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Lateral Flow and Rapid In Vitro Diagnostics
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Q & A
Whether people are lateral flow novices or industry experts, the technology raises numerous questions.
We've answered a few of the regular ones here.
If you've got a question of your own, please get in touch.
2
What can be tested on a lateral flow device?
On a traditional lateral flow device, any substance that is soluble enough to flow along the strip and can react with antibodies, can be engineered to produce a measurable signal. This includes hormones, proteins, viruses, allergens, bacteria, vitamins and pollutants.
3
How quick is a rapid test?
Compared to other methods of diagnostic testing, lateral flow tests normally provide a result very quickly. Different tests produce results at different speeds. Some are visible soon after the sample fluid has passed the test line, others take longer to develop. The average test will take between 5 and 30 minutes to run. The run time should be clearly indicated on the test, packaging or insert.
4
What do the letters C and T mean on a lateral flow test?
T shows the position of the Test Line. This is the indicator that, depending on the type of test being performed, shows whether or not the targeted substance is present in the sample. C shows the Control Line and this indicates if the test is working properly. If the C Line does not show on a test, it means that something has gone wrong – and the test is invalid.
5
Are lateral flow tests recyclable?
A lot of work has been done to make lateral flow test more environmentally friendly by reducing the use of single-use materials, using biodegradable alternatives to plastic and responsibly sourcing packaging. Most devices are not fully recyclable, but advances in materials technology are continuing to provide more options for reducing waste.
6
How long does it take to make a new lateral flow test?
Turning a concept into a functioning prototype normally takes 6 to 8 months. Obviously, this depends upon the number of people working on a project, the availability of reagents and the complexity of the development work involved. The type of testing required to validate the product before it is available on the market depends on how the product will be used and promoted. A medical diagnostic device for a serious illness that requires regulatory approval might take another 2 years to be market ready, but a test that checks a food ingredient in a manufacturing process could be ready for use almost immediately.
7
What are the lines on a lateral flow test made of?
There are several materials that can be used as a label to indicate the presence of a target substance. Polymer nanoparticles are available in multiple colours, including those in the ultraviolet and infrared spectrum, selenium tends to be a deep rusty brown and europium glows a bright pinky-red under UV light. The most common label used in lateral flow devices are gold nanoparticles. These are a deep red colour and around 40 to 60 nm in size (around 20,000 particles per millimetre).
8
How long does it take to prove the concept for a new lateral flow test?
The first stage of development is to obtain a suitable signal (measurable reaction) from the selected reagents. This should take no longer than 4 weeks. The quality of the signal in this phase provides a good indication of the chances of success.
9
Do lateral flow tests just provide binary yes/no, positive/negative results?
Lateral flow tests can be measured in many ways. The most basic is a straightforward qualitative result (e.g. yes, no). With the aid of a reader or reference card, the strength of the signal can provide a semi-qualitative result (e.g. low, medium, high). A digital reader or app can also provide results in semi-quantitative bands (e.g. 0-50, 50-200, 200-1000) or a specific numerical quantitative reading (e.g. 4.78).
