Instructions for Use

Place the cassette on a level surface at room temperature (15-25°C, 59-77°F).	Wash hands thoroughly with soap and water to ensure fingertips are clean and dry.	Puncture one of your fingers using the lancet provided.
Use a clean paper towel or similar material to wipe off the first drop of blood.	Gently massage the finger from knuckle to fingertip to allow a second drop of blood to form.	Add 1 drop of blood (using the pipette provided) into the cassette’s well directly above the arrow.
Add 3 drops of buffer (using the same pipette) into the well.	Wait 10 minutes.	Read the results (see interpretation of results section).

How does the coronavirus test work?

COVID-19 Rapid Test Kit is a qualitative lateral flow immunochromatographic assay for the detection of IgM and IgG antibodies to SARS-CoV-2 in human whole blood, serum or plasma samples.

The cassette contains antigens from SARS-CoV-2 / COVID-19 conjugated to gold nanoparticles, which are collected by antibodies in the sample. Antibodies against human IgM and IgG are coated in their respective regions on a nitrocellulose membrane, where they create a coloured line due to the gold nanoparticles. A control region on the upper end of the cassette confirms if the test has been successful.

How quickly can I get the results?

Within 15 minutes.

How do I understand the results?

The readout should show 1 line in the C (control) region. Purple lines may appear next to the G (IgG) and M (IgM) regions depending on exposure to coronavirus. Faint lines are treated as a positive result.

1. C, G, and M regions are positive: user recently infected or re-infected with coronavirus.
2. C and G regions positive, M region negative: user previously infected with coronavirus.
3. C and M regions positive, G region negative: user recently infected with coronavirus for the first time.
4. C region positive, G and M regions negative: user not showing immune response to coronavirus.
5. C region negative, G and M regions either positive or negative: test did not function correctly.

#1 IgM/IgG Positive

#2 IgG Positive

#3 IgM Positive

#4 IgM/IgG Negative

#5 Test Failure

#6 Test Failure

#7 Test Failure

#8 Test Failure

What should I do if the test result is positive?

If you tested positive:

• Do not leave your home
• Sanitise frequently-touched surfaces, such as doorknobs and bannisters.
• If you live in the UK and have COVID-19 symptoms, urgently book a test online through https://www.gov.uk/get-coronavirus-test
• If you live in the USA and are having difficulty breathing, call 911 and inform them of your symptoms. You may also wish to confirm your positive result by requesting the hospital to run a PCR test

If you tested positive (results #1 or #3):

• It is recommended to isolate in a dedicated room for a minimum of 2 weeks to prevent contagion of other people in the household

If you tested positive (results #2):

• You may or may not be infectious, and separation from vulnerable people is recommended

If you tested negative (result #4):

• You may not have encountered the virus, or you encountered the virus very recently and have not yet formed an antibody response to it.
• If available, a PCR test may help confirm if you have been infected with the virus.

In the event of a serious event using this kit, please contact the relevant authorities. Our contact details can be found at https://www.abbexa.com/contact

How accurate is the COVID-19 test?

Based off a sample of 615 people (403 positive and 212 negative), the test is 95.12% accurate. For best results, we recommend testing between 7 and 14 days after first exposure.

For further information on COVID-19 and how to stay safe visit our COVID-19 Information page.

Target	SARS-CoV-2 IgG/IgM
Reactivity	Human
Tested Applications	LF
Storage	Store at 2-30 °C.
Validity	The validity for this kit is 12 months.
Sample Type	Serum, plasma or whole blood.
Specificity	This kit may not detect neutralizing antibodies produced by vaccine injection, as vaccines normally use S Proteins while this kit uses the N Protein for detection.
Kit Components	25 Tests 50 Tests 25 Test Cassettes 50 Test Cassettes 25 Pipettes 50 Pipettes 1 Buffer Bottle 1 Buffer Bottle 25 Disposable Lancets 50 Disposable Lancets
Material Required But Not Provided	Paper towel Soap Clean water
Availability	Shipped within 3-7 working days.
Note	This product is intended for use by healthcare professionals and laboratory scientists only. This product is for research use only.

Research Articles on SARS-CoV-2 IgG/IgM

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