Hotgen - Rapid Short Swab For Single SARS-COV-2 Antigen Test

Rapid swab (immunochromatography with colloidal gold) for the qualitative detection of antigens of SARS-CoV-2, the new human coronavirus responsible for the COVID-19 infection. The test is to be performed on biological sample from throat or nasal swab. Thanks to the high sensitivity of the reagent used, the nasal sample is taken only in the first part of the nasal root. The test is less invasive and suitable for children. For healthcare professionals, it allows for self-diagnosis. The kit is complete with everything needed to proceed with the analysis. The test is also effective in detecting new variants of the SARS-CoV-2 virus. Due to it responds to antigens not affected by the mutation.

CONTENT:

1 Test cassette for the antigen | 1 Biological sample extraction swab | 1 Swab solution for virus sampling (single use) | 1 Package leaflet

HOW TO PERFORM THE TEST:

These products are for professional use, it is necessary to contact a healthcare professional for their use. In any case, for information purposes also for the benefit of healthcare personnel, this video explains how to proceed.

RELEVANT TECHNICAL FEATURES:

The test has high performance in terms of sensitivity and specificity.

SENSITIVITY: 97.10% (95% CI: 93.80-98.93%)

SPECIFICITY: 99.76% (95% CI: 98.65-99.99%)

QUICKNESS: results in 15 minutes

MECHANISM OF ACTION:

The test is based on colloidal gold immuno-chromatographic technology and uses the double antibody sandwich method: the detection line (T) of the is coated with the SARS-CoV-2 antibody while the control line (C ) is coated with a secondary anti-sheep secondary antibody labeled with the novel coronavirus. During the test, the sample is placed on the test strip and the liquid rises along the strip by capillarity. Any virus antigen present in the biological sample first binds to the gold-colloidal labeled antibody found in the extraction liquid and then to the antibody present in the T line. The antibody from the extraction liquid also binds to the antigens of line C. At the end of the test, the color reaction of the gold-colloid must be observed.

HOW TO INTERPRET THE RESULTS:

This kit is a qualitative test and is not capable of quantifying the concentration of the coronavirus antigen.

Positive: Two color bands appear in the observation window, i.e. a red or magenta line at the position of the quality control line (line C) and the detection line (line T) (as shown in outcome 1), indicating that the result of the antibody against the new coronavirus in the sample was positive.

Negative: Only one line appears in the observation window, i.e. a red or magenta line in the position of the quality control line (line C) and no line in the position of the test line (line T) (as shown in outcome 2) , indicating that the antibody outcomes against the novel coronavirus in the sample were negative or the concentration was below the limit of the kit's detection capability.

Invalid: In the observation window, no line appears in the position of the quality control line (line C) (as shown in outcome 3), indicating that the test is invalid. In this case it should collect the sample again and repeat the test.

TECHNICAL DOCUMENTATION:

Multilingual leaflet
Medical device registration with the Italian Ministry of Health
TUV certified
Clinical studies summary report

STORAGE:

The kit must be stored in a temperature between 4-30 ° C, in this case, the expected expiration is 18 months.

After opening the foil pouch, this kit should be used within 30 minutes (temperature between 10-30 ° C, humidity ≤70%) or immediately after opening if the temperature exceeds 30 ° C.

ATTENTION 

 The device is authorized as an autodiagnosis product only in some states, such as Germany, in other state like Italy the product is considered for professional use only and mustn't be use by yourself, we invite you to consult the laws of your country regarding purchase and use.