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Measurement of Thyroid disease related markers in small amount of specimen obtained by self-blood collection device

Measurement of Thyroid disease related markers in small amount of specimen

55

There were 5 healthy volunteers and 50 outpatients at Ito Hospital. 26 people were collected the plasma with volume 125 uL or more by a self-blood collection device, 24 people were collected the plasma with 25 uL - 125 uL, and 5 people were collected plasma less than 25 uL. The people who could collect more than 25 uL was though as FAS, and 24 of them who could not perform biochemical measurements were treated as PPS. Of the 55 participants, the age range was 23-81, with a median age of 52. There were 46 women and 9 men. Of the 55 people, 30 had Basedow's disease, 13 had Hashimoto's disease, 5 were healthy, and 7 were others. There were 41 patients under treatment, 9 untreated, 4 after treatment, and 1 relapse after treatment.

On Tuesday and Wednesday, July 12-20, 2023, 5 healthy-volunteer cases were obtained. After that, 50 outpatient cases were obtained. The cases were obtained during the morning when outpatient visit to investigator or co-investigator. 0-3 cases were obtained per day, 0-2 times a week. The final case was obtained on October 25, 2022.

No diseases were observed

For marker A, the analyzed data were 49 out of 50 FAS cases (one case was outside the measurement range). y = 0.0 + 0.9 x (Passing-Bablok). The Spearman correlation coefficient was 0.99, which was significant at 95% significance level (p<0.001). In addition, there were 31 cases that exceeded the standard value. For marker B, the analyzed data were 49 out of 50 FAS cases (1 case was excluded because it was outside the control range at the time of measurement). The regression line y = -0.0 + 1.0 x (Passing-Bablok). The Spearman correlation coefficient was 0.97, which was significant at 95% significance level (p<0.001). In secondary end points, correlations in marker C, marker D, marker E, marker F were examined by the instrument under development and conventional instrument. For measurement items other than marker E, the Spearman correlation coefficient showed 0.9 or more, indicating a good correlation. Only marker E had a spearman correlation coefficient of 0.77, which was a little less correlated. In both measurements, the slope of the regression was 1.0 +/- 0.1 (Passing-Bablok). Data were analyzed for marker C, resulting in 26 cases. The regression was y = 4.7 + 0.9 x (Passing-Bablok). The Spearman correlation coefficient was 0.92, which was significant at 95% significance level (p<0.001). Data for marker D were analyzed in 26 cases. The regression was y = -0.1 + 0.9 x (Passing-Bablok). The Spearman correlation coefficient was 0.98, which was significant at 95% significance level (p<0.001). Data for marker E were analyzed in 26 cases. The regression was y = -0.1 + 1.0 x (Passing-Bablok). The Spearman correlation coefficient was 0.77, which was significant at 95% significance level (p<0.001). Data for marker F were analyzed in 26 cases. The regression was y = -0.1 + 1.0 x (Passing-Bablok). The Spearman correlation coefficient was 0.97, which was significant at 95% significance level (p<0.001). The correlation between the instrument under development and the conventional instrument was determined. It showed a good correlation.

Measurements of thyroid disease-related markers indicated a good correlation.

Mar. 31, 2024

No

None

https://jrct.mhlw.go.jp/latest-detail/jRCTs032210630

Yoshimura Hiroshi

Ito hospital

4-3-6, Jingumae, Shibuya-ku, Tokyo, Japan

yoshimura@ito-hospital.jp

Yoshimura Hiroshi

Ito hospital

4-3-6, Jingumae, Shibuya-ku, Tokyo, Japan

+81-3-3402-7411

yoshimura@ito-hospital.jp

Complete

Feb. 25, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

basic science

1. Those whose age is 21 or older. (Helthy volunteers, patients)
2. Those who come to Ito Hospital. (Patients)
3. Those who collected blood on the day of obtaining consent (Patients)
4. Those who can agree informed consent by their own intention. (Healthy volunteers, patients)
5. P.I. or contributor decide the sample as appropriate for this research. (patients)

1. Those who come to Ito Hospital at first time. (Patients)
2. Those who have injured skin (broken, swollen, rash) on their upper arms. (Healthy volunteers, patients)
3. Those who have allergic to stainless steel. (Healthy volunteers, patients)
4. P.I. or contributor decide the sample as inappropriate for this research. (Healthy volunteers, patients)

Both

Thyroid disease

In addition to regular medical care, the participants are collected their blood with an unapproved self-blood collection apparatus.

Obtain patient samples with thyroid disease derived from venous blood and capillary blood taken by microneedle self-sampling device. The number of samples are equal to or greater than 50, including 7 patients who have high TSH value. Comparison of slope and correlation by Passing-Bablok method for both TSH and FreeT4.

Use same sample set used for TSH and FreeT4 measurements to measure the biomarkers for monitoring the side effect by thyroid disease treatment such as ALT, AST, Total bilirubin, and Creatinine.

+81-3-5841-0818

Dec. 22, 2021

none