Immunofixation Control Instructions for Use

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INTENDED PURPOSE

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

Good laboratory practices require that test procedures be monitored with materials containing known constituents in order to determine that the test reagents are performing correctly. The controls contain known IgG kappa, IgA lambda and IgM monoclonal proteins.

The Immunofixation Control is designed so that a control for each antisera can be run on each gel. Following electrophoresis, the appropriate control is applied to a well at the end of an electrophoresis pattern area on the gel. Antisera applied to the antisera slots comes into contact with the control serum and an antigen / antibody reaction occurs between the monospecific antiserum and its specific immunoglobulin. An appropriate reaction is indicated by the appearance of a precipitin ring around each well of the completed gel.

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. IgG KAPPA (1 x 0.5mL) REF HL-3-2490SA 2. IgA LAMBDA (1 x 0.5mL) REF HL-3-2491SA 3. IgM (1 x 0.5mL) REF HL-3-2492SA The controls are prepared from human sera containing an IgG kappa monoclonal protein, IgA lambda monoclonal protein and an IgM monocolonal protein with sodium azide added as a preservative.

RECONSTITUTION

The controls are ready for use as packaged.

STORAGE, SHELF-LIFE AND STABILITY

1. IgG KAPPA, IgA LAMBDA and IgM The controls should be stored at 2...8°C and are stable until the expiry date indicated on the label.

HL-2-1407P-EN 2015/12(4) Immunofixation Control EN 2019-09-06 06:00:31 1 Signs of deterioration: The controls should be free of particulate matter and straw-yellow in colour.

ITEMS REQUIRED BUT NOT PROVIDED

This product is to be used in conjunction with:

REF 100300 SAS-MX IFE-1 Kit REF 100400 SAS-MX IFE-2 Kit

PROCEDURE

1. Refer to the appropriate kit Instructions for Use for detailed instructions.

INTERPRETATION OF RESULTS

Additional use of controls: Immunofixation Control also can be used to verify all phases of the procedure. The controls can be used as a patient sample and taken through every step of the procedure. Used in this manner the control can verify correct electrophoresis and the specificity and activity of the antisera.

HL-2-1407P-EN 2015/12(4) Immunofixation Control EN 2019-09-06 06:00:31 2