SERACCESS® MILESTONE 7B

Written by: Dagmar Brunner

Continuous automated blood sampling including glucose measurement in an animal model

Authors: Dagmar Brunner; Konstantinos Tzikas; Dr Reto Rapold; Dr med. vet. Karina Klein; Dr Beatrice Schär
Securecell AG/Vetsuisse-Fakultät ZH, MSRU/CABMM, May and November 2022

Keywords: Seraccess, automated blood sampling, animal model

 

Background

Automated blood glucose measure-ment with Securecell’s SeraMaster prototype was tested in a clinical setting as part of a feasibility study (see Milestone 6).

Several experiments on live sheep were defined to test automated blood sampling in vivo. In a first se-ries of experiments, the automated sampling process, including dilution with NaCl, was compared with man-ual sampling. In a second series of experiments, automated blood sam-pling was combined with automated glucose measurement.


Study design

The trial (national authorization number: 34196, cantonal: ZH215/2021) was conducted in col-laboration with the Vetsuisse Faculty of the University of Zurich. It includ-ed seven full-day trials. Blood sam-ples were automatically collected with the SeraMaster prototype via central venous catheter (n=128) or arterial catheter (n=104) every 15 minutes. They were then compared with the manually collected refer-ence samples by measuring the glu-cose concentration of each sample.

Results

To evaluate the automated method, the bias (=mean deviation from the reference method) was calculated. For samples from the central vein the bias was 1.8 mg/dl (n=96) and for samples from the peripheral artery it was 0.8 mg/dl (n=104). All 200 data points (100%) are within the margin of error of ± 10.0 mg/dl. 
The following figure shows the re-gression analysis between SeraMaster glucose values (y-axis) and manual sampling (x-axis). The correlation coefficient (R2) is 0.9930, which means that the two methods are equivalent and therefore inter-changeable.

REC_SER_Results animal test
The regression analysis between the glucose values of SeraMaster (Y-axis) and of Cobas C111 (X-axis).
 

Furthermore, it could be shown that a continuously administered glucose infusion in the same two-lumen central venous catheter (proximal lumen: sampling, distal lumen: glucose infusion) had no influence on the automatic glucose measurement with the SeraMaster prototype (n=32). 
The images illustrate the experimental setup in the stables of the university. At the end of the day, the laboratory animals were allowed to return to the pasture.

experimental setup-MS7B

 The experimental setup in the stables of the university
 

Next steps

Next, automated blood sampling will be tested in a clinical trial.

Continuous automated blood sampling combined with automated glucose measurement with the SeraMaster prototype is equivalent to the manual reference method. The bias, a measure of the accu-racy of the method, is 1.8 mg/dl (venous) and 0.8 mg/dl (arterial) compared to the reference method. The regression analysis shows that the two methods are interchangeable.

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Dagmar Brunner

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