Manufacturing precise PoC Rapid Tests

In the dynamic landscape of healthcare, the need for fast and accurate diagnostic tools has never been greater. As the world grapples with various health challenges, from infectious diseases to chronic conditions, the ability to quickly detect and respond to these threats is paramount. One of the most important aspects of this response is the production of rapid Point of Care (PoC) tests. Point-of-care tests are used daily for many different symptoms and are the standard for rapid diagnosis. The arbitrary formats of microfluidic test substrates require flexible and precise solutions for the pre-storage of test reagents.

Quality Control Measures

 

Compliance with FDA and CE standards requires stringent quality control measures throughout the manufacturing process and is essential for market approval and distribution.

They ensure that batches meet the stringent standards for accuracy and consistency that are essential for reliable diagnostics and effective patient management.

Quality control ensures consistent and reproducible rapid PoC tests that provide reliable results regardless of production time and location.

 

Consistency and reproducibility

 

The production of tests requires a high level of consistency and reproducibility to ensure accurate and reliable results. The production system must therefore be subject to strict quality controls and be able to guarantee reproducible processes.

Here´s why BIOSPOT®

 

Cutting Edge Features of BIOSPOT®

  1. Automated volume calibration | SmartDrop
  2. Integrated process control | TopView
  3. Precision | increment < 1 µm
  4. Dynamic volume range from picoliters to microliters
  5. Substrate-independent
  6. Fiducial Alignment | Substrate recognition

Any Substrate Any Time

 

Discover the ultimate solution for Point of Care (PoC) rapid test manufacturing with our BIOSPOT® workstation. Engineered for unparalleled versatility, it excels in dispensing on any substrate at any time. Whether it's microfluidic test substrates or other formats, our workstation ensures seamless and precise dispensing, making it the perfect fit for PoC rapid test manufacturing. Experience the power of flexibility and reliability in your diagnostic processes with BIOSPOT®.

Our BIOSPOT® DX workstation automates your production with incredible precision and accuracy.

Scalability

 

BIOSPOT® system excels in diagnostics and point-of-care settings, offering scalable liquid handling that ensures precise and reliable dispensing for rapid test development. Its flexible integration and capability to transition seamlessly from R&D to production make it ideal for enhancing throughput in diagnostic labs without sacrificing accuracy, facilitating quick responses to healthcare needs.

Speed LFA

Accuracy and Sensitivity

 

BIOSPOT® Technology enables rapid and scalable production of PoC Rapid Tests, ensuring timely availability to meet surging demand during outbreaks or public health emergencies.

Flexibility

 

Since the requirements for point-of-care tests can differ depending on the area of application and target analytes, the production system must be flexible enough to support different test formats and parameters.

Relevant literature

Whitepaper on the development and production of Lateral Flow Assay Test Stripes (LFA)

Lateral flow assays (LFAs) are widely used for rapid diagnostic testing and initial screening. A one-step and low-cost analysis of an analyte in a sample solution, such as pathogens, biomarkers and chemical contaminants, makes it a powerful point-of-care device without the need of trained personnel. Read how to optimize, develop and to produce LFA applying BioFluidix technology.

Iridium oxide (IV) nanoparticle-based lateral flow immunoassay | 2019

Nanomaterials have been widely reported in lateral flow biosensors, offering new sensing strategies based on optical or electrical detection techniques. Looking for other advantageous nanomaterials, we propose for the first time the use of iridium oxide (IV) nanoparticles in lateral flow assays for the detection of human immunoglobulin as a model protein.

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Signal enhancement on gold nanoparticle-based lateral flow tests using cellulose nanofibers | 2019

Lateral flow paper-based biosensors merge as powerful tools in point-of-care diagnostics since they are cheap, portable, robust, selective, fast and easy to use. However, the sensitivity of this type of biosensors is not always as high as required, often not permitting a clear quantification. To improve the colorimetric response of standard lateral flow strips (LFs), we have applied a new enhancement strategy that increases the sensitivity of LFs based on the use of cellulose nanofibers (CNF). CNF penetrate inside the pores of LFs nitrocellulose paper, compacting the pore size only in the test line, particularly near the surface of the strip. This modification retains the bioreceptors (antibodies) close to the surface of the strips, and thus further increasing the density of selectively attached gold nanoparticles (AuNPs) in the top part of the membrane, in the test line area, only when the sample is positive.

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Flow control for lateral flow strips with centrifugal microfluidics | 2019

Lateral flow strips (LFSs) are widely used for clinical diagnostics. The restricted flow control of the current designs is one challenge to the development of quantitative and highly sensitive LFSs. Here, we present a flow control for LFSs using centrifugal microfluidics. In contrast to previously presented implementations of lateral flow membranes into centrifugal microfluidic cartridges, we direct the flow radially outwards through the membrane. We control the flow using only the centrifugal force, thus it is independent of membrane wetting properties and permeability. The flow rate can be decreased and increased, enabling control of incubation times for a wide variety of samples.

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Uranium (VI) detection in groundwater using a gold nanoparticle/paper-based lateral flow device | 2018

The contamination in groundwater due to the presence of uranium is nowadays a subject of concern due to the severe health problems associated with renal failure, genotoxicity and cancer. [...] For the first time, we propose a portable, fast, inexpensive and sensitive paper-based biosensor able to detect in situ U(VI) in water samples: U(VI) selective gold nanoparticle-based lateral flow strips. Antibody-coated gold nanoparticles are used as labels in the proposed lateral flow system because of their biocompatibility; in addition, these nanoparticles provide high sensitivity due to their intense plasmonic effect.

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Photoluminescent lateral flow based on non-radiative energy transfer for protein detection in human serum | 2018

The assay is intended for the detection of a model protein in human serum, that is, human immunoglobulin G, with the aim to demonstrate a virtually universal protein detection platform. Once the sample is added in the strip, the analyte is selectively captured by antibody-decorated silica beads (Ab-SiO2) onto the conjugate pad and the sample flows by capillarity throughout the strip until reaching the test line, where a sandwich-like immunocomplex takes place due to the presence of antibody-functionalized QDs (Ab-QDs) onto the test line.

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