Fluorecare Covid-19 Antigen Test Kit (5 Single Tests)

5 x Fluorecare Covid-19 Antigen Test Kit (1 Test) uses a lateral flow immunofluorescent sandwich assay to detect the novel coronavirus in human nasopharyngeal (NP) or nasal  swabs sample. COVID-19 antigen can detect the presence of viral protein. It can identify acute or early infection. Suitable for large-scale screening of the general population and epidemiological investigations in low-endemic areas. The SARS-CoV-2 Rapid Antigen Test is a reliable, rapid chromatopgraphic immunoassay for the qualitative detection of specific antigens of SARS-CoV-2 present in the human nasopharynx. This test is an aid in detecting antigen from the SARS-CoV-2 virus in individuals suspected of COVID-19.

SARS-CoV-2: An overview of virus structure, transmission and detection

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is an enveloped, single-stranded RNA virus of the family Coronaviridae. Coronaviruses share structural similarities and are composed of 16 nonstructural proteins and 4 structural proteins: spike (S), envelope (E), membrane (M), and nucleocapsid (N). Coronaviruses cause diseases with symptoms ranging from those of a mild common cold to more severe ones such as Coronavirus Disease 2019 (COVID-19) caused by SARS-CoV-2

SARS-CoV-2 is transmitted from person-to-person primarily via respiratory droplets, while indirect transmission through contaminated surfaces is also possible. The virus accesses host cells via the angiotensin-converting enzyme 2 (ACE2) receptor, which is most abundant in the lungs.

The incubation period for COVID-19 ranges from 2 - 14 days following exposure, with most cases showing symptoms approximately 4 - 5 days after exposure. The spectrum of symptomatic infection ranges from mild (fever, cough, fatigue, loss of smell and taste, shortness of breath) to critical. While most symptomatic cases are not severe, severe illness occurs predominantly in adults with advanced age or underlying medical comorbidities and requires intensive care. Acute respiratory distress syndrome (ARDS) is a major complication in patients with severe disease. Critical cases are characterized by e.g., respiratory failure, shock and/or multiple organ dysfunction, or failure.

Benefits of the SARS-CoV-2 Rapid Antigen Test:

• Getting a quick result within 15-30 minutes – no need for a follow-up appointment to discuss the result
• Easy handling which does not require specific training
• No instrument required
• Allowing decentralized testing or access to testing in areas where laboratory testing is not available

Testing the quick and easy way

Collecting a sample (nasypharyngeal swab)

Insert a sterile swab into the nostril of the patient and then rotate the swab 3-4 times against the nasopharyngeal surface. Withdraw the swab from the nasal cavity. When collecting a combined NP/OP sample be sure to follow the procedures described in the Instructions for Use.

Preparing a sample

Insert the swab into an extraction buffer tube. While squeezing the buffer tube, stir the swab more than 5 times.

Preparing a sample

Remove the swab while squeezing the sides of the tube to extract the liquid from the swab.

Preparing a sample

Press the nozzle cap tightly onto the tube. Continue with 3a. Performing a test.

Performing a test

Place the test device on a flat surface and apply 3 drops of extracted sample in a 90° angle to the specimen well of the test device.

Performing a test

Read the test result at 15 to 30 min. Warning: Risk of incorrect results. Do not read the test result after 30 min.

Interpreting results

A coloured line appears in the top section of the result window to show that the test is working properly. This is the control line (C). Even if the control line is faint, the test should be considered to have been performed properly. If no control line is visible the test is invalid.  In case of a positive result, a coloured line appears in the lower section of the result window. This is the test line (T). Even if the test line is very faint or not uniform, the test result should be interpreted as a positive result.