Table of Contents
AI Summary:
This article provides a detailed procurement and clinical guide to the iCARE One Step HBV-5 Combo Rapid Test manufactured and exported by JAL Medical. This is one of the most comprehensive hepatitis B rapid test kits available on the global market – simultaneously detecting all five key hepatitis B virus (HBV) markers – HBsAg, HBsAb, HBeAg, HBeAb, and HBcAb – from a single whole blood, serum, or plasma specimen, delivering results in 15–20 minutes. This article covers the science behind Hepatitis B profiling, clinical performance data, step-by-step testing procedures, global procurement considerations, and answers the most pressing questions from government health organizations, hospitals, NGOs, and institutional bulk buyers seeking reliable, WHO-standard Hepatitis B diagnostic test kits.
Hepatitis B: The World’s Most Significant Vaccine-Preventable Infectious Disease
Hepatitis B virus (HBV) is responsible for one of the most significant infectious disease burdens on the planet. According to the World Health Organization:
- An estimated 296 million people live with chronic hepatitis B infection globally
- HBV causes approximately 820,000 deaths per year, primarily from cirrhosis and hepatocellular carcinoma (liver cancer)
- The carrier rate ranges from 0.3% in Western countries to 20% in parts of Asia and Africa
- Approximately 5–10% of people acutely infected with HBV progress to chronic infection
Despite the existence of an effective vaccine since the 1980s, billions of people – particularly in Sub-Saharan Africa and Asia – remain unvaccinated or undiagnosed. The “test and treat” approach championed by the WHO’s Global Health Sector Strategy on Viral Hepatitis requires massively scaled testing capacity in low- and middle-income countries.
At the heart of hepatitis B management is the ability to accurately determine a patient’s serological profile – which combination of surface antigens, surface antibodies, envelope antigens, envelope antibodies, and core antibodies are present – to guide clinical decisions on:
- Whether a patient is actively infected
- Whether they have recovered and developed immunity
- Whether they are immune from vaccination
- Whether they are in the high-replication phase (high infectivity)
- Whether they are eligible for antiviral treatment
This is precisely where the iCARE One Step HBV-5 Combo Rapid Test delivers unmatched clinical value.
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What Is the iCARE One Step HBV-5 Combo Rapid Test?
The iCARE One Step HBV-5 Combo Rapid Test is a professional-grade, serological lateral flow chromatographic immunoassay that simultaneously detects five Hepatitis B virus markers in a single test device from a single patient specimen.
The 5 markers detected:
- HBsAg – Hepatitis B Surface Antigen (indicates active HBV infection)
- HBsAb – Hepatitis B Surface Antibody (indicates recovery or vaccine-induced immunity)
- HBeAg – Hepatitis B Envelope Antigen (indicates high viral replication and infectivity)
- HBeAb – Hepatitis B Envelope Antibody (indicates lower viral replication)
- HBcAb – Hepatitis B Core Antibody (indicates past or current infection)
Key product details:
- Manufacturer/Supplier: JAL Medical
- Brand: iCARE ADVANCED
- Specimen types: Whole blood (venipuncture or fingerstick), serum, or plasma
- Detection targets: HBsAg, HBsAb, HBeAg, HBeAb, HBcAb (5 markers in one test)
- Result time: 15–20 minutes
- Pack size: 10 Tests/Kit
- Storage temperature: 2–30°C (no freezing required)
- Shelf life: 24 months from date of manufacture
- Certifications: CE marked; ISO 13485:2016 and GMP certified manufacturing
Understanding the 5 Hepatitis B Markers: A Clinical Reference for Healthcare Buyers
For procurement professionals and healthcare administrators, understanding what each marker means helps justify the value of a 5-in-1 profile test over individual single-marker tests.
| Marker | What It Means | Clinical Significance |
| HBsAg (Hepatitis B Surface Antigen) | HBV is present in the body | Confirms active HBV infection (acute or chronic) |
| HBsAb (Hepatitis B Surface Antibody) | Immunity to HBV is present | Indicates recovery from infection OR successful vaccination |
| HBeAg (Hepatitis B e-Antigen) | High viral replication is occurring | High infectivity; patient may need antiviral treatment |
| HBeAb (Hepatitis B e-Antibody) | Seroconversion from HBeAg | Lower replication phase; better prognosis in chronic patients |
| HBcAb (Hepatitis B Core Antibody) | Past or current exposure to HBV | Indicates prior infection even when HBsAg is negative |
Running all 5 tests simultaneously from a single sample provides the complete hepatitis B serological picture in one patient encounter – eliminating the need for multiple separate tests, multiple sample collections, or referral to reference laboratories.
How the iCARE HBV-5 Combo Rapid Test Works
Dual Detection Mechanisms in One Device
The HBV-5 Combo test employs two different immunoassay principles within one device to accommodate the different chemistries of antigen and antibody detection:
Sandwich Immunoassay (for HBsAg and HBeAg): The membrane is pre-coated with anti-HBsAg or anti-HBeAg antibodies. When the specimen is applied, HBsAg or HBeAg antigens bind to gold-conjugated antibodies, and the complex is captured at the test line – generating a positive colored band.
Competitive Binding Immunoassay (for HBeAb and HBcAb): This is a reverse readout test. The membrane is pre-coated with HBeAg or HBcAg. If anti-HBe or anti-HBc antibodies are present in the specimen, they compete with gold-conjugated antibodies for binding sites. When the patient’s antibodies outcompete the gold conjugate, no colored band forms at the test line – indicating a POSITIVE result (absence of line = positive for HBeAb and HBcAb).
Step-by-Step: How to Perform the HBV-5 Combo Rapid Test
Step 1: Prepare the Test Environment
Allow the test device, sample diluent, and specimens/controls to reach room temperature (15–30°C). Shake the sample diluent gently before use.
Step 2: Remove the Test Device
Take the test device from its sealed foil pouch. Place on a dry, clean, level surface. Label with the patient’s specimen ID number.
Step 3: Apply the Specimen
Using the provided dropper, transfer one drop of whole blood/serum/plasma (approximately 30 µL) into each specimen well (S). Then immediately add two drops of sample diluent (approximately 80–100 µL) into each specimen well (S). Ensure there are no air bubbles.
Step 4: Start the Timer
Begin timing immediately after specimen and diluent addition.
Step 5: Wait for Results at 15 Minutes
Do not interpret results after 20 minutes.
Step 6: Read and Interpret Results – Critical Notes
For HBsAg, HBsAb, and HBeAg strips:
- Positive: Two lines appear (C + T). Any shade of color at T = positive.
- Negative: Only C line appears. No T line.
- Invalid: No C line appears.
For HBeAb and HBcAb strips (REVERSE logic):
- Positive: Only C line appears. No T line = POSITIVE.
- Negative: Two lines appear (C + T).
- Invalid: No C line appears.
Clinical Performance: Validated Accuracy Across All Five Markers
The iCARE One Step HBV-5 Combo Rapid Test has been extensively validated against reference ELISA assays. Performance data is summarized below:
| HBV Marker | Sensitivity | Specificity | Overall Accuracy |
| HBsAg | 98.6% | 99.7% | 99.4% |
| HBsAb | 99.7% | 99.7% | 99.7% |
| HBeAg | 98.0% | 99.1% | 98.6% |
| HBeAb | 97.8% | 99.1% | 98.6% |
| HBcAb | 97.6% | 99.0% | 98.4% |
Analytical Sensitivity (Limits of Detection)
- HBsAg: 0.5 ng/mL (1.0 IU/mL)
- HBsAb: 10 mIU/mL
- HBeAg: 2.0 NCU/mL
- HBeAb: 2.0 NCU/mL
- HBcAb: 2.0 NCU/mL
Cross-Reactivity: No Interference
The test was evaluated against: HAMA, Rheumatoid Factor (RF), HAV, Syphilis, HIV, H. Pylori, HCV, CMV, Rubella, and TOXO. No cross-reactivity was observed with any of these potentially interfering conditions.
Precision
- Intra-assay (within-run) precision: Negative and positive specimens correctly identified 99% of the time using 15 replicates
- Inter-assay (between-run) precision: 99% correct identification across 15 independent assays using three different kit lots over 10 days
Why Hospitals and Bulk Buyers Choose the iCARE HBV-5 Combo Over Single-Marker Tests
Complete Hepatitis B Profiling in One Test
Rather than purchasing and running five separate rapid tests for each patient, the HBV-5 Combo delivers a full serological hepatitis B profile from a single specimen application. This reduces cost per patient profile, simplifies inventory management, and shortens time to clinical decision-making.
Critical for Chronic HBV Management
Chronic hepatitis B management requires repeated monitoring of HBeAg/HBeAb status to track viral replication phase and guide antiviral therapy. The HBV-5 Combo provides all needed data in a single visit.
Vaccination Status Verification
The presence of HBsAb alone (without HBcAb) indicates vaccine-induced immunity, which is important for healthcare worker screening, pre-travel assessment, and neonatal vaccination program verification.
Blood Bank Screening Programs
Blood transfusion services require HBsAg screening at minimum. The HBV-5 Combo provides comprehensive donor profiling, supporting safer blood supply programs in resource-limited settings.
Suitable for Multiple Specimen Types
The test accepts whole blood (fingerstick or venipuncture), serum, and plasma – providing flexibility for hospital laboratories, field clinics, and community screening programs.
Who Should Procure the HBV-5 Combo Rapid Test?
- Government National Hepatitis B Control Programs requiring large-volume procurement for population screening
- Hospital Laboratories and Clinical Chemistry Departments needing efficient, same-visit Hepatitis B profiling
- Blood Banks and Transfusion Services for donor screening
- Antenatal Care Programs for PMTCT (Prevention of Mother-to-Child Transmission of HBV)
- International NGOs and UN Health Programs (WHO, UNICEF, MSF) supplying diagnostics to low-resource settings
- Prison Health Services – where HBV prevalence is elevated
- Military and Defence Medical Services
- Occupational Health Services for healthcare worker vaccination status confirmation
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Hepatitis B Profile Test Kit: Procurement and Logistics Guide
Pack Size
- 10 Tests/Kit
- Bulk supply arrangements and OEM/co-branded packaging available through JAL Medical
Storage Requirements
- Temperature: 2–30°C – no cold chain required
- Away from direct sunlight; keep dry
- Do not freeze
Shelf Life
- 24 months from date of manufacture
Specimen Stability
- Serum/plasma: up to 3 days at 2–8°C; up to several months at –20°C
- Whole blood: test within 24 hours of collection; store at 2–8°C
Quality Certifications Available
- CE Certificate
- ISO 13485:2016 Certificate
- GMP Compliance Documentation
- IFU (Instructions for Use) in multiple languages on request
- Regulatory dossiers for national registration
Frequently Asked Questions on HBV-5 Combo Rapid Test
What are the 5 Hepatitis B markers tested in this kit?
The iCARE One Step HBV-5 Combo detects: HBsAg (surface antigen), HBsAb (surface antibody), HBeAg (envelope antigen), HBeAb (envelope antibody), and HBcAb (core antibody) - all from a single specimen in one test device.
Why is a 5-in-1 hepatitis B test more valuable than running individual tests?
A full Hepatitis B serological profile requires all 5 markers to determine infection status, immune status, viral replication phase, and treatment eligibility. Running a 5-in-1 test from a single patient sample in one step reduces testing time, reagent costs, sample volume requirements, and the complexity of multi-test panel management.
Can this test confirm hepatitis B vaccination immunity?
Yes. The HBsAb test strip detects surface antibodies generated by vaccination. A reactive HBsAb result with negative HBsAg and HBcAb confirms vaccine-induced immunity - distinguishing it from natural infection immunity (where HBcAb would also be positive).
What is the sensitivity and specificity for HBsAg detection?
The HBsAg strip demonstrates 98.6% sensitivity and 99.7% specificity against an ELISA reference, evaluated across 2,845 clinical specimens.
How do I correctly interpret the HBeAb and HBcAb strips?
The HBeAb and HBcAb strips use competitive binding immunoassay - the readout is inverted. Absence of the T line = POSITIVE result for HBeAb and HBcAb. Presence of both C and T lines = NEGATIVE. This is the opposite of the HBsAg, HBsAb, and HBeAg strips, and staff training must address this critical difference.
Can this test be used for blood donor screening?
Yes. HBsAg screening is a WHO-recommended minimum standard for blood donor testing. The HBV-5 Combo provides a more comprehensive donor profile. However, blood banks should follow national regulatory requirements for confirmatory testing of reactive donations.
How does this test support PMTCT (Prevention of Mother-to-Child Transmission) programs?
Antenatal HBsAg screening identifies HBV-positive pregnant women whose newborns need hepatitis B immunoglobulin (HBIG) and vaccination at birth. The HBV-5 Combo additionally identifies HBeAg-positive mothers (high viral replication), who have the highest transmission risk and may benefit from antiviral prophylaxis.
What specimens are acceptable and how much volume is required?
The test accepts whole blood (from venipuncture or fingerstick), serum, or plasma. Approximately 30 µL (one drop) of specimen is required per test device.
Is there cross-reactivity with HIV, HCV, or other infections?
No. The test has been evaluated against HIV, HCV, HAV, Syphilis, H. Pylori, CMV, Rubella, TOXO, and Rheumatoid Factor. No cross-reactivity was observed.
How does JAL Medical fulfill large-scale government hepatitis B program orders?
JAL Medical has extensive experience fulfilling large-volume government and NGO orders across 57 African countries and other international markets. The company provides product documentation for regulatory registration, co-branded OEM options, export compliance, and technical support. Contact www.jalmedical.com for tender participation and bulk pricing.
