Importance of antibody pair validation in LFA development
Rapid diagnostic tests, especially lateral flow immunoassays (LFIAs) are critical for early detection of viruses like Dengue NS1 and HBsAg, particularly in resource-limited settings. But assay performance hinges on one component: highly validated antibody pairs that ensure both sensitivity and specificity.
Without rigorously tested pairs, LFAs can deliver inaccurate results, risking misdiagnoses, delays in treatment, or reduced trust in diagnostic tools. Ensuring validated antibody pairs, especially for targets like Dengue NS1 and HBsAg, is essential to developing reliable, regulatory-ready diagnostics.
Dengue NS1
How validated pairs improve LFA accuracy?
1. Clinical performance benchmarks
- Dengue NS1 rapid tests typically show sensitivity between 60–70%, with specificity above 95% in early infection (within first 5–7 days)
(PLOS). - One recent NS1 kit demonstrated overall sensitivity of 61% and specificity of 97%, improving to ~66% sensitivity when used within five days of fever onset
(PMC). - High-performance kits such as Fujifilm NS1 showed sensitivity up to 94.3% and 100% specificity, rivaling RT-PCR accuracy when using validated reagents
(MDPI).
2.Impact of Quality antibody pairs
Using well-validated antibody pairs in NS1 LFAs ensures:
- High early detection of dengue infections with minimized false positives.
- Consistency across serotypes, especially important where multiple dengue strains circulate, as shown in multiplex NS1 LFAs achieving 82–90% sensitivity per serotype and >96% specificity
(Frontiers).
HBsAg LFAs
Why antibody pair tech is crucial?
- According to WHO, HBsAg LFAs can reach >99% sensitivity and >98% specificity, with examples like Determine™ HBsAg 2 tests detecting down to 0.13 IU/mL (MDPI).
- These metrics are achievable only when antibody reagents are highly specific, well-characterized, and optimized for point-of-care conditions.
deNOVO’s expertise
In developing LFA-validated antibody pairs
At deNOVO Biolabs, we specialize in designing and validating monoclonal antibody pairs for LFA platforms targeting Dengue NS1 and HBsAg:
- Screening of antibodies for high affinity, low cross-reactivity, and consistent performance across batches.
- Dual testing using clinical samples to validate sensitivity, specificity, and serotype coverage.
- Compatibility validation for high-performance formats (e.g., gold nanoparticle conjugation, nitrocellulose membranes).
- Regulatory-ready documentation, including COAs, specificity/sensitivity data, and stability profiles for easy integration into diagnostic kits.
Real-world benefits to diagnostic manufacturers
- Reduced assay development time, by starting with proven antibody pairs.
- Better diagnostic confidence with sensitivity up to ~90% (NS1) or >99% (HBsAg).
- Scalable consistency, eliminating variability across production lots.
- Regulatory alignment, enabling smoother CE-IVD or FDA applications.
- Flexible formats, validated for both rapid strips and combo LFAs with IgM/IgG detection.
Case Use
Dengue multiplex LFIA development
A recent study developed a multiplex NS1 LFIA using monoclonal antibody pairs for dengue serotypes 1–4, achieving 82.6–90.0% sensitivity across serotypes with >96–99% specificity, and no cross-reactivity with other flaviviruses or chikungunya virus (Frontiers). This exemplifies how precise reagent design drives accuracy in real-world diagnostic tools.
Best practices
To choose validated antibody pairs
- Use serotype- or subtype-specific antibodies to reduce cross-reactivity.
- Validate performance with a broad panel of real clinical samples early in development.
- Test under intended LFA conditions, including conjugation, buffer matrix, and strip materials.
- Assess lot-to-lot consistency and stability, especially for temperature variability in field use.
Validated antibody pairs are not just components, they are the backbone of rapid diagnostic accuracy. If you are someone who is building Dengue NS1 LFAs or HBsAg screening kits, choosing high-quality, proven reagents is the difference between reliable diagnostics and missed detection.
At deNOVO Biolabs, our LFA-validated antibody pair expertise supports diagnostic manufacturers with faster, more accurate, and regulatory-ready solutions.
Ready to accelerate your LFA development for Dengue or Hepatitis B?
Get in touch to request:
- A technical datasheet on our validated antibody pairs
- A sample kit for evaluation
- A consultation on integrating our reagents into your diagnostic workflow
Contact us or explore our products or services for more details.