Intended use

The One Step SARS-CoV2(COVID-19)lgG/lgM Test is a rapid chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) to COVID-19 virus in whole blood/serum/plasma to aid in the diagnosis of COVID-19 viral infection.

The package includes

  • a non-woven fabric pad for skin disinfection before an injection
  • a disposable lancet
  • one test kit: a test plate + a pipette
  • buffering solution
  • leaflet (download here)

Collecting the sample

  • 1. Open the bag with the disinfection pad. Rub it in the place on your finger where you will be collecting the blood sample.
  • 2. Take the included lancet and press it onto the finger. Next, press the button at the lancet with one quick movement.
  • 3. Wait until a drop of blood shows on the finger (for this purpose you can gently press your fingertip near the injected place).

Test procedure

Read the leaflet carefully before use.

Remember to store the contents of the package at room temperature (15-30 degrees if Celsius) before performing the test.

  • 1. Take the test plate out of the aluminium bag and place it horizontally on a flat surface.
  • 2. Extract the blood sample from your finger.
  • 3. Using the plastic pipette, take a bit of blood from the injected place and place one big drop of the sampled blood in the round test well (S) on the test plate.
  • 4. Wait for it to saturate the surface of the membrane. Next, apply two drops of the buffer solution to the same test well.
  • 5. Wait for the colored line(s) appear. After 15 minutes read the result. (Caution! Do not read the result after more than 20 minutes because it can be inaccurate.)

Notes:

Applying sufficient amount of specimen is essential for a valid test result. If migration (the wetting of membrane) is not observed in the test window after one minute, add one more drop of buffer to the specimen well.

Interpretation of results

Positive: Control line and at least one test line appear on the membrane. The appearance of T2 test line indicates the presence of COVID-19 specific IgG antibodies. The appearance of T1 test line indicates the presence of COVID-19 specific IgM antibodies. And if both T1 and T2 line appear, it indicates that the presence of both COVID-19 specific IgG and IgM antibodies. The lower the antibody oncentration is, the weaker the result line is. What next?

Negative: One colored line appears in the control region (C). No apparent colored line appear in the test line region.

Invalid: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for color line failure. Review the procedure and repeat the test with a new test device.

Operating instructions

Warnings and precautions

  • 1. This kit can be used only for in vitro diagnostic examination, only to examine blood samples - do not test any other human body fluids.
  • 2. Store the test kit at room temperature to prevent moisture from entering the kit. If the foil packaging is damaged, the kit cannot be used.
  • 3. If the test kit is opened, use it as fast as possible to prevent too much air from entering the kit which may result in moisture and damage of the test.
  • 4. While reading the results conform to the time requirements included in the manual.
  • 5. The kit can be used only for one-off in vitro diagnostics and cannot be used more than once.
  • 6. Do not use the test kit after the expiry date.
  • 7. The test kit cannot be frozen and exposed to direct sunlight.
  • 8. Keep the package and its contents away from children.
  • 9. Do not drink, eat or smoke in the area where the specimens and kits are handled.
  • 10. If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended.

Order a test to home

In an anonymous package, no leaving home, no problems.