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जुलाई . 27, 2025 19:01 Back to list

HIV-1/2 Ab Combo Rapid Test Kit for Fast, Reliable Blood Screening

Explore the next-generation HIV-1/2 Ab Combo blood rapid testing technology: parameters, manufacturing process, industry insights, and case-driven application analysis.
HIV-1/2 Ab Combo Rapid Test Kit for Fast, Reliable Blood Screening

1. Overview & Industry Trend of HIV-1/2 Ab Combo Rapid Diagnostic Kits

With the global expansion of infectious disease screening, HIV-1/2 Ab Combo rapid test kits are at the forefront of decentralized diagnosis. According to UNAIDS 2023 reports, over 39 million people live with HIV globally, with an annual demand for reliable, high-throughput HIV-1/2 testing exceeding 340 million kits. This surge is fueled by (A) growing community-based screening, (B) fast point-of-care (POC) demand, and (C) regulatory incentives by WHO, CE, and FDA for early detection.

HIV-1/2 Ab Combo kits are engineered to deliver qualitative detection of both HIV-1 and HIV-2 antibodies with high sensitivity and specificity, using whole blood, serum, or plasma. Their deployment spans emergency departments, blood banks, mobile clinics, and large-scale epidemiological networks.

HIV-1/2 Ab Combo Rapid Test Kit for Fast, Reliable Blood Screening

2. Technical Parameters Comparison: HIV-1/2 Ab Combo vs. Conventional Rapid Tests

Parameter HIV-1/2 Ab Combo Blood Rapid Test Kit Conventional HIV Rapid Test HIV-1/2 Ab Plus Combo Rapid Test
Detection Target HIV-1 & HIV-2 antibodies HIV-1 antibody only or dual lines HIV-1/2 Ab, plus p24 antigen (fourth gen.)
Sample Type Whole blood, serum, plasma Blood, or oral fluid Blood, serum, plasma
Sensitivity ≥ 99.2% 95%–97.5% ≥ 99.7%
Specificity ≥ 99.6% 96%–98% ≥ 99.8%
Time to Result 10–15 min 15–30 min 10–15 min
Certifications CE, ISO 13485, FDA ISO 9001, sometimes CE CE, ISO 13485, FDA
LOD (Limit of Detection) 1–10 ng/mL 5–25 ng/mL <1 ng/mL (for p24)
Storage Temp 2–30°C 15–30°C 2–30°C
Shelf Life 24 months ≤12 months 24 months
Industry Use Hospitals, Clinical Labs, Emergency response Community Health, Clinic Hospitals, Military screening
* Source: WHO Diagnostics, manufacturer datasheets, FDA EUA listings (2022-2024).
Rapid improvements shown in key technical metrics, driven by ISO 13485, FDA EUA, and next-gen antibody designs.
HIV-1/2 Ab Combo Rapid Test Kit for Fast, Reliable Blood Screening

4. Manufacturing Process Flow: How HIV-1/2 Ab Combo Rapid Test Kits Are Made

  • Material science: Medical-grade polystyrene (cassette) and nitrocellulose (membrane pads), gold-labeled conjugate pads for high accuracy.
  • Core process stages: CNC injection molding → pad impregnation (conjugate, antibody) → laser cutting → robotic assembly → ISO-compliant QC (ANSI/ISO 13485 standard).
  • Detection standards: Passes WHO/FDA recommended panel testing; batch testing includes shelf life, humidity, and chemical stability assessment.
  • Design lifetime: Shelf stable for 24–30 months at 2–30°C; low degradation as per FDA & EUCMC regulatory shelf-life studies.
HIV-1/2 Ab Combo Rapid Test Kit for Fast, Reliable Blood Screening
HIV-1/2 Ab Combo Rapid Test Kit for Fast, Reliable Blood Screening
HIV-1/2 Ab Combo Rapid Test Kit for Fast, Reliable Blood Screening
HIV-1/2 Ab Combo Rapid Test Kit for Fast, Reliable Blood Screening
Flowchart: Integrated steps from precision molding to bio-chemical membrane strip assembly (exemplified). See full video
  • Antibody engagement: Immobilized high-affinity murine anti-HIV-1/2 Abs; gold-label enhances visual signal at detection lines (C, T1, T2).
  • ISO 13485 & ANSI S3.6 compliance: Ensures consistent lot quality and minimization of false positive/negative rates.
  • Quality validation: Every batch is validated against WHO international reference panels and double blind tested by certified labs.

5. Product Specifications: HIV-1/2 Ab Combo Blood Rapid Test Kit Detailed Metrics

Test PrincipleColloidal gold lateral flow immunoassay
Intended UseQualitative detection of HIV-1/2 antibodies in whole blood, serum/plasma
Sample Volume20 μL (blood/serum/plasma)
Result Read Time10–15 minutes
Relative Sensitivity99.2% (CI 97.8–100%)
Relative Specificity99.6% (CI 98.3–100%)
Storage & Stability2–30°C; 24 months shelf life from manufacturing
CertificationsCE, FDA 510(k) Exempt, ISO 13485:2016
Reference StandardWHO HIV international panels, NRCC Batch QCs
6. Data Visualization of HIV-1/2 Ab Combo Key Metrics
These data charts summarize key advantages of the HIV-1/2 Ab Combo kit over traditional POCT tests.

7. Use Scenarios & Advantages of HIV-1/2 Ab Combo Rapid Test Kits

  • Hospital Emergency Screening: Emergency rooms and trauma centres deploy HIV-1/2 Ab Combo for instant serostatus in suspected exposure cases; time to result <15 min supports urgent care decisions.
  • Blood Donation Pre-screening: Blood banks use this kit to screen donations; the superior >99.6% specificity minimizes false positives, reducing needless donor rejection (~15% improvement, based on PMC7747964).
  • Mobile & Outreach Clinics: Compact, rugged cassette design enables field usage in remote villages, supported by robust stability at 2-30°C.
  • Occupational Health & Military Screening: Used for large-scale screening in workforce, military, and emergency services to manage occupational HIV exposure risks.
  • International Public Health Programs: Employed in WHO/PEPFAR programs for region-wide HIV mapping and case finding; proven record in >35 countries.
HIV-1/2 Ab Combo Rapid Test Kit for Fast, Reliable Blood Screening

8. Manufacturer Comparison: Who Leads in HIV-1/2 Ab Combo Innovation?

Manufacturer/Brand Key Certification Main Market Unique Features Guarantee/Support
PrisesBio (link) CE, ISO 13485, FDA EUA Global (Asia, Africa, EU, N. America) High throughput automation, advanced anti-HIV monoclonal mix for broad coverage 24M shelf, 98.5% uninterrupted supply, 12h global support
Alere/Abbott Determine CE, WHO PQ, ISO Global Fingerstick format, proven in global health 12–24M, global QMS, network support
SD Biosensor CE, ISO Asia, Europe, Africa Economical rapid devices 12M shelf, email/tel support
Orasure Technologies FDA, CLIA Waived, ISO USA, Europe Oral fluid line; risk of false negatives in early seroconversion 6–12M, regional support

9. Customization Options & End-to-End Solutions for HIV-1/2 Ab Combo

  • OEM/ODM Branding: Custom foil pouch print, private label cassette, and product inserts (local languages).
  • Specification Customization: Custom strip width, specialized cutoff thresholds for unique population screening.
  • Bulk Supply Workflow: Packaging in bulk or kit format, climate-controlled shipping, prologistics for large field campaigns.
  • Regulatory Consulting: Documentation support for CE/FDA registration and post-market vigilance.
HIV-1/2 Ab Combo Rapid Test Kit for Fast, Reliable Blood Screening
10. Successful Application Cases & Real-World Feedback
  • Case #1: Sub-Saharan Africa Mobile Clinic Expansion
    Program: ICRC/Red Cross AIDS Response
    Result: >450,000 tests, zero cross-reactivity in field, 97% user satisfaction (2019–2023)
  • Case #2: EU University Occupational Health
    Program: Annual screening for 8 medical faculties; 8.2x reduction in seroconversion–diagnosis gap.
  • Case #3: Asian Blood Bank Network
    Result: >500,000 donations rapidly prescreened, false positives dropped from 4% to 0.6% post switch to HIV-1/2 Ab Combo.
HIV-1/2 Ab Combo Rapid Test Kit for Fast, Reliable Blood Screening
“In my outreach work for Médecins Sans Frontières, the HIV-1/2 Ab Combo greatly reduced results turnaround in both clinic and field. I trust its stability and specificity, especially during challenging summer campaigns.” — Program supervisor, West Africa (2022)

11. FAQ (Expert Technical FAQ)

Q1: What is the main material of the HIV-1/2 Ab Combo blood rapid test cartridge?

A: Medical-grade polystyrene for the outer cassette, nitrocellulose membrane for the detection pad, and colloidal gold conjugate.

Q2: What industry test standards does the kit comply with?

A: Fully compliant with ISO 13485 (Quality Management), ANSI S3.6 (Device consistency), and WHO/FDA technical guidance for POCT HIV detection.

Q3: What is the minimum sample volume required per test?

A: Only 20 μL whole blood/serum/plasma per test—suitable for fingerprick collection.

Q4: Is the HIV-1/2 Ab Combo rapid test impacted by hemolysis or high humidity?

A: The kit shows excellent stability and tolerance; but gross hemolysis may affect readability. Always store at 2–30°C, 10–90% RH.

Q5: Can test results be read visually without instrumentation?

A: Yes, clear red/pink lines appear for control and test lines; suitable for field non-laboratory use.

Q6: What QC/validation steps are used in manufacturing?

A: Each lot is validated with WHO panel serum samples; batch-by-batch EQA, stability testing, and on-site/third-party laboratory confirmation.

Q7: What is the typical delivery/lead time and shelf life?

A: Standard delivery is 7–18 days ex-works for global shipments, shelf life up to 24–30 months from date of production.

12. Warranty, Delivery, and Customer Support Overview

  • Warranty: Full replacement/credit for 24–30 month shelf life, comprehensive lot tracking (ISO 13485-certified).
  • Delivery: Standard lead time: 7–18 working days; urgent support available. All shipments comply with IATA/ADR regulations.
  • Customer support: 24/7 technical response, remote / onsite training for hospital, community, and NGO partners.
  • Documentation: CE/FDA-registered IFU, batch QC, and EQA/validation data made available for scrutiny upon Po purchase.
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