Hemorrhoids are a common anal disease, with 10% to 20% of patients requiring surgical treatment ^[1]. Common issues with traditional hemorrhoidectomy are postoperative bleeding and pain. The Agiseal electrosurgical vessel sealer divider, a novel tissue-cutting and coagulating device, brings significant improvements to hemorrhoid surgery.

 

Agiseal,independently developed by ShouLiang-med, uses advanced real-time feedback and intelligent generator technology. By delivering high-frequency electrical energy combined with constant pressure between the jaws, it causes denaturation of collagen and fibrin within the target vessels. It fuses the vessel walls, forming a transparent band that achieves permanent lumen closure. Its advantages include: no need for excessive separation during closure, and faster closure speed; no smoke, maintaining a clear surgical field; and low local temperatures, minimizing damage to surrounding tissues. According to reports ^[2], the United Kingdom has successfully applied electrosurgical vessel sealer divider in haemorrhoidectomy procedures, achieving excellent haemostasis outcomes and significantly reducing postoperative pain in patients. 

 

Traditional mixed hemorrhoidectomy is often associated with significant bleeding, which not only prolongs surgery time but also obscures the surgical field and reduces procedural accuracy. Conventional haemostasis methodssuch as ligation or electrocoagulation are also prone to causing collateral damage to surrounding tissues, thereby delaying wound healing. The application of the electrosurgical vessel sealer divider allows for pre-closure of haemorrhoidal tissue vessels prior to excision., resulting in minimal bleeding during excision along the closure zone. Furthermore, this technique eliminates the need for conventional suture ligation of the stump, simplifying the procedure and shortening operative time. Its core principle (inducing fibrin deformation and coagulation) also ensures safe and reliable hemostasis ^[3].

 

In traditional surgery, suture ligation of the hemorrhoidal pedicle tissue easily triggers sphincter spasm, leading to severe postoperative pain.  The Agiseal hemorrhoidectomy does not require ligation of the haemorrhoidal tissue, thereby reducing the incidence and intensity of postoperative pain from the source. Additionally, the sealing process causes minimal thermal damage to surrounding tissues, effectively avoiding burns and tissue edema caused by the thermal effects of electrocautery. Postoperative pain is typically controlled with oral medications alone, significantly reducing discomfort and minimizing the risk of drug side effects ^[4].

 

Benefiting from advantages such as minimal intraoperative bleeding, minimal tissue damage, and milder postoperative pain, patient recovery is accelerated, and hospital stays are significantly shortened. Although the single-use cost of the electrosurgical vessel sealer divider may be higher than traditional instruments, preliminary statistics show that the overall hospitalization costs for patients do not increase significantly,which may be mainly attributed to the effective reduction in the number of hospital days ^[3].

 

In summary, for patients with grade III to IV mixed hemorrhoids, the use of electrosurgical vessel sealer divider for hemorrhoidectomy is more advantageous than traditional hemorrhoid surgery in terms of reducing intraoperative blood loss and shortening hospital stay ^[3]. Its precise, efficient, and minimally invasive characteristics provide patients with a more comfortable and faster recovery experience.

 

 

Reference:

[1] BLEDAY R，PENA JP，ROTHENBERGER DA，et al.Symptomatic hemorrhoids: current incidence and compli -cations of operative surgery［J］.Dis Colon Rectum，1992，35（5）:471-481.

[2] PALAZZO FF，FRANCIS DL，CLIFTON MA. et al. Randomized clinical trial of Ligasure versus open haemorrhoid -ectomy［J］. Br J Surg，2002，89（2）:154-157．

[3] Wang Zhanjun, Jia Shan, Wang Zhengliang,et al.A Comparative Study of Hemorrhoidectomy with Ligasure Technique and Milligan-Morgan Surgery［J］.Journal of Colorectal & Anal Surgery,2017,23(04):477-480.

[4] NIENHUIJS SW， DE HINGH IH. Pain after conventional versus Ligasure haemorrhoidectomy.A meta -analysis［J］.International Journal of Surgery，2010，8（4）:269-273.

Hemorrhoids, also known as anal fistula disease, have an incidence rate of 40%-50%. There's a  folk saying that "nine out of ten people develop hemorrhoids." Modern medical research has found that hemorrhoids are a physiological change, and humans naturally have a risk of developing hemorrhoids. Hemorrhoids can cause significant harm, with severe pain being the primary symptom during an episode. META analysis indicates that hemorrhoids are an important risk factor for colorectal cancer and are closely related to constipation, among other conditions. They negatively impact patients' daily lives and work, severely impairing their quality of life.

 

Hemorrhoid treatment can be divided into surgical and conservative therapies. Among them, surgical treatment has been increasingly popular due to its continuous improvement in technology and significantly reduced trauma. External excision and internal ligation, automatic hemorrhoid ligation, and circular mucosal resection and stapling of the hemorrhoids have gradually become widespread. Minimally invasive surgery has been proven effective, but its indications are limited. High-frequency electrosurgical unit combines the advantages of traditional ligation and circular ligation, using the electrosurgical unit to remove hemorrhoidal tissue, achieving good removal results.^[1]

 

According to research data from the Department of Anorectal Surgery at Wuhan Fifth Hospital involving 174 patients, the incidence of complications in the observation group treated with high-frequency electrosurgical unit surgery was 26.4%, significantly lower than the 52.9% in the control group treated with traditional ligation surgery. particularly in key indicators such as anal-rectal stenosis (13.8% vs. 23.0%) and postoperative edema (8.0% vs. 14.9%), where the differences were statistically significant. This technique combines electrocoagulation hemostasis with ligation technology to achieve simultaneous hemostasis during surgery, reduce nerve ending exposure, and lower the pain score to 2.5 ± 1.4 points within three days postoperatively (3.9 ± 1.2 points in the traditional group). The pain score during dressing changes was controlled at 5.6 ± 1.3 points (7.1 ± 1.6 points in the traditional group). Patients recovered faster postoperatively, with time to ambulation shortened to 7.3 ± 1.3 hours and time to first bowel movement reduced to 4.3 ± 1.1 minutes. At the 6-month follow-up, the incidence of defecation difficulties (3.4%) and symptomatic recurrence rate (5.7%) in the observation group were significantly lower than those in the traditional surgery group (16.1%). The precise resection characteristics of the observation group preserved more normal anal cushion tissue, effectively reducing the risk of anal functional damage.

 

In summary, high-frequency electrosurgery unit enables simultaneous resection and hemostasis through minimally invasive procedures, demonstrating significant clinical advantages—particularly for treating multiple mixed hemorrhoids.  

 

ShouLiang-med's independently developed high-frequency electrosurgical unit offers multiple cutting and coagulation modes, meeting all functional requirements for hemorrhoid surgery while further reducing patient injury and complications. Additionally, the monopolar electrodes and electrical pencils provided by ShouLiang-med are made from high-quality anti-adhesive materials, further optimizing surgical efficiency.  

 

[1] Dai Luo, Hu Qi. Clinical Study on High-Frequency Electrosurgery Unit for Hemorrhoid Treatment [J]. *Journal of North Sichuan Medical College*, 2017, 32(3): 419-421.  

In modern healthcare settings, maintaining strict hygiene without sacrificing patient comfort is non-negotiable — and that’s where a high-quality Disposable Examination Bedsheet makes the difference. Designed for single-use convenience, these sheets protect examination couches and treatment tables from contamination while offering a soft, breathable surface that patients appreciate. Whether you’re equipping a busy clinic, an outpatient center, or a mobile screening unit, choosing the right Medical Bed Sheet reduces cross-infection risk and simplifies turnover between patients.

Material choice and manufacturing control determine real-world performance. Our disposable sheets are engineered from durable, non-woven fabrics that balance fluid resistance with comfort; they meet the practical needs of clinicians who require reliable barrier protection during routine exams and procedures. For more demanding environments, we also offer options that meet standards expected of a Surgical Bed Sheet, providing the extra protection and dimensional stability required in minor surgical procedures and sterile prep areas.

Versatility is key: from general check-ups and dermatology to dental, physiotherapy, and surgical prep, a properly specified bedsheet streamlines workflow, lowers laundry costs, and improves patient perception of clinical cleanliness. Hospitals and practices serving international patients or operating large screening programs value consistent supply, simple disposal, and clear product specifications — all factors that make inventory management and regulatory compliance easier.

A well-designed Face Cradle Cover can transform a routine massage into a comfortable, hygienic experience your clients will remember. As a factory with over 20 years serving the global market, we know that therapists and spas need reliable, easy-to-clean protection that fits securely and looks professional. Whether you’re replacing worn fabric or specifying supplies for a busy clinic, choosing the right Headrest Cover is the first step toward better client care and smoother operations.

Hygiene and comfort are the two pillars of a great treatment room — and that’s exactly what a premium Massage Face Cove delivers. High-quality covers protect foam and upholstery from oils and sweat, reduce laundering time, and keep your headrest smelling fresh between sessions. For clients, a soft, breathable surface reduces skin irritation and improves relaxation; for practitioners, a snug Face Cradle Cover that’s simple to remove and wash means less downtime and more bookings.

Material and fit matter: look for covers made from durable, washable fabrics with reinforced seams and a tailored design that stays in place during movement. A well-fitted Headrest Cover not only looks neater but also extends the life of your equipment, protecting investment and maintaining the professional appearance of your studio. Many of our customers prefer covers that balance stretch for easy fitting with enough structure to prevent slipping — the result is a smoother treatment and fewer mid-session adjustments.

At Telijie, we combine two decades of factory experience with customer-focused service to make sourcing Massage Face Cover solutions effortless. Beyond product quality, Telijie offers flexible OEM/ODM options, small-sample runs for evaluation, responsive global logistics, and dedicated after-sales support so you get exactly the fit and finish your brand requires. Partnering with Telijie means steady supply from a manufacturer who understands spa and therapy needs worldwide — reliable lead times, clear communication, and customization options that help your business stand out. Contact Telijie to request samples or discuss branded Face Cradle Cover and Headrest Cover options tailored to your market.

1.  What It Is

 

C-reactive protein (CRP) is an acute-phase protein mainly produced by the liver into the blood in response to inflammation. CRP levels rise rapidly following inflammatory stimuli and decline promptly once the trigger resolves, making it a valuable tool for early diagnosis and treatment monitoring. 

Parameter	C-reactive protein (CRP)
Primary Site of Production	Liver
Clinical Utility	●  Monitor inflammation and guide patient management ●  Differentiate bacterial from viral infections: CRP level ≥ 50 mg/L are linked to bacterial infections in ~ 90% of cases
CRP Response & Half-life	● Onset of increase: 6–8 hours ● Peak: 24–48 hours ● Half-life: ~19 hours

 

2.  Why It Matters

(1)  Reliable biomarker: Clinically validated indicator of systemic inflammation, infection, autoimmune disorders, and cardiovascular risk.

(2)  Actionable insights: Supports differential diagnosis (bacterial vs viral), informs antibiotic prescribing, and monitors disease activity to guide treatment.

(3)  POC advantage: Rapid, on-site testing enables timely clinical decisions in primary care, emergency, and bedside settings.

 

3.  Reference Ranges:

 

Item	Result	Interpretation
High-sensitivity C-reactive protein (hs-CRP Assay Kit) (assessing risk of cardiovascular events)	1 mg/L	Low cardiovascular risk
	1–3 mg/L	Moderate cardiovascular risk; anti-inflammatory therapy recommended
	≥ 3 mg/L	High cardiovascular risk; anti-inflammatory and antithrombotic therapy recommended
C-Reactive Protein (CRP Test Kit)	< 10 mg/L	Normal
	> 10 mg/L	Indicates inflammation; possible infection, autoimmune disease, or chronic inflammation
	> 50 mg/L	Indicates bacterial infection (~90%); viral infection uncommon
	> 100 mg/L	Severe elevation, generally seen in acute bacterial infections

Note: Results should be interpreted in the context of the patient’s clinical condition. Laboratories are recommended to establish population-specific reference values for their region, as the levels may vary with demographic and methodological factors.

 

4.  When and Where to Measure CRP

 

Clinical Setting	When / Indication	Purpose / Clinical Use
Primary care / Outpatient clinics	At onset of acute symptoms; routine follow-up for chronic inflammation	Rapid assessment of infection; guide antibiotic use; monitor autoimmune disease activity
Emergency department / Urgent care	Suspected acute infection, fever, or trauma	Triage patients; monitor acute inflammation and treatment response
Hospital / Laboratory / ICU	Post-surgery, trauma, sepsis, or during treatment	Assess inflammation; monitor therapy effectiveness, and track disease progression

 

 

5.  Why Poclight CRP Stands Out: Facts & Features

 

(1)  Assay Specifications

Item	Specification / Value
Detection Limit (LOD)	≤ 0.5 mg/L
Measurement Range	0.5 - 320 mg/L within this linear range, the linear correlation coefficient r should be not less than 0.990
Sample Volume	5 μL
Sample Type	Serum, Plasma, Whole Blood
Assay Time / Turnaround	3 min
Precision (CV%)	5%
Reference Range	<10 mg/L

 

(2)  Key Features:

a.  Advanced patent technology: 5th generation homogenous CLIA, CRET technology

b.  Compatible with Poclight C5000 analyzer: Designed for POC settings, auto-calibration, built-in scanner, internal mixing component, and more

 

 

 

c.  Individually packaged: on-demand testing

d.  Room-temperature transport, no cold chain required: saves logistic costs

e.  Lyophilized reagents: freeze-dried reagent for room temperature storage (2–30°C) with extended shelf life of 18 months

f.  Operational efficiency: intuitive process, reduced workload, and optimal lab performance

 

Biological sample collection is a cornerstone of clinical research, providing critical data for evaluating drug pharmacokinetics (PK), immunogenicity, efficacy, and safety. Diverse specimen containers are employed for various sample types, ranging from common biological fluids like blood (whole blood, serum, plasma), urine, and feces, to more specialized in vivo samples such as arterial blood, saliva, cerebrospinal fluid, alveolar lavage fluid, wound exudate, tears, pathological tissue, and skin microdialysis samples. In studies involving viral vector test drugs, samples may also include those from the nose and wound surfaces, or even dressings.

 

The overarching purpose of sample collection dictates the specific design, categorized into PK, immunogenicity, efficacy/exploratory pharmacodynamic (PD), and safety sample collection. This document primarily details the design methodology for PK sample collection, with brief insights into considerations for efficacy/PD, safety, and immunogenicity evaluations.

 

Design of Pharmacokinetic (PK) Sample Collection

 

The fundamental principle guiding PK sampling point design is to balance thorough coverage of pharmacokinetic characteristics with minimizing burden on subjects and researchers. Sampling points should be as concise and infrequent as possible while ensuring subject safety and encompassing the entire PK profile. Ideally, sampling points should align with study visit points, and sampling times should be scheduled to avoid disrupting sleep, though exceptions may arise.

 

Beyond time points, the entire sampling process—including collection, processing, and storage environment—is critical. The selection of anticoagulants, temperature, and processing time limits must be explicitly defined. If not detailed in the study protocol, these specifics require precise documentation in an independent sample processing manual.

 

PK studies necessitate evaluating not only the parent drug's metabolic characteristics but also those of its primary active metabolites. A judicious selection of sampling times is crucial, typically informed by non-clinical research, predicted or existing human PK data, and formulation characteristics. The sampling points must span the absorption, distribution, and elimination phases to comprehensively describe the drug's PK in the human body.

 

Potential interferences from diet, time of day, and other factors must be considered.

 

 

Detection Indicators:

 

Single-Dose Administration: Tmax (time to maximum concentration), Cmax (maximum concentration), AUC (0-t) (area under the curve from time 0 to t), AUC (0-∞) (area under the curve from time 0 to infinity), Vd (volume of distribution), Kel (elimination rate constant), t1/2 (half-life), MRT (mean residence time), CL (clearance) or CL/F (apparent clearance).

 

Multiple-Dose Administration: Peak time (Tmax), steady-state trough concentration (Css_min), steady-state peak concentration (Css_max), average steady-state blood drug concentration (Css_av), elimination half-life (t1/2), clearance (CL or CL/F), area under the steady-state blood drug concentration-time curve (AUCss), and fluctuation coefficient (DF).

 

Sampling Points Specifics:

Generally, a minimum of 11-12 sampling points are recommended, extending for 3-5 elimination half-lives, or until the drug concentration falls to 1/20 to 1/10 of Cmax.

Commonly, 12-20 sampling points are utilized. For long half-life test drugs, sampling typically extends for at least 72 hours.

 

For multiple administrations, trough concentrations (prior to administration) should be measured three times (usually for three consecutive days) to confirm the achievement of steady-state conditions. A series of blood samples are then collected after the final administration.

 

Sampling points are ideally arranged for fasting administration in the morning to mitigate interference from diet, time of day, and other confounding factors.

 

Route of Administration Considerations:

Different routes of administration (e.g., intravenous injection, intravenous drip, nebulized inhalation) exhibit distinct PK characteristics, necessitating route-specific sampling point designs. For instance, intravenous injection lacks an absorption phase. Intravenous drip and nebulized inhalation, however, typically require sample collection pre-administration, immediately before administration, and 5-10 minutes post-administration or at the end of administration.

 

For urine/feces collection, samples should be taken at various intervals pre- and post-medication. The determination of these sampling points can be informed by drug excretion characteristics observed in animal PK studies, encompassing the onset of excretion, peak excretion, and the approximate end of the excretion process.

 

General PK Collection Process:

Subjects typically enter the Phase I clinical trial ward the day before the study, consuming a standardized light dinner followed by a 10-hour fast (not necessarily overnight).

The next morning, the drug is administered orally on an empty stomach (fasting is not required for injections), accompanied by 200-250ml of water. If urine samples are required, the bladder should be emptied before drug administration. Blood or urine samples are then collected at specific time points before and after dosing, as per the study plan.

For urine samples, the total volume should be recorded, and the required aliquot retained. Subjects generally remain within the Phase I clinical trial ward for the duration of the trial, avoiding strenuous exercise, consumption of caffeinated or alcoholic beverages, and smoking.

 

Other Sample Collection Precautions

Immunogenicity and Efficacy/Exploratory PD Sample Collection:

Specimen container collection for immunogenicity and efficacy/exploratory PD requires careful consideration of relevant signaling pathway response characteristics and alignment with other planned biological sample collection time points.

Immunogenicity responses to biological products are typically not immediate. The initial post-treatment immunogenicity specimen container collection can be set at 21-28 days after administration (EMA recommends no earlier than 4 weeks post-last dose), but never earlier than 14 days. The impact of existing subject reactivity to therapeutic biological products on the immunogenicity response time should also be considered. The frequency of sampling points and the extent of analysis depend on the test drug's risk assessment.

 

For efficacy/PD-related samples, such as glycated hemoglobin in diabetes studies, sampling points are determined by integrating the pharmacological time-effect relationship (onset, duration, optimal efficacy), prior monitoring experience, and preclinical animal study data. To ensure reproducibility of efficacy data, protocols may specify that samples are collected within a relatively fixed time period.

 

Safety Sample Collection:

Laboratory examination time points for safety assessments are typically designed in conjunction with pharmacokinetic characteristics. The general principle is to have denser sampling points initially, becoming sparser later (applicable after a single dose, during long-term administration, and in early clinical research for clinical practice verification).

 

It's generally understood that after five consecutive doses, blood drug concentrations can reach a steady state. For drugs with ideal metabolism that achieve steady-state blood concentrations, if steady-state levels are confirmed safe for subjects, the interval between subsequent sampling points can be extended. However, for experimental drugs that may exhibit blood drug accumulation, close monitoring of potential safety impacts is crucial, necessitating a relatively dense schedule for safety visit points.

Pharyngeal swab collection is a standard method for detecting respiratory pathogens. A properly collected pharyngeal swab specimen is critical for helping physicians accurately diagnose a patient's condition.

 

Method for Correct Pharyngeal Swab Collection

The operator should first verify the patient's information and perform hand hygiene. A sterile single-use virus specimen collection kit is then opened. The patient should open their mouth wide and say "ahh" to expose the pharynx.

 

Using the swab from the virus specimen collection kit, the operator should firmly rub the posterior pharynx, including both tonsillar crypts and the palatine arches. Swab back and forth 3 times to ensure sufficient cell collection.

 

Important Precautions

Avoid collecting samples within two hours of eating or drinking. This prevents contamination of the specimen.

Rinse the mouth with plain water or a saline solution if there is any bleeding or foreign matter present before collection.

Ensure a broad and thorough collection area while carefully avoiding contact with the tongue to maximize cellular yield.

 

After collection, securely tighten the cap of the collection tube to prevent leakage and ensure the integrity of the specimen.

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