Does the LFD test kit work in all temperatures?
The LFD devices and reagents should be used at room temperature (between 15˚C and 30˚C). If the kit has been stored in a cool area (less than 15°C), leave it at normal room temperature for 30 minutes before using.
What is the shelf life of the lateral flow test kits?
The shelf life of the Innova LFD test kits is 24 months from the date of manufacture. Expiry date information can be found on the test kit packaging.
Are there any hazardous substances in the device or the test kit ingredients?
No. The products within the Innova lateral flow test kit (including the devices themselves and the extraction buffer fluid) are not hazardous.
The swabbing and processing of a test does not inactivate the virus so caution should be taken when handling the test and when managing spillages as live virus may be present.
If a spillage does occur use a disposable cloth or paper towel, mop up the spillage and dispose of in the bag provided. The area should then be cleaned and disinfected, again the disposable cloth or paper towel should be disposed of in the bag provided.
Can open leftover extraction fluid bottles be stored overnight? If yes, at what temperature?
The extraction fluid bottles may be opened and resealed for each assay. The extraction bottle cap should be firmly sealed after each use. The extraction solution is stable until expiration date if kept at 2-30˚C.
What's the best way to dispose of used LFD tests and associated PPE?
The Department for Environment, Food, & Rural Affairs (DEFRA) have directed that LFD tests and Personal Protective Equipment (PPE) waste used as part of the Workplace Surveillance Testing programme can be disposed of as part of residual waste (‘black bags’). If you already have alternate waste provision for this category of waste (chemical non-hazardous) then please continue to use these means to protect the environment and aid recycling, but if not, it can now go in your “normal” waste.
Are the swabs latex free?
Yes, the Innova swabs are latex free. The swabs are also supplied in sterile packaging, labelled as sterile, to protect from exposure to latex within the external environment. This means that if testing staff handling the test kit are wearing latex gloves there should be no impact on the swab itself. If any part of the swab packaging looks damaged in any way, please do not use the test and report this via the appropriate channel.
Do the tests contain animal products or have they been tested on animals?
The monoclonal antibody technology present in our lateral flow devices are necessarily generated from animal cells. This is in common with other tests of this kind, including commercially available pregnancy tests. The Innova swab itself does not contain animal products.
During development, at no time have any component parts been tested on animals.
The Vegan Society advises vegans avoid using products made from animals as far as is practicable and possible and vegans should never stop taking prescribed medications without first talking to your doctor.
Are the LFD tests halal?
No animal products have been used in the production of the swabs that come into direct contact with the individual using the test.
The thin paper like material inside the LFD is coated with antibodies from animal cells. No direct contact will be made between the person and this material. The monoclonal antibody technology present in our lateral flow devices are necessarily generated from animal cells. This is in common with other tests of this kind, including commercially available pregnancy tests. It is for individuals to make their own decisions based on their religious practises or dietary choices.
If a positive line appears at e.g. 20mins, is it possible it can become negative by 30mins?
No, if the test is read as positive after 20mins no further analysis is needed.
Positive results can be reported at 20 minutes. Negative and void results must be reported at 30 minutes. If a positive signal appears after 30 minutes, it should not be reported as positive. Line C must be coloured to have a valid test result.
Are there any lessons learned about how to avoid void tests?
There are two factors which cause a void or invalid test (i.e. no control line is produced):
- The inner membrane of the test strip is not coated properly
- Not enough solution is dripped into the sample well on the device during processing In order to reduce the risk of a void test the guidance for processing a test must be adhered to
Ensure you complete 10 seconds’ worth of extraction of the sample. The lateral flow device cartridge must be on a flat and level surface throughout. Ensure the 2 drops of extracted sample fluid are air-bubble free before releasing them into the sample well of the lateral flow device cartridge. Check that the liquid can be seen seeping through the cartridge. The results should be read within the allocated time (20-30 minutes). Strong positive results can be reported at 20 minutes, however, negative results must be reported at 30 minutes.
What is the typical void rate for lateral flow antigen tests?
According to published lateral flow data, lateral flow tests reported via the existing National Testing Programme infrastructure have a void rate of 0.37%.
What is an IFU?
An IFU is the manufacturer’s Instructions for Use (IFU). This is a step-by-step guide to carrying out a lateral flow test.
What happens if more than two drops of extraction fluid have been dropped on the sample well of the LFD?
For Innova tests, more than two drops (three to four) of extraction solution dripped into the sample well will still give a valid test.
Will the Innova test kits supplied come with control sets provided (positive and negative controls), so that we can validate our environments?
No. Control sets are for batch validation and are not currently available for onsite quality assurance or training. Batch validation for Innova is being completed centrally for the programme by an independent accredited laboratory and therefore there is not a requirement for this to be done locally. The process of batch validation is in line with the Innova process using the prescribed control sets - for every batch, 100 in every 1,000,000 test kits are sent for batch validation. The outcome of the batch validation will not be communicated to the programme unless the failure rate is greater than 3.5% at which point the entire batch will be recalled from the programme.