (UK) Limited trading as Helena Biosciences Europe. All rights reserved.

INTENDED PURPOSE

The Lipotrol Control is intended for use as a quality control material.

Good laboratory practices require that test procedures be monitored with materials containing known concentrations of those
constituents to be assayed. Lipotrol Control is a control material in which the relative concentrations of the alpha, pre-beta and
beta lipoprotein fractions have been determined using recommended Helena Biosciences Europe procedures.

WARNINGS AND PRECAUTIONS

The reagents contained in this kit are for in vitro diagnostic use only – DO NOT INGEST. Wear appropriate personal protective
equipment when handling all kit components. Refer to the product safety declaration for the link to appropriate hazard and
precautionary statements where applicable. Dispose of components in accordance with local regulations.

Blood products have been screened and found negative (unless otherwise stated on the kit box or vial) for the presence of:
Hepatitis B Antigen (HbsAg)
HIV 1 antibody
HIV 2 antibody
HCV antibody
However they should be handled with the same precautions as a human patient sample.

COMPOSITION

1. LIPOTROL CONTROL (5 x 1mL)

LIPOTROL CONTROL is a Iyophilised control prepared from human serum, stabilisers have been added.

RECONSTITUTION

Reconstitute LIPOTROL CONTROL with 1mL of purified water. Swirl gently to mix and do not use until there is complete
dissolution.

STORAGE, SHELF-LIFE AND STABILITY

1. LIPOTROL CONTROL
The LIPOTROL CONTROL should be stored at 2...8°C and is stable until the expiry date indicated on the label. Reconstituted
control is stable for 3 days at 2...8°C.

Signs of Deterioration: Repeated failure of the assay value to fall within the expected ranges or failure of the fractions to
separate by electrophoresis may indicate deterioration.

INTERPRETATION OF RESULTS

The expected means and acceptable ranges for Lipotrol Control are printed on the assay sheet. The assay data was obtained
using Helena Biosciences Europe equipment and supplies. It is recommended that laboratories using other systems establish
their own acceptable range.

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Ensure the lot number on the vial corresponds with the lot number on the assay sheet.

LIMITATIONS

Total lipid content of each fraction of Lipotrol Control has not been determined. The Lipoprotein Stain, Sudan Red 7B, used in the
Helena Biosciences Europe procedure has a much greater affinity for triglycerides and cholesterol esters than it does for
free cholesterol and phospholipids1. The relative intensity of bands seen after staining with this dye does not reflect a true
quantitation of the total plasma lipids in each band. Therefore, only relative percentages of the lipoprotein bands should be
reported. The results obtained with the control depend upon several factors associated with methods and instrumentation.
Test systems other than those supplied by Helena Biosciences Europe may result in values which differ from those printed on the
assay sheet.

BIBLIOGRAPHY

1. Davidsohn, I. and Henry, J. B., Ed., Todd-Sanford: Clinical Diagnosis by Laboratory Methods 15th Ed. W.B. Saunders Co.,
Philadelphia, 639.

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