Sienna COVID-19 IgM- IgG Antibody Test

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Sienna COVID-19 IgM- IgG Antibody Test

  • The Sienna COVID-19 IgG/IgM Rapid Test Cassettes are designed to detect the presents of IgG and IgM antibodies to SARS-CoV-2 in blood, serum, or plasma samples. The test is intended to identify individuals with an adaptive immune response to SARS-CoV-2. This test offers results easy to interpret in less than 10-15 minutes with over 96% accuracy rates.
  • How it Works:
    Fill one of the capillary tubes provided in the kit to its fill line with blood from fingertip. To do this, squeeze the capillary and place the end of the capillary that is close to the marked fill line in the blood drop.
  • When the blood has been absorbed from the sample well into the cassette, add two (2) drops of test buffer into the Buffer well (marked with a B) in the cassette. Add the buffer by taking off the cap, flipping the bottle, holding it over the Buffer well and allowing two drops of buffer to drip into the Buffer well.
  • Gently release the pressure and the blood will automatically flow into the tube. Remove the capillary from the blood drop when the column of blood reaches the fill line as shown in the following figure. Transfer the blood from the capillary tube into the Sample well (marked with an S) in the capillary.
  • Immediately after adding the buffer to the Buffer well, set the timer for 10 minutes and start the timer. After 10 minutes have passed, read the result. Do not read the result after 20 minutes.
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    Analytical Performance:

  • Cross Reactivity: The SiennaTM-Clarity COVIBLOCKTM COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/ Plasma/ Serum) has been tested for anti- influenza A virus, anti-influenza B virus, anti-RSV, anti-Adenovirus, HBsAg, anti-Syphilis, anti-H. Pylori, anti-HIV, anti-HCV, ANA and HAMA positive specimens. The results showed no cross-reactivity.
  • Interfering Substances: None of the below substances at the concentration tested interfered in the assay: Acetaminophen (20mg/dL), caffeine (20mg/dL), albumin (2g/dL), acetylsalicylic acid (20mg/dL), gentisic acid (20mg/dL), ethanol (1%), ascorbic acid (2g/dL), creatinine (200mg/dL), bilirubin (1g/dL), hemoglobin (1000mg/dL), oxalic acid (60mg/dL), uric acid (20mg/dL).
  • Kit Contains:
    • (1) IFU
    • (20) Individually pouched test cassettes
    • (20) Single pack buffer bottles OR (1) single 3mL buffer bottle
    • (20) Safety lancets
    • (20) Alcohol swabs
    • (1) Quick Reference Guide
    • (20) Disposable plastic pipettes
  • Accurate Results:
    • Sensitivity: 93.3%
    • Specificity: 98.8%
    • Accuracy: 99.6%
  • Sienna Deck:
  • IgG and IgM antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post infection is not well
    characterized. Individuals may have detectable virus present for several weeks following seroconversion. Negative results do not preclude acute SARS-CoV-2 infection.