Frequently asked questions

• What does it mean if the specimen tests positive for the virus that causes COVID-19?
  A positive test result for COVID-19 indicates that antigens from SARS-CoV-2 were detected, and the patient is infected with the virus and presumed to be contagious. COVID-19 test results should always be considered in the context of clinical observations and epidemiological data in making a final diagnosis and patient management decisions. Patient management decisions should be made by a healthcare provided and follow current CDC guidelines.
  The InspiroBio COVID-19 Antigen Self-Test has been designed to minimize the likelihood of false positive test results. However, in the event of a false positive result, risks to patients could include the following: a recommendation for isolation of the patient, monitoring of household or other close contacts for symptoms, patient isolation that might limit contact with family or friends and may increase contact with other potentially COVID-19-infected patients, limits in the ability to work, the delayed diagnosis and treatment for the true infection causing the symptoms, unnecessary prescription of a treatment or therapy, or other unintended adverse effects.
  All healthcare providers must follow the standard testing and reporting guidelines according to their appropriate public health authorities.
• What are the symptoms of COVID-19?
  Many patients with COVID-19 have developed fever and/or symptoms of acute respiratory illness (e.g., cough, dyspnea), although some individuals experience only mild symptoms or no symptoms at all. The current informational available to characterize the spectrum of clinical illness associated with COVID-19 suggests that when present, symptoms include cough, shortness of breath or dyspnea, fever, chills, myalgias, headache, sore throat, new loss of taste of smell, nausea, vomiting or diarrhea. Signs and symptoms may appear any time from 2 to 14 days after exposure to the virus, and the median time to symptom onset is approximately 5 days.
  Public health officials have identified cases of COVID-19 infection throughout the world, including the United States, which poses risks to public health. Please check the CDC COVID-19 webpage (see link provided in “Where can I go for updates and more information” section at the end of this document) or your local jurisdictions website for the most up to date information.
• Can children use the test kit?
  1) Do not use on anyone under 2 years old.
  2) Children aged 2-13 years should be tested by an adult.
• Any requirements for storage?
  1) Store the kit between 35.6-86°F (2-30°C). Avoid direct sunlight. Do not freeze the kit. Bring the test kit to room temperature 59-86°F (15-30°C) before use.
  2) The expiration date can be found on the outside of the box. Do not use beyond the expiration date.
• What is the principles of the test?
  The InspiroBio COVID-19 Antigen Self-Test is a lateral flow colloidal gold immunoassay, which is intended for the qualitative detection of nucleocapsid protein from SARS-CoV-2 in anterior nasal (AN) swab specimens from individuals who are suspected of COVID-19 within the first six (6) days of symptom onset. When the sample is added to the sample well, the nucleocapsid SARS-CoV-2 protein in the sample (if present) reacts with the ISB-IF202201 pg. 3 gold-labeled antibody. It forms an immuno-complex, which flows onto the nitrocellulose membrane. When the immuno-complex reaches the position of the T Line (Test band), it reacts with the COVID-19 antibody precoated on the nitrocellulose membrane. A colored T Line (Test band) becomes visible in the result window, which indicates a positive result. Regardless of whether the sample contains nucleocapsid protein or not, the gold labeled quality control antigen binds to the coated antibody at the position of the C line (Control band) and a colored C Line (Control band) becomes visible in the result window.