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| Product Name | Specimen Collection Swabs, Flocked, Sterile, Individually Wrapped |
| Catalog No. | IGM-HMM-0063 |
| Description | Flocked nylon fiber specimen collection swabs with breakpoint handle for clinical diagnostic sample collection. Vertical nylon microfiber coating provides superior sample uptake and elution compared to traditional wound fiber swabs. Sterile, individually wrapped. |
| Intended Use | Collection, transport, and release of clinical specimens from nasopharyngeal, oropharyngeal, urogenital, wound, and other anatomical sites for microbiological culture, molecular diagnostic testing, and virological analysis. |
| Principle / Technology | Perpendicular nylon fibers applied via electrostatic flocking process create high-surface-area brush-like tip structure. Capillary action between fibers promotes rapid sample absorption and enhanced particle entrapment. Upon contact with transport medium, the open fiber matrix releases >80% of collected sample compared to <40% for spun fiber swabs. |
| Detection Method | Sample uptake and elution efficiency by gravimetric and protein recovery assay; sterility to ISO 11137; breakpoint force testing; flock adhesion durability testing |
| Sample Type | Nasopharyngeal and oropharyngeal secretions, wound exudates, urogenital specimens, buccal cells, skin swabs, environmental surface samples |
| Performance Range / Specifications | Elution efficiency >80% of collected sample; flock fiber density approximately 2.5 denier; breakpoint 80 mm from tip; total length 150 mm; tip diameter approximately 4.5 mm |
| Sensitivity / LOD | Endotoxin <0.1 EU/swab; nuclease non-detectable; no PCR inhibition in qPCR assay at 1:1 swab eluate concentration |
| Specificity | No DNA/RNA background from swab material (<0.1 ng/swab total nucleic acid); non-cytotoxic per ISO 10993-5; no bacterial or fungal DNA contamination |
| Reaction Conditions / Protocol | Open peel pouch at handle end; hold swab at breakpoint score line; collect specimen by rotating swab tip against mucosal surface for 5-10 seconds; place swab into transport medium tube; break handle at score line and discard upper portion; cap tube securely. |
| Components / Formulation | Polystyrene or polypropylene handle with scored breakpoint, flocked nylon fiber tip, individually sealed in medical-grade peel pouch, EO or gamma sterilized |
| Storage Conditions | 15-30 C; store in original packaging; protect from humidity and direct sunlight |
| Shelf Life | 36 months from sterilization date |
| Package Specifications | 100 swabs individually wrapped per box; 500 swabs per case; kits with transport medium tube (1 mL or 3 mL) available |
| Product Form | Flocked swab with breakpoint handle, individually wrapped in sterile peel pouch, with or without transport medium |
| Quality Control | Elution efficiency per lot by standardized protein absorption/elution assay; flock adhesion by tape test; sterility batch release per ISO 11137; breakpoint force within specification; PCR compatibility verified per lot |
| Key Features | Flocked tip for superior sample collection and release; breakpoint handle for transport tube compatibility; individually wrapped sterile; PCR and culture compatible; validated for molecular diagnostics; RNase/DNase-free |
| Purity | Sterile (SAL 10^-6); DNase/RNase-free certified; PCR inhibitor-free; human DNA-free; endotoxin tested; non-cytotoxic (ISO 10993-5) |
| Concentration | N/A |
| Activity / Unit Definition | N/A |
| Molecular Weight | N/A |
| Source / Origin | Nylon flock fiber on molded handle substrate; manufactured in ISO Class 8 cleanroom per ISO 13485; sterilized by validated EO or gamma method |
| pH Range / Optimal pH | Swab material inert pH 3-11; compatible with viral transport medium (VTM), universal transport medium (UTM), Amies medium, and sterile saline |
| Shipping Conditions | Ambient temperature; swabs in individual peel pouches packed in cartons; maintain packaging integrity for sterility |
| Expiration Date / Stability | 3 years from sterilization date; flock adhesion and elution properties maintained throughout shelf life |
| Regulatory / Compliance | ISO 13485:2016; CE IVD marked; ISO 10993 biocompatibility series; ISO 11137 sterilization; FDA 510(k) cleared; compliant with CLSI M40-A2 for microbiological transport devices |
| Compatibility | Compatible with all standard viral and bacterial transport media; suitable for PCR, RT-PCR, isothermal amplification, antigen rapid testing, and culture-based detection; swab handle diameter compatible with standard transport tube cap seal mechanisms |
| Recommended Buffer System | Compatible with VTM (Hanks BSS with BSA, antibiotics, antimycotics), UTM, PBS, sterile saline, Amies transport medium, and liquid-based cytology preservatives |
| Application Notes / Precautions | Rotate swab 3-5 times during specimen collection for maximum cell pickup; break handle at scored line only after swab is inside transport tube; do not use calcium alginate swabs for PCR as alginate inhibits polymerase; flocked swabs are preferred over cotton for molecular testing due to superior elution and lower PCR inhibition |
| Batch-to-Batch Consistency | Flock fiber length and density controlled per batch to +/- 10%; elution efficiency >80% maintained across all production lots; PCR inhibition testing with standardized qPCR assay per batch release; breakpoint force within 4-8 N specification |
For research use only, not for clinical use.
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