IgG/IgM Control Solutions for COVID-19 Serology Test Kits | https://testcountry.com/products/igg-igm-control-solutions-for-covid-19-serology-test-kits

IgG/IgM Control Solutions for COVID-19 Serology Test Kits

Product Description
Ideal for use in: Validation Studies, CLIA Laboratories and other Clinical settings
Product Details:
  • 10 Pack: 5 positive vials + 5 negative vials
  • 20 Pack: 10 positive vials + 10 negative vials
  • Overnight shipping with ice pack required ($80)
  • For Emergency Authorization Use only
  • For in vitro diagnostic use only
  • Color coded caps for easy identification
  • 100 μL per vial
  • Storage and Stability: -20°C (12 months), 2-8°C (30 Days)
The COVID-19 IgG/IgM Control Kit is an external quality control kit containing human plasma based positive and negative controls for use with COVID-19 IgG/IgM Rapid Test Cassette. The positive control contains a proprietary solution of anti-SARS-CoV-2 IgG and IgM antibodies. The negative control is non-reactive plasma. *For Best Results: Only use with Healgen’s COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma). Incompatibilities between this product and other manufacturer test kits may occur.

Storage Instructions:

  • This product is shipped on ice packs.
  • Store at -20°C for long-term storage. Once opened, the remaining controls may be stored at 2-8°C/36-46°F for up to 30 days. Controls should avoid repeated freeze and thaw cycles.
  • Do not use past the expiration date.
  • Vials should always be stored upright.

Preparation Instructions:

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 Instructions:

  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 control specimen to exceed the specimen line as shown in the following image and then transfer drawn 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.
    Note: Practice a few times prior to testing if you are not familiar with the mini dropper. For better precision, transfer specimens by pipette capable of delivering 5 μL of volume.
  4. Wait for the colored line(s) to appear. After 2 minutes, if the red color has not moved across the test window, add 1 additional drop of the sample buffer to the buffer well (B).
  5. The result should be read in 10 minutes. Do not interpret the result after 15 minutes.

Result Interpretation

  • Negative: The colored line in the control line region (C) changes from blue to red. No line appears in the test line regions M or G. The result is negative.
  • IgG and IgM Positive: The colored line in the control line region (C) changes from blue to red, and two colored lines appear in test line regions M and G. The result is anti-COVID-19 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. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your test kit distributor.
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The COVID-19 IgG/IgM Control Kit is an external quality control kit containing human plasma based positive and negative controls for use with COVID-19 IgG/IgM Rapid Test Cassette. The positive control contains a proprietary solution of anti-SARS-CoV-2 IgG and IgM antibodies. The negative control is non-reactive plasma. *For Best Results: Only use with Healgen’s COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma). Incompatibilities between this product and other manufacturer test kits may occur.

Storage Instructions:

  • This product is shipped on ice packs.
  • Store at -20°C for long-term storage. Once opened, the remaining controls may be stored at 2-8°C/36-46°F for up to 30 days. Controls should avoid repeated freeze and thaw cycles.
  • Do not use past the expiration date.
  • Vials should always be stored upright.

Preparation Instructions:

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 Instructions:

  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 control specimen to exceed the specimen line as shown in the following image and then transfer drawn 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.
    Note: Practice a few times prior to testing if you are not familiar with the mini dropper. For better precision, transfer specimens by pipette capable of delivering 5 μL of volume.
  4. Wait for the colored line(s) to appear. After 2 minutes, if the red color has not moved across the test window, add 1 additional drop of the sample buffer to the buffer well (B).
  5. The result should be read in 10 minutes. Do not interpret the result after 15 minutes.

Result Interpretation

  • Negative: The colored line in the control line region (C) changes from blue to red. No line appears in the test line regions M or G. The result is negative.
  • IgG and IgM Positive: The colored line in the control line region (C) changes from blue to red, and two colored lines appear in test line regions M and G. The result is anti-COVID-19 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. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your test kit distributor.