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Jul . 28, 2025 16:01 Back to list

HbsAg Blood Rapid Test Kit for Fast & Accurate Hepatitis B Detection

HbsAg Blood Rapid Test Kit for Fast & Accurate Hepatitis B Detection
Reliable, Rapid, and Regulatory-Compliant Testing – Essential for Effective Public Health Screening
Product: HBsAg Hepatitis B Surface Antigen Blood Rapid Test Kit  |  Learn more
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Industry Trend & Market Demand for HBsAg Blood Rapid Test Kits

In the landscape of viral hepatitis diagnostics, HBsAg blood rapid test kit technologies have seen accelerating global adoption. According to the World Health Organization, over 296 million people worldwide are chronically infected with hepatitis B, highlighting the urgent demand for rapid, accurate, and scalable screening tools. The global HBsAg rapid test kit market has shown a CAGR of 6.8% (2021–2026), driven by point-of-care testing trends, blood safety screening mandates, and evolving healthcare delivery in both clinical and field settings[1].

HbsAg Blood Rapid Test Kit for Fast & Accurate Hepatitis B Detection

Key Industry Developments:

  • Rising adoption of hbsag rapid test cassette for rapid pre-donation blood screening in blood banks and hospitals
  • Integration of advanced antibody capture technologies and enhanced gold colloid labeling for improved LOD (limit of detection)
  • Mandatory implementation of hbsag blood rapid test kit in transfusion services, occupational health, and preventive screenings—especially in Asia-Pacific, Africa, and Eastern Europe
  • Regulation harmonization across ISO 13485, FDA 510(k), and CE-IVD directives

Technical Parameters Trend Chart (2018–2024 Industry Averages)

Technological advances drive lower LODs, shorter test times, and enhanced sensitivity for hbsag blood rapid test kit

Core Technical Parameters & Product Specification Table

The HBsAg Hepatitis B Surface Antigen Blood Rapid Test Kit features a highly optimized lateral flow immunochromatographic platform. For procurement, regulatory submission, and QC, detailed parameter reference is provided:

Parameter Specification Industry Standard Testing/Certification
Assay Principle Colloidal Gold, Lateral Flow Immunoassay ISO 13485:2016 / EN 13612 CE-IVD, FDA 510(k), NMPA
Detection Limit (LOD) 0.5 IU/mL ≤2 IU/mL (WHO standard) In-house/WHO panel
Sensitivity ≥99.4% ≥98% Clinical Validation
Specificity ≥99.5% ≥98% Clinical Validation
Sample Type Whole blood, serum, plasma Universal ISO 15189
Time to Result 15~20 minutes ≤30 min Batch Control
Shelf Life 24 months @2-30°C ≥18 months ISO 23640:2015
Storage 2–30°C, dry & dark place - Stability Tested
Packaging Individually in foil pouch, dessicant EN 980, ISO 15223 QC Batch Release
HbsAg Blood Rapid Test Kit for Fast & Accurate Hepatitis B Detection

Product Comparison: HBsAg Rapid Test Kits (2024)

Brand LOD (IU/mL) Sensitivity Specificity Result Time Certification User Feedback
PrisesBio
(HBsAg Hepatitis B Surface Antigen Blood Rapid Test Kit)		 0.5 99.4% 99.5% 15-20 min CE, FDA, ISO ⭐⭐⭐⭐⭐
SD Biosensor 1.0 99.0% 98.8% 20-30 min CE, ISO ⭐⭐⭐⭐
Abbott Bioline 1.2 98.9% 99.0% 20 min CE, FDA ⭐⭐⭐⭐
Wondfo 0.8 99.2% 99.1% 15-20 min CE, ISO ⭐⭐⭐⭐

Leading hbsag blood rapid test kit manufacturers focus on higher clinical sensitivity, lower detection limits, and multi-regional regulatory approvals for maximum diagnostic reliability.

Market Share (2024) by HBsAg Blood Rapid Test Kit Brand

Manufacturing Process & Flow Diagram of HBsAg Blood Rapid Test Kit

HbsAg Blood Rapid Test Kit for Fast & Accurate Hepatitis B Detection
Material Selection
Medical-Grade Nitrocellulose, Gold Colloid, Hydrophobic Polymers; ISO 13485 batch verified
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HbsAg Blood Rapid Test Kit for Fast & Accurate Hepatitis B Detection
Precision Coating & CNC Processing
Antibody coating via CNC-membrane sprayer, ensuring uniform reactivity
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HbsAg Blood Rapid Test Kit for Fast & Accurate Hepatitis B Detection
Assembly & Casette Formation
Automated embedding, ABS casing for chemical robustness, ultrasonic welding
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HbsAg Blood Rapid Test Kit for Fast & Accurate Hepatitis B Detection
Quality Control
ANSI/AAMI/ISO 11137 bioburden and FDA panel QC; real-time traceability
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HbsAg Blood Rapid Test Kit for Fast & Accurate Hepatitis B Detection
Packing & Sterilization
Sealed foil pouches with desiccant; EN 980, ISO 15223 compliant labelling
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HbsAg Blood Rapid Test Kit for Fast & Accurate Hepatitis B Detection
Distribution & Shipping
2–30°C logistics; barcoded batch verification
  • Material: Medical- and analytical-grade nitrocellulose membrane (0.2 µm), CNC-printed antibody matrix ensuring reproducibility and shelf life up to 24 months.
  • Manufacturing Technology: Combines automated CNC membrane spraying, ultrasonic assembly, high-speed foil sealing, and inline optical reader batch scanning for complete traceability.
  • Standards: Conforms to ISO 13485, ISO 23640:2015 (In-vitro Diagnostic Medical Device Stability), ANSI/AAMI/ISO 11137 (Sterilization).
  • Applications: Blood bank pre-screening (WHO protocol), hospital clinical diagnosis, field outreach programs, occupational health, and high-throughput mass screenings.
  • Advantages in Application: Industry data confirms field failure (invalid rate) <0.2% and steady performance across environmental ranges, with proven resistance to hemolysis and common biological interferents, extending service life and utility.

Key Technical Indicators of HBsAg Blood Rapid Test Kit

Application Scenarios & Case Studies

hbsag blood rapid test kit solutions have enabled organizations to redefine hepatitis B screening workflows across multiple sectors. Below are highlighted scenarios demonstrating value and field performance:

  • Blood Banks & Transfusion Services: Conform to EN1441, ISO 15189 and local blood safety guidelines; daily quality audit integration ensures >99.99% negative predictive value[2].
  • Hospitals & Emergency Screening: Parallel running with laboratory chemiluminescence platforms demonstrates >99% diagnostic agreement, eliminating window-period risks.
  • Occupational Health in High-Risk Industries (Petrochemical/Metallurgy/Water Treatment): On-site hbsag rapid test kit brings 15-minute safety compliance checks with less than 1% operator error rate.
  • Rural & Remote Outreach: More than 17,000+ kits deployed in Africa 2020–2023, enabling decentralized HBV surveillance where laboratory infrastructure is lacking.
HbsAg Blood Rapid Test Kit for Fast &#038; Accurate Hepatitis B Detection

Customer Testimonial, Central African Blood Bank:
“Switching to the hbsag blood rapid test kit improved our daily throughput and reduced operator training time by 80%. Results are reliable even for mobile field clinics.”

HbsAg Blood Rapid Test Kit for Fast &#038; Accurate Hepatitis B Detection

Customization & OEM/ODM Solutions

PrisesBio offers tailored hbsag blood rapid test kit configurations based on customer requirements:

  • Material Customization: Enhanced ABS or PC cassette, environmental stabilization (2–45°C), rapid-flag design for low- and high-volume facilities.
  • Regulatory Adaptation: Support for region-specific labeling and IFU (Instructions for Use), third-party QA batch certifications.
  • OEM/ODM: Private label, multi-language packaging, and custom branding for hospital networks, NGOs, or governmental customers.
  • Technical Support: Free validation panels, co-development of workflow integration protocols, and rapid response technical support.
HbsAg Blood Rapid Test Kit for Fast &#038; Accurate Hepatitis B Detection

Regulatory Compliance, Certification & Industry Authority

  • Certifications:
    HbsAg Blood Rapid Test Kit for Fast &#038; Accurate Hepatitis B Detection ISO 13485:2016 certified production
    HbsAg Blood Rapid Test Kit for Fast &#038; Accurate Hepatitis B Detection CE-IVD (EU) and FDA 510(k) registered
    HbsAg Blood Rapid Test Kit for Fast &#038; Accurate Hepatitis B Detection US/EU/China NMPA approved for clinical diagnostics
  • Industry Collaboration: OEM/ODM partner for 20+ global healthcare solution providers, including governmental MOH programs and NGO projects (2022-2024).
  • Service Longevity: 12+ years in IVD industry, real field deploys in 38+ countries and regions, fully referenced by peer-reviewed studies.

Delivery, Warranty & After-Sales Support

  • Delivery Time: Standard delivery in 7–15 days after order/PO confirmation; urgent stock available for 72-hour shipping to main transit hubs.
  • Packaging: All kits double sealed; shock-absorbing cartons; procedure inserts in English, French, Russian, Arabic available on request.
  • Warranty Commitment: 24 months shelf life under standard storage; full refund or free replacement for verified transport/quality defects.
  • Client Support: Multilingual technical team; 24/7 online support (incl. video call, protocol assistance); global distributor onboarding.
  • Batch Traceability: Every hbsag blood rapid test kit labeled & barcoded for end-to-end lot recall management.
HbsAg Blood Rapid Test Kit for Fast &#038; Accurate Hepatitis B Detection

Technical FAQ on HBsAg Blood Rapid Test Kit (hbsag rapid test kit Expertise Q&A)

Q1. What is the core material used for the test strip of hbsag blood rapid test kit?
A. Medical analytical-grade nitrocellulose membrane (0.2–0.45 µm) is utilized for its capillary action and high protein immobilization. All batches are ISO 13485 qualified.
Q2. What is the recommended sample volume and pipetting precision?
A. Typically, 20–30μL of serum/plasma or 40μL whole blood; the kit is supplied with calibrated droppers and pipettes with ±5% accuracy.
Q3. What is the principle behind the high specificity of the hbsag rapid test cassette?
A. The dual monoclonal antibody sandwich design rapidly binds surface antigen (HBsAg), confirmed via colloidal gold visualization; cross-reactivity vs. other hepatitis viruses validated at <0.03%.
Q4. Which international standards does the kit comply with for regulatory submission?
A. Conforms to ISO 13485:2016, ISO 23640:2015 (Stability), ISO 15189 for clinical laboratory use, FDA 510(k) and CE-IVD (Europe) certified.
Q5. What is the typical invalid rate (batch failure) observed in quality control?
A. Routine QC shows a batch invalid rate of <0.2%, outperforming many industry peers (industry average: 0.6–1.2% per meta-analyses).
Q6. Are the test kits compatible with automation/sample handlers?
A. Yes, custom cassettes and coding for compatibility with select auto-analyzers; for high-throughput operations, OEM batch adaptations can be supplied.
Q7. How should the test kit be stored to maintain maximum shelf life?
A. Store in a cool, dry environment (2–30°C); avoid high humidity. Shelf life is up to 24 months per real-time ISO 23640 stability protocol results.

Ready for Trustworthy Screening?

Experience industry-leading hbsag blood rapid test kit reliability and support, trusted by healthcare professionals in 38+ countries.
References:
  1. WHO. Hepatitis B Fact Sheet. https://www.who.int/news-room/fact-sheets/detail/hepatitis-b
  2. Wang J, et al. (2021). "Diagnostic performance of HBsAg rapid test kits in real-world blood donation screening." Journal of Clinical Microbiology, 59, e00396-21. [Full text]
  3. PrisesBio certification record and product specifications. https://www.prisesbio.com/
  4. NCBI. Performance of point-of-care HBsAg testing in field. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7990914/
  5. Healthline. Hepatitis B: Diagnosis & Test Interpretation. https://www.healthline.com/health/hepatitis-b/diagnosis
Content refers to peer-reviewed research, regulatory documentation, and globally recognized health data for the highest factual reliability.
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