Testing items
Morphological Detection Items
- Red Blood Cells
- White Blood Cells
- Epithelial Cells
- Clue Cells
- Vaginal Trichomonas
- Cocci
- Bacilli
- Fungi
- Pathogenic Microorganisms
Additional Indicators
- Can expand to include microbial density, diversity, dominant bacteria.
- Supports scoring systems like Nugent score, Donders score, etc.
Dry Chemical Detection Items
- pH: Reflects vaginal microecological balance.
- Hydrogen Peroxide (H₂O₂): Metabolic product of Lactobacillus, positively correlated with its count—indicates normal function.
- Lactic Acid (LA): Evaluates Lactobacillus levels and vaginal flora balance.
- Leukocyte Esterase (LE): Inflammation marker, indicating white blood cell count in vaginal secretions.
- Sialidase (SNA): Secreted by Gardnerella and anaerobic bacteria. A pathogenic bacteria indicator—positive results suggest bacterial vaginosis.
- β-Glucuronidase (β-G): Aerobic bacteria enzyme—positive results suggest aerobic bacterial vaginitis.
- N-Acetyl-β-glucosaminidase (NAG): Specific enzyme from fungi and Trichomonas. Combined with pH, can indicate fungal vaginitis (pH ≤ 4.6) or Trichomoniasis (pH > 4.8).
- Proline Aminopeptidase (PLD): Positive results suggest fungal or anaerobic bacterial vaginitis.
- Coagulase (CG): Aerobic bacteria enzyme—positive results suggest aerobic bacterial vaginitis.
- Oxidase (OX): Positive results suggest gonococcal infection.
- Alkaline Phosphatase (ALP): Positive results suggest mixed bacterial vaginitis.
Detection Principle
Morphological Detection
- Uses AI-powered machine vision for real-time imaging, ensuring precise identification and classification of formed elements in specimens.
- Employs automated microscopy, reducing human error and improving diagnostic accuracy.
- Capable of detecting red blood cells, white blood cells, epithelial cells, clue cells, bacteria, fungi, and other microorganisms.
- Generates scatter plots and curve analyses to assist in clinical interpretation.
Dry Chemical Detection
- Utilizes the colorimetric analysis method, where chemical reagents react with urine components, producing color changes that indicate analyte concentration.
- Applies photometric measurement to quantify substances like pH, hydrogen peroxide, lactic acid, leukocyte esterase, and bacterial enzymes.
- Based on the Beer-Lambert Law, ensuring precise readings of analyte concentrations.
- Supports early detection of bacterial vaginosis, fungal infections, and inflammatory conditions.
Working Procedure
Product Features
Precision Imaging and Automated Recognition in Microscopy
Microscope Automatic Control & Image Acquisition: Integrates AI and machine vision to enable multi-threaded automation of microscopic examinations. It uses low magnification for positioning and high magnification for tracking, allowing rapid image capture of morphological components. Real-time images are displayed, and confirmatory reports can be generated for diagnostic validation.
Intelligent Recognition Technology: Simulates human cognitive processes using self-learning and deep learning algorithms. Trained on extensive image datasets, it delivers high-accuracy recognition of diverse pathological morphological components, supporting precise diagnostics.
Intelligent Review Technology: Automatically analyzes both microscopic and dry chemical results, intelligently determining whether manual review is necessary. This reduces examiner workload and enhances laboratory efficiency by focusing human expertise where it’s most needed.
Optimized Precision Control for Comprehensive Testing
Innovative Integrated Design: Combines morphological and dry chemical detection within a single sample, minimizing the risk of misdiagnosis or missed diagnoses that can occur with isolated testing methods. This integration enhances detection accuracy and reduces manual workload, streamlining laboratory operations.
Rich Dry Chemical Detection Indicators: Offers up to 11 configurable dry chemical testing items, making it one of the most comprehensive solutions available. The flexible test combinations cater to a wide range of diagnostic needs, supporting diverse clinical applications.
Precise Constant Temperature Control System: Employs computer-controlled temperature regulation to maintain optimal reaction conditions, ensuring accurate detection even in low-concentration samples. This stability is crucial for sensitive assays and reliable test outcomes.
Integrated Quality Control System for Diagnostic Accuracy
Factory-Calibrated Quality Control: Equipped with original manufacturer-supplied quality control items for both morphological components and eleven vaginitis co-testing indicators, ensuring high testing accuracy and consistency across a wide diagnostic spectrum.
Traceable Test Results: Delivers real-time microscopic images and dynamic videos of Trichomonas vaginalis, enabling manual review, case traceability, and research documentation. This transparency supports clinical validation and enhances diagnostic confidence.
Clasification
| Testing Criteria | Performance Evaluation |
|---|---|
|
Troughput |
AVE-321>120 tests/h; |
|
Accuracy |
>95% |
|
Carryover |
Microscopy:<1 cell/ul(At concentration of 5000 cells/ul) |
|
Report |
Comprehensive report showing both images and diagrams, with microscopy images, morphological analysis results, chemistry results and Trichomonas video |
|
Sampler |
6 racks of 10 tubes |
|
Magnification |
Standard 10X & 40X |
|
Memory |
>1,000,000 results |
|
Interfaces |
Bi-direction connection data transmission with LIS/HIS |
|
Network function |
Connectable to the networks of laboratory and hospital to realize paperless transmission of reports |
