Original Article Laboratory Informatics Annals of Laboratory Medicine 2026

AI-Powered Serum Quality Assessment

A two-step deep learning system combining YOLOv5 and ResNet-50 to identify hemolysis, icterus and lipemia before compromised serum samples enter downstream clinical testing.

Research article: Weixin Chen, Yuxuan Xiong, Chenxi Zhang, Zhifang Sui, Fengning Yang, Zikun Ma, Qinglin Liu, Yuexin Cui & Ran Han
21K Primary serum samples for model development
21K Separate independent test dataset
97% Independent-test accuracy for hemolysis
<100 Milliseconds inference time per sample
2-Step ROI detection followed by serum classification
224 × 224 Standardized image input for ResNet-50
72% AI exact agreement in human–machine comparison
96% AI sensitivity in the classification comparison
Clinical Problem

Why serum quality matters before a result is reported

Hemolysis, icterus and lipemia can interfere with biochemical measurements. Visual inspection is still vulnerable to subjectivity and variability, creating a need for fast, reproducible pre-analytical quality control.

H

Hemolysis

Ruptured erythrocytes release intracellular components into serum. Analytes such as AST, LDH and potassium may therefore appear artificially elevated.

2.4% of the study cohort
I

Icterus

Bilirubin and related pigments have spectral properties capable of interfering with photometric and peroxidase-coupled biochemical measurements.

1.4% of the study cohort
L

Lipemia

Excess serum lipids and chylomicrons can increase light scattering and absorbance, compromising multiple laboratory measurements.

3.6% of the study cohort
Dataset Design

Built on real-world clinical sample distributions

The model-development dataset contained 21,000 serum samples. Eighty percent were assigned to training and twenty percent to validation. A separate 21,000-sample dataset was subsequently used for independent evaluation.

Primary dataset

Clinical serum samples used during development
21K samples
Training 16,800 · 80%
Validation 4,200 · 20%

Observed serum abnormalities

Distribution in the 21,000-sample study cohort
2.4% Hemolysis
513 abnormal / rejected samples
1.4% Icterus
286 abnormal samples
3.6% Lipemia
754 abnormal / rejected samples
Normal samples 19,597
One HIL category 1,254
Two categories simultaneously 148
All three HIL categories 1
Model Architecture

One model finds the serum.
The next model understands it.

Instead of classifying an entire laboratory image directly, the system first isolates the biologically relevant serum region. ResNet-50 then performs multi-level HIL classification.

01 · CAPTURE

Serum Image

Sample images are automatically captured during preprocessing in the clinical laboratory workflow.

CLINICAL INPUT
02 · LOCALIZE

ROI Detection

The model identifies the visible serum area while excluding irrelevant information such as labels, caps and background regions.

YOLOv5
03 · STANDARDIZE

Image Processing

Extracted serum images are normalized and resized to 224 × 224 pixels for classification.

224 × 224
04 · CLASSIFY

HIL Classification

Deep residual features are used to identify hemolysis, icterus, lipemia and their severity grades.

RESNET-50
05 · ACT

Clinical Decision

The resulting severity class can support actions such as acceptance, advisory comments, further review or sample rejection.

QC OUTPUT
800 ROI images manually annotated
720 / 80 Detector train / test split
32 Training batch size
0.001 Initial learning rate
50 Training epochs
A100 NVIDIA GPU used for training
Computer Vision Benchmark

Deep learning localized serum more reliably

The researchers compared YOLOv5-based ROI localization against a traditional computer-vision workflow based on manually engineered image-processing features.

Traditional CV

Engineered image processing

Recall 0.70
Intersection over Union 0.82
Independent Evaluation

Performance on previously unseen clinical data

The final model was evaluated on an independent dataset that was not used during model training or hyperparameter tuning. The figures below show binary detection performance.

Hemolysis

H > 30
97 % ACCURACY
Specificity 97%
Sensitivity 87%
Precision 23%
High sensitivity was prioritized because missing a compromised specimen may allow an erroneous clinical result to progress downstream.

Icterus

I > 5
93 % ACCURACY
Specificity 93%
Sensitivity 97%
Precision 17%
The screening-oriented design accepts more false-positive flags in exchange for reducing the risk of overlooked abnormal samples.

Lipemia

L > 25
97 % ACCURACY
Specificity 97%
Sensitivity 100%
Precision 15%
The model detected all positive lipemia cases in this binary independent-test evaluation, yielding 100% sensitivity.
Human–Machine Comparison

Consistency where visual judgment varies

Nine trained laboratory professionals independently classified representative serum samples under standardized conditions. Their results were compared with the AI system.

Metric
Manual visual assessment
AI model
Exact Match
42–68%
72%
Fuzzy Match
73–93%
82%
Specificity
90–100%
92%
Sensitivity
47–88%
96%
i

Exact match requires complete agreement with the reference category. A fuzzy match allows a difference of no more than one severity level.

Clinical Grading

From “normal” to “reject”

Rather than producing only a positive or negative flag, the system was designed around severity grades that correspond to practical laboratory decisions.

Hemolysis Index · H

Five clinical categories
Normal H ≤ 30
Mild 30 < H < 50
Moderate 50 ≤ H < 70
Severe 70 ≤ H < 100
Reject H ≥ 100

Icterus Index · I

Three clinical categories
Normal I ≤ 5
Icterus 5 < I < 8
Severe Icterus I ≥ 8

Lipemia Index · L

Five clinical categories
Normal L ≤ 25
Mild 25 < L < 50
Moderate 50 ≤ L < 130
Severe 130 ≤ L < 150
Reject L ≥ 150
Clinical Integration

Designed for a high-throughput laboratory workflow

The model was evaluated in a clinical preprocessing workflow using existing laboratory equipment rather than a separate experimental imaging system.

AI inference at laboratory speed

The study reports mean inference time below 100 milliseconds per serum sample, supporting deployment in a high-throughput workflow.

<100 ms / sample
Accept Normal serum quality
Review / Comment Mild or moderate interference
Reject Severe interference
Platform context · Roche Diagnostics

cobas® c 701

The research prototype was integrated with preprocessing associated with the Roche cobas c 701 module. Roche describes the platform as a high-throughput clinical chemistry analyzer capable of determining hemolytic, icteric and lipemic serum indices.

2,000 tests / hour · platform specification
H · I · L serum indices supported
External context: Roche Diagnostics product specifications
Technology Context

Two established computer-vision ideas, applied to laboratory medicine

The study combines object localization and deep residual classification rather than asking a single network to interpret the entire raw laboratory image.

01

YOLOv5

Used in the study to localize the serum region of interest. YOLO-family models are designed for efficient visual object detection, making them suitable for rapid image localization.

Technology context: Ultralytics
02

ResNet-50

A deep residual convolutional network used here for HIL classification after ROI extraction. Residual connections were originally developed to make much deeper neural networks easier to optimize.

Technology context: He et al. · CVPR
03

Clinical QC

The AI output is not presented simply as an image label. It maps visual assessment to graded categories intended to support actionable pre-analytical quality-control decisions.

Application context: clinical laboratory workflow
Interpretation

What the results establish — and what remains to be tested

Study limitations

1

The research was conducted as a single-center study.

2

Generalizability to other institutions, patient populations, instruments and pre-analytical workflows remains to be confirmed.

3

A prospective multicenter validation study is required before widespread clinical adoption.

4

Future work may compare the architecture with newer deep-learning models and explore continuous HIL index regression.

Why the research matters

The study moves serum-quality AI beyond a simple proof-of-concept. It evaluates a two-stage computer-vision workflow with clinically collected samples, an independent test dataset and direct comparison with trained laboratory professionals.

Its central contribution is the translation of visual serum inspection into a rapid, standardized and graded QC process that can potentially operate before compromised samples generate misleading downstream measurements.

Published Research

From serum image to clinical quality signal.

Development and Evaluation of Artificial Intelligence-Based Two-Step Model for Automated Serum Quality Assessment in Clinical Laboratories.

DOI · 10.3343/alm.2025.0509   ·   Annals of Laboratory Medicine
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