A New Rapid Test for Hepatitis B: Making Diagnosis Fast, Affordable, and Accessible in Nigeria
Every day, millions of people live with hepatitis B and never know it. Our team has developed a simple “just-add-heat” laboratory-free DNA test that can spot hidden infections in under an hour - even when electricity is unreliable. Below is an in-depth yet easy-to-read overview of how this project works, why it matters, and how it could help you, your family, or your patients.
Global and Nigerian Context
Hepatitis B virus (HBV) chronically infects roughly 296 million people worldwide and causes around 887,000 deaths each year through liver cirrhosis and cancer 1 2. Nigeria carries one of the heaviest burdens: more than 8% of the population—about 16 million people—live with chronic infection, often without knowing it 3. Because 90% of Nigerians who have HBV have never been tested, most miss the chance for early treatment or to protect their newborns from infection.
The Diagnostic Gap
| Current Method | Detects | Time to Result | Cost per Test | Equipment Needed | Limitations |
|---|---|---|---|---|---|
| Rapid HBsAg strip | Surface protein | 15 min | Low | None | Misses “occult” cases and cannot measure virus amount1 |
| qPCR (Nucleic Acid Test) | Viral DNA | 2–4 h | High | Expensive PCR machine, cold chain | Costs >$25 per test and unavailable in >70% of Nigerian clinics 4 |
| Our LAMP assay | Viral DNA | 30-60 min | <$3 | Small heat block or thermos flask | Field-ready; needs validation |
What Is LAMP and Why Is It Different?
Loop-mediated isothermal amplification (LAMP) is like a molecular photocopier that runs at one steady temperature - no cycling up and down like PCR. By swapping a bulky machine for a pocket-sized heater (or even a thermos with hot water), LAMP makes DNA testing possible in remote clinics with unreliable power. A built-in dye changes color from pink to yellow when HBV DNA is present, so health workers can read results by eye.
Our Research Goals in Plain Language
- Design a LAMP test that works for Nigeria’s common HBV genotype E.
- Prove it is sensitive, able to spot as few as 10 virus copies in a sample.
- Compare quick “heat-and-go” sample prep with standard laboratory extraction.
- Train frontline nurses and midwives to run the test without lab training.
- Create easy-to-follow guidelines so the Ministry of Health can scale it nationwide.
How We Designed and Tested the Assay
Phase 1 – Laboratory Development
- Collected DNA sequences from 200 genotype E samples in Abuja and Lagos.
- Used computer software to design six LAMP primers that “lock on” to conserved regions.
- Optimized reaction at 65 °C for 30 min using a simple $40 heating block.
- Compared two readouts: a color-changing dye and a real-time fluorescence stain (CYBR). Color change gave clearer yes/no results for non-experts.
Phase 2 – Analytical Validation
| Performance Metric | LAMP Result | WHO Target |
|---|---|---|
| Limit of Detection | 10 IU/mL1 | ≤20 IU/mL |
| Specificity vs. other viruses (HCV, HIV) | 100% | ≥98% |
| Precision (repeatability) | CV <5% | <10% |
Heat-treated plasma worked nearly as well as column extraction, cutting prep time to 5 min and eliminating expensive kits.
Phase 3 – Field Evaluation
- Enrolled 300 pregnant women across six primary-care centers with only intermittent electricity.
- Midwives ran LAMP on site; referral labs ran qPCR on the same samples.
- LAMP correctly identified 97% of high-viral-load mothers (>2,000 IU/mL), who qualify for preventive antiviral therapy 5.
- Results were available before the women left the clinic, enabling same-day counseling.
Impact for Communities
- Earlier Treatment: People can start antiviral pills before liver damage occurs, improving survival.
- Protecting Babies: Pregnant women with high virus levels can receive medication plus birth-dose vaccine to cut mother-to-child transmission by 90% 6.
- Equity: Clinics without laboratories can finally offer world-class molecular testing.
- Cost Savings: At <$3 per test, LAMP reduces expenditure by >85% compared with PCR.
- Empowered Health Workers: Minimal training lets nurses perform sophisticated testing, boosting morale and skills.
How the Test Works – Step-by-Step (A Story)
- A nurse warms a small thermos of water to 65 °C - the “sweet spot” for HBV DNA copying.
- She adds a drop of the patient’s blood plasma to a tube containing special “primers,” enzymes, and a color dye.
- The tube sits in the warm water for 30 min. If HBV DNA is there, it copies itself millions of times.
- Positive tubes turn bright yellow; negatives stay pink.
- The nurse shows the patient the result and explains the next steps - no return visits needed.
What Makes Our Approach Unique
- Genotype-E Tailoring: Many existing kits were designed for Asian genotypes B and C, leading to false negatives in West Africa.
- Electric-Free Option: A low-cost candle-powered incubator keeps the reaction warm during blackouts.
- One-Step Sample Prep: A 5-min heat pulse releases the virus and inactivates pathogens, eliminating expensive extraction columns.
- Community Co-Design: We held focus groups with patients and midwives to simplify result language - using traffic-light icons (green = safe, red = needs treatment).
Frequently Asked Questions
Q1. Is the test safe?
Yes. Tubes stay sealed, so no infectious material is released. Heat treatment also kills other viruses.
Q2. Can I run the test at home?
Not yet. It still requires a health worker to collect blood plasma safely.
Q3. Will it replace PCR completely?
PCR remains the gold standard for very low viral levels and research studies, but LAMP can screen and triage patients in resource-limited settings.
Limitations and Next Steps
- Occult Infections: Rare surface-antigen-negative, DNA-positive cases need larger studies.
- Temperature Control: Extreme ambient heat (>40 °C) may cause dye evaporation; we are testing insulated boxes.
- Regulatory Approval: We are partnering with Nigeria’s NAFDAC for in-country manufacturing licenses (target: Q2 2026).
How You Can Get Involved
- Vote and Comment: Your likes and questions boost community awards and help shape our study.
- Pilot Partners: We seek rural clinics or NGOs willing to pilot the test kit.
- Share Stories: Tell us if you or someone you know had trouble accessing HBV DNA testing - your experience guides improvements.
Glossary
- HBsAg: A protein on the virus surface; rapid tests detect it.
- HBV DNA: The virus’s genetic material. Detecting it shows active infection.
- LAMP: Loop-mediated isothermal amplification—a DNA copy method that works at one temperature.
- IU/mL: International units per milliliter—a measure of how much virus is in the blood.
- Genotype: A “family” of HBV strains; genotype E is common in West Africa.
A Note of Thanks
This project aligns with Nigeria’s National Viral Hepatitis Strategic Plan and the World Health Organization’s 2024 call for point-of-care DNA testing 7. We thank the midwives, patients, and community advocates who co-designed training materials and ensured the assay meets real-world needs.
Let’s work together to make sure no one is left undiagnosed or untreated.
Questions, ideas, or feedback? Please post below - your voice drives our next breakthrough.