UN3373 & CE Certified
Full compliance with UN3373 Category B biological transport standards, ISO 13485 quality systems, and EU MDR 2017/745 regulatory frameworks.
Engineered for absolute sample stability, zero cold-chain dependency, and seamless LC-MS/MS laboratory workflow integration. ISO 13485:2016 & CE MDR compliant custom DBS collection assemblies for clinical trial CROs, newborn screening programs, and global diagnostic networks.
Full compliance with UN3373 Category B biological transport standards, ISO 13485 quality systems, and EU MDR 2017/745 regulatory frameworks.
Standardized 100% pure cotton lint filter substrate with zero chemical additives, delivering accurate spot absorption and consistent elution yields.
Full turn-key kit configurations including custom pre-printed barcoded collection cards, safety lancets, desiccants, and multi-language IFU mailers.
In modern clinical research and diagnostic medicine, traditional venipuncture presents substantial friction: expensive cold-chain logistics, rapid analyte degradation during transport, high biohazard risks, and invasive phlebotomy requirements. Dried Blood Spot (DBS) Kits have emerged as the definitive micro-sampling technology for decentralized clinical trials (DCT), newborn screening, therapeutic drug monitoring (TDM), and epidemiological surveillance.
Surgeine Healthcare’s engineered DBS collection systems utilize ultra-pure 100% cotton cellulose filter media (Whatman 903 equivalent) manufactured under strict humidity-controlled Class 100,000 cleanroom environments. When a capillary blood droplet (~50–75 µL) contacts our optimized matrix, rapid absorption and capillary drying occur, immobilizing target biomolecules within a porous matrix. This solid-state stabilization preserves small-molecule pharmaceuticals, monoclonal antibodies, nucleic acids (DNA/RNA), and metabolic biomarkers at ambient temperatures for extended periods—eliminating dry-ice reliance and dramatically lowering shipping costs worldwide.
Surgeine Healthcare provides tailored micro-sampling solutions configured for specific clinical applications, analytical assays, and patient collection environments.
5-spot pre-printed filter collection cards made from 100% pure cotton cellulose. Designed for heel-stick capillary blood sampling in infants to screen for congenital metabolic disorders.
View Product DetailsTurnkey, patient-friendly home collection packs containing 2D barcoded DBS cards, pressure-activated auto-safety lancets, alcohol wipes, gauze, desiccant, and pre-addressed return mailers.
View Product DetailsEngineered substrate matrices paired with precise volumetric capillary microsamplers to eliminate Hematocrit (HCT) spreading bias in LC-MS/MS drug quantification.
View Product DetailsChemically treated collection cards designed for cell lysis and nucleic acid (DNA/RNA) stabilization at ambient temperatures during global infectious disease surveillance.
View Product DetailsTamper-evident sampling assemblies with integrated chain-of-custody documentation, barcoded transport vials, and active moisture barrier packaging.
View Product DetailsComplete custom branding, card format engineering, multi-language instructions for use (IFU), component selection, and country-specific regulatory dossier support.
View Product DetailsSelecting the ideal collection card media is essential for ensuring analytical sensitivity, linear extraction efficiency, and matrix stability across different analytical platforms.
| Substrate / Media Grade | Composition & Treatment | Spot Volume / Diameter | Target Analytes | Primary Clinical / Diagnostic Application |
|---|---|---|---|---|
| Grade 903 Cotton Cellulose | 100% pure cotton lint, untreated, zero additives | 50 – 75 µL per spot (12–13mm circle) | Amino acids, acylcarnitines, small molecules, antibodies | Newborn metabolic screening, basic PK/PD clinical trial monitoring |
| Chemically Treated Lysis Substrate | Cotton lint impregnated with protein denaturants & buffers | 40 – 60 µL per spot (10–12mm circle) | Genomic DNA, viral RNA, infectious pathogens | Population genomics, HIV/HCV viral load monitoring, bio-banking |
| Volumetric Absorptive Matrix (VAMS) | Porous polymeric hydrophilic tip (exact volume capture) | Fixed 10 µL, 20 µL, or 30 µL tip capture | Therapeutic drugs, immunosuppressants, steroids | Quantitative LC-MS/MS TDM, home sampling without HCT bias |
| Lipid-Free Low-Background Media | Purified cellulose with lipid-extraction pre-treatment | 30 – 50 µL per spot | Fatty acids, lipidomics, toxicological profiles | Endocrinology research, specialized nutritional assessment |
Note: Spot size and absorption time vary according to patient hematocrit (HCT) levels. All Surgeine DBS cards are manufactured under ISO 13485 quality controls and tested to comply with international bio-analytical validation guidelines. Contact our technical team for custom paper weight and sizing requirements.
As healthcare systems accelerate the transition toward decentralized patient care, diagnostic bio-logistics is undergoing a structural transformation. Global procurement leaders must adapt to five core macro trends shaping Dried Blood Spot kit acquisition over the next decade.
Pharma sponsors and Contract Research Organizations (CROs) are phasing out central site phlebotomy in favor of direct-to-patient (DTP) trial kits. Pre-packaged, patient-executable DBS kits significantly boost subject recruitment, reduce trial dropout rates, and enable remote decentralized pharmacokinetic (PK) blood collection across rural or international cohorts.
Historically, variations in blood viscosity (hematocrit range 20–65%) caused inconsistent blood spot spreading, introducing quantitative analytical errors. Next-generation procurement strategies prioritize volumetric micro-sampling techniques, such as integrated microcapillary dispensers and VAMS tips, ensuring precise fixed-volume sampling regardless of patient HCT levels.
Transporting wet serum or plasma samples under frozen conditions consumes vast amounts of energy, dry ice, and bulky styrofoam packaging. Ambient-temperature shipping enabled by DBS kits reduces bio-freight carbon emissions by up to 85%, directly supporting corporate ESG sustainability targets for diagnostic labs and pharmaceutical enterprises.
Modern high-throughput analytical laboratories rely on automated card handlers and optical spot recognition software. Future DBS card procurement mandates 2D DataMatrix barcodes, high-contrast alignment markers, and rigid card frames designed to prevent jam-ups in robotic punching systems (such as BSD600 or PerkinElmer Panthera-Puncher).
Global postal regulations and air freight carriers (IATA) enforce strict packaging standards for human biological specimens. Procurement teams are moving away from piecemeal component sourcing toward fully certified, turn-key kit assemblies that include secondary pressure-resistant bags, absorbent pouches, desiccants, and UN3373 Category B compliance labels.
Telehealth platforms and home-health providers are increasingly deploying self-sampling DBS kits for routine lipid panels, HbA1c monitoring, hormone profiling, and therapeutic drug monitoring. Easy-to-use safety lancets and color-coded step-by-step instructions ensure high sample adequacy when performed by non-clinical end users.
Surgeine Healthcare’s R&D division focuses on continuous product development to solve complex bio-analytical challenges in blood micro-sampling.
Recent advancements include integrated microfluidic plasma separation cards that isolate clear plasma from capillary whole blood directly at the point of collection—without centrifugation. This allows labs requiring plasma-only matrices (such as certain viral load assays or biomarker measurements) to utilize simple dry-state collection without field lab equipment.
Furthermore, our advanced substrate impregnation formulations preserve delicate RNA transcripts and volatile metabolites at room temperatures for up to 28 days, opening new horizons for global bio-banking, population genomics, and field epidemiology in tropical regions.
All Surgeine DBS collection cards and micro-sampling kit packaging occur in certified ISO Class 8 (100,000) cleanrooms. In-house automated cutting, printing, and pouching guarantee complete sterility, controlled humidity, and zero biological contamination.
Since 2002, Surgeine Healthcare has specialized in medical disposable manufacturing and infection prevention solutions. Our vertically integrated manufacturing structure delivers decisive operational and economic advantages to global diagnostic companies, CROs, and public health agencies.
Select a core capability panel to explore how our manufacturing foundation supports your supply chain reliability and regulatory compliance.
Surgeine maintains an ISO 13485:2016 certified quality management system, with device families CE marked under EU MDR 2017/745. Every lot undergoes strict bio-burden, absorption rate, and mechanical integrity testing.
Our dedicated internal testing laboratory evaluates substrate grammage, fluid flow rates, extraction recoveries, and chemical purity—ensuring zero background contamination across sensitive mass spectrometry assays.
With automated high-precision paper converting, 2D barcode inline printing, medical pouch sealing, and customized kit assembly under one roof, we eliminate intermediate vendor markups and supply delays.
We offer global partners complete private-label execution: customized artwork design, multi-language instructions for use (IFU), barcoded return mailers, and flexible kitting component selection.
Combining decades of medical device manufacturing experience with modern bio-analytical substrate expertise.
Using only 100% pure virgin cotton lint without chemical binders, guaranteeing clean baseline chromatograms across sensitive LC-MS/MS assays.
Tight manufacturing tolerances control substrate density and thickness, ensuring consistent spot absorption rates and minimal area variation.
Included safety lancets and skin prep materials carry full medical device CE marking, ensuring zero cross-contamination risk during sample collection.
Direct thermal and inkjet 1D/2D DataMatrix printing directly on collection cards facilitates automated sample tracking and LIMS integration.
Heavy-duty aluminum foil pouches and calibrated silica gel packets protect collected spots against humidity-induced analyte degradation.
Our regulatory team assists global distributors with technical dossiers, import permits, and local health authority compliance filings.
In micro-sampling and diagnostic disposables, compliance is non-negotiable. Surgeine Healthcare operates under strict international regulatory frameworks. Our quality management system is certified to ISO 13485:2016, and our medical device lines hold CE marking under EU MDR 2017/745—building upon continuous CE compliance maintained since 2008. Additional quality credentials include SFDA, BIS, ZED Gold, and Star Export House recognition.
For global pharmaceutical sponsors, diagnostic laboratories, and government tender submissions, we provide comprehensive technical files, declarations of conformity, sterilisation validation reports, biocompatibility documentation, and batch-level certificates of analysis.
Contact Us to Request Quality Dossiers
CE Certificate
ISO 13485
ZED Gold
Export House
BIS“Surgeine’s OEM Dried Blood Spot kits transformed our decentralized trial operations. Card absorption uniformity across sites is excellent, and their custom UN3373 mailer packaging simplified subject compliance significantly.”Dr. Marcus VanceDirector of Bio-Analytical Operations, European CRO
“As a neonatal screening center, card quality and zero background interference are paramount. Surgeine’s Whatman 903 equivalent cards deliver 100% batch consistency and punch cleanly in our automated equipment.”Dr. Elena RostovaHead of Newborn Screening, Clinical Reference Laboratory
“Working with Surgeine for private-label DBS home collection kits has been flawless. Regulatory documentation for CE MDR compliance was thorough, and production lead times are highly dependable.”David ChenVP of Global Procurement, Diagnostic Solutions Enterprise
Analytical stability in DBS sampling depends on filter card purity (such as 100% pure cotton cellulose with no chemical wet-strength additives), strict control over card drying times (typically 2-4 hours at ambient temperature), humidity control during transport using active silica gel desiccants, and matrix preservation chemistry. Surgeine's DBS cards comply with rigorous absorption uniformities, preserving proteins, small molecule drugs, DNA, and RNA for ambient transport without requiring cold-chain refrigeration.
Hematocrit bias occurs when blood viscosity alters spot spreading on standard filter paper. Surgeine addresses this by offering precision-calibrated collection cards, pre-printed volumetric target circles, optional volumetric absorptive micro-sampling (VAMS) device integration, and specialized chemical substrate coatings that ensure uniform sample dispersion across varying hematocrit ranges (20% to 65%).
Yes. Surgeine designs all turnkey Dried Blood Spot Kits with secondary sealable biohazard bags, outer rigid packaging, shock-absorbing mailers, and pre-printed UN3373 Biological Substance Category B markings required by IATA, postal services, and international bio-logistics carriers for ambient sample shipping.
We provide extensive OEM customization, including custom card printing with 1D/2D matrix barcodes, facility-specific logo branding, customized lancet penetration depth selection (e.g., 1.5mm to 2.2mm), tailored instructions for use (IFU) in multiple languages, pre-addressed return mailers, and specialized desiccant payload sizing.
All Surgeine DBS collection cards and micro-sampling components are manufactured within ISO Class 8 (100,000) and ISO Class 7 cleanrooms certified under ISO 13485:2016. Every production lot undergoes rigorous quality testing for microbial bio-burden, blood spot absorption rate, grammage uniformity, and background chemical interference.
Yes. The card dimensions, thickness, and rigid paperboard outer frames are engineered to standard industrial dimensions compatible with automated punchers (such as BSD600, Panthera-Puncher, and Wallac AutoDelfia systems), ensuring reliable card feeding and clean disk punching without paper fraying.
Whether you are launching a global decentralized clinical trial, scaling a newborn screening initiative, or developing a private-label at-home diagnostic kit, Surgeine Healthcare provides end-to-end manufacturing support—from substrate formulation to final CE-certified kit packaging.
Contact our micro-sampling product engineering team today to request samples, technical specifications, or a competitive OEM quotation.
