In Vitro Diagnostic Industry in China - Urine XIV

2.4.2 MUS-3600/ MUS-9600 Urinalysis System

It is a modular urinalysis workflow launched by DIRUI, which can meet the realistic needs of clinical laboratories for automated and high-throughput urine testing.

1. Structure: MUS-3600 series is composed of FUS-360 urine sediment analyzer and H-1600 automatic urine dry chemistry analyzer online, supporting 11 combinations of linear layout, and can realize the maximum combination mode of 2 + 4. MUS-9600 series is composed of a new all-in-one module. The test modules are connected together by a pre-storage device, a recycle device and a delivery device, supporting a maximum of four modules for joint detection.

2. Test principle: Using multi-wavelength photoelectric colorimetric method, the dry chemical test results are obtained by measuring the color value of the test strip after reaction. Using planar flow cytometry + high-speed shooting technology + AI recognition technology, the formed element images are segmented by software, converted into digital information, and then classified.

3. Parameters: MUS-3600/ MUS-9600 can load up to 520 samples at a time. The testing speed is 480 T/H. A total of 44 parameters could be completed by one-key test, including 25 items of urine formed elements, 14 items of dry chemistry, four items of physical parameter, and 1 research parameter.

•   25 items of formed element: NRBC, Micro RBC, Acanthocyte, Ghost cell, Other Poikilocyte, WBC, WBCC, Squamous Epithelial Cell, Renal Tubular Epithelium Cell, Transitional epithelial cell, Hyaline Cast, Granular Cast, Waxy Cast, Broad Cast, Other cast, Bacillus, Suspicious coccus, Pseudohypha yeast, Yeast, Calcium Oxalate Crystal, Uric Acid Crystal, Ammonium Magnesium Phosphate Crystal, Other crystal, Spermatozoa, MUCS, etc. 10–14 items of dry chemistry can be selected: URO, BIL, KRT, BLD, PRO, NIT, WBC, GLU, pH, SG, VC (optional), MA (optional), CR (optional), Ca (optional).

•   Physical items: Colour, SG, turbidity and COND.

•   Research parameter: ACR.

4. Technological innovation and clinical significance: (1) Urine sample is wrapped in the sheath fluid and enters the detection system, which ensures that the formed elements of the urine always pass through the microscope lens in a single layer and independent way to avoid particle overlap and aggregation. More than 2500 pictures of each sample are taken by using high-speed photograph technology and 40x objective magnification to avoid missing detection. (2) Based on massive clinical samples, a large image database of urine formed elements is established by using AI recognition technology. Artificial neural network technology is used to accurately extract image feature information and automatically complete the recognition and classification of formed elements. (3) The system provides red blood cell morphology information (phase prompts), prompting homogeneous red blood cells, heterogeneous red blood cells and mixed red blood cells, assisting in the diagnosis of renal diseases and bleeding parts, and showing abnormal red blood cell morphology in detail. The subclassification of cast is rich, which can effectively assist in clinical diagnosis and monitoring of renal parenchymal lesions and the process of nephropathy. (4) It can distinguish the pathogenic bacteria, indicate the information of urine culture, and provide reference for the diagnosis and treatment of urinary tract infection. Also, it provides ACR parameters, which is a basis for early screening of nephropathy. (5) Review condition is settable. The instrument prompts microscopic examination automatically when review condition is satisfied.

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