• Positive control, vial with red cap containing SARS-CoV-2 Spike protein specific recombinant human IgG and IgM diluted with human plasma
  • Negative control, vial with blue cap containing human plasma
  • Preservatives: sodium azide, 0.02%
  • For Emergency Authorization Use only
  • For in vitro diagnostic use only
  • For professional use only
  • 12 month shelf life, do not use after expiration date
  • Store at -20°C for long-term storage
  • Once opened, the remaining controls may be stores at 2-8°C/36-46°F for up to 30 days.

IgG IgM Controls

Confirm BioSciences is now offering IgG and IgM controls to be used with COVID-19 serology testing kits.

If you are interested in this product, please complete the form below and one of our representatives will reach out to discuss the details.

COVID-19 IgG/IgM CONTROL Kit Product Details

The COVID-19 IgG/IgM CONTROL Kit is an external qualitative control for anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG for use with the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood / Serem / Plasma), a solid phase immunochromatographic assay for the rapid, qualitative and differential detection of IgG and IgM antibodies to 2019 Novel Coronavirus in human whole blood, serum or plasma to aid in the diagnosis of COVID-19 infection.

Ideal for use in: Validation Studies, CLIA Laboratories and other Clinical settings.

Liquid control solutions are designed to ensure the accuracy of serology tests that detect IgG and IgM (COVID-19) antibodies- before they are administered.

This standardization solution is typically offered in positive and negative formats to provide total peace of mind before administering antibody detection tests.

How To Use The COVID-19 IgG/IgM CONTROL Kit

Prior to use, please review and follow the manufacturer’s product insert included with this product.

Control Kit Test Procedure

Preparation for Use

Allow controls to equilibrate to room temperature (15-30°C/59-86°F) prior to testing.

Prior to each use, mix by gentle inversion.

Control Testing

  1. Remove the test cassette from the sealed foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
  2. Place the test device on a clean and level surface.
  3. With the 5 μL mini plastic dropper provided with the test, draw negative OR positive control specimen to exceed the specimen line as show in the following image and then transfer drawn negative control specimen into the sample well ( S ). Then add 2 drops (about 80 μL) of sample buffer to the buffer well ( B ) immediately. Avoid air bubbles.
  4. Note: Practice a few times prior to testing if you are not familiar with the minidropper. For better precision, transfer specimens by pipette capable of delivering 5 μL of volume.
  5. Wait for the colord line(s) to appear. After 2 minutes, if the red color has no moved across the test window, add 1 additional drop of the sample buffer to the buffer well ( B ).
  6. The result should be read in 10 minutes. Do not interpret after 15 minutes.

Example Negative

Example Positive

Interpretation of Results

  • NEGATIVE: The colored line in the conrol line region (C) changes from blue to red. No line appears in the test line region M or G. The result in negative.
  • IgG and IgM POSITIVE: The colored line in the control region (C) changes from blue to red, and two colored lines appear in the test line regions M and G. The result is anti-COVID019 IgM and IgG positive.
  • INVALID: Control line is still completely or partially blue and fails to completely change from blue to red. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Reviw the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

Why Confirm BioSciences?

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