iCARE One Step HBV-5 Combo Rapid Test – Hepatitis B Profile (5) Test Kit
Complete 5-Marker Hepatitis B Profile Rapid Test Kit
JAL Medical is a leading Manufacturer, Exporter & Supplier of the iCARE One Step HBV-5 Combo Rapid Test (Whole Blood/Serum/Plasma) from Singapore to government health programs, hospitals, blood banks, and NGOs worldwide. This Hepatitis B profile test simultaneously detects all 5 key HBV serological markers – HBsAg, HBsAb, HBeAg, HBeAb, and HBcAb – from a single patient specimen in just 15–20 minutes, without laboratory equipment.
With an estimated 296 million people living with chronic hepatitis B globally and 820,000 deaths annually from cirrhosis and liver cancer, comprehensive Hepatitis B serological profiling is foundational to national HBV control programs. The iCARE HBV-5 Combo is the most cost-effective, field-ready solution for full HBV profiling available on the global market.
Key Product Specifications – iCARE Hepatitis B Profile (5) Rapid Test Kit
| Specification | Detail |
| Product Name | iCARE One Step HBV-5 Combo Rapid Test |
| Brand | iCARE ADVANCED |
| 5 Markers Detected | HBsAg, HBsAb, HBeAg, HBeAb, HBcAb |
| Specimen Types | Whole blood (venipuncture / fingerstick), serum, or plasma |
| Methodology | Lateral flow immunoassay (sandwich + competitive binding) |
| Result Time | 15–20 minutes |
| Pack Size | 10 Tests/Kit |
| Storage Temperature | 2–30°C (no cold chain required) |
| Shelf Life | 24 months from date of manufacture |
| Intended Use | Professional in vitro diagnostic (IVD) use |
| Certification | CE marked; ISO 13485:2016; GMP certified |
Understanding the 5 Hepatitis B Markers Detected in One Test
| Marker | Clinical Significance |
| HBsAg (Surface Antigen) | Confirms active HBV infection (acute or chronic) |
| HBsAb (Surface Antibody) | Indicates recovery from infection or vaccine-induced immunity |
| HBeAg (e-Antigen) | Indicates high viral replication and infectivity |
| HBeAb (e-Antibody) | Seroconversion from HBeAg – lower replication phase |
| HBcAb (Core Antibody) | Indicates past or current HBV exposure |
Clinical Performance: ELISA-Validated Accuracy Across All 5 Hepatitis B Markers
| HBV Marker | Sensitivity / Specificity / Accuracy |
| HBsAg | Sensitivity 98.6% | Specificity 99.7% | Accuracy 99.4% |
| HBsAb | Sensitivity 99.7% | Specificity 99.7% | Accuracy 99.7% |
| HBeAg | Sensitivity 98.0% | Specificity 99.1% | Accuracy 98.6% |
| HBeAb | Sensitivity 97.8% | Specificity 99.1% | Accuracy 98.6% |
| HBcAb | Sensitivity 97.6% | Specificity 99.0% | Accuracy 98.4% |
Intra-assay and inter-assay precision: All 5 markers correctly identified 99% of the time across 15 replicates and 15 independent assays. No cross-reactivity with HIV, HCV, HAV, Syphilis, H. Pylori, CMV, Rubella, or TOXO.
Step-by-Step Protocol: How to Perform the HBV-5 Combo Hepatitis B Profile Test
- Equilibrate test device, sample diluent, and specimen to room temperature (15–30°C). Shake diluent gently before use.
- Remove test device from the foil pouch; place on a dry, clean, level surface; label with patient ID.
- Add 1 drop (approx. 30 µL) of specimen into each specimen well (S); immediately add 2 drops (80–100 µL) of sample diluent into each well (S). Avoid air bubbles.
- Start the timer immediately after adding specimen and diluent.
- Read results at 15 minutes (not after 20 minutes).
- IMPORTANT – Different readout logic for HBeAb and HBcAb strips: For HBsAg, HBsAb, HBeAg: C+T lines = Positive; C only = Negative. For HBeAb, HBcAb: C only = POSITIVE (no T line); C+T = Negative. Staff must be trained on this critical difference.
Why Choose iCARE HBV-5 Combo?
- Complete 5-in-1 Profile: One test replaces five separate HBV tests – lower cost, less complexity, faster decision-making
- PMTCT Programs: Identifies HBeAg-positive pregnant women at highest risk of mother-to-child HBV transmission
- Blood Bank Donor Screening: Comprehensive donor HBV profiling from a single fingerstick whole blood specimen
- Chronic HBV Management: Monitors HBeAg/HBeAb seroconversion to guide antiviral therapy decisions
- Vaccination Status Confirmation: HBsAb alone (without HBcAb) = vaccine-induced immunity – used for healthcare worker screening
- No Cold Chain: 2–30°C storage – suitable for all tropical and remote supply destinations
- Analytically Sensitive: Detects HBsAg at 0.5 ng/mL (1.0 IU/mL), HBsAb at 10 mIU/mL
Frequently Asked Questions – HBV-5 Combo Rapid Test
What are the 5 Hepatitis B markers detected in the iCARE HBV-5 Combo?
The test detects HBsAg (surface antigen confirming active infection), HBsAb (surface antibody confirming immunity), HBeAg (envelope antigen indicating high viral replication), HBeAb (envelope antibody indicating lower replication), and HBcAb (core antibody indicating past/current exposure) - all from a single specimen.
Why is the HBsAb result important for vaccination programs?
A positive HBsAb with negative HBsAg and negative HBcAb specifically indicates vaccine-induced immunity - distinguishing it from natural infection immunity. This is essential for healthcare worker occupational health screening, neonatal vaccination programs, and pre-travel assessments.
How do I correctly interpret the HBeAb and HBcAb strips?
These strips use competitive binding immunoassay - the result interpretation is inverted. Absence of the T line = POSITIVE for HBeAb and HBcAb. Presence of both C and T lines = NEGATIVE. Healthcare staff must be trained on this critical difference before using the device.
Can this test be used for blood donor HBV screening?
Yes. The HBV-5 Combo is suitable for blood bank donor screening, providing a comprehensive HBV profile from a single whole blood specimen. Blood banks should follow national confirmatory testing requirements for reactive donations.
What is the analytical sensitivity of the HBsAg strip?
The HBsAg strip can detect concentrations as low as 0.5 ng/mL (1.0 IU/mL) - meeting WHO-recommended sensitivity thresholds for HBsAg screening.
Is the test suitable for PMTCT (Prevention of Mother-to-Child Transmission) programs?
Yes. The HBV-5 Combo identifies HBeAg-positive pregnant women who carry the highest risk of vertical HBV transmission. Combined with HBsAg and HBcAb results, it enables comprehensive antenatal HBV assessment to guide HBIG administration and infant vaccination decisions.
How does JAL Medical support government hepatitis B control program procurement?
JAL Medical provides full tender documentation, CE and ISO 13485 certificates, GMP compliance records, multi-language IFUs, product performance data, and OEM/co-branded options. The company supplies to 57+ African countries and other international markets. Contact www.jalmedical.com for bulk pricing and tender support.