General information:

Severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) is the name given to the new coronavirus that originated in 2019 and is the causative agent of COVID-19 (the disease caused by the SARS-CoV-2 virus). The virus was originally known as the 2019-nCoV nomenclature. SARS-CoV-2 is a new coronavirus strain that has not been previously identified in humans. The genome of these viruses consists of single-stranded RNA protected by two protein coatings - nucleocapsid and capsid. Its genetic characteristics are significantly different from SARS-CoV and MERS-CoV.

Intended use:

Humasis COVID-19 test is a one step in vitro diagnostic test based on immunochromatographic assay. It is designed for qualitative detection of SARS-CoV-2 antigens in nasopharyngeal swab specimen of suspected patients.

• Fast results within 15 mins
• Easy to use - in 3 rapid steps
• Specimen: Nasopharyngeal swab
• All necessary reagents provided (individually packed)
• Highest accuracy - Sensitivity and Specificity

Principle of the Test:

COVID-19 Ag Test
A nitrocellulose membrane strip on the left side of the device contains one test line and one control line. The test line is pre-coated with anti-mouse monoclonal antibody to SARS-CoV-2 nucleocapsid and RBD for detection of SARS-CoV-2 antigens, and the control line is coated with goat anti-mouse lgG. A nitrocellulose membrane strip on the right side of the device contains two test lines and one control line. Test line A is pre-coated with monoclonal antibody to influenza A, test line B is coated with monoclonal antibody to influenza B and the control line is coated with goat anti-mouse lgG.

Influenza A/B Ag Test
When the swab sample is added to the sample well, it will migrate to the conjugate pad, which contains conjugated antibodies conjugated with colloidal gold directed against the SARS-CoV-2 influenza A/B antigen. If the sample contains the targeted antigens, antigen-conjugate complex will be formed. The complex will continue to migrate across the membrane until it reaches the capture zone (test line) where the complex will bind to immobilized antibodies and form visible colored band in the test line. The sample will continue to move along the membrane until it reaches the control line where excess conjugate binds and produces a second visible line. This control line indicates that the sample has migrated across the membrane as intended and the test was performed properly.

Contents:

• Test devices individually packed in aluminum bags (25 tests / box)
• Disposable test tubes with extraction buffer (25 pieces / box )
• Filter cap (25 pieces / box )
• Sterilized swabs for sampling (25 pieces / box )
• Instructions for use (1 St.)

Sensitivity and Specificity:

>> Sensitivity

COVID-19 – 95,5 %

Influenza A – 100 %

Influenza B – 100 %

>> Specificity

COVID-19 – 100 %

Influenza A – 98.6 %

Influenza B – 100 %