Assure Fastep – Point of Care Rapid IgG & IgM

Assure Fastep – Point of Care Rapid IgG & IgM

Detection of IgG and IgM antibodies to aid in the diagnosis of COVID-19. The Assure Fastep COVID-19 IgG & IgM Rapid Test Kit is a rapid lateral flow chromatographic immunoassay intended for the qualitative detection and differentiation of IgG and IgM antibodies to SARS-CoV-2 in human venous whole blood, serum, and plasma.


Features

  • 15 Minute COVID-19 Test
  • Test either Whole Blood, Plasm or Serum
  • IgG & IgM combined test
  • EUA for Point of Care Settings

Test Procedure

Specimen Collection:

Allow the test device, specimen, buffer, and/or controls to reach room temperature (15-30°C / 59-86°F) prior to testing.

  1. Bring the pouch to room temperature before opening. Remove the test device from the sealed pouch and use it as soon as possible.
  2. Place the test device on a clean and level surface. Label the test with patient control identification.

For Serum or Plasma Specimens:

a) Using the provided 5uL disposable pipette, draw the specimen up to the Fill Line, and transfer 1 drop of the specimens (appr. 5uL) onto the specimen well of the test device, then add 2 drops of buffer and start the timer.

3. Wait for the colored line(s) to appear. Read the results at 15 minutes.

Note: Specimens can also be applied using a micropipette.


For Whole Blood Specimens:

a) Using the provided 5uL disposable pipette, draw the specimen up to the Fill Line, and transfer 1 drop of whole blood (appr. 10uL) onto the specimen well of the test device, then add 2 drops of buffer and start the timer.

3. Wait for the colored line(s) to appear. Read the results at 15 minutes.

Note: Specimens can also be applied using a micropipette.


Results Interpretation For Covid-19 igG/igM Test

IgG Positive:* The colored line in the control region (C) changes from blue, and a colored line appears in the igM test region. The result is positive for COVID-19 virus specific-igM antibodies.

IgG Positive:* The colored line in the control region (C) changes from blue to red, and a colored line appears in the igG test region. The result is positive for COVID-19 virus specific-igG antibodies.

igM and igG Positive:* The colored line in the control region (C) changes from blue to red, and two colored lines should appear in igG and igM test regions. The color intensities of the lines do not have to match. The result is positive for igM and igG antibodies.

Negative: The colored line in the control region (C) changes from blue to red. No line appears in igM or igG test regions.

Invalid: Control line (C) is still completely or partially blue/gray, and falls to completely change from blue to red. Insufficient buffer volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the procedure with new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

NOTE:

  1. The color intensity in the test region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of color in the test region should be considered positive. Note that this is a qualitative test only, and cannot determine the concentration of anlytes in the specimen.
  2. Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.