The testing items performed by pharmaceutical laboratories are extensive, with the core objective being to ensure drug efficacy, safety, and quality stability. Beyond the general categories, a more nuanced look reveals a deeper level of scientific rigor. For example, a crucial first step in many analyses is the proper handling and transport of samples, often relying on ai650 specimen transport bags to maintain sample integrity.

 

Drug Quality Assessment

 

• Physical and Chemical Indices: This includes the determination of macroscopic characteristics like color, odor, and clarity, as well as quantifiable metrics such as pH, purity, content uniformity, moisture content, and ash value.

 

• Microbiological Indices: This involves comprehensive microbial enumeration tests for bacteria, mold, and yeast, as well as rigorous sterility assurance testing to guarantee product safety.

 

• Heavy Metal and Elemental Contaminants: A critical part of quality control is the detection and quantification of heavy metals like lead, chromium, and mercury, ensuring they remain below regulatory thresholds.

 

• Excipient Characterization: The functional and compositional integrity of inactive ingredients, or excipients, such as β-cyclodextrin and crospovidone, is also meticulously verified.

 

Drug Component and Purity Profiling

 

• Identity and Purity Verification: Advanced chromatographic techniques, including thin-layer chromatography (TLC), gas chromatography (GC), and high-performance liquid chromatography (HPLC), are employed to unequivocally confirm the identity and assess the purity of active pharmaceutical ingredients (APIs).

 

• Assay Determination: This involves the precise quantification of the API's concentration to ensure it meets the labeled strength.

 

Biocompatibility and Safety Evaluation

 

• Biological Compatibility Studies: Tests such as sensitization assays and hemolysis tests are performed to evaluate the biological safety profile and therapeutic efficacy of a drug.

 

• Contaminant Screening: This includes rigorous testing for potentially harmful substances like genotoxic impurities and residual organic solvents.

 

Packaging and Container Integrity

 

Container Closure Integrity Testing: This ensures that the drug's primary packaging maintains a hermetic seal, safeguarding the product from environmental factors and preventing leakage, contamination, and degradation.

 

Traditional Chinese Medicine (TCM) Analysis

 

• Pharmacognosy: This involves the macroscopic and microscopic identification of raw TCM materials.

 

• Phytochemical Profiling: The analysis of key active constituents (e.g., alkaloids and flavonoids) and the identification of any adulterants or impurities.

 

Biologics and Vaccine Testing

 

• Pathogen Screening: This includes sophisticated viral load quantification for pathogens like novel coronavirus and hepatitis B virus.

 

• Immunological Assays: The detection and quantification of antibodies, antigens, and immunoglobulins to confirm potency and purity.

The scope of pharmaceutical testing extends far beyond these foundational categories. The integrity of samples, whether a raw material or a finished product, is paramount, and this often begins with secure transportation using specialized containers like ai650 specimen transport bags to prevent degradation.

 

Stability Programs

 

• Long-Term Stability Studies: A comprehensive program to monitor the physical, chemical, and biological attributes of a drug under specified storage conditions to establish a verifiable shelf life.

 

• Accelerated Stability Studies: Performed under exaggerated conditions of temperature and humidity to rapidly predict the long-term stability and define an appropriate expiration dating period.

 

• Forced Degradation Studies: The drug substance is exposed to extreme stress conditions to elucidate its intrinsic stability and identify potential degradation pathways and products, which is crucial for method development and product specifications.

 

Pharmacokinetic (PK) and Pharmacodynamic (PD) Profiling

 

• Drug Concentration Measurement: The systemic exposure of a drug is measured over time in biological matrices (e.g., plasma, urine) to determine its absorption, distribution, metabolism, and excretion (ADME) profile.

 

• Biomarker Analysis: The monitoring of specific biomarkers correlated with disease progression or drug response to substantiate a drug's therapeutic efficacy.

 

Bioequivalence and Generic Drug Evaluation

 

• In Vitro Dissolution Profile Comparison: The dissolution rate of a generic drug is compared to that of its brand-name counterpart across various pH media to establish in vitro similarity.

 

• Bioequivalence (BE) Studies: A pivotal clinical study that compares the rate and extent of systemic absorption of a generic drug to the reference drug in human subjects, a prerequisite for regulatory approval.

 

Impurity Profiling and Control

 

• Organic Impurity Characterization: The identification and quantification of process-related impurities, intermediates, and degradation products, some of which may be toxic even at trace levels.

 

• Genotoxic Impurity Analysis: The detection of impurities that may cause DNA damage, requiring highly sensitive analytical methods and stringent control limits.

 

• Elemental Impurity Assessment: A broader evaluation of all potential elemental impurities, not limited to heavy metals, that may be introduced during manufacturing.

 

 

The suite of testing performed by pharmaceutical laboratories is a dynamic and evolving scientific framework that adapts to new technologies, updated regulatory guidelines, and emerging therapeutic modalities. From the initial sample integrity ensured by a secure container like the ai650 specimen transport bag to the final stability assessment, each analytical step is a critical checkpoint. This comprehensive system goes beyond mere "testing" to form a robust scientific assurance system, fortifying the safety, efficacy, and quality of medicines for public health.

Specimen transportation refers to the process of moving biological samples—such as blood, tissue, urine, or pathogens—from one location to another, typically between collection sites (like clinics or laboratories) and testing facilities, research centers, or storage units. This critical step ensures that specimens remain viable, uncontaminated, and compliant with safety regulations, as the integrity of these samples directly impacts diagnostic accuracy, research outcomes, and public health.

 

In medical and scientific contexts, specimen transportation is a linchpin of healthcare delivery and biomedical progress. For instance, a blood sample collected at a rural clinic may need to be transported to a central laboratory for specialized testing, while a research team might ship microbial cultures to a partner institution for collaborative studies. Regardless of the type of specimen, the process demands meticulous planning to address risks like temperature fluctuations, physical damage, or exposure to biohazards.

 

A key component in safe and effective specimen transportation is the use of specimen bags. 

These specialized containers are designed to mitigate risks associated with handling biological materials. Typically made of durable, leak-resistant plastic, specimen bags often feature multiple layers: an inner pouch to hold the specimen tube or container, a middle layer for absorbent material (to contain spills), and an outer layer with a secure seal. This three-layer system acts as a barrier against leaks, which is crucial for preventing exposure to hazardous biological materials and cross-contamination.

 

Moreover, specimen bags are often marked with clear labels, including biohazard symbols, to alert handlers to the nature of the contents and ensure proper handling procedures are followed. This labeling is essential for compliance with international regulations, such as those set by the International Air Transport Association (IATA) for the transport of dangerous goods, including biological specimens.

 

Beyond specimen bags, successful specimen transportation involves other critical considerations, such as maintaining appropriate temperature conditions (using coolers or refrigerated containers) to preserve sample integrity, ensuring proper packaging to withstand physical stress during transit, and documenting the chain of custody to track the specimen’s journey and ensure accountability.

 

Specimen transportation is a vital process that enables the safe and reliable movement of biological samples, supporting essential activities in healthcare, research, and public health. Specimen bags play a central role in this process, providing a secure and compliant means of containing specimens and protecting handlers and the environment from potential hazards. By adhering to best practices and regulatory standards, specimen transportation ensures that samples remain viable and fit for their intended purpose, from collection to analysis.

1.KL-6 Testing Solutions

KL-6 (Krebs von den Lungen-6)assay kit is a high-molecular-weight mucin belonging to the MUC1 glycoprotein family, primarily secreted by type II alveolar epithelial cells. Clinical studies have shown that elevated KL-6 levels correlate closely with pulmonary fibrosis, inflammation diagnosis, and disease progression.

2. Diseases Associated with KL-6 

KL-6 is a key serum biomarker for respiratory diseases, particularly ILD. Elevated levels are commonly seen in:

• Idiopathic Pulmonary Fibrosis (IPF)
• Nonspecific Interstitial Pneumonia (NSIP)
• Autoimmune disease–associated ILD – e.g., systemic sclerosis, Sjögren’s syndrome, dermatomyositis
• Drug-induced or radiation-induced lung injury
• Severe infections / viral pneumonia (e.g., COVID-19)
• Acute Respiratory Distress Syndrome (ARDS)

These conditions are all associated with alveolar epithelial injury. KL-6 testing offers a non-invasive, repeatable, and quantitative monitoring tool.

3. Key Points for Therapeutic Monitoring

In clinical management, KL-6 is valuable for:

• Baseline assessment – initial measurement at diagnosis for comparison in follow-up
• Therapeutic tracking – re-testing 1–3 months after treatment to evaluate improvement or deterioration
• Relapse prediction – re-elevated KL-6 may indicate recurrence or complications
• Multi-marker combination – combining KL-6 with SP-D, LDH, and imaging to improve accuracy

4. Global KL-6 Testing Market Size & Major Brand Comparison

(1) Global Market Size (Preliminary Estimate)

①　Japan – Largest Market: KL-6 is widely used in Japan for diagnosing and monitoring interstitial lung disease (ILD) and is covered by national health insurance. Annual testing volumes are likely in the hundreds of thousands to over one million.

②　Europe & North America: KL-6 is used mainly for research or as an auxiliary diagnostic biomarker. It has not yet been widely adopted as part of routine clinical practice, but the market is in a growth phase.

③　Impact of COVID-19: The pandemic increased global awareness of KL-6, especially in respiratory disease monitoring. Future application scenarios may further expand.

(2) Major Brands & Product Comparison

Brand / Platform	Detection Method	Product Features	QC & Price*
Fujirebio	CLEIA	High sensitivity,high-throughput	Auto QC; $$$ (High)
Eisai / EIDIA	ECLIA	Clinical-grade stability	Hospital labs; $$$
BioVendor	ELISA / Latex	Simple, low-cost	~$630 / 96 wells
MyBioSource / Creative Diagnostics	ELISA	Multi-brand, research use	€500–600 / 96 tests
Poclight	Homogeneous CLIA	No cold chain, portable, 3-15 min TAT,18-month RT;	Free QC with MOQ reagent purchase

*Price: $ = low, $$ = medium, $$$ = high 

5. Accurate KL-6 Measurement with Chemiluminescence Immunoassay (CLIA)

Compared with ELISA, CLIA offers clear benefits in KL-6 detection.CLIA is a technique that combines immunoreactions with chemiluminescent signal detection, well-suited for highly sensitive quantitative measurement of low-concentration biomarkers like KL-6.

Testing workflow:

• Antigen–antibody binding – KL-6 binds to an immobilized primary antibody
• Signal amplification – a labeled secondary antibody forms a sandwich complex
• Chemiluminescent reaction – the label catalyzes substrate to emit light
• Signal detection & calculation – light intensity is proportional to KL-6 concentration

6. Typical Case

Case: A patient with systemic sclerosis presented with a KL-6 level of 1800 U/mL at diagnosis (significantly elevated). After 3 months of immunosuppressive therapy, the level decreased to 950 U/mL, imaging showed reduced fibrotic lesions, and dyspnea symptoms improved.

Insight: KL-6 is not only useful for disease detection, but also for quantifying therapeutic response, providing physicians with evidence to adjust treatment plans.

7. Rapid Testing Advantages of the Poclight C5000

The Poclight C5000 POCT CLIA analyzer offers several competitive advantages for KL-6 testing:

• No cold-chain reagent requirement – easier transport and storage, reduced wastage
• Portable and compact – suitable for primary hospitals, clinics, and mobile healthcare units
• Simple operation – six steps to complete testing, results within 5 minutes
• Multi-assay platform – runs KL-6 alongside other inflammatory markers on the same device
• High-precision results – CLIA sensitivity comparable to large fully automated platforms
• On-demand testing – ideal for emergency and bedside use in inpatient wards

1. Equipment selection and calibration

(1) Select the appropriate Vein Finder type

Infrared type (such as ZD Medical Vein Finder Systemr) : Suitable for superficial veins (back of the hand, forearm, leg and so on).

Portable (such as wireless handheld type) : Suitable for emergency or mobile blood collection.

(2) Equipment calibration and environmental adjustment

Adjust the brightness/contrast: Ensure that the veins are clearly visible (avoid overexposure or underexposure).

Turn off strong light interference: It works better in a darker environment (such as by drawing the curtains).

Clean the skin: After wiping with an alcohol swab, wait for it to dry (wet skin scatters infrared light).



2. Patient assessment and preparation

(1) Select the best puncture site

Preferred areas: dorsal hand vein, anterior elbow vein (vital vein, head vein).

Avoid areas: joint bends, scar tissue, and edematous regions.

(2) Improve venous filling

Apply a tourniquet (with appropriate pressure, not too tight).

Have the patient clench or loosen their fist (to promote venous dilation).

Hot compress (optional) : Apply a heat pack or warm water bag for 2-3 minutes to dilate blood vessels.



3. Use Vein Finder correctly

(1) Equipment placement skills

Maintain an appropriate distance (usually 25-35cm, adjust according to the equipment instructions).

The Angle should be vertical or slightly inclined (to avoid interference from light reflection).

Stabilize the device (to avoid image blurring caused by hand tremors).

(2) Identify the optimal puncture point

Select straight, thick and unbranched venous segments (avoid curved or bifurcated parts).

Mark the vein course (use a sterile marker pen to indicate the puncture path).



4. Puncture techniques

(1) Needle insertion Angle

Conventional veins: 15°-30° (the Angle of superficial veins is smaller, while that of deep veins is slightly larger).

Obesity/deep veins: 30°-45° (with ultrasound guidance).

(2) Needle insertion technique

“First penetrate the skin, then enter the blood vessels” (avoid slanting and causing the veins to roll).

After blood return, lower the Angle (to avoid puncturing the posterior wall of the blood vessel).

(3) Adjustment for special groups

Patient type skills

For children/newborns, the smallest needle size (25G-27G) should be used, with priority given to the dorsal hand vein.

Elderly people (with fragile blood vessels) should reduce negative pressure suction and avoid excessive compression.

Obese patients use the ultrasound Vein Finder to select deeper veins.

For patients with dehydration or hypotension, apply hot compresses, tourniquets and make a fist. Use a smaller needle if necessary.



5. Handling after blood drawing

Quickly remove the tourniquet (to avoid interference with blood return).

Gently pull out the needle and press for 3 to 5 minutes (avoid bruising).

Observe complications (such as hematoma, nerve injury).

Also welcome to contact us, we are ZD Medical Inc.
Tel : +86-187 9586 9515
Email : sales@zd-med.com
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1. Function of Active B12

Active B12, or holo-transcobalamin (holoTC), is the only biologically active form of vitamin B12 that can be absorbed by cells. It plays a direct role in cellular metabolism, particularly in maintaining nervous system function and red blood cell production. Compared to total B12 testing, Active B12 provides a more accurate snapshot of current physiological status and serves as a sensitive early marker of vitamin B12 deficiency.

2. Testing Methods

Common methods for Active B12 assay testing include:

• ELISA / EIA (Enzyme Immunoassay) – e.g., Axis-Shield’s Active-B12 assay, which captures holoTC with specific antibodies and quantifies it using colorimetric detection (with chemiluminescent variants also available).
• CLIA (Chemiluminescence Immunoassay) –e.g., Poclight’s POCT CLIA system C5000 offers high throughput and rapid turnaround on automated analyzers, making it well-suited for clinical laboratories and POCT settings .

 

3. Clinical Applications

Active B12 testing(HoloTC) for diagnosing vitamin B12 deficiency enables earlier detection of B12 deficiency than total B12 measurement, helping prevent related complications such as anemia, neurological disorders, cognitive decline, and adverse pregnancy outcomes. Studies have demonstrated higher sensitivity and specificity for holoTC, especially in patients with normal renal function.

4. Market Size and Pricing

Market size – The global Active B12 testing market was valued at approximately USD 216.7 million in 2023 and is projected to reach around USD 2.05 billion by 2033, with a CAGR of about 6.1% .

Pricing reference – In the UK, total B12 tests cost around £10–15 per test in NHS laboratories. Active B12 assays (e.g., ARCHITECT Active-B12) are priced higher due to their enhanced accuracy and specialized reagents. The Poclight C5000 provides equally fast and accurate Active B12 results at a much lower cost, making it a smart choice for laboratories.

5. Regional Demand Distribution

North America – Holds the largest share at approximately 41.7%, driven by rising awareness of micronutrient diagnostics, precision medicine adoption, and modernized lab infrastructure.

Other high-growth regions – Asia-Pacific and Europe are experiencing rapid uptake, supported by increasing demand for early disease screening and improved access to diagnostic technology.

6. Poclight C5000 – Active B12 Testing Made Simple and Accessible

With no cold chain required, Poclight’s Active B12 reagents make testing easy, portable, and cost-efficient. The CLIA POCT C5000 system supports both serum and plasma samples, delivering accurate results in just 15 minutes. Operation is straightforward—only four steps to completion—allowing even small or remote clinics and laboratories to perform high-quality testing. Its compact design ensures it fits seamlessly into limited spaces, bringing reliable Active B12 diagnostics within reach, anywhere.

Chemiluminescence immunoassay (CLIA) has gradually expanded from tertiary hospitals into specialized departments and primary care settings. With its high sensitivity, specificity, and automation potential, CLIA is rapidly replacing traditional ELISA as the mainstream immunoassay method in developed markets such as Europe and the United States.

 

1. Why Poclight compact CLIA is a Game-Changer

Rapid Turnaround: From Sample to Result in Minutes

Unlike conventional systems that require batch processing and long incubation, POCT CLIA system offer test results in as little as 10 minutes, ideal for emergency rooms, ICUs, and point-of-care use.

 

Lab-Grade Accuracy, Miniaturized

Backed by latest technology CRET technology, optimized chemiluminescent reagents, and advanced signal processing, portable CLIA platforms maintain sensitivity and specificity on par with large-scale lab systems, supporting reliable CLIA diagnosis at the bedside or in rural clinics.

 

All-in-One Automation: Mix, detect

Modern CLIA analyzers are equipped with automated mixing, and detecting without a complex liquid circuit—minimizing contamination and consumable costs.

 

Cost-Effective Operation

Designed to work without cold-chain reagents and bulky hardware, mini CLIA system slower total cost of ownership, supporting both public health deployments and private clinical settings.

 

2. Use Case Scenarios

Emergency Departments & ICUs

Where every second counts, rapid, on-site testing for cardiac markers, infection indicators, or hormones can guide life-saving decisions without waiting for central lab results.

 

Community Clinics & Primary Care

In rural or suburban clinics, mini CLIA enables lab-quality results for chronic disease management and preventive screenings without requiring advanced lab infrastructure.

 

Mobile Labs & Emergency Response

Disaster relief, remote field hospitals, and medical vehicles benefit from battery-powered, compact  diagnostic units that are easy to deploy and operate on the move.

 

Global Health Missions

Organizations working in low-resource countries can rely on CLIA systems for affordable, high-quality testing across multiple disease categories—improving equity in diagnostics.

 

3. Global Market Landscape

According to Grand View Research, the global POCT market is expected to exceed USD 57 billion by 2030, growing at a CAGR of over 10%. CLIA is emerging as a high-growth subsegment within this space.

• Latin America: Rising healthcare investments and remote populations create strong demand for compact  diagnostics.
• Southeast Asia: Aging populations and government-driven decentralization initiatives open vast market opportunities.
• Africa: Diagnostic access in rural areas is critical for combating infectious and chronic diseases—compact  CLIA fits this need precisely.
• North America & Europe: While centralized labs dominate, compact systems fill critical gaps in emergency and home testing scenarios.

 

4. Evolving Toward Smarter and Higher Throughput Solutions

With the rising demand for interoperability, digital health, and cloud connectivity,  CLIA systems are evolving into intelligent platforms. Poclight is enhancing its system software to optimize module coordination, improve operational efficiency, and enable features like remote monitoring, QC tracking, and centralized data sharing.

 

5. Discover the Future of Decentralized Diagnostics with Poclight

Whether you're looking to expand testing capacity in small labs, bring high-quality diagnostics to remote areas, or streamline operations in emergency settings — Poclight’s POCT chemiluminescence systems C5000 offer the ideal solution. With cutting-edge automation, cost-efficient design, and a growing assay menu for clinical testing, we help healthcare providers deliver faster, more accurate, and more accessible diagnostics.

 

Connect with us today to learn how Poclight can support your diagnostic needs — from OEM/ODM partnerships to ready-to-deploy solutions tailored to your market.

Vitamin D plays a critical role in maintaining bone health, supporting immune function, and reducing inflammation. With growing awareness of vitamin D deficiency and its health implications, more people are seeking ways to accurately check their vitamin D levels.

 

1. Why Test for Vitamin D?

• Vitamin D deficiency is surprisingly common, especially in individuals who:
• Spend limited time outdoors
• Live in areas with limited sunlight
• Follow vegan diets or have digestive conditions
• Are elderly, obese, or have darker skin
• A deficiency in vitamin D can lead to:
• Osteomalacia or rickets (soft bones)
• Increased risk of fractures
• Weakened immune response
• Muscle weakness and fatigue

Routine testing is essential for at-risk individuals or anyone wanting to optimize their long-term health.

 

2. Common Types of Vitamin D Tests

There are two primary forms of vitamin D that can be measured in the blood:

Test Name	What It Measures	Pros	Cons
25-hydroxyvitamin D [25(OH)VD]	The main circulating form	Gold standard for assessing deficiency	May not reflect real-time biological activity
1,25-dihydroxyvitamin D [1,25(OH)₂D]	The active hormone form	Useful in specific diseases (kidney issues)	Not recommended for general screening

Among these, 25(OH)VD is the preferred and most reliable marker for evaluating vitamin D status.

 

3. Testing Technologies: Which Is Most Accurate?

Vitamin D levels can be tested using various technologies:

Technologies	Principle:	Pros	Cons
Immunoassays (e.g., CLIA – Chemiluminescence Immunoassay)	Detects 25(OH)VD through a highly sensitive reaction between antigens and antibodies.	Fast, automated, cost-effective, widely used in clinical laboratories.	Conventional analyzers often require large spaces and significant investment.
LC-MS/MS (Liquid Chromatography–Mass Spectrometry)		Very accurate, can detect multiple forms of vitamin D.	Expensive, requires specialized equipment and skilled technicians.
Home Test Kits		Convenient, no lab visit needed.	Limited accuracy, inconsistent quality, often based on dried blood spot collection.

 

Compared to other methods, CLIA-based 25(OH)VD testing stands out by offering the best combination of clinical accuracy, affordability, and accessibility.

Poclight offer a compact and efficient chemiluminescence immunoassay system C5000 designed to provide rapid and accurate vitamin D results.

Based on CRET technology (Chemiluminescence Resonance Energy Transfer), Poclight Delivers results within 10 minutes, ideal for point-of-care testing. Compact size: A4 footprint, weighs only 7kg, affordable for most clinics and laboratories; Lyophilized reagents, no cold chain required–easy global shipment;CE-marked and suitable for international OEM/ODM collaboration.Our system enables clinics, laboratories, and primary care facilities to perform reliable testing even in decentralized or resource-limited settings.

If you're wondering which test is the most accurate for detecting vitamin D deficiency, the answer is clear:Test the 25(OH)VD level using a high-quality, standardized CLIA method.With Poclight’s chemiluminescence technology, you can trust the results–whether you're a healthcare provider or a distributor seeking advanced, compact diagnostic solutions.

 

4. Want to Learn More?

Contact us to learn how our vitamin D testing system can support your clinical or commercial needs.

Download our product brochure or request a live demo.

 

Clinics and laboratories are constantly seeking diagnostic equipment that is efficient, accurate, and space-saving. Poclight's Semi-Automated CLIA Analyzer is a true game-changer for both veterinary and human applications, delivering powerful testing capabilities in an ultra-compact design — manufactured in China under high-quality standards.

This compact, high-performance poct clia analyzer is designed for versatility across a wide range of clinical settings—from hospitals and outpatient labs to veterinary clinics and mobile diagnostic units. Combining innovation with thoughtful engineering, it offers outstanding performance in a remarkably small footprint.

Key Product Features:

• Ultra-Compact Design
  The analyzer is impressively space-efficient, occupying no more than the area of a standard A4 sheet. It easily fits on any benchtop, making it ideal for small laboratories or facilities with limited space.

• Rapid Turnaround Time
  With a fast detection process, the first test result is available in just 3 minutes. This rapid performance helps healthcare providers make timely decisions, especially in urgent environments.

• Lyophilized Reagents, No Cold Chain Required
  Reagents are supplied in lyophilized (freeze-dried) bead form, eliminating the need for cold chain logistics. This not only reduces shipping and storage costs but also enhances the product’s accessibility and shelf-life.

• No Washing, No Separation – Just Accurate Results
  Utilizing the latest advancements in CLIA technology, the system is completely wash-free and separation-free. This simplifies operation, reduces the risk of contamination, and ensures highly accurate, reliable results with minimal maintenance.

• Single-Use Reagent Format
  Reagents are packaged per test, minimizing waste and maximizing cost-efficiency. This format is ideal for laboratories with variable test volumes or for those focused on inventory control.

• OEM-Friendly for Brand Customization
  The analyzer supports full OEM customization, allowing partners to tailor the system’s appearance, interface, and packaging to match their brand identity or regional market needs.

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This semi-auto CLIA analyzer is more than a product—it’s a complete diagnostic solution. Compact, fast, and cost-effective, it meets the growing demand for flexible, high-quality testing in both human and veterinary fields. 

 

1.Improvements at the hardware level

(1) Increase the scanning speed

Frequency domain OCT (FD-OCT) : Compared with time domain OCT (TD-OCT), FD-OCT has A faster scanning speed (up to tens of thousands to hundreds of thousands of A-scans per second), significantly reducing artifacts caused by patients’ minor movements (such as eye tremors and breathing).

Swept-frequency OCT (SS-OCT) : By rapidly tuning the laser light source to achieve high-speed scanning, it further shortens the single imaging time.

(2) Eye-tracking system

Real-time active tracking: In ophthalmic OCT, infrared cameras or pupil tracking technology (such as Zeiss’s Follow-Up Mode) are integrated to dynamically adjust the scanning position to compensate for eye movement.

Adaptive scanning: Adjust the scanning path based on real-time tracking data to avoid image shift caused by sudden movement of the patient.

(3) Probe stability design

Handheld OCT: For non-cooperative patients (such as children and Parkinson’s disease patients), lightweight probes or head fixation devices (such as jaw supports) are used.

Contact OCT: In intravascular OCT (IVOCT), the movement caused by heartbeats or breathing is reduced by touching the vessel wall through a catheter.



2. Correction of software algorithms

(1) Image Registration

Feature point matching: Align B-scan images from multiple scans using stable anatomical structures in the image (such as retinal vascular bifurcations).

Registration based on mutual information: Motion compensation is achieved by maximizing the similarity index between images (such as normalized mutual information).

(2) Motion detection and rejection

Abnormal frame detection: Identify invalid frames caused by intense movement (such as signal loss and distortion) and eliminate them during reconstruction.

Dynamic weighted average: Weights are assigned to images scanned multiple times (frames with smaller motion have higher weights), and the influence of random motion is reduced after fusion.

(3) Deep learning for artifact removal

Generative Adversarial networks (Gans) : Train models to restore clear structures from motion-degraded images (such as Artifact-Net).

Time series prediction model: Utilizing networks such as LSTM to predict eye movement trajectories and correct scanning positions in advance.



3. Optimization of operation processes

(1) Patient preparation

Fixed position: During ophthalmic examinations, use a head support and a forehead support, and remind the patient to avoid speaking or swallowing.

Shorten the time of a single scan: Prioritize small-area high-definition scanning (such as 5× 5mm instead of 12× 12mm) and complete large-area imaging in different regions.

Anesthesia or sedation: In animal experiments or pediatric examinations, surface anesthesia (such as in ophthalmology) or mild sedation may be used when necessary.

(2) Scanning strategy

Repeated scanning: Collect multiple sets of data from the same area and improve the signal-to-noise ratio through software fusion.

Orthogonal scanning: Scan the same area from a vertical direction (such as horizontal + vertical) to cross-verify the influence of motion.

(3) Real-time feedback

Operator monitoring: Observe real-time images during the scanning process. If motion artifacts are detected, immediately pause and re-scan.

Patient cooperation prompt: Guide the patient to remain stable through the gaze light or voice prompt (such as “Please gaze at the green light flashing”).



4. Solutions for special scenarios

Cardiovascular OCT (IVOCT)

Trigger the scan synchronously with the electrocardiogram (ECG), avoiding the cardiac pulsation period (collection during the diastolic period).

Use rapid withdrawal catheters (such as 20 mm/s) to reduce the impact of vascular displacement.

Intraoperative OCT

Combine the navigation system (such as neurosurgical robots) to update the scanning position in real time.

Non-contact probes are adopted to avoid interference from instruments.

Also welcome to contact us, we are ZD Medical Inc.
Tel : +86-187 9586 9515
Email : sales@zd-med.com
Whatsapp/Mobile : +86-187 9586 9515

1. Patients with difficulty in venipuncture

Typical population

Obese people (with thick subcutaneous fat layers and deeply hidden veins).

Infants and children (with thin blood vessels and low cooperation).

The elderly (with poor vascular elasticity and prone to rolling).

Patients who have received long-term intravenous infusion or chemotherapy (with hardened blood vessels and many scars).

Scene value

Reduce the number of repeated punctures (for example, from an average of 3 to 1) to lower the patient’s pain and the risk of complications (such as hematoma).



2. People with dark skin

Problem: Traditional visual/touch methods have difficulty locating veins in dark skin.

Technical adaptation

Choose multi-wavelength Vein Finder (for example, 850nm infrared light has better penetration).

Contrast adjustment function (such as the “Dark Skin Mode” of VeinViewer).



3. Emergency and critically ill patients

Applicable scenarios

Patients with shock/dehydration (vascular collapse).

Rescue for massive hemorrhage (rapid establishment of intravenous access is required).

Case: The emergency department uses AR projection devices (such as AccuVein) to locate the external jugular vein within 5 seconds.



4. Patients with chronic diseases and special treatment needs

Diabetes: Monitor the condition of blood vessels on the back of the hand/foot to prevent ulcers.

Hemodialysis: Protect the fistula and prevent accidental puncture.

Blood transfusion/plasma exchange: Ensure the precise establishment of high-flow pathways.



5. Areas with insufficient medical resources

Primary clinics: Making up for the lack of experience among medical staff.

Battlefield/Disaster rescue: Rapid operation under poor lighting and rudimentary equipment conditions.



6. Users outside the medical field

Veterinarian: Intravenous infusion for pets (such as the ear vein of cats and dogs).

Tattoo artist/beautician: Avoid injecting fillers into blood vessels or getting tattoos.

Medical student teaching: Vascular anatomy visualization teaching AIDS.

Also welcome to contact us, we are ZD Medical Inc.
Tel : +86-187 9586 9515
Email : sales@zd-med.com
Whatsapp/Mobile : +86-187 9586 9515