The severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) virus and resulting COVID‐19 pandemic present important diagnostic evaluation challenges. These range from understanding the value of signs and symptoms in predicting possible infection, assessing whether existing biochemical and imaging tests can identify infection and people needing critical care, and evaluating whether new diagnostic tests can allow accurate rapid and point‐of‐care testing, either to identify current infection, rule out infection, identify people in need of care escalation, or to test for past infection and immunity.

The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases. As it is a novel disease diagnosis of which are being explored, please refer to the latest guidelines for diagnosis and treatment of COVID-19.

SARS‐CoV‐2 infection can be asymptomatic (no symptoms); mild or moderate (symptoms such as fever, cough, aches, lethargy but without difficulty breathing at rest); severe (symptoms with breathlessness and increased respiratory rate indicative of pneumonia); or critical (requiring respiratory support due to severe acute respiratory syndrome (SARS) or ARDS). People with COVID‐19 pneumonia (severe or critical disease) require different patient management, and it is important to be able to identify them. Point‐of‐care testing can also be undertaken using disposable lateral flow assays, akin to a pregnancy test, which indicate by colour change whether a SARS‐CoV‐2 antigen has been detected in a swab sample or sample of bodily fluids. These tests are portable and do not require laboratory facilities or technology platforms.

Getein One Step Test for SARS -CoV-2 Antigen (Colloidal Gold) is intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in human nasal swab samples from patients suspected of COVID-19 infection by a healthcare provider. Getein One Step Test for SARS-CoV-2 Antigen (Colloidal Gold) is an aid in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. This test is only intended for professional and laboratory use, not for home testing. Results from the test should not be used as the sole basis for diagnosis and exclusion of SARS-CoV-2 infection.

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