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record_id
stringlengths
14
20
record_type
stringclasses
2 values
lot
int64
21.1M
21.1M
device
stringclasses
1 value
temperature_c
float64
10
40
sample_type
stringclasses
3 values
control_level
float64
1
2
analyzer_id
stringclasses
2 values
sample_no
float64
1
8
reference_value_pct
float64
4.3
14.3
shyrai_test1_pct
float64
4.3
14.5
shyrai_test2_pct
float64
4.3
14.6
shyrai_test3_pct
float64
4.2
14.8
shyrai_mean_pct
float64
5
10.3
bias_pct
float64
-3
3.3
cv_pct
float64
0.8
2.8
bias_pass
stringclasses
1 value
q_accuracy
float64
0.34
1
q_repeatability
float64
0.44
0.84
label_quality_ok
int64
1
1
TEMP_40_L1_Analyzer1
temperature_control
21,062,021
Shyrai A1c
40
control_solution
1
Analyzer 1
null
5.15
5.1
5.2
null
5.2
0
null
PASS
1
null
1
TEMP_40_L1_Analyzer2
temperature_control
21,062,021
Shyrai A1c
40
control_solution
1
Analyzer 2
null
5.12
4.9
5
null
5
3.3
null
PASS
0.34
null
1
TEMP_40_L2_Analyzer1
temperature_control
21,062,021
Shyrai A1c
40
control_solution
2
Analyzer 1
null
10.2
10.1
10.2
null
10.2
-0.5
null
PASS
0.9
null
1
TEMP_40_L2_Analyzer2
temperature_control
21,062,021
Shyrai A1c
40
control_solution
2
Analyzer 2
null
10.3
9.9
10.3
null
10.1
-1.9
null
PASS
0.62
null
1
TEMP_10_L1_Analyzer1
temperature_control
21,062,021
Shyrai A1c
10
control_solution
1
Analyzer 1
null
5.2
5.2
5.1
null
5.2
-1
null
PASS
0.8
null
1
TEMP_10_L1_Analyzer2
temperature_control
21,062,021
Shyrai A1c
10
control_solution
1
Analyzer 2
null
5.1
4.9
5.2
null
5.2
-1
null
PASS
0.8
null
1
TEMP_10_L2_Analyzer1
temperature_control
21,062,021
Shyrai A1c
10
control_solution
2
Analyzer 1
null
10.2
10.4
10.2
null
10.3
1
null
PASS
0.8
null
1
TEMP_10_L2_Analyzer2
temperature_control
21,062,021
Shyrai A1c
10
control_solution
2
Analyzer 2
null
10.3
10.2
10.3
null
10.3
-0.5
null
PASS
0.9
null
1
VENOUS_BLOOD_1
accuracy_assessment
21,062,021
Shyrai A1c
null
venous_blood
null
null
1
4.4
4.3
4.3
4.2
null
-3
1.4
PASS
0.4
0.72
1
VENOUS_BLOOD_2
accuracy_assessment
21,062,021
Shyrai A1c
null
venous_blood
null
null
2
5.12
5.1
5.2
5.1
null
0.3
1.1
PASS
0.94
0.78
1
VENOUS_BLOOD_3
accuracy_assessment
21,062,021
Shyrai A1c
null
venous_blood
null
null
3
6.73
6.8
6.7
6.7
null
0
0.9
PASS
1
0.82
1
VENOUS_BLOOD_4
accuracy_assessment
21,062,021
Shyrai A1c
null
venous_blood
null
null
4
7.52
7.6
7.5
7.2
null
-1.2
2.8
PASS
0.76
0.44
1
VENOUS_BLOOD_5
accuracy_assessment
21,062,021
Shyrai A1c
null
venous_blood
null
null
5
8.3
8.2
8.3
8.4
null
0
1.2
PASS
1
0.76
1
VENOUS_BLOOD_6
accuracy_assessment
21,062,021
Shyrai A1c
null
venous_blood
null
null
6
11.5
11.2
11.4
11.5
null
-1.2
1.3
PASS
0.76
0.74
1
VENOUS_BLOOD_7
accuracy_assessment
21,062,021
Shyrai A1c
null
venous_blood
null
null
7
12.8
12.6
12.7
12.4
null
-1.8
1.2
PASS
0.64
0.76
1
VENOUS_BLOOD_8
accuracy_assessment
21,062,021
Shyrai A1c
null
venous_blood
null
null
8
14.3
14.5
14.6
14.8
null
2.3
1
PASS
0.54
0.8
1
CAPILLARY_BLOOD_1
accuracy_assessment
21,062,021
Shyrai A1c
null
capillary_blood
null
null
1
4.3
4.3
4.4
4.2
null
0
2.3
PASS
1
0.54
1
CAPILLARY_BLOOD_2
accuracy_assessment
21,062,021
Shyrai A1c
null
capillary_blood
null
null
2
5.14
5.1
5.2
5.2
null
0.5
1.1
PASS
0.9
0.78
1
CAPILLARY_BLOOD_3
accuracy_assessment
21,062,021
Shyrai A1c
null
capillary_blood
null
null
3
6.73
6.9
6.7
6.7
null
0.5
1.7
PASS
0.9
0.66
1
CAPILLARY_BLOOD_4
accuracy_assessment
21,062,021
Shyrai A1c
null
capillary_blood
null
null
4
7.52
7.6
7.4
7.2
null
-1.6
2.7
PASS
0.68
0.46
1
CAPILLARY_BLOOD_5
accuracy_assessment
21,062,021
Shyrai A1c
null
capillary_blood
null
null
5
8.3
8.5
8.3
8.4
null
1.2
1.2
PASS
0.76
0.76
1
CAPILLARY_BLOOD_6
accuracy_assessment
21,062,021
Shyrai A1c
null
capillary_blood
null
null
6
11.5
11.2
11.4
11.5
null
1.2
1.3
PASS
0.76
0.74
1
CAPILLARY_BLOOD_7
accuracy_assessment
21,062,021
Shyrai A1c
null
capillary_blood
null
null
7
12.8
12.6
12.5
12.4
null
-2.3
0.8
PASS
0.54
0.84
1
CAPILLARY_BLOOD_8
accuracy_assessment
21,062,021
Shyrai A1c
null
capillary_blood
null
null
8
14.3
14.5
14.4
14.8
null
1.9
1.4
PASS
0.62
0.72
1

Shyrai A1c Quality Control Dataset

Description

This dataset contains real-world quality control (QC) data collected during the production and testing of the Shyrai A1c glycated hemoglobin analyzer, used for diabetes diagnostics.

The dataset is designed to support research in:

  • AI-driven quality management systems (QMS)
  • anomaly detection
  • predictive quality analytics
  • medical device manufacturing

Dataset Structure

The dataset includes the following types of data:

  • Production data: lot ID, production date, serial numbers
  • Measurement data: repeated measurements, mean values
  • Reference values: ABX Pentra C400
  • Quality metrics:
    • Bias (%)
    • CV (%)
    • Pass/Fail status
  • Test conditions:
    • temperature (10°C, 40°C)
    • control material levels
  • Biological samples:
    • venous blood
    • capillary blood
  • Error logs:
    • error codes (101–310)
    • error categories
  • Derived features:
    • ML-ready features
    • IDQI-HbA1c quality index

Use Cases

This dataset can be used for:

  • quality classification (Pass/Fail)
  • anomaly detection in production
  • prediction of measurement deviations
  • development of digital twin models
  • AI integration in QMS systems

Data Format

The dataset is provided in CSV format, structured for machine learning (ML-ready).


Source

Data collected from real production processes at:

LLP “Axel and A” — the first domestic manufacturer of diagnostic test strips for glucose, cholesterol, and triglyceride measurement.


Limitations

  • small dataset size (pilot study)
  • limited to one analyzer type (Shyrai A1c)
  • further validation required for generalization

Citation

If you use this dataset, please cite:

Karimkyzy, B. (2026). Shyrai A1c Quality Control Dataset for AI-driven QMS research.


Author

Bekzat Karimkyzy — PhD doctoral student in Information Technologies (professional track), D. Serikbayev East Kazakhstan Technical University; employee of Axel & A LLP. ORCID: 0009-0004-4696-7927


Future Work

  • dataset expansion
  • integration with real-time monitoring systems
  • development of predictive AI models
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