The Getein COVID-19 Rapid POC (Point-of-Care) kit is a One Step Test for Novel Coronavirus (2019-nCoV) IgM/IgG antibody (Colloidal Gold) detection and is intended for the qualitative detection of 2019-Novel Coronavirus IgM and IgG antibody in serum, plasma, fingertip blood or whole blood samples of pneumonitis patients or suspected cases.

Coronavirus disease 2019 (COVID-19) is an infectious disease caused by 2019-nCoV, a new strain of coronavirus that has not been previously identified in humans. The disease is primarily spread between people via respiratory droplets from infected individuals when they cough or sneeze. Time from exposure to onset of symptoms is generally between 2 and 14 days. The disease may initially present with few or no symptoms, or may develop into fever, coughing, shortness of breath, pain in the muscles and tiredness. Further development may include pneumonia and acute respiratory distress syndrome.

Detection of 2019-nCoV IgM and IgG antibodies in human blood can be used as an auxiliary means for screening of COVID-19.

The test uses mixed recombinant 2019-nCoV nucleocapsid protein (N protein) and spike protein (S protein) both conjugated with colloidal gold and anti-human IgM and IgG antibody coated on different test lines respectively. After the samples has been applied to the test strip, the gold-labelled recombinant 2019-nCoV N protein and S protein will bind with 2019-nCoV IgM or IgG antibody in sample and form marked antigen-antibody complexes. These complexes move to the
test card detection zone by capillary action. Then marked antigen-antibody complexes will be captured on different test lines by anti-human IgM and IgG antibody resulting in purplish red streaks on the test lines. The color intensity of each test line increases in proportion to the amount of 2019-nCoV IgM and IgG antibody in sample.

Store the test card at 4-30℃ with a valid period of 24 months. Use the test card within 1 hour once the foil pouch is opened. Store the sample diluent at 0-30℃ with a valid period of 24 months.
Store the sample diluent at 2-8℃ for better results.

Read the manual carefully before using and operate according to the manual to avoid incorrect results.

1. The test is for in vitro diagnostic use only.
2. The test results of this kit are for clinical reference only. The clinical diagnosis and treatment of patients should be considered in combination with their symptoms/signs, medical history, other laboratory tests, and treatment response.

While we believe this kit is to be an effective indicator of infection we cannot guarantee 100% accuracy so the patient should still be advised to follow government guidelines for those exhibiting symptoms and those who aren’t regarding hygiene, self-isolation and other measures even if the test is negative.

• Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
• Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
• Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
• This kit is for Professional-Use-Only.