Abstract: The application provides competition assays used to detect free-light chains or intact immunoglobulins comprising incubating the sample with anti-FLC antibody, or heavy chain class-light chain type-specific antibodies, or fragments of such antibodies, and a known amount of FLC or intact immunoglobulin and detecting the binding of the antibody to the known amount of FLC or immunoglobulin. Assay kits and methods of producing particles coated with FLC are also provided.

Abstract: The invention relates to a method of coating beads with a biological molecule comprising: (i) coating a plurality of beads with the biological molecule; (ii) mixing the coated beads with a liquid stabilizing and/or blocking agent (iii) dispersing the coated beads still substantially surrounded by a liquid phase comprising the liquid stabilizing and/or blocking agent across a surface that is at least partially liquid permeable; (iv) drying the beads on the surface to substantially remove the liquid phase; and (v) removing the dried beads from the surface.

Abstract: The invention provides a method for characterising a plasma cell associated disease in a patient comprising: (i) providing at least one sample from the patient; (ii) determining in the sample(s) two or more of; (a) the ?:? free light chain (FLC) ratio; (b) the ratio of ? light chains bound to a class of heavy chain:? light chain bound to the same class of heavy chain (HLC?:HLC ? ratio); (c) the total amount of FLC in the samples and (d) the total amount of ? light chains bound to the heavy chain class plus ? light chains bound to the same heavy chain class (total HLC); (iii) comparing each ratio or amount from (a) (b), (c) and/or (d) to predetermined values and assigning a score to each amount or ratio; and (iv) using the scores to characterise the plasma cell associated disease. Apparatus configured to carry out the method of the invention are also provided.

Abstract: The invention provides a method of estimating free light chain production (FLC) in a subject comprising (i) determining an amount of FLC in a sample from the subject; and (ii) correcting the amount of FLC in the sample for FLC cleared from the source of the sample by glomerular filtration and by reticuloendothelial (RE) clearance.

Abstract: The invention relates to a method of coating beads with a biological molecule comprising: (i) coating a plurality of beads with the biological molecule; (ii) mixing the coated beads with a liquid stabilising and/or blocking agent (iii) dispersing the coated beads still substantially surrounded by a liquid phase comprising the liquid stabilising and/or blocking agent across a surface that is at least partially liquid permeable; (iv) drying the beads on the surface to substantially remove the liquid phase; and (v) removing the dried beads from the surface.

Abstract: The present invention is directed to antibodies having specificity for a heavy chain class at the same time as having specificity for a first light chain. Such antibodies can be used in a method of detecting or monitoring a malignant plasma cell disease comprising determining in a sample the ratio between the relative amounts of immunoglobulins having: (i) a heavy chain class bound to ? light chains; and (ii) immunoglobulins having the same heavy chain class but bound to ? light chains.

Abstract: The invention provides a method of prognosis of a subject with an infection, identifying a subject at greater risk of death from an infection and/or identifying a subject at greater risk of developing an infection, the method comprising detecting an amount of free light chains (FLC) in a sample from the subject, wherein a higher amount of FLC is associated with decreased survival due to the infection and/or increased risk from an infection and/or having an increased risk of developing an infection. A method of monitoring an infection, comprising detecting an amount of free light chains (FLC) in a sample from a patient having an infection and comparing the amount of FLC in the sample with an amount of FLC detected in a sample previously obtained from the patient, wherein an increase in the amount FLC detected, compared to the previous sample, indicates an increase in the infection in the patient, and a decrease in the amount of FLC indicates a decrease in the infection in the patient.

Abstract: The application provides competition assays used to detect free-light chains or intact immunoglobulins comprising incubating the sample with anti-FLC antibody, or heavy chain class-light chain type-specific antibodies, or fragments of such antibodies, and a known amount of FLC or intact immunoglobulin and detecting the binding of the antibody to the known amount of FLC or immunoglobulin. Assay kits and methods of producing particles coated with FLC are also provided.

Abstract: The invention provides a method detecting free light chains (FLCs) comprising: (i)providing a sample from a subject; (ii)mixing the sample with an anti-FLC specific antibody, or fragments thereof capable of specifically binding the FLC, to form a mixture; (iii)passing the mixture through a capillary tube by capillary zone electrophoresis (CZE); and (iv)detecting the presence of the antibody or fragment thereof after passage through at least a portion of the capillary tube. Capillary tubes for use in CZE and kits comprising capilliary tubes and at least one anti-FLC antibody are also provided.

Abstract: The invention provides a method of prognosis of a subject with a cancer, identifying a subject having a greater risk of having an undiagnosed cancer and/or identifying a subject at greater risk of developing a cancer the method comprising detecting an amount of free light chains (FLC) in a sample from a subject, wherein a higher amount of FLC is associated with decreased survival due to a cancer and/or increased risk of the subject having an undiagnosed cancer and/or having an increased risk of developing a cancer.

Abstract: A method of detecting or monitoring a malignant plasma cell disease comprising detecting in a sample the ratio between the relative amounts of immunoglobulins having: (i) a heavy chain class bound to ? light chains; and (ii) immunoglobulins having the same heavy chain class but bound to ? light chains. More particularly, in one embodiment the method comprises the steps of measuring the relative amounts of the respective immunoglobulins by using: (i) at least one antibody, or a fragment thereof, specific for the heavy chain class; (ii) an antibody, or a fragment thereof, specific for ? light chains; and (iii) an antibody, or a fragment thereof, specific for ? light chains.

Abstract: The invention provides a method of predicting subjects at risk of loss of kidney function and/or identifying subjects at greater risk of loss of kidney function, and/or identifying subjects at risk of kidney failure/end stage kidney disease, the method comprising detecting an amount of free light chains (FLC) in a sample from the subject, wherein a higher amount of FLC is associated with increased risk of loss of kidney function and/or increased risk of renal failure/end stage kidney disease.

Abstract: The invention provides a method of identifying a subject likely to have liver disease, or for determining the prognosis of a subject previously identified as having a liver disease comprising detecting an amount of free light chains in a sample from the subject, wherein a higher amount of FLC is associated with an increased likelihood of the subject having a liver disease or an increased likelihood of having a poor prognosis of a liver disease. Assay kits for use in such methods are also provided.

Abstract: Assay kit and Assay for determination of likely survival of a subject Assay kits for determining the total amount of free-light chains (FLC) in a sample are provided. Also provided are a general health screen method comprising detecting an amount of free light chains (FLC) in a sample from a subject, wherein a lower amount of FLC is associated with increased survival and/or better general health of the subject, and a higher level of FLC indicates the possible presence of an undetected medical problem.

Abstract: A method of making antibodies to a selected part P of an immunoglobulin molecule ZP, Z comprising the non-selected part of ZP, P being the selected part of ZP which comprises a hidden epitope of the light chain, said method comprises tolerizing the source of antibodies, by administering to the source a compound containing the non-selected part Z or a part of Z and administering antibodies to the non-selected part Z or a part of Z; wherein these administered antibodies are specific to an Fc region of ZP; and immunizing the source of antibodies with part of ZP having the selected part P exposed; and wherein Z comprises non-hidden epitopes of said immunoglobulin molecule, and wherein said compound containing the non-selected part of said molecule comprises a whole immunoglobulin, and wherein immunizing the source of antibodies with part of ZP comprises immunizing with free light chain.

Abstract: A method of detecting or monitoring a malignant plasma cell disease comprising detecting in a sample the ratio between the relative amounts of immunoglobulins having: (i) a heavy chain class bound to ? light chains; and (ii) immunoglobulins having the same heavy chain class but bound to ? light chains. More particularly, in one embodiment the method comprises the steps of measuring the relative amounts of the respective immunoglobulins by using: (i) at least one antibody, or a fragment thereof, specific for the heavy chain class; (ii) an antibody, or a fragment thereof, specific for ? light chains; and (iii) an antibody, or a fragment thereof, specific for ? light chains.

Abstract: The present invention is directed to antibodies having specificity for a heavy chain class at the same time as having specificity for a first light chain. Such antibodies can be used in a method of detecting or monitoring a malignant plasma cell disease comprising determining in a sample the ratio between the relative amounts of immunoglobulins having: (i) a heavy chain class bound to ? light chains; and (ii) immunoglobulins having the same heavy chain class but bound to ? light chains.

Abstract: A method of detecting or monitoring a malignant plasma cell disease comprising detecting in a sample the ratio between the relative amounts of immunoglobulins having: (i) a heavy chain class bound to ? light chains; and (ii) immunoglobulins having the same heavy chain class but bound to ? light chains. Preferably the ratio is determined by (1) a method wherein the ratio is determined using: (i) an antibody, or a fragment thereof, having specificity for a heavy chain class at the same time as having specificity for a first light chain in combination with either: (ii) an antibody, or a fragment thereof, having specificity for the heavy chain class at the same time as having specificity for the second light chain; or (iii) an antibody, or fragment thereof, having specificity for the heavy chain and a further antibody, or fragment thereof, having specificity for the second light chain.

Abstract: There is provided a method of reducing blood free light chain concentration in a subject, the method comprising the step of subjecting the subject's blood to haemodialysis, haemodiafiltration or haemofiltration. There is also provided the use of a dialysis membrane which is a membrane that allows passage of molecules having a molecular weight of up to 45 kDa in presence of whole blood, and has a molecular weight exclusion limit in water of about 200 kDa in the preparation of a haemodialysis unit for conducting haemodialysis, haemodiafiltration or haemofiltration on a subject to reduce blood free light chain concentration in the patient.