Diagnostic test CITO Test (Cyto Test) COVID-19 Ag for the determination of coronavirus antigens
CITO TEST® COVID-19 Ag is a rapid test for the qualitative determination of coronavirus antigens (SARS-CoV-2) in swabs from the nasopharynx of persons with suspected coronavirus infection.
Please follow the setup instructions for use for correct results. There are many reasons for getting erroneous results.
After testing the results obtained, you should consult a doctor. The final diagnosis should be established by a doctor after clinical and additional laboratory tests.
COVID-19 (Corona Virus Disease-2019) is an infectious disease with a droplet transmission mechanism caused by the latest of the recently discovered coronaviruses (SARS-CoV-2), characterized by a predominant upper respiratory tract injury and general intoxication (patients have fever, cough, difficulty breathing (shortness of breath), sore throat, nasal congestion, malaise, headache, muscle pain, fatigue, weakness, loss of taste and smell), and can also lead to the development of SARS, severe acute respiratory syndrome, septic shock, and even of death.
You can become infected with COVID-19 from a person infected with the virus, mainly by inhaling small droplets that are released from the nose or mouth by an infected person when coughing, sneezing or talking. That is why it is necessary to keep a distance of at least 1.5 m from the sick person. These drops can settle on objects and surfaces surrounding the patient, for example tables, doorknobs and stair railings. As a result, others can become infected with COVID-19 by first touching these objects or surfaces and then in the eyes, mouth or nose. Therefore, it is important to regularly wash your hands with soap and water or treat them with an alcohol-based hand rub.
In our country, the incidence of COVID-19 remains very high. According to scientists, the actual number of diseases exceeds the official statistics. Infections are susceptible to people of all ages, especially those with weakened immunity. People over 60 years of age, pregnant women and people with chronic diseases are at risk, since they develop very high adverse effects of the disease. Complications resulting from this disease pose a serious threat to human health and life. In order to avoid complications, it is necessary to diagnose COVID-19 in a timely manner and consult a doctor for help.
Rapid tests are used as a preliminary screening diagnosis for coronavirus infection. These tests can detect either IgM or IgG antibodies or SARS-CoV-2 specific antigens. Each test has a different diagnostic value at different periods of the disease. Rapid tests for the detection of SARS-CoV-2 antigens are used for early preliminary diagnosis of the disease in persons with suspected COVID-19. As a rule, coronavirus antigens are detected in samples from the upper respiratory tract during the acute phase of infection within 5-7 d (e) * after the first symptoms of acute respiratory disease appear. Subsequently, the viral load falls, and the immune response grows, therefore, from the 2nd week of the disease, it is advisable to carry out tests for antibodies. It should be noted that the combined use of antigen and antibody tests increases the efficiency of diagnostics of coronavirus infection.
Sterile swab / applicator
Do not use after the expiration date.
Do not eat, drink or smoke at the test site.
Do not use the test if the package is damaged.
Use for testing only the components provided with the test.
The testing procedure and interpretation of the test result must be strictly followed. Correct sampling is critical to perform the test. Failure to follow the procedure may result in inaccurate results.
Samples should be handled as if they were potentially infectious material. If the sample is taken by an unauthorized person, she should wear disposable gloves and a protective mask.
After use, the test and used components should be placed in a plastic bag and disposed of in a waste container.
The CITO TEST® COVID-19 Ag rapid test for the detection of coronavirus antigens is a qualitative rapid analysis with visual feedback of test results. During testing, the sample reacts with reagents that have been previously applied and dried on the test membrane. If positive, a colored test line will be generated if the sample contains SARS-CoV-2 antigens. The presence of a control line serves as confirmation of a sufficient amount of used sample, filling of the membrane capillaries and internal quality control of reagents.
Mode of application
Tilt your head back about 45-70 °.
Lightly insert the tip of the sterile swab into the nostril and slide it along the outer wall of the nose parallel to the palate to about 5 cm (cm) for adults and 3 cm (cm) for children until you feel resistance against the back of the throat.
Rotate the inside of the swab for several s (s) ** so that the swab is saturated with secretion.
Rotate slowly to remove the swab from the nasal cavity.
NOTE: Testing should be performed as soon as possible after sample collection. If testing cannot be done immediately, place the sample swab in a dry, sterile and tightly closed storage tube. Such a sample can be stored for 8 h (h) at room temperature and 24 h (h) at 2-8 ° C.
Unscrew the cap of the buffer tube.
Insert a sterile swab into a buffer tube. Rotate the swab for approximately 10 s (s) while pressing the swab against the inner wall of the tube.
Remove the swab by squeezing the sides of the tube in order to draw the maximum amount of liquid from the swab.
Cap the vial.
Prepare all the materials needed for testing: watch, test cassette, sterile swab, tube with buffer and sample. Bring them to room temperature.
Open the sealed bag, remove the test cassette from the packaging and use within 1 h (year). The best results can be obtained by testing immediately after opening the package.
Place the test cassette on a clean and level surface.
Unscrew the top of the sample vial cap, invert it and dispense 3 drops of the resulting mixture into the cassette window marked with a letter (S). Start timing.
Take account of the result after 15 min. Do not take into account the test results later than 20 min (min).
Positive: *** two colored lines appear, one colored line should appear in the control zone (C) and the other in the test zone (T). A positive result indicates the presence of coronavirus antigens in the sample. *** NOTE: The color intensity of the lines in the test area may vary depending on the concentration of coronavirus antigens in the sample. Therefore, the appearance of a colored line of any intensity in the test area should be considered a positive result.
Negative: One colored line appears in the control zone (C); there is no line in the test zone.
Invalid: No control line appears. This could be due to insufficient sample quantity, failure to adhere to testing procedures, expiration dates, and storage conditions for rapid tests. If you receive an invalid test result, you must repeat the study using a different test cassette.
The test is equipped with an internal quality control (color control (C) line formation). The appearance of the control line indicates that the sample used is sufficient and the testing procedure is followed.
The sensitivity and specificity of CITO TEST® COVID-19 Ag have been determined in clinical studies and are: sensitivity 90.4% and specificity 99.5%.
Storage and transportation conditions
The test can be stored and transported at 2-30 ° C. The test is stable until the expiration date printed on the sealed container. The test must be in an airtight container until use. Do not freeze. Do not use after the expiration date. The test has a shelf life of 24 months.
The CITO TEST® COVID-19 Ag Rapid Test should only be used to detect SARS-CoV-2 virus antigens in nasopharyngeal swabs of persons with suspected coronavirus infection. The test can neither quantify nor increase the concentration of SARS-CoV-2 antigens in the sample.
A positive test result only indicates the presence of SARS-CoV-2 antigens in the sample and should not be the only criterion for making a diagnosis of coronavirus infection. After testing the results obtained, you should consult a doctor. The final diagnosis should be established by a doctor after clinical and additional laboratory tests.
In the event that the test result is negative and symptoms of COVID-19 are present, it is recommended to repeat the test after a few days or conduct a PCR test.
A negative test result does not exclude infection with the coronavirus, especially contact persons. Further testing by PCR should be considered.
A negative test result is possible if the sample contains coronavirus antigens at a concentration below the detection limit of the test.
Excessive blood or mucus in the sample can cause false results.
* D - time
** s - second
Made in Europe, Ukraine