METHOD AND DEVICE FOR TESTING FOR BENCE-JONES PROTEIN

摘要

A method, device, and various kits for a specific binding assay is provided for the detection of free light chains in untreated urine. Such methods, devices or kits may be used for screening for a disease state producing bence jones protein, comprising testing for bence jones protein presence in unspun or un-centrifuged urine. Such methods, devices or kits may be for monitoring for and adjunctive testing of such disease states. An in vitro device (IVD) may provide for detection of unspun urine light chains (BJP). Such device may be an IVD test assay, a tube (which may be used in a clinical laboratory or doctor's office, among others) incorporating a dipstick, or a cassette using lateral flow technology (which cassette may be used for home testing or point-of-care testing, among others). The device is effective for any or all of the following with regard to the discussed disease states, which produce BJP detectable by the device: screening, monitoring and adjunctive testing. Accordingly, the present disclosure provides a method of screening for a disease state producing BJP, comprising testing for BJP presence in unspun/un-centrifuged urine. Similar methods for monitoring for and adjunctive testing of such disease states are also provide herein.