Antibody Product Training

Prior to testing it is important that you are prepared. You should first make sure that the following items are set out and readily available to begin testing; alcohol wipe to sterilize finger, lancet to initiate finger prick, collection pipette, test cassette, and buffer solution. Before you begin testing, it is recommended that you read the Instructions for Use and Quick Guide thoroughly before performing the test. Other items that may be needed but are not included in the box; mask, timer, and disposable gloves.

Product Storage

The test cassettes should be stored at room temperature (36-86⁰F) and should be kept away from direct sunlight or heat sources. Do Not Freeze. Containers containing anticoagulants such as sodium EDTA, should be used for whole blood storage. The kit contents are stable until the expiration dates marked on their packaging.

Test Instructions

When the test cassette is removed from the sealed pouch, place it on a clean surface and label the cassette with a donor identifier using their name or ID Number. The test should be used within 1 hour of opening the sealed pouch. If the temperature in the room is higher than 86⁰F then the test should be used immediately. Proper specimen collection and handling is critical to the performance of this test. Specimens should be tested as soon as possible after the sample is collected.

Step 1. Alcohol Wipe

The first step is to clean the finger of the person being tested with the alcohol wipe provided in the kit. It is recommended that the finger is cleaned thoroughly by wiping 4-5 times and allowing the finger to dry before you begin lancing. *Note: It is important to remember that the lancing will be done on the side of the finger tip where the skin is less thick.

Step 2. Lancet

The spring-loaded safety lancet can only be activated once. You will begin with removing the cap from the lancet to prepare it for activation. The spring-loaded feature will only release the blade one time. Once the blade is released, it will automatically retract and will not activate a second time. Make sure to place the lancet on the side of the finger of the person being tested. You will need to apply some pressure onto the lancet which will then activate the spring-loaded blade and lance the finger of the person being tested. *Note: Once completed, put the cap back onto the lancet and dispose of the lancet using the appropriate biosafety procedures.

Step 3. Pipette

After performing the lancet, a blood droplet should immediately begin to develop. You will need to wait until enough blood is available to be drawn. It is recommended that around 3mm of blood is formed on the finger before the pipette is used. When enough blood is available, take the pipette (10μL) and squeeze the bulb at the top to release all of the air. Once the bulb of the pipette is all the way depressed, touch the end of the pipette to the blood drop and slowly release the bulb. As the bulb is released, the blood will be drawn up into the pipette and will fill the pipette tube. You will need to draw the blood until it passes the fill line which is labeled on the side of the pipette. Do not overflow the pipette by allowing the blood to enter into the bulb. *Note: If it appears that not enough blood is being produced from the finger, it is recommended that you begin applying pressure to the finger beginning at the base to cause more blood to exit the punctured skin.

Step 4. Cassette

Remove the cassette from the sealed pouch and place it on a clean, level surface. Once the pipette is filled with an appropriate amount of blood, place the tip of the pipette above the sample well on the cassette (labeled with an "S") and carefully squeeze the bulb of the pipette to begin releasing the blood into the sample well. The pipette is intended for one time use only. After depositing the blood into the sample well, the pipette should be disposed of using the appropriate biosafety procedures.

Step 5. Buffer (Test Activation)

Finally, to activate the test, add two drops of buffer fluid into the sample well of the test cassette. After the buffer fluid has been added, you should immediately start a 15 minute timer. *Note: If the buffer fluid is discolored or contains a thick texture, this could be a sign of microbial contamination and should not be used.

Reading Results

After the 15 minutes is up, you should promptly read the results displayed on the test region of the cassette. Do NOT interpret the results after 15 minutes. Any IgG or IgM line is still considered a line regardless of the intensity of the color development. The intensity of the color development in the IgG and IgM lines should not be compared to the control line. If ONLY the control line (C) is visible, that would suggest that the test is negative for both COVID-19 IgG and IgM antibodies. *Note: A negative result does not exclude the possible infection with SARS-CoV-2 virus.

 

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Interpreting Results

IgG Positive: This result suggests that the person is in the late stage of infection or has already recovered from the infection.

IgM Positive: This result suggests that the person may be in the early to middle stage of infection and the body's immune system has produced the IgM antibody.

IgG & IgM Positive: This result suggests that the person is in the middle-to-late stage of infection, and has already started producing the IgG antibody that will provide some level of immunity from the infection.

Positive Result

A positive result is a presumptive positive. If you test positive for the IgM antibody you should contact your local or national health department for consultation and guidance on COVID-19 infections. This will usually involve self-isolation for up-to 14 days to avoid contact with others and prevent further transmission. Speak with your healthcare practitioner for further advice.

Negative Result

A negative result is a presumptive negative. This would suggest that the antibody biomarkers are not present in your blood. You should continue to exercise caution if you have COVID-19 related symptoms as you might still be in the early stages of infection. If symptoms persist, follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals. If symptoms do not develop, it is unlikely that you have COVID-19 but you should still be conscience of your hygiene procedures. There is no need to retest unless you are displaying symptoms for 5 days or more and suspect you have contracted the infection.

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Invalid Result

If the blue control line does not change to red, this would be considered an invalid result. Invalid results should not be read regardless of any other lines that appear. In the event of an invalid result, it is recommended that the healthcare practitioner conduct the test again using a new test cassette. 

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Test Limitations

This is a test that screens for the qualitative detection of antibodies specific for the COVID-19 (SARS-CoV-2) virus. It is not designed to diagnose a person with an infection. The recommended method of receiving a diagnosis is by Nucleic Acid via Polymerase Chain Reaction (PCR) test. Read more about this in our testing protocols tab. 

When using the COVID-19 IgG/IgM Rapid Test false positive results for IgG and IgM antibodies may arise due to a cross-reactivity from pre-existing antibodies, previous infections (such as other coronaviruses), or other possible causes. If the quantity of antibodies for the SARS-CoV-2 virus present in the specimen is less than the detection limit of the assay, a negative or non-reactive result may occur. The test procedure and the interpretation of result must be followed closely when testing for the presence of SARS-CoV-2 virus specific antibodies in whole blood, serum, or plasma specimen. Proper sample collection is critical for optimal test performance.