2.4 Product and Technology Innovation of Urinalysis System (Workflow)
2.4.1 US-3000/US-1680 Urinalysis Workflow
It is a product of URIT. On the basis of the original urine routine analysis workflow, US-3000 series has added urine-specific protein module and urine biochemistry detection module to realize one-stop detection of urine physics, dry chemistry, formed element, specific protein, and biochemical quantification. On the basis of all-in-one machine, US-1680 series adds online functions to meet the needs of different markets.
1. Structure: US-3000 series is composed of dry chemistry test module, urine formed elements test module, specific protein test module, biochemical test module, and fully automatic sample processing module. It supports a variety of combinations of five layout: “I,” “L-90,” “L-270,” “U,” and “Z.” US-1680 series is composed of one or more dry chemistry and formed elements test modules, and automatic sample processing modules connected. The system integrates the dry chemistry test module, the formed elements test module, and the physical test module, combined with ST pre-processing device, SS conveying device, YC post-storage device, and SZ transition device of automatic sample processing system, to form urinalysis workflow.
2. Test principle: For physical test, the specific gravity, turbidity, color, electrical conductivity, and osmotic pressure of urine are measured by refraction/transmission method, RGB color method, and impedance method. For dry chemistry, it adopts contact image scanning analysis technology to judge the reaction color of the test strips and output test results. For urine formed elements, digital imaging automatic identification, planar flow cytometry, and deep learning AI technology are used to automatically identify the morphology of formed particles and classify them correctly. Immune scatter turbidimetry is used to quantify each specific protein index. For biochemistry, colorimetry and transmission turbidimetry are used to quantify each trace proteins, enzymes, and other indexes.
3. Parameters: The testing speed of US-3000 series is up to 800 samples/hour. US-1680 series system is divided into dry chemistry and formed element combined mode, single mode of dry chemistry, and single mode of formed element. When two US-1680 are online, the testing speed is up to 240 samples/hour. Up to 87 comprehensive items can be measured, including 38 items of formed elements, 14 items of dry chemistry, 4 items of red blood cell morphology, 5 items of physical parameter, 10 items of specific protein, 14 items of biochemistry, and 2 items of research parameter.
Formed element items: Normal RBC, Acanthocyte, Humped spherocyte, Humped spherocyte, WBC, Macrophage, Urothelial Cells, Renal Tubular Epithelium Cell, Cell Cast, Blood Cast, Broad Cast, CAOX, Uric Acid Crystal, Amorphous Phosphate, Coccus, Bacillus, Yeast, Fusarium, etc.
• Dry chemistry items: VC, WBC, KET, NIT, URO, BIL,PRO, GLU, SG, BLD, pH, CR, Ca, and Ma.
• RBC morphology: MCV, MCV-CV, R-RATE, RBC volume distribution histogram.
• Physical items: Physical items: color, SG, turbidity, COND and OS.
• Specific protein quantitative test items: mALB, TRF, IgG, A1M, BMG, CRE, ACR, etc.
• Urine biochemical quantitative test items: mALB, UTP,α-AMY, TRF, IgG, RBP, NGAL, CRE, etc.
• Research parameter: ACR and PCR.
4. Technological innovation and clinical significance: (1) The sheath fluid wraps and compresses the formed particles into a single layer to pass through a high-power microscope lens, avoiding accumulation and overlap. (2) Upgraded and optimized deep learning AI recognition technology, perfect expert database of formed particles, and AI autonomous learning, training and automatic iteration in the cloud, truly solve the fuzzy identification problem of urine formed elements in complex environments. (3) Five erythrocyte subclasses are provided, which can effectively help clinical judgment of the source of hematuria. (4) It can accurately identify macrophages, renal tubular epithelium cells and cell casts, and provide laboratory evidence for clinical differentiation of urinary tract inflammation and tubulointerstitial nephritis. (5) ACR/PCR can provide important basis for early diagnosis, treatment, and prognosis of renal diseases. (6) High-definition pictures of the original particles and test strips reaction are retained, and the results can be traced. (7) The specific protein and biochemical module can quantitatively detect more than 20 items and accurately locate the protein source, which is helpful for clinical judgment of the damaged kidney parts.
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