iCARE HIV Ag/Ab Tri-line Rapid Test – HIV 1 & 2 4th Generation Test Kit
WHO PQ-Listed HIV 4th Generation Rapid Test Kit
JAL Medical is a leading Manufacturer, Exporter & Supplier of the iCARE HIV Ag/Ab Tri-line Rapid Test (Whole Blood/Serum/Plasma) – a 4th Generation HIV 1 & 2 Rapid Diagnostic Test Kit – from Singapore to governments, hospitals, NGOs, and bulk buyers across Africa, Asia, the Caribbean, and beyond. This WHO Pre-Qualified (PQ-listed) HIV rapid test simultaneously detects HIV-1 p24 antigen, HIV-1 antibody, and HIV-2 antibody in a single tri-line cassette – delivering results in 15 minutes with 99.75% sensitivity and 99.89% specificity.
iCARE HIV 4th Generation Ag/Ab Tri-line Rapid Test Product Specifications
| Specification | Detail |
| Product Name | iCARE HIV Ag/Ab Tri-line Rapid Test (4th Generation) |
| Brand | iCARE ADVANCED |
| Detection Targets | HIV-1 p24 Antigen + HIV-1 Antibody + HIV-2 Antibody |
| Specimen Types | Whole blood (fingerstick / venipuncture), serum, plasma |
| Methodology | Tri-line lateral flow chromatographic immunoassay |
| Result Time | 15 minutes (read within 20 minutes) |
| p24 Antigen Analytical Sensitivity | 2 IU/mL |
| Pack Sizes | 1, 2, 5, 7, 10, 20, 25, 40 Tests/Kit |
| Storage Temperature | 2–30°C (no cold chain required) |
| Shelf Life | 24 months from date of manufacture |
| Certifications | WHO PQ Listed (co-branded); CE; ISO 13485:2016; GMP |
4th Generation vs 3rd Generation HIV Test: Why It Matters for Global Health Programs
| Feature | 3rd Generation (Ab Only) vs 4th Generation (Ag+Ab) |
| What is detected | HIV antibodies only vs HIV antibodies + HIV-1 p24 antigen |
| Window period | 22–26 days vs ~15–20 days |
| Detects acute infection | No vs Yes (p24 antigen present before seroconversion) |
| Recommended by WHO | Still in use vs Current global standard |
| Suitable for high-risk screening | Limited vs Yes – ideal for high-risk populations |
Clinical Performance: ELISA-Validated Accuracy of iCARE HIV 4th Gen Rapid Test
| Detection Target | Sensitivity / Specificity / Accuracy |
| HIV-1 / HIV-2 Antibodies | Sensitivity 99.75% | Specificity 99.89% | Accuracy 99.84% (n=1,320) |
| HIV-1 p24 Antigen | Sensitivity 99.72% | Specificity 99.88% | Accuracy 99.83% (n=1,226) |
| p24 Analytical Sensitivity | 2 IU/mL in serum |
| Cross-Reactivity | None with HBsAg, HCV, H. pylori, MONO, CMV, Rubella, TOXO, HAMA |
Step-by-Step Protocol: How to Perform the HIV 4th Generation Tri-line Rapid Test
- Equilibrate test device, sample diluent, and specimen to room temperature (15–30°C). Shake diluent gently before use.
- Remove test device from the sealed foil pouch; place on a dry, clean, level surface; label with patient ID.
- Hold dropper vertically; add 3 drops of whole blood/serum/plasma (approx. 30 µL) into specimen well (S). No air bubbles.
- Immediately add 1 drop of sample diluent (30–40 µL) to the diluent well (D).
- Start the timer immediately.
- Read results at exactly 15 minutes (do not read after 20 minutes): C + Ab + Ag lines = HIV Ag & Ab Positive; C + Ab only = HIV Ab Positive; C + Ag only = HIV Ag Positive; C only = Negative; No C = Invalid. Any visible line at Ab or Ag = POSITIVE regardless of intensity.
Key Advantages: Why Governments & NGOs Choose iCARE HIV 4th Gen Test Kits
- WHO PQ Listed: Eligible for procurement through UNICEF, Global Fund, PEPFAR, and WHO-backed tenders
- 4th Generation Window Closure: p24 antigen detection at 2 IU/mL identifies acute HIV – the highest transmission risk period
- Dual HIV-1 + HIV-2 Detection: Critical for West African programs where HIV-2 is endemic
- Tri-line Readout: Visual differentiation of Ag-only, Ab-only, or Ag+Ab reactive results for richer clinical information
- Proven WHO Tender Track Record: Supplier to the world’s largest WHO HIV test tender – 50 million tests per 3-year cycle
- No Cold Chain: 2–30°C storage – compatible with all tropical and remote supply destinations
- No. 1 Market Share: Whole blood HIV rapid test leader in Australia, New Zealand, Japan, Malaysia, Myanmar, Laos
Global Procurement Applications for HIV 4th Generation Rapid Test Kits
- National HIV Testing Programs and Universal Testing Campaigns
- Voluntary Counselling and Testing (VCT) Centres
- PMTCT (Prevention of Mother-to-Child Transmission) Antenatal Programs
- Blood Transfusion Services and Blood Bank Donor Screening
- STD Clinics, Sexual Health Programs, and Post-Exposure Prophylaxis (PEP)
- Prison / Correctional Facility Health Services
- Military and Defence Medical Units
- Refugee, Humanitarian, and Emergency Health Programs
Frequently Asked Questions on HIV 4th Generation Rapid Test Kit
What makes a 4th generation HIV test superior to a 3rd generation test?
4th generation HIV tests detect both HIV antibodies AND the HIV-1 p24 antigen - present as early as 10–14 days post-infection. This reduces the diagnostic window period by approximately one week compared to antibody-only tests, enabling earlier detection of acute infection when transmission risk is highest.
Is this test WHO Pre-Qualified (WHO PQ)?
Yes. The iCARE HIV 1&2 Rapid Test is WHO Pre-Qualification Listed (co-branded), making it eligible for procurement through UNICEF, the Global Fund, PEPFAR, and WHO-backed government tenders worldwide.
Does this test detect both HIV-1 and HIV-2?
Yes. The Ab test line simultaneously detects HIV-1 antibodies (via recombinant gp41/120 antigen) and HIV-2 antibodies (via recombinant gp36 antigen) - essential for programs in West Africa where HIV-2 is endemic.
Can patients on antiretroviral therapy (HAART) give false-negative results?
Yes. Patients receiving HAART may have suppressed viral antigen and antibody levels, which could result in a false-negative result. Clinical history and patient context should always be considered when interpreting results.
What is the p24 antigen analytical sensitivity of the iCARE test?
The iCARE HIV Ag/Ab Tri-line Rapid Test detects HIV-1 p24 antigen at a concentration of 2 IU/mL in serum - enabling detection during the acute infection window before antibody seroconversion.
What is JAL Medical's track record in large-scale HIV test supply?
JAL Medical, in partnership with South African collaborators, has been the supplier to the world's largest WHO-backed HIV test tender - a 3-year supply of 50 million HIV tests - and has won consecutive tender cycles (2014–2017 and 2017–2020). JAL Medical holds the No. 1 market share for whole blood HIV rapid tests in Australia, New Zealand, Japan, Malaysia, Myanmar, and Laos.
What documents does JAL Medical provide to support tender submissions?
JAL Medical provides complete tender documentation packages: WHO PQ listing certificates, CE certificates, ISO 13485:2016 certification, GMP compliance records, product performance data, IFUs in multiple languages, and OEM/co-branded product options to meet tender-specific requirements.
What specimen volume is required, and what specimen types are accepted?
The test requires approximately 30 µL (3 drops) of whole blood, serum, or plasma. The fingerstick whole blood option makes it especially suited for community-based testing, mobile VCT programs, and field settings without venipuncture capability.