The clearer pictures,  the better classification

Performance verification of Medicside urinalysis line and summary of  clinical comparison results .

Medical institutions generally evaluate the  urinalysis line  in the following aspects:

（1） The accuracy of the test results: including the accuracy of quantitative counting of formed elements, the accuracy of classification and identification of formed elements, 

and the dry chemistry test results close to the

 true value (can be verified by quantitative detection);

（2） Processing ability of abnormal specimens: such as hematuria, pyuria and other specimens, can still ensure the accuracy of counting and automatic identification and classification, and will not cause pollution to the next specimen;

（3） Automatic identification of the types of formed elements and agreement rate with microscopic examination: clearly photograph and automatically identify a variety of other Poikilocyte, casts, epithelial cells and other formed components;

（4） Detection efficiency: on the premise of ensuring that more than 2000 images are collected for each specimen, the processing  and  analysis ability  of  the  specimen and the detection speed are obtained.

 In  the  first  half  of  2023,  the CA-500 & MA-500  automatic  urinalysis  assembly  line, which was independently developed and produced by Medicside, was verified based on  the performance verification requirements of the urinalysis instrument, based on 15189 samples in a large number of tertiary hospitals in China, . The results of clinical samples were compared with two imported brand instruments and one domestic brand instrument with high market share.

 In the process of performance verification and comparison of clinical results, the professor and the director of the laboratory department who participated in the comparison praised the Medicside instruments. They have brand new understanding of domestic instruments based on the accuracy of test results, the clarity of pictures, the efficiency of test and the clinical information prompts.

The recognition  of the domestic  well-known tertiary hospitals is also based on the leading flat flow image technology , the hardware upgrade  of  the  instrument  optical system  and  image  acquisition  and  processing  system, the optimization of AI algorithm, the quality control in the process of production and instrument use, and other aspects of excellence.

I、Comparison results between Medicside  and an imported brand urinalysis line with fluorescence flow cytometry technology:

（I）Formed elements:

(2) Dry chemistry

Summary of results:

The results of Medicside are in high accordance with the results of the imported brand assembly line, but the turbidity test results of the other side are not accurate.

When the results of Medicside occult blood and leukocyte esterase test were not consistent with those of the imported brand assembly line, 

the coincidence rate of Medicside occult blood and leukocyte esterase test results with formed components (red blood cells and white blood cells) was higher by microscopic examination. 

Ii. Comparison  results  between   Medicside  and   domestic  brand   urinalysis line using flat flow technology:

(1) Formed components:

(2) Dry chemistry:

Iii. Comparison results between Medicside and an imported brand urinalysis line using centrifugal microscopy technology:

(1) Morphology:

(2) Dry chemistry

In  our   experiment, we found     that   the   positive   coincidence  rate of   CA-500 

and this urinalysis line for bilirubin was low (49.43%). After analysis, the reason was that 44 samples out of 1500 urine samples tested by the urinalysis line were "1+"; The Medicside CA-500 test result was "-".

To determine the true amount of bilirubin in urine samples, we measured direct bilirubin (DBIL) in 10 urine samples using a biochemical analyzer, and compared the results of Medicside CA-500 with that of the urinalysis line. The results were as follows:

The  results  are as follows: the "1+" result of bilirubin of the imported brand 

urine dry chemistry analyzer is false positive.

By comparing with the current mainstream imported brands and domestic brands urinalysis assembly line in the market, the Medicside urinalysis assembly line can be said to be at present:

1、The results of dry chemical test were the closest to the true value, the count of formed  elements was the most accurate, and the automatic identification and classification of formed 

components had the highest coincidence rate with manual microscopic examination.

2、The most types of tangible components were identified automatically. 

3、The fastest detection efficiency;

4、The ability to handle abnormal specimens was the strongest

The urinalysis  line fully meets the needs of medical institutions for urinalysis.

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