Creative Biolabs is a famous expert in the in vitro diagnostics (IVD) manufacture, including IVD antibody productions and fast kit developments. Currently, we offer lateral-flow immunochromatographic assay (LFIA) based kits developed services to complete disease screening and diagnosis, infection detection and therapeutic monitoring. Our company satisfies application-specific customized services based on client’s diverse needs.

Lateral-flow Immunochromatographic Assay

LFIA, also known as lateral flow immunoassay, lateral flow assay (LFA), lateral flow test (LFT) or lateral flow device (LFD), is a type of solid-phase immunoassay that combines the principles of thin layer chromatography and immune recognition reaction. In this assay, colored particles (colloidal gold, colloidal carbon, colloidal selenium, liposome, latex, quantum dot, and so on) can be selected as labels of antibody to detect the presence of an analyte. Based on the elements of recognition used, LFIA can be categorized into different types as follows.

Fig.1 FM-LFIA test strip.Fig.1 The structure chart and principle of FM-LFIA test strip.1,3

LFIA is a paper-based system for the detection and quantification of the target analyte in complex mixtures, where the sample is put into a test device, and results showed within few minutes. Compared to the laboratory-oriented instrumental analysis, LFIA is a simple, inexpensive, and fast-response technique useful for medical diagnosis, basic research, home testing, and point of care testing, as well as detecting various agricultural and environmental contaminations.

Advantages of LFIA

As the increasing popularity of this method, there are a number of prominent and unique merits performed in LFIA, including:

  • Rapidity and less time analysis (One step analysis)
  • Simple instruments and low operational cost
  • High specificity and better sensitivity
  • User-friendly format
  • Mostly, no more extra pretreatment with samples
  • Less or no interferences due to chromatographic separation
  • Long-term stability under different environmental conditions
  • Portability of the device

LFIA-based Kits Development

LFIA is designed to confirm the presence or absence of the desired analyte, including pathogens and biomarkers in humans or animals, or contaminants in foodstuffs, water supplies, or animal feeds. The most commonly known application of this assay is the pregnancy test. Ease of productions and low development costs of LFIA have led the expansion of its applications to multiple areas in which rapid tests are basically required. LFIA-based tests are widely applied in hospitals, biological and clinical laboratories for the qualitative and quantitative detection of specific antigens, antibodies, and gene amplification products.

In Creative Biolabs, we have developed high-quality LFIA-based kits for IVD. By using our IVD kits, varieties of biological specimens can be tested, involving saliva, sweat, urine, serum, plasma, whole blood, and other fluids. Moreover, further industries in which LFIA-based kits can be served that include quality control, veterinary medicine, product safety of food production, and environmental health and safety. For more detailed information, please feel free to contact us.

Published Data

1. Development of Monoclonal Antibody-Based Colorimetric Lateral Flow Immunoassay

Fig.2 The schematic of the CLFIA and judgment of the test results.Fig.2 Generation of the colorimetric signal on the CLFIA.2,3

In this study, researchers first synthesized a pyridaben hapten to generate mAbs, with 6E3G8D7 demonstrating the greatest sensitivity in an indirect competitive ELISA, yielding a 50% inhibitory concentration (IC50) of 3.49 ng/mL. This mAb was then used in a colorimetric lateral flow immunoassay (CLFIA) utilizing gold nanoparticles to detect pyridaben. The CLFIA exhibited a visual detection limit of 5 ng/mL, with high specificity and outstanding accuracy across various matrices. Pyridaben concentrations in blind samples detected by CLFIA correlated well with results from high-performance liquid chromatography. Overall, the CLFIA offers a promising, dependable, and portable platform for the rapid, on-site detection of pyridaben in agricultural products and environmental samples.

2. Development of Dual-Signal Fluorescence-Enhanced Lateral Flow Immunoassay

Fig.3 Overview of fluorescence-enhanced dual signal LFIA analysis based on Si-Au/DQD for MPXV A29L protein detection.Fig.3 Schematic diagram of Si-Au/DQD-based LFIA analysis of MPXV A29L protein.4

This work presented a dual-signal lateral flow immunoassay (LFIA) featuring an improved fluorescence pattern for rapid, on-site, and ultrasensitive identification of the monkeypox virus (MPXV) antigen. The researchers developed a multilayered SiO2-Au core dual-quantum dot (QD) shell nanocomposite (SiO2-Au/DQD) as a novel nanotag, replacing traditional gold nanoparticles and QD nanobeads. This composite offered excellent stability, strong colorimetric capability, and superior fluorescence intensity. The dual-signal LFIA detected MPXV antigen (A29L) within 15 minutes, with detection limits of 0.5 ng/mL for colorimetric and 0.0021 ng/mL for fluorometric modes. The SiO2-Au/DQD-LFIA's colorimetric performance matched that of the AuNP-LFIA, but the fluorescent signal boosted sensitivity by 238-fold compared to AuNP-LFIA and 3.3-fold compared to ELISA, demonstrating its exceptional sensitivity and versatility for point-of-care MPXV testing.

References

  1. Wang, Zifei, Pengjie Luo, and Baodong Zheng. "A rapid and sensitive fluorescent microsphere-based lateral flow immunoassay for determination of aflatoxin B1 in distillers' grains." Foods 10.9 (2021): 2109.
  2. Chen, He, et al. "Monoclonal antibody-based colorimetric lateral flow immunoassay for the detection of pyridaben in the environment." Biosensors 13.5 (2023): 545.
  3. Distributed under Open Access license CC BY 4.0, without modification.
  4. Yang, Xingsheng, et al. "Fluorescence-enhanced dual signal lateral flow immunoassay for flexible and ultrasensitive detection of monkeypox virus." Journal of Nanobiotechnology 21.1 (2023): 450. Distributed under Open Access license CC BY 4.0. The image was modified by extracting and using only part of the original image.

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