15 Min SARS-CoV-2 Fast Coronavirus Test Kit

Product Specification

1. Novel Coronavirus (2019-nCoV) Antibody IgG/IgM Rapid Test Cassette

   COVID-19 (2019-nCoV) SARS-CoV-2 Colloidal Gold Antibody IgG/IgM Fast Test Kit For In Vitro Diagnostic use

   

    

2. Main Features:

   1. Fast to get the result in 15～20 mins.

   2. High sensitivity and specificity.

   3. Simple to use.

   4. High Accurate (97.51%) and Reliable (Credibility Interval: 95.79%～98.67%)

   5. Ambient storage.

   6. Certified by Authoritative Certification

   7. Unique 3-line Patented Design

   8. Meet Multiple Criteria as follows:

   EN ISO 13485:2016 EN 13612:2002

   EN ISO 14971:2012 EN ISO 23640:2015

   EN ISO 18113-1:2011 EN ISO 18113-2:2011

   EN ISO 15223-1:2016 EN 13641:2002

3. Principle

   This kit uses Colloidal Gold Immunochromatography and indirect immune capture principle of comprehensive detection technology to detect IgG/lgM of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in human serum, plasma and whole blood.

    

   During detection, the colloidal gold labeled recombinant antigens bind to the SARS-CoV-2 antibodies in the sample to form immune complexes. The immune complexes move forward along the cassette by chromatography.

    

   The IgM in the immune complexes will be captured by the pre-coated anti-human IgM on the test zone, condense the color to form the reaction line M. The IgG in the immune complexes will be captured by the pre-coated anti-human IgG on the test zone, condense the color to form the reaction line G.

    

   The colloidal gold-labeled chicken IgY antibodies are combined with the pre-coated goat anti-chicken IgY antibodies on the quality control line to form the quality control line C

4. Warning

   For in vitro diagnostic use ONLY

   Read the instruction carefully before use. It is very important that the correct operation procedure is followed. Fail to add the patient specimen may cause false negative result (i.e.a missed positive) .

    

    

5. Storage

   COVID-19IgG/IgM Rapid Diagnostic Kit should be placed in dark place at 2-30°C for 12 months from the date of manufacture. Keep the test kit in sealed pouch until use. Once you have taken the test cassette out of the pouch, use it immediately. Do not use the test kit once it exceeds the indicated expiration date.

6. Assay Procedure

    

   ☀ Remove the test device from foil pouch by tearing along the notch.

    

   ☀ Specimen collection. Please see Specimen Collection and Preparation.

    

   ☀ Shake the sample collection device several times.

    

   ☀ Holding the sample collection device upright, carefully screw off the cap of collection device.

    

   ☀ Squeeze 2-3 drops (80-100ul) of the sample solution on the test cassette.

    

   ☀ Observe the result in15 minutes.

    

    

   Interpretation of Results

   

    

   Negative: Only one pink band appears. This indicates that no H. pylori antibodies have been detected.

   
   Positive: Two pink bands appear. This indicates that the specimen contains H. pylori antibodies.

   
   Invalid: If no band appears, this indicates a possible error in performing the test. The test should be repeated using a new device.

    

   Storage

    

   The H. pylori Rapid Test should be stored at temperature 4-30°C the sealed pouch for the duration of the shelf life (24months).

   Do the test in 1 hour when you open the pouch

    

   

    

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