Intended Purpose; Warnings And Precautions - helena BioSciences SAS-3 Immunofix Instrucciones De Uso

INTENDED PURPOSE

The SAS-3 IFE kit is intended for the separation and identification of monoclonal gammopathies by
agarose gel electrophoresis.
Immunofixation electrophoresis (IFE) is a two stage procedure using high resolution agarose
electrophoresis in the first stage, and immunoprecipitation in the second phase.
The greatest demand for IFE is in the clinical laboratory, where it is used primarily for the detection of
monoclonal gammopathies. A monoclonal gammopathy is a primary disease state in which a single
clone of plasma cells produce elevated levels of an immunoglobulin of a single class and type.
Such immunoglobulins are referred to as monoclonal proteins, M-proteins or paraproteins.
Their presence may be of a benign nature or of uncertain significance. In some cases, they are
indicative of a malignancy, such as multiple myeloma or Waldenström's macroglobulinaemia.
Differentiation must be made between polyclonal and monoclonal gammopathies, as polyclonal
gammopathies are a secondary disease state due to clinical disorders such as chronic liver disease,
collagen disorders, rheumatoid arthritis and chronic infection.
Urinary proteins are derived primarily from plasma proteins that filter through the kidney.
The appearance of abnormal plasma proteins in the urine is of great value in evaluating renal function.
The appropriate study of proteinuria should include quantitative and qualitative assessment of the type
and amount of proteins excreted
coupled to the identification of specific protein types by immunoprecipitation allows the differentiation
of several types of proteinuria - Physiological, Glomerular (selective and non-selective), Tubular and
proteinuria associated with Dysglobulinaemias
Alfonso first described immunofixation in the literature in 1964
practical procedure in 1969, and published a number of studies utilising this technique
Immunofixation has been used as a procedure for the investigation of immunoglobulins since 1976
The SAS-3 IFE kit separates serum proteins according to charge in an agarose gel. The proteins are
then incubated with monospecific antisera, washed and stained to allow visualization of the
immunoprecipitate for qualitative interpretation.

WARNINGS AND PRECAUTIONS

All reagents are for in-vitro diagnostic use only. Do not ingest or pipette by mouth any kit component.
Wear gloves when handling all kit components. Refer to the product safety data sheet for risk and
safety phrases and disposal information.
COMPOSITION
1. SAS-3 IFE Gel
Contains agarose in a Tris / Barbital buffer with thiomersal and sodium azide as preservative.
The gel is ready for use as packaged.
2. Acid Violet Stain Concentrate
Contains concentrated Acid Violet stain. Dilute the contents of the bottle to 700ml with purified
water. Stir overnight and filter before use. Store in a tightly stoppered bottle.
1-5
. The combination of electrophoretic separation of urine proteins,
1-5
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1
SAS-3 IMMUNOFIX
6
. Alper and Johnson published a more
7-9
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10-11
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English