Introduction
Diagnostics is the frontline of healthcare. The earlier and more accurately we detect disease markers, the faster patients can access treatment and the easier it becomes to control outbreaks.
Among rapid testing platforms, lateral flow assays (LFAs) have become indispensable—offering point-of-care results in minutes. Their simplicity, affordability, and scalability make them the backbone of diagnostics in both developed and developing regions.
But here’s the catch:
The reliability of every LFA depends on its antibody pairs.
At deNOVO Biolabs, we have made it our mission to supply LFA-validated antibody pairs for Dengue NS1 and Hepatitis B surface antigen (HBsAg) — two of the most pressing global health challenges.
This blog explains why validation matters, how our antibodies perform, and why diagnostic manufacturers across the world trust deNOVO to power their assays.
Why antibody validation is critical in LFA development?
LFAs function through a simple principle: if the target analyte (such as Dengue NS1 antigen or HBsAg) is present in a patient sample, antibodies immobilized on the test strip will capture it and produce a visible line.
But the success of this principle depends on:
- Sensitivity → detecting analytes at very low concentrations
- Specificity → avoiding false positives from cross-reactivity
- Reproducibility → ensuring the same performance across batches
Unvalidated antibody pairs introduce serious risks:
- Missed detections in early-stage infection
- Inconsistent results across different samples
- Higher regulatory hurdles for diagnostic manufacturers
According to a Nature report, up to 50% of commercial antibodies fail to perform as claimed in published research (Nature, 2015).
For diagnostics, this is unacceptable.
That is why antibody validation is not optional, it is the differentiator.
Dengue NS1
The Global Burden
- Dengue infects 390 million people annually worldwide, with 96 million showing clinical symptoms (WHO).
- Dengue cases have increased 8-fold in the last 20 years due to urbanization and climate change.
Why NS1 matters?
NS1 (Non-Structural Protein 1) is a key biomarker detectable in blood during the early stages of Dengue infection (day 1–7), when interventions are most effective.
deNOVO’s Role
Our LFA-validated Dengue NS1 antibody pairs have been tested using clinically positive serum/plasma samples. They are designed to:
- Enable early-stage detection
- Deliver high sensitivity at low antigen concentrations
- Provide reproducibility across clinical samples
For diagnostic manufacturers, this means building LFAs that are fit for outbreak control and early diagnosis.
HBsAg
The Global Burden
- Over 296 million people worldwide live with chronic Hepatitis B infection (WHO, 2023).
- Hepatitis B causes 820,000 deaths every year, primarily due to cirrhosis and liver cancer.
Why HBsAg matters?
Hepatitis B surface antigen (HBsAg) is the most reliable marker for active infection and is critical for:
- Blood bank screening
- Public health programs in high-burden regions
- Point-of-care testing in clinics and rural settings
deNOVO’s Role
Our LFA-validated HBsAg antibody pairs provide:
- Recognition of both Ad and Ay subtypes (without distinction bias)
- Strong performance in screening applications
- Validation with real patient samples
This ensures diagnostic kits can be scaled confidently across diverse populations.
Why deNOVO’s Validated Antibody Pairs stand out?
1. Clinically Tested
All pairs are validated with clinically positive plasma/serum samples, not just lab-prepared conditions.
2. Monoclonal Precision
We supply monoclonal antibody pairs, ensuring consistency batch after batch (unlike polyclonals, which vary).
3. Focused Applications
Our antibodies are specifically validated for LFA platforms, giving diagnostic manufacturers confidence in real-world use.
4. Trusted by Industry
Multiple diagnostic manufacturers across Asia, Africa, and beyond already use our pairs in commercial assays.
Case Study
When one of our diagnostic partners faced inconsistent results with a third-party NS1 antibody, their time-to-market stalled. By switching to deNOVO’s validated pairs, they reduced troubleshooting by >50% and launched their product faster.
This is the difference validated antibodies can make:
less waste, faster launches and more reliable outcomes.
The Bigger Picture
The COVID-19 pandemic exposed how fragile diagnostic supply chains can be.
India, despite its biotech capacity, still imports nearly 70% of its diagnostic raw materials
(ICMR Reports).
By offering globally trusted antibody pairs manufactured in India, deNOVO is helping:
- Reduce dependence on imports
- Empower local manufacturers
- Support global diagnostic accessibility
The Future of LFA Diagnostics
LFA technology is evolving rapidly, with next-gen applications in:
- Oncology biomarker detection
- Antimicrobial resistance monitoring
- Multi-analyte “combo” strips for rapid screening
But one principle will never change: validation is king.
And that is where we continue to focus — making sure every product leaving our labs is globally reproducible, validated and trusted.
At deNOVO Biolabs, every antibody pair is more than a product.
It’s a promise of reproducibility and trust.
If you are a diagnostic manufacturer or CRO looking for validated antibody pairs for Dengue NS1 and HBsAg, let’s talk.
Because in diagnostics, every result counts.