Lateral Flow Immunoassays are used by point-of-care markets for immunological testing. Examples of utilization of immunoassays include cholesterol, cardiac markers, diabetes testing. Recently, and due to some constraining patent issues, many manufacturers of lateral flow assays have invested into R&D to develop multiplexing assays on complex platforms for very specific applications, and to improve the design of current lateral flow substrate to increase reproducibility in the final product.
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BioDot's modular lamination system, suitable for many test formats.
BioDot is an expert in offering a range of batch auto lamination instruments. These instruments can print batch codes on Liquid, Ointments and even Tablet cartons. This category comprises of many auto coded machines. The products are famous all over the market and are known for durability, value for money and are user friendly.
We all know that for continuous lamination, auto lamination is the most important process. BioDot has developed a modular lamination system, which is suitable for many test formats, which consists of multi-layers, which are glued together.
Each material comes from spindles, which can be adjusted easily through guides. Under pressure of the roller complete adhesion occurs. This automated system gets easily configured with cutting technologies and dispensing.
The first type of module is the Reel Feed. The reel feed, feeds the roll stock of plastic backing with cut liners.
The second module is the magazine strip feed. In many test designs, it is observed that the plastic backing is very thick. This makes it difficult to supply it to a roll format, which causes curling problems. This problem is overcome by supplying plastic as flat sheet with 300-1500 mm long and approximately 100 mm wide. In a magazine feed system for feeding plastic sheet, application of adhesive is required. In BioDot, both Material Feed module and Roll Feed module are the types of magazine strips present. The roll feed module can feed three different roll materials into a roll format. You can configure a take up reel for release liners.
In a normal procedure, there are quite a few different materials like adhesives, sample pads, conjugate pads, absorbent pads and cover layers. You will have to take care of individual pad positions. In dry chemistry and solid transfer applications, almost 10 chemistry pads are laminated with auto laminator. If the pad thickness is the same, different pad rolls of various reagents can be placed on spindle with spacers. In some cases, due to process or material, limit the use of material in the sheet formats. In such cases the Material Feed Strip model is incorporated. The sheet feed system adjusts the widths and position. The strips are fed from end to end onto each other. Pneumatically a lamination layer controls this module.
For Auto batch mode, a clamshell or manual approach should be incorporated. This results in finely pre-cut materials, which are used for test strip products. To formulate the lateral flow test strip, pre-cut membrane, conjugate pads, absorbent materials and plastic backing are all brought together and conjugated.
With the clamshell laminator, you can easily hold the test strip in correct position with the help of top and bottom vacuum nests. These nests can be customised according to customer's requirements. You can, however, easily interchange the nest, which helps in lamination of other designs. Once these nets are brought together in a proper alignment with each other, accurate lamination is achieved.
BioDot has mastered in the field of automatic carton batch coding system. With the industrial machine and experience it provides coding requirements and customized solutions to its consumers.
A century old tool used in laboratory testing to guide healthcare professionals in patient care, diagnosis and treatment.
The lateral flow immunoassay tests are often times performed with simple devices. Some use this method for certain tests (i.e. pregnancy) or perhaps to perform drug usage tests on individuals. Many healthcare professionals use these specific tests to assist them in determining a patient's diagnosis.
Although traditional lateral flow immunoassay technology has been designed towards techniques that provide a directly observable visible signal, there are sometimes limitations when using the visual approach testing method.
The visual approaches can sometimes be more difficult to measure. They can give results that vary between users. This is sometimes caused by the subjective nature of the visual response itself, and most often is not sensitive enough to enable the production of certain kinds of desirable immunoassays results. Therefore, a lateral flow immunoassay device which includes a membrane strip for enabling capillary migration of a sample along with a labeled reagent disposed on the membrane is often times a better selection when it comes to performing these particular tests.
These devices that are used to take these tests are often performed and color- coded to let the end user see accurate test results (i.e. pregnancy test results). Other tests that use this method can be to perhaps test drug usage in certain individuals.
There are new market requirements for high-quality drugs-of-abuse testing to be performed outside the laboratory setting. The most common method to date has been with the usage of lateral flow immunoassay tests. Many may be more familiar with the terms of strip tests, or on some of these lateral flow tests drug cups may be used to carry out the procedures to capture the end results.
There is one new testing device called the oral fluid drug test which is currently on the market. While this type of method for testing is non-invasive for the end user, it still offers instant detection of various drugs in oral fluids of the tested person.
Using a multi-drug, multi-line lateral flow immunoassay, the oral fluid drug test enables the qualitative detection of drugs and drug metabolites. This can also aid in more accurately definition as to what type of drug the person has in their body during the time the test is performed.
These specific types of tests have been used within the healthcare profession for nearly a century. Many times the healthcare professional will use the lateral flow immunoassay test to further evaluate their patients' specific medical treatments. Many medical professionals agree that the use of these particular testing devices is easier for the technology which handles the reading results. Furthermore, these devices are often times inexpensive to produce by the marketing companies.
However, as technology has advanced, many are now seeking more accurate lateral devices with which to help them more accurately diagnose their patients. While these tests are still very helpful, they are meant to be a guide for the healthcare profession, aiding in the property treatment - all of which is based on the end result from these types of test.
When it comes to using the lateral flow immunoassay testing devices, there are many on the market that the consumer can select from, as well as the ones that the medical professional may perhaps use. However, before selecting any one given device the consumer will want to ensure that they spend some time doing their own advance research into these specific testing procedures.
The lateral flow immunoassay format was developed in the seventies and within 10 years became a standard platform for a variety of Point of Care (POC) tests. The benefits of this format were:
- Ease of use
- Requires relatively small amount of sample
- Adequate level of sensitivity
- Ease of manufacture in large scale
- Stability of the final product at room temperature (shelf life)
- Ease of implementation with a reader technology
- Ease of approval by regulatory instances (format well know by the market)
- Relatively inexpensive to manufacture
For many tests, this format was very attractive. However, recent market
needs have evolved into higher demands, requiring LFIA tests to produce
more than the traditional “yes/no” result. The progression of lateral flow
tests to true quantitative formats is an active area of current research and
Traditionally, a lateral flow immunoassay device is assembled with a variety
of materials and reagents (Figure 1). Typical components are a backing
card, membrane, sample pad, absorbent pad, conjugate pad, and
possible a wick. The tests are assembled during a “Batch Process” or
an “In Line Process”, the first one being far more common until recent
The batch process starts with a roll of each material; i.e. membrane,
sample pad, conjugate pad, sample pad, wick material, and individual
backing cards. Each material goes through its own process independently
and then once complete the final test is assembled.
The other alternative to the Batch process is the In-Line method. An In
Line process starts with all materials in roll format, and is typically
achieved with three types of modules. The first is the reagent dispensing
and drying module, the second is the slitting module, where
processed webs are cut down to narrower widths for lamination, and
the third module is the actual lamination of the LFIA.
Typically In-Line approaches are designed to meet the specific needs of
an application. The In Line approach allows multi-tasking between both
dispensing and impregnation applications, and has capacity for in-line
drying and quality control monitoring.