Leccurate, everything you need to know

Characteristics of Leccurate SARS-CoV-2 IgG/IgM test

Leccurate SARS-CoV-2 IgG/IgM is a professional tool used to diagnose a potential COVID-19 infection. Leccurate is registered with the FDA- and the CE mark.

The Leccurate SARS-CoV-2 IgG/IgM test clarifies within 15 minutes whether specific antibodies have been produced against the Coronavirus (SARS-CoV-2 infection) The Leccurate SARS-CoV-2 IgG/IgM test detects the presence of SARS-CoV-2 antibodies, however, should not be used as the sole criterion of a COVID-19 diagnosis. Studies on the accuracy of the Leccurate SARS-CoV-2 IgG/IgM test are available on request over at Leccurate’s official website.

How does the Leccurate SARS-CoV-2 IgG/IgM test work?

leccurate antibodyWith the use of this test, it’s easy to check whether antibodies against the Coronavirus are present in the body, the bloodsample is taken by a simple fingerprick.

2 to 3 days after the client or employee has been in contact with the virus, the body will start to produce antibodies against it. These antibodies will be demonstrable after 3 to 7 days.

The first symptoms can appear up to 14 days after infection. There is a possibility a client or employee may not develop any symptoms, on the other hand non-specific symptoms may develop. After the test it is clear whether the tested SARS-CoV-2 patient has been infected.

Operating instructions in short

  1. Read the entire user manual
  2. Bring the test cassette and buffer to room temperature (15-30°C) prior to testing
  3. Prepare everything before testing
    1. Required protective equipment
    2. Test kit
    3. Test cassette
    4. Capillary blood transfer pipettte
    5. Single-use safety lancet Accu-Chek
    6. Buffer liquid
    7. Alcohol cloth
    8. Band aid
    9. Stopwatch/clock
  4. Remove the test cassette from the aluminum envelope and use it as soon as possible. The best result is achieved if the test is used immediately after opening. Label (if necessary) the test casette with the client data. Place the test cassette on a sterile and flat surface.
  5. To collect fingerstick blood samples:
    1. Use gloves
    2. Wash the client’s hand with warm water or clean it with an alcohol cloth
    3. Let the hand dry
    4. Massage the hand, without touching the puncture site, by rubbing the hand towards the fingertip of the middle or ringfinger
    5. Prick the skin with the supplied Accu-Chek safety lancet at the deepest piercing position
    6. Rub away the first drop of blood
    7. Gently rub the hand from the wrist, though the palm, to the finger to make a round drop of blood flow from the site of puncture
    8. With the pipette, draw the blood drop up to the second line (approx. 15μL)
  6. Add this drop of blood to the sample container of the test cassete. The obtained blood from the fingerstick should be tested immediately.leccurate example1
  7. With the buffer bottle holded vertically, add 2 drops (approx. 80 μL) of buffer liquid to the buffer reservoir. Avoid bubble formation.leccurate example2
  8. Start the stopwatch/record the time on the clock
  9. Wait for a colored line or lines to appear. Read the result after a maximum of 15 minutes, do not interpret the results after 20 minutes
  10. Note: The buffer should be used for 20 tests. After opening, the buffer liquid can be kept until the indicated expiry date on the label

Possible Leccurate results

Negative result

The control line is colored: The internal control of the test went well. No antibodies are (yet) detected. It is most likely that the tested person has not (yet) been in contact with the Coronavirus or that the tested person is still in the incubation period. The incubation period is 14 days before symtpoms can actually occur. During this period, the tested person can infect others, even if no complaints are experienced.

Advice: Test again after 14 days or when there are complaints or symptoms. However, it may also be that the immune system of the person being tested is weakened, that it cannot produce antibodies or that the tested person takes medication to slow the immune system’s reaction.

leccurate negative1

Positive results

The control line and the IgM are colored: This means IgM positive: At this moment the tested person has an acute (primary) infection with the Coronavirus and the tested antibodies have been made and/or are still being produced. This rash appears about 3-7 days after the appearance of the first symptoms. The tested one is currently contagious to others.

Advice: Contact the doctor (by telephone) to report the results and ensure that the person being tested has no (physical) contact with others. Take the necessary (protective) measures.

leccurate positive1

The control line and the IgG are colored: This means IgG positive: The person tested has been exposed to the Coronavirus and the body has produces antibodies. This rash occurs from the 7th day after the appearance of the symptoms. The tested person may still be contagious to others at this time.

Advice: Contact the doctor (by telephone) to report the results and ensure that the person being tested has no (physical) contact with others. Take the necessary (protective) measures.

leccurate_positive2

The control line, IgM and IgG are colored: That means IgM and IgG positive: The person tested has been exposed to the Coronavirus and the body has produced antibodies and is still making antibodies. This may be a second (secondary) infection or it may be a transitional phase. This occurs after the 7th day and the tested person remains contagious to others.

Advice: Contact the doctor (by telephone) to report the results and ensure that the person being tested has no (physical) contact with others. Take the necessary (protective) measures.

leccurate postive3Invalid result

The control line is not colored: This means an incorrect result.

Possible causes:

  • Insufficient sample material
  • Incorrectly performed test
  • Use of a test that has passed the expiration date

Advice: Take the test again.

leccurate invalid1

Color strength: The color strength of the IgM and IgG lines may differ, therefore any visible color line should be considered positive. After 20 minutes, the color lines are no longer usable as a result. For a good assessment, the test cassette should also be viewed tilted in the light so that less strong color lines become clearly visible.

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