BTNX Rapid Response COVID-19 IgG/IgM Antibody Test

👉 Please note this product is on backorder with an anticipated shipping date of September 27

Looking for a smaller quantity? ORDER THE ANTIBODY 5-PACK!

Sample: Whole Blood / Serum / Plasma
Format: Cassette
Time to result: 15 minutes
Quantity: 25 Tests/Box
Volume Pricing:

  • $17/test – 25-75 tests (1-3 boxes)
  • $16/test – 100-475 tests (4-19 boxes)
  • $15/test – 500-999 tests (20-39 boxes)
  • 1000+ tests – contact us for a quote

International Orderslearn more & get a quote.

$17.00/test

Available on backorder

SKU: BTNX-AB Category: Tag:

Product Code: COV-13C25
Sample: Whole Blood / Serum / Plasma
Format: Cassette
Quantity: 25 Tests/Box
Specificity: COVID-19 virus IgG and IgM antibody
Time to result: 15 minutes
Storage Condition: 2-30°C/35.6-86°F
Test Principle: Immunochromatographic Lateral Flow Assay

The Rapid Responseâ„¢ COVID-19 IgG/IgM Rapid Test Device is an in vitro immunoassay for the direct and qualitative detection of anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG in human whole blood (including venous whole blood and capillary whole blood), serum, or plasma.

At the Point of Care setting, this test is only authorized for use with fingerstick whole blood specimens.

This test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. The Rapid Responseâ„¢ COVID-19 IgG/IgM Rapid Test Device should not be used for screening patients or to diagnose or exclude acute SARS-CoV-2 infection.

At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. A negative or non-reactive result for an individual subject indicates the absence of detectable COVID-19 virus antibodies. However, a negative or non-reactive test result does not preclude the possibility of exposure to or infection with the COVID-19 virus.

False-positive results may occur due to cross-reactivity from pre-existing antibodies or other possible causes. Due to the risk of false-positive results, confirmation of positive results should be confirmed using a second, different IgG/IgM detection method. Laboratories are required to report all results to the appropriate public health authorities. The test is for professional use only. This assay is not intended for home testing (or self-testing).

The Rapid Responseâ„¢ COVID-19 IgG/IgM Rapid Test Device may detect a response to vaccination.

Pursuant to section 5 of the Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19, made by the Minister of Health on March 18, 2020, the Rapid Responseâ„¢ COVID-19 IgG/IgM Rapid Test Device is now authorized for sale or importation in Canada.

Clinical Evaluation Data

Clinical evaluation data for venous whole blood and serum samples:

  • IgG Detection: Relative Sensitivity 94.6% (CI: 84.2%-98.6%), Relative Specificity: 100% (CI: 96.5%-100%)
  • IgM Detection: Relative Sensitivity 92.9% (CI: 81.9%-97.6%), Relative Specificity: 98.1% (CI: 93.3%-99.5%
Weight 0.05 lbs
Dimensions 12 × 6 × 6 in

Instructions

Proudly trusted by hundreds of organizations across Canada

Stay up to date with Rapid Test & Trace Canada

Scroll to Top

On Backorder

The ANTIBODY 25 box is on backorder

Order today for an anticipated shipping date of SEPTEMBER 27