SARS-CoV-2 IgM/IgG Antibody Detection Kit
(Colloidal Gold)

Rapid test for personal use:

Easy to use and operation
High Specificity and Accuracy
Instant Result in 15-20 min.

Operation procedure
1. Collection the human whole blood, serum or plasma
2. For plasma /serum specimen:
Add 10μL of sample into sample well and add 3 drops of dilute into sample well.
For whole blood specimen:
Add 20μL of sample into sample well and add 3 drops of dilute into sample well.
3. Read results in 15-20 min.

Materials Provided
1. Test cassette 1×25 cassettes
2. Sample diluent 4ml × 1 bottle
3. Safety lancet 1×25 pieces
4. Alcohol pad 1×25 pieces
5. Disposable transfer pipette 1×25 pieces
6. Instructions for use 1 piece

Specimen types:
Human serum, plasma, and whole blood (venous and capillary) specimens are validated to be used with this assay.

This product is intended for detection of antibodies against SARS-CoV-2 from individuals to aid in the diagnosis of COVID-19 infection. The assay can be used for clinical reference and should not be the only basis for the diagnosis and treatment. The clinical management of patients should be considered in combination with patients’ symptoms and medical history, other laboratory tests, treatment response, epidemiology and other information.

Diagnostic specificity
• 54 samples of symptomatic patients, classified as negative in the search of the viral genome, were tested and the Diagnostic Kit for SARS-CoV-2 IgM/IgG Antibody (Colloidal Gold) identified 52 negative results with a specificity of 96.3%.
• Diagnostic sensitivity 75 samples of symptomatic patients, classified as positive in the search of the viral genome, were tested; the sensitivity is depending on the time between the onset of symptoms and the positivity of the serological test. The Diagnostic Kit for SARSCoV-2 IgM/IgG Antibody (Colloidal Gold) provided 27 out of 30 positive results with a sensitivity of 90.0%, considering a seroconversion period >10 days. Depending on the time of onset of the symptoms, the following values of antibody positivity were obtained:

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