T/CAGR 010-2023 Active

Scope: This standard specifies the technical requirements for laboratory testing of multiple myeloma. This standard applies to medical laboratories conducting multiple myeloma testing; Main technical content: Multiple myeloma is a malignant disease characterized by the abnormal proliferation of clonal plasma cells, and it is a common malignant tumor of the hematological system, often occurring in the elderly. Multiple myeloma has an insidious onset and complex clinical manifestations, with many atypical cases being easily misdiagnosed or overlooked. Laboratory tests involve multidisciplinary detection techniques such as hematology, fluid analysis, biochemistry, immunology, molecular biology, histology, and imaging, which are methodologically complex and require high technical skills from laboratory personnel. Therefore, the "entire process" of multiple myeloma laboratory testing requires close collaboration and integration among various specialties. With the diversification of examination methods and the improvement of detection techniques, laboratory testing for multiple myeloma has been continuously improved and refined. However, due to factors such as instruments, reagents, personnel, and methodologies, there may be certain deviations in test results within the same laboratory and between different laboratories. To guide medical laboratories in establishing standard methods for multiple myeloma laboratory testing, this standard is based on existing multiple myeloma-related guidance documents and clinical practices, and provides guidance on aspects such as clinical manifestations of multiple myeloma, sample collection and processing, laboratory testing, diagnostic criteria and staging, and differential diagnosis, with the aim of improving the accuracy and reliability of multiple myeloma diagnosis.