Intended Use:

The NADAL® COVID-19 IgG / IgM Test is a lateral flow chromatographic immunoassay for the qualitative detection of anti-SARS-CoV-2 IgG and IgM in human whole blood, serum or plasma specimens.

Benefits at a glance:

• Optimized testing process
• High specificity and sensitivity
• Fast and reliable results in just 15 minutes
• Storage at room temperature
• No cross-reactivity with antibodies against a variety of infectious diseases

Test Principle:

Anti-human IgM are pre-coated onto the test line region ‘IgM’ and anti-human IgG are pre-coated onto the test line region ‘IgG’ of the membrane. During testing, the specimen reacts with SARS-CoV-2 antigens which are conjugated to coloured particles. The mixture then migrates along the membrane chromatographically by capillary action and reacts with the anti-human IgM and anti-human IgG in the test line region ‘IgM’ and ‘IgG’ of the membrane. The presence of a red line in the test line region ‘IgM’ and/or ‘IgG’ indicates a positive result. The absence of a red line in the test line region ‘IgM’ and/or ‘IgG’ indicates a negative result.

Specimen collection and test procedure:

1. Specimen collection- can be used as capillary or venous blood, serum or plasma
2. Add a certain amount of sample to the test well
3. Add 2 drops of buffer
4. Interpret results after 15 minutes

Contents:

① Test cassettes (individually packaged)

② Disposable capillary pipettes

③ Buffer tube

④ Package insert

Performance characteristics:

• Sensitivity - 93.7% (IgM), 98.8% (IgG)
• Specificity - 99.1% (IgM), 98.7% (IgG)

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• CE-IVD certificated