TSH Rapid Quantitative Test

Clinical Report Summary

Product Name: TSH Rapid Quantitative Test

Start Time of Clinical Trial: June, 2017

End Time of Clinical Trial: September, 2017

Executor: Guangzhou Wondfo Biotech Co., Ltd.

Contact: Bin Chen Tel Number: 13922288599

 Abstract

The synchronous blind comparison test of TSH Rapid Quantitative Test (fluorescence
immunochromatography) of Guangzhou Wondfo Biotech Co., Ltd. and Roche thyroid
stimulating hormone assay kit (electrochemiluminescence) is conducted to investigate the
equivalence between this reagent and the same product that has been approved for listing.
Result:
(1) The content and process of this study meet the experimental design.
(2) The concentration range of the selected samples of the center meets the study
requirements.
(3) The qualitative analysis of the results of serum samples obtained from 220serum
sample evaluation reagents and reference reagents is conducted and a total of 210
samples with the same results as the evaluation reagent and the reference reagent.
Of which 86 cases are detected with abnormalities, 124 cases are detected normal
and 10 cases with inconsistent results. The two methods total compliance rate:
95.45%, 95%CI is [91.80%～97.80%], positive compliance rate: 93.48%, 95%CI
is [86.34%～97.57%], negative compliance rate: 96.88%，95%CI is [ 92.19%～
97.80% ], kappa consistency coefficient k = 0.906, p = 0.000 <0.05. After 11
samples outside the linear range are excluded, the results of 209 serum samples are
statistically analyzed. The Spearman's correlation coefficient between the reagent
and the reference reagent is 0.982 and p=0. Linear regression is used to estimate
the results. The results showed a good linear relationship between the two methods.
The regression coefficient obtained is 1.051, the 95% confidence interval of the
regression coefficient is [1.023~1.079], and the intercept obtained is -0.111. The
95% confidence interval for the intercept is [-0.629～0.408], and the linear
regression equation is y=1.051x-0.111; When the medical decision level is
0.1mIU/L, estimated expected bias is -0.106, the expected bias is 95% confidence
interval [-0.595 ～ 0.383], and when the medical decision level is 10mIU/L,
estimated expected bias is 0.399, and the expected bias is 95% confidence interval
 [-0.089～0.888]. The bias at the medical decision level is outside the 12.5%
tolerance. For the Bland-Altman analysis, the mean difference is -0.292, the
standard deviation difference is 3.534, the 95% cutoff is [-7.218 ～ 6.634],
out-of-bounds point is 10 and the ratio of out-of-bounds points is 4.78%.
(4) A total of 116 samples of homologous serum and plasma samples are tested by
evaluation reagents. After 8 samples outside the linear range are excluded, the
results of 108 homologous samples are statistically analyzed. The Spearman
correlation coefficient of the statistical results is 0.994, p = 0; Linear regression is
used to estimate the results and its results showed a good linear relationship
between the two types of samples. The regression coefficient obtained is 1.123, the
95% confidence interval of the regression coefficient is [1.099~1.148], and the
intercepts obtained at the same time for -0.233, the 95% confidence interval for the
intercept is [-0.396~-0.070] and the linear regression equation is y=1.123x-0.233.
When the medical decision level is0.1mIU/L, the estimated expected bias is -0.221,
the expected bias is 95% confidence interval[-0.425～-0.016], and when the
medical decision level is 10mIU/L, estimated expected bias is 0.997, the expected
bias. 95% confidence interval [0.792～1.202]. The bias at the medical decision
level is within 12.5% of the allowable error. The results are analyzed by
Bland-Altman, with a mean difference of -0.138, a standard deviation of 1.064, a
95% cutoff value of [-2.223~1.946], out-of-bounds point is 7 and the ratio of
out-of-bounds points is 6.48%.
(5) A total of 120samples of homologous serum and whole blood samples are tested
by evaluation reagents. After 9 samples outside the linear range are excluded, the
results of 111 homologous samples are statistically analyzed. The Spearman
correlation coefficient of the statistical results is 0.989, p = 0; Linear regression is
used to estimate the results and its results showed a good linear relationship
between the two types of samples. The regression coefficient obtained is 1.120, the
95% confidence interval of the regression coefficient is [1.088~1.152], and the
intercepts obtained at the same time for -0.320, the 95% confidence interval for the
intercept is [-0.554~-0.086] and the linear regression equation is y=1.120x-0.320.
 When the medical decision level is 0.1mIU/L, the estimated expected bias is
-0.308, the expected bias is 95% confidence interval[-0.565～-0.051], and when
the medical decision level is 10mIU/L, the estimated expected bias is 0.880, the
expected bias. 95% confidence interval [0.623～1.137]. The bias at the medical
decision level is within 12.5% of the allowable error. The results are analyzed by
Bland-Altman, with a mean difference of -0.076, a standard deviation of 1.354, a
95% cutoff value of [-2.730～2.578], out-of-bounds point is 3 and the ratio of
out-of-bounds points is 2.70%.

Conclusion:
Guangzhou Wondfo Biotech Co., Ltd.'s TSH Rapid Quantitative Test (fluorescent
immunochromatography) does not have a statistically significant difference from the test
results of the same product that has been approved for marketing, and has a high degree of
consistency, that is clinical application performance is equivalent. In addition, the
evaluation reagent also has equivalence in detecting homologous serum and plasma, whole
blood samples.
 1. Establishment of reference reagent
Reference reagent: Roche thyroid stimulating hormone assay kit
(electrochemiluminescence).
Sample Type: Serum/Plasma.
Registration No.: National Food and Drug Administration (Jin) 2014 No. 2404873.
The Roche thyroid stimulating hormone assay kit (Electrochemiluminescence) has a
higher market share and a better market evaluation. Therefore, this product is selected as a
reference reagent.

2. Instruments and reagents used in this test

Table 1 Instrument reagent information table used for the test

Evaluation system Contrast system

Instrument Finecare series : FS112 German Roche: cobas e 602, e411

Roche thyroid stimulating hormone assay kit

Product TSH Rapid Quantitative Test
(electrochemiluminescence).

specifications 25 tests/kit 200 tests/kit

Batch No. W220FB01A 21249101

Validity of reagents 2017-11-01 2017-09-30

Storage Conditions 4~30℃ 2~8℃

Reagent registration number / National Food and Drug Administration (Jin)

2014 No. 2404873

3. Statistical analysis methods for clinical trial data

(1) Evaluation reagent and reference reagent sample evaluation method
① Use SPSS to calculate the correlation coefficient r or r2.
② SPSS is used to establish the regression equation. Calculate a and b. List linear
regression equations.
Y=a+bX
SPSS is used to calculate the sum of squared deviations of the reference
 N
reagents=  ( X i  X ) 2
i 1 .
^
Expected value: Yi =a+b X i

N ^
 (Yi  Yi ) 2
i 1

Standard error of regression S y x

= N 2

B̂c
Calculate the estimated expected bias ( ) and its 95% confidence interval at the

clinical cutoff ( X C ).

Bˆ c  a  (b  1) X c

B̂c ^
1 ( X  X )2
95% confidence interval = B C
 t  / 2, N  2 S y  x  N C
 ( X i  X )2
N
i 1

[ t / 2, N 2 is a t-critical value of (1-α) bilateral tail area corresponding to the

t-distribution of residual degree of freedom N-2.]
③ A Bland-Altman data model is established to analyze the consistency of the
quantitative detection results of the evaluation reagents and the reference reagents.
(2) Evaluation reagent homologous sample evaluation method
The homologous sample consistency assessment method is as described in (1).

4. Clinical Test Results

4.1 Evaluation of Serum Samples by Evaluation and Reference Reagents
4.1.1 Selected sample basic situation
A total of 222 serum samples are selected from the two centers, of which 220 are valid
serum samples (99.10%). See Table2 for detailed selection results.
Table2 Selected sample basic situation

Sample Type
Selected serum
Center Excluding samples Effective serum samples
samples

102 0 102
120 2 （ Repeated sample and 118
 operational errors result in
insufficient sample size）
Total 222 2 220
Conformance evaluation of effective samples
4.1.2 Qualitative analysis
According to the decision thresholds recommended in the kit instructions for the two
methods, as for the Roche thyroid stimulating hormone assay kit
(electrochemiluminescence) kit, 0.27mIU/L<sample concentration <4.2mIU/L judged
negative and the sample concentration outside its range is judged to be positive. As for T4
Rapid Quantitative Test of Guangzhou Wondfo Biotech Co.,Ltd., 0.3mIU/L<sample
concentration <4.2mIU/L judged negative and the sample concentration outside its range is
judged to be positive.

Table3 Analysis of Consistency of Qualitative Results of Two Methods

Roche + Roche - Total

Wondfo+ 86 4 90

Wondfo - 6 124 130

Total 92 128 220

Total conformity rate :（86+124）/220=95.45%, 95%CI is [91.80%～97.80%]

Positive conformity rate: 86/92=93.48%, 95%CI is [86.34%～97.57%]
Negative conformity rate: 124/128=96.88% 95%CI is [92.19%～97.80%].

Kappa consistency analysis

Table 4 Symmetrical measure

Value Progressive standard errora Approximate Tb Approximate Sig.

By interval R of Pearson .906 .029 31.694 .000c
Spearman
In order .906 .029 31.694 .000c
correlation
Consistency
Kappa .906 .029 13.445 .000
measure
In the effective
N 220
case
 a. Not assumed null hypothesis.
b. Use assumption of asymptotic standard error zero hypothesis.
c. Based on a normal approximation.
From the test results, it can be seen that k=0.906, P<0.05, it can be considered that the
consistency between the evaluation reagent and the reference reagent is better
(k=0.906>0.75).
4.1.3 Outlier calculation
In the course of clinical trials, there are 10 cases of evaluation reagents, the result is
<0.1, there is 1 case result> 100, and no specific values are given, so these 11 cases are not
counted. According to the data, the average absolute difference between the evaluation
reagent and the reference reagent is 1.33, and the average relative difference is 1.18. From
the calculations, there is no data at the same time greater than 4 times the average of the
absolute difference and 4 times the average of the relative difference, eliminating the need
to reject the sample.The following quantitative analysis of the evaluation reagents and
reference reagents has a sample size of 209 samples.
4.1.4 Correlation analysis

Table 5 Two methods of measurement result correlation coefficient

Index Statistical magnitude Result

Two methods of measurement Number of cases(Number of
209(11)
result correlation coefficient missing cases)
Two methods of measurement
Spearman correlation coefficient 0.982
result correlation coefficient
Two methods of measurement
P 0
result correlation coefficient

Table 6 Model summary

Model R R Adjust R party Standard estimate

error
1 .982a .964 .964 3.43702

a. Predictor variables: (constant), reference reagent.

4.1.5 Regression analysis
The regression coefficient obtained by linear regression is 1.051, the 95% confidence
interval of the regression coefficient is [1.023~1.079], the intercept item obtained is -0.111,
and the 95% confidence interval of the intercept item is [-0.629~0.408]. The regression
equation is y=1.051x-0.111.

Table7 Coefficienta

Non-standardized Standard 95.0% confidence

coefficient coefficient interval for B
Model
Standard trial Lower Upper
B
error version t Sig. limit limit
1 (constant) -.111 .263 -.421 .674 -.629 .408
Reference
1.051 .014 .982 74.211 .000 1.023 1.079
reagent
a. Dependent variable: Evaluation reagent

4.1.6 Expected Biases and Confidence Intervals at Medical Decision-making Levels

Calculate the allowable bias value at the clinical critical value (Xc), expected bias

B̂c
estimate ( ) and its 95% confidence interval (The confidence interval of the expected

bias includes the lower limit of the confidence interval that allows the bias or allows the
bias to be less than the expected bias or the upper limit of the confidence interval that
allows the bias to be greater than the expected bias.). By comparing the confidence interval
of the expected bias of the medical decision level with the limit of the allowable error, it is
less than the allowable error, and the equivalent of the evaluation reagent and the reference
 reagent can be judged. If it is greater than the allowable error, further clinical verification is
required.

B̂c Bˆ c  a  (b  1) X c
Expected bias estimate ( ):

B̂c ^
1 ( X  X )2
95% confidence interval = B C
 t  / 2, N  2 S y  x  N C
 ( X i  X )2
N
i 1

[ t / 2, N 2 is a t-critical value of (1-α) bilateral tail area corresponding to the

t-distribution of residual degree of freedom N-2.]
We selected two medically determined levels of 0.1mIU/L and 10mIU/L for statistical
analysis as recommend by ‘China Guide for Diagnosis and Treatment of Thyroid Diseases
(2007 Edition)’.The regression equation obtained by the linear regression in 4.1.5 is
Y=1.051X-0.111, in which the intercept (a) is -0.111 and the slope (b) is 1.051. According
to the above formula, allowable bias value at the clinical critical value (Xc) and expected

B̂c
bias estimate ( )are calculated respectively, and compared with the tolerance error of half

of ±25%(that is ±12.5%) required by the inter-office quality evaluation standard of the

Ministry of Health Clinical Laboratory, the results are shown in Table 8.

Table 8 Comparison of Allowable Error and Expected Bias

Medical decision Regression The estimated value of the expected 10% allowable Expected bias
level（Xc）nmol/L equation y=bx+a bias of the medical decision-making error 95%
level; a+（b-1）Xc confidence
interval
Lower Upper Lower Upper
limit limit limit limit
X1=0.1mIU/L y=1.051x-0.111 -0.106 -0.0125 0.0125 -0.595 0.383
X2=10mIU/L 0.399 -1.250 1.250 -0.089 0.888

4.1.7Absolute bias analysis

As shown in the following figure, the Bland-Altman analysis of the mean value of the
difference between the evaluation reagent and the reference reagent yields an average of
-0.292 between the two methods (absolute bias) with a standard deviation of 3.534, 95%
The boundary value is [-7.218 ～ 6.634], the out-of-bounds point is 10 and the
out-of-bounds point ratio is 4.78%.

4.1.8 Inconsistent sample analysis

Table 9 Sample information with inconsistent qualitative results for both methods

Roche Wondfo
Sample
Hospital Diagnose symptoms concentration concentration
No.
(mIU/L) (mIU/L)
Eighth People's Hospital of Primary
6 3.93 4.38
Guangzhou hyperthyroidism
Eighth People's Hospital of
92 Hepatitis B virus 0.092 0.77
Guangzhou
Eighth People's Hospital of
101 Diabetes NOS 4.38 2.96
Guangzhou
Eighth People's Hospital of
102 Medical examination 4.72 4.02
Guangzhou
Eighth People's Hospital of Normal pregnancy
106 4.37 3.85
Guangzhou supervision
Eighth People's Hospital of
110 Thyroid nodules 5.07 3.5
Guangzhou
The Second Affiliated
Hospital of Guangzhou 7 stomach ache 3.90 5.04
Medical University
The Second Affiliated
46 Lung malignancy 0.394 0.28
Hospital of Guangzhou
 Medical University
The Second Affiliated
Hospital of Guangzhou 54 Early pregnancy 0.289 0.26
Medical University
The Second Affiliated
Hospital of Guangzhou 99 4.69 3.93
Medical University
The 220 effective serum samples are tested with the evaluation reagent and the
reference reagent. There are 10 samples inconsistent with a ratio of 4.55%. The inconsistent
sample values of the two methods are all close to the reference range and are acceptable.

4.2 Test results and analysis of homologous serum and plasma samples
4.2.1A total of 116 serum samples are selected from the two centers, of which 116 are valid
serum samples (100%). See Table 1 for detailed selection results.
Table10 Selected sample basic situation

Item Eighth People's Hospital of Guangzhou,

The Second Affiliated Hospital of Guangzhou Medical University
Homologous serum and plasma samples
Valid sample 116（100%）
Excluding samples 0（0%）
Total 166
4.2.2 Outlier calculation
In the course of clinical trials, the homologous serum and homologous plasma are in
good agreement. There are 6 cases of homologous serum results <0.1, 1 case of results>
100, did not give specific values, and 6 cases of homologous plasma results <0.1, 1 case of
results> 100, no specific values. So these 7 cases are not counted. The average absolute
value of homologous serum and homologous plasma calculated from the data is 0.57; the
average relative difference is 0.23. According to the calculation, the test result of one
sample is greater than 4 times the average value of the absolute difference and 4 times the
average value of the relative difference. After the rejection, the sample size of the
homologous serum and homologous plasma is 108 cases.
4.2.3 Correlation analysis

Table 11 Two methods of measurement result correlation coefficient

Index Statistical magnitude Result

Two methods of measurement Number of cases(Number of
108(8)
result correlation coefficient missing cases)
Two methods of measurement
Spearman correlation coefficient 0.994
result correlation coefficient
Two methods of measurement
P 0
result correlation coefficient

Table 12 Model summary

Model R R Adjust R party Standard estimate

error
1 .994a .988 .988 .76230

a. Predictor variables: (constant), homologous serum.

4.2.4 Regression analysis
The regression coefficient obtained by linear regression is 1.123, the 95% confidence
interval of the regression coefficient is [1.099~1.148], the intercept item obtained is -0.233,
and the 95% confidence interval of the intercept item is [-0.396~-0.070]. The regression
equation is y=1.123x-0.233.
Table 13 Coefficienta
Non-standardized Standard 95.0% confidence
coefficient coefficient interval for B
Model
Standard trial Lower Upper
B t Sig.
error version limit limit
1 (constant) -.233 .082 -2.841 .005 -.396 -.070
Homologous
1.123 .012 .994 92.066 .000 1.099 1.148
serum
a. Dependent variable: Homologous plasma
 4.2.5 Expected Biases and Confidence Intervals at Medical Decision-making Levels
Calculate the allowable bias value at the clinical critical value (Xc), expected bias

B̂c
estimate ( ) and its 95% confidence interval (The confidence interval of the expected

bias includes the lower limit of the confidence interval that allows the bias or allows the
bias to be less than the expected bias or the upper limit of the confidence interval that
allows the bias to be greater than the expected bias.). By comparing the confidence interval
of the expected bias of the medical decision level with the limit of the allowable error, it is
less than the allowable error, and the equivalent of the evaluation reagent and the reference
reagent can be judged. If it is greater than the allowable error, further clinical verification is
required.

B̂c Bˆ c  a  (b  1) X c
Expected bias estimate ( ):

B̂c ^
1 ( X  X )2
95% confidence interval = B C
 t  / 2, N  2 S y  x  N C
 ( X i  X )2
N
i 1

[ t / 2, N 2 is a t-critical value of (1-α) bilateral tail area corresponding to the

t-distribution of residual degree of freedom N-2.]
We selected two medically determined levels of 0.1mIU/L and 10mIU/L for statistical
 analysis. The regression equation obtained by the linear regression in 4.2.4 is
y=1.123x-0.233,in which the intercept (a) is -0.233 and the slope (b) is 1.123. According to
the above formula, allowable bias value at the clinical critical value (Xc) and expected bias

B̂c
estimate ( )are calculated respectively, and compared with the tolerance error of half of

±25%(that is ±12.5%) required by the inter-office quality evaluation standard of the

Ministry of Health Clinical Laboratory, the results are shown in Table 14.

Table 14 Comparison of Allowable Error and Expected Bias

Medical decision Regression The estimated value of the expected 10% allowable Expected bias
level（Xc）nmol/L equation y=bx+a bias of the medical decision-making error 95%
level; a+（b-1）Xc confidence
interval
Lower Upper Lower Upper
limit limit limit limit
X1=0.1mIU/L y=1.123x-0.233 -0.221 -0.0125 0.0125 -0.425 -0.016
X2=10mIU/L 0.997 -1.250 1.250 0.792 1.202

4.2.6 Absolute bias analysis

As shown in the following figure, the Bland-Altman analysis of the mean value of the
difference between the evaluation reagent and the reference reagent yields an average of
-0.138 between the two methods (absolute bias) with a standard deviation of 1.064, 95%
The boundary value is[-2.223～1.946], the out-of-bounds point is 7 and the out-of-bounds
point ratio is 6.48%.
4.3 Test results and analysis of homologous serum and whole blood samples
4.3.1A total of 120 whole blood samples are selected from the two centers, of which 120
are valid serum samples (100%). See Table 15 for detailed selection results.
Table15 Selected sample basic situation

Item Eighth People's Hospital of Guangzhou,

The Second Affiliated Hospital of Guangzhou Medical University
Homologous serum and whole blood samples
Valid sample 120（100%）
Excluding samples 0（0%）
Total 120

4.3.2 Outlier calculation

In the course of clinical trials, the homologous serum and homologous plasma are in
good agreement. There are 6 cases of homologous serum <0.1, 1 case of> 100, no specific
values are given; homologous whole blood had 7 cases < 0.1, 1 case had> 100, no specific
values are given, so this 8 cases are excluded. The average absolute value of homologous
serum and homologous plasma calculated from the data is 0.69; the average relative
difference is 0.27. From the calculation, the test result of one sample is greater than 4 times
the average of the absolute difference value and 4 times the average value of the relative
difference, and the rejection and rejection rate is 0.89%. The homogenous serum and
homologous plasma are quantitatively analyzed. The number of samples is 111 cases.
4.3.3 Correlation analysis
Table 16 Two methods of measurement result correlation coefficient
Index Statistical magnitude Result
Two methods of measurement Number of cases(Number of
111(9)
result correlation coefficient missing cases)
Two methods of measurement
Spearman correlation coefficient 0.989
result correlation coefficient
Two methods of measurement
P 0
result correlation coefficient

Table 17 Model summary

Model R R Adjust R party Standard estimate

error
1 .989a .978 .978 1.10917
a. Predictor variables: (constant), homologous serum.
 4.3.4 Regression analysis
The regression coefficient obtained by linear regression is 1.120, the 95% confidence
interval of the regression coefficient is [1.088~1.152], the intercept item obtained is -0.320,
and the 95% confidence interval of the intercept item is [-0.554~-0.086]. The regression
equation is y=1.120x-0.320.

Table 18 Coefficienta

Non-standardized Standard 95.0% confidence

coefficient coefficient interval for B
Model
Standard trial Lower Upper
B t Sig.
error version limit limit
1 (constant) -.320 .118 -2.711 .008 -.554 -.086
Homologous
1.120 .016 .989 69.177 .000 1.088 1.152
serum
a. Dependent variable: Homologous whole blood

4.3.5 Expected Biases and Confidence Intervals at Medical Decision-making Levels

Calculate the allowable bias value at the clinical critical value (Xc), expected bias

B̂c
estimate ( ) and its 95% confidence interval (The confidence interval of the expected

bias includes the lower limit of the confidence interval that allows the bias or allows the
bias to be less than the expected bias or the upper limit of the confidence interval that
allows the bias to be greater than the expected bias.). By comparing the confidence interval
of the expected bias of the medical decision level with the limit of the allowable error, it is
 less than the allowable error, and the equivalent of the evaluation reagent and the reference
reagent can be judged. If it is greater than the allowable error, further clinical verification is
required.

B̂c Bˆ c  a  (b  1) X c
Expected bias estimate ( ):

B̂c ^
1 ( X  X )2
95% confidence interval = B C
 t  / 2, N  2 S y  x  N C
 ( X i  X )2
N
i 1

[ t / 2, N 2 is a t-critical value of (1-α) bilateral tail area corresponding to the

t-distribution of residual degree of freedom N-2.]
We selected two medically determined levels of 0.1mIU/L and 10mIU/L for statistical
analysis. The regression equation obtained by the linear regression in 4.3.4 is
y=1.120x-0.320,in which its intercept (a) is -0.320 and the slope (b) is 1.120. According to
the above formula, allowable bias value at the clinical critical value (Xc) and expected bias

B̂c
estimate ( )are calculated respectively, and compared with the tolerance error of half of

±25%(that is ±12.5%) required by the inter-office quality evaluation standard of the

Ministry of Health Clinical Laboratory, the results are shown in Table 19.

Table 19 Comparison of Allowable Error and Expected Bias

Medical decision Regression The estimated value of the expected 10% allowable Expected bias
level（Xc）nmol/L equation y=bx+a bias of the medical decision-making error 95%
level; a+（b-1）Xc confidence
interval
Lower Upper Lower Upper
limit limit limit limit
X1=0.1mIU/L y=1.120x-0.320 -0.308 -0.0125 0.0125 -0.565 -0.051
X2=10mIU/L 0.880 -1.250 1.250 0.623 1.137
4.3.6Absolute bias analysis
As shown in the following figure, the Bland-Altman analysis of the mean value of the
difference between the evaluation reagent and the reference reagent yields an average of
1.354 between the two methods (absolute bias) with a standard deviation of 19.397, 95%
The boundary value is [-2.730～2.578], the out-of-bounds point is 3 and the out-of-bounds
point ratio is 2.70%.
5. Conclusion

The qualitative analysis of the results of serum samples obtained from 220serum
sample evaluation reagents and reference reagents is conducted and a total of 210 samples
with the same results as the evaluation reagent and the reference reagent. Of which 86 cases
are detected with abnormalities, 124 cases are detected normal and 10 cases with
inconsistent results. The two methods total compliance rate: 95.45%, 95%CI is [91.80%～
97.80%], positive compliance rate: 93.48%, 95%CI is [86.34% ～ 97.57%], negative
compliance rate: 96.88%，95%CI is [ 92.19%～97.80% ], kappa consistency coefficient k =
0.906, p = 0.000 <0.05. After 11 samples outside the linear range are excluded, the results
of 209 serum samples are statistically analyzed. The Spearman's correlation coefficient
between the reagent and the reference reagent is 0.982 and p=0. Linear regression is used to
estimate the results. The results showed a good linear relationship between the two methods.
The regression coefficient obtained is 1.051, the 95% confidence interval of the regression
coefficient is [1.023~1.079], and the intercept obtained is -0.111. The 95% confidence
interval for the intercept is [-0.629 ～ 0.408], and the linear regression equation is
y=1.051x-0.111; When the medical decision level is 0.1mIU/L, estimated expected bias is
-0.106, the expected bias is 95% confidence interval [-0.595～0.383], and when the
medical decision level is 10mIU/L, estimated expected bias is 0.399, and the expected bias
is 95% confidence interval [-0.089～0.888]. The bias at the medical decision level is
outside the 12.5% tolerance. For the Bland-Altman analysis, the mean difference is -0.292,
the standard deviation difference is 3.534, the 95% cutoff is[-7.218～6.634], out-of-bounds
point is 10 and the ratio of out-of-bounds points is 4.78%.
A total of 116 samples of homologous serum and plasma samples are tested by
evaluation reagents. After 8 samples outside the linear range are excluded, the results of
108 homologous samples are statistically analyzed. The Spearman correlation coefficient of
the statistical results is 0.994, p = 0; Linear regression is used to estimate the results and its
results showed a good linear relationship between the two types of samples. The regression
coefficient obtained is 1.123, the 95% confidence interval of the regression coefficient is
[1.099~1.148], and the intercepts obtained at the same time for -0.233, the 95% confidence
interval for the intercept is [--0.936~-0.070] and the linear regression equation is
y=1.123x-0.233. When the medical decision level is0.1mIU/L, the estimated expected bias
is -0.221, the expected bias is 95% confidence interval[-0.425～-0.016], and when the
medical decision level is 10mIU/L, estimated expected bias is 0.997, the expected bias.
95% confidence interval [0.792～1.202]. The bias at the medical decision level is within
12.5% of the allowable error. The results are analyzed by Bland-Altman, with a mean
difference of -0.138, a standard deviation of 1.064, a 95% cutoff value of [-2.223~1.946],
out-of-bounds point is 7 and the ratio of out-of-bounds points is 6.48%.
A total of 120samples of homologous serum and whole blood samples are tested by
evaluation reagents. After 9 samples outside the linear range are excluded, the results of 111
homologous samples are statistically analyzed. The Spearman correlation coefficient of the
statistical results is 0.989, p = 0; Linear regression is used to estimate the results and its
results showed a good linear relationship between the two types of samples. The regression
coefficient obtained is 1.120, the 95% confidence interval of the regression coefficient is
[1.088~1.152], and the intercepts obtained at the same time for -0.320, the 95% confidence
interval for the intercept is [-0.554~-0.086] and the linear regression equation is
y=1.120x-0.320. When the medical decision level is 0.1mIU/L, the estimated expected bias
is -0.308, the expected bias is 95% confidence interval[-0.565～-0.051], and when the
medical decision level is 10mIU/L, the estimated expected bias is 0.880, the expected bias.
95% confidence interval [0.623～1.137]. The bias at the medical decision level is within
12.5% of the allowable error. The results are analyzed by Bland-Altman, with a mean
difference of -0.076, a standard deviation of 1.354, a 95% cutoff value of [-2.730～2.578],
out-of-bounds point is 3 and the ratio of out-of-bounds points is 2.70%.

Conclusion:
Guangzhou Wondfo Biotech Co., Ltd.'s TSH Rapid Quantitative Test (fluorescent
immunochromatography) does not have a statistically significant difference from the test
results of the same product that has been approved for marketing, and has a high degree of
consistency, that is clinical application performance is equivalent. In addition, the
evaluation reagent also has equivalence in detecting homologous serum and plasma, whole
blood samples.