Cito Test Combo Ag Covid-19- Influenza A and B rapid test #1

Recommendations for use

CITO TEST® COMBO Ag COVID-19 - FLU is a rapid test for the qualitative detection of coronavirus antigens (SARS-CoV-2) and influenza A and B viruses in nasopharyngeal swabs of individuals with suspected coronavirus infection and influenza A or B.

For self-control.

IMPORTANTLY

Please follow the instructions for use to obtain accurate results. There are many reasons for obtaining false results.

After testing, you should consult a doctor with the results. The final diagnosis should be established by a doctor after conducting clinical and additional laboratory tests.

General properties

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 lesion of the upper respiratory tract and general intoxication.

Influenza is an acute respiratory viral disease with a droplet transmission mechanism, characterized by an acute onset, predominantly affecting the upper respiratory tract, and accompanied by severe intoxication and fever.

The novel coronavirus infection COVID-19 and influenza have similar clinical presentations. Both cause respiratory illness that can range from mild to severe and even fatal.

People of all ages are susceptible to infection, especially those with weakened immune systems. People over 60 years of age, especially those living in nursing homes, with chronic lung disease, with cardiovascular disease, diabetes, kidney failure and liver disease, with HIV/AIDS, those with cancer, those who have recently undergone transplantation, pregnant women are at risk of COVID-19. Children have a milder form of coronavirus infection and often have an asymptomatic course, therefore they play an important role in the transmission of coronavirus. While the susceptibility to influenza in children is very high. Children, people over 60 years of age, pregnant women and people with chronic diseases are at risk of influenza.

Complications that develop as a result of both coronavirus infection and influenza pose a serious threat to human health and life. In order to avoid complications, it is necessary to diagnose the disease in a timely manner and seek medical help.

Rapid tests are used as a preliminary screening diagnosis for coronavirus infection and influenza.

The CITO TEST® COMBO Ag COVID-19 - FLU rapid test detects coronavirus (SARS-CoV-2) antigens, as well as influenza A and B viruses in samples obtained from the upper respiratory tract during the acute phase of infection. The test may be useful for identifying new cases of the disease for early self-isolation of the patient and his contacts in order to limit the spread of infection, screening the most vulnerable population groups, conducting differential diagnostics of coronavirus infection and influenza for the justified appointment of timely and correct treatment by your doctor.

Equipment

Reservation

• For self-control.
• Do not use after the expiration date.
• Do not eat, drink or smoke in the testing area.
• Do not use the test if the integrity of the packaging is damaged.
• Use only the components provided with the test for testing.
• The testing procedure and interpretation of the test result must be strictly followed. Proper specimen collection is critical to the performance of the test. Failure to follow the procedure may result in inaccurate results.
• Samples should be handled as potentially infectious material. If a third party collects the sample, they 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.

PRINCIPLE OF THE METHOD

The rapid test for the detection of coronavirus antigens, influenza A and B viruses is a high-quality rapid analysis with visual recording of test results.

The principle of the test is based on the binding of antibodies to the antigen in a specific way. During testing, the sample reacts with reagents that have been previously applied and dried on the test membrane. The mixture then migrates along the test under the action of capillary force. In the case of a positive result, the reagents present in the test result area will capture the mixture, resulting in the formation of test lines. The mixture will continue to move along the membrane in the direction of the control area where the control line always appears. The presence of the control line serves as confirmation of a sufficient amount of sample used, filling the membrane capillaries, and also as an internal quality control for the reagents.

Method of application

Sample collection

Instructions for using a tampon.

1. Tilt your head back about 45-70°.
2. Gently insert the tip of the sterile swab into the nostril and advance it along the outer wall of the nose parallel to the palate to a depth of approximately 5 cm (cm) for adults and 3 cm (cm) for children until you feel resistance against the back wall of the pharynx.
3. Make rotational movements with the swab inside for a few seconds* to soak the swab with the secretion.

Sample preparation

5. Unscrew the cap of the buffer tube.

6. Insert a sterile swab into the buffer tube. Press it against the inside wall of the tube and rotate the swab for approximately 10 s (s) while pressing the swab against the inside wall of the tube.

7. Remove the swab by squeezing the walls of the tube to extract the maximum amount of fluid from the swab.

8. Close the tube with a cap.

TESTING PROCEDURE

1. Open the sealed pouch, remove the test cassette from the packaging and use within 1 h. For best results, test immediately after opening the packaging.
2. Place the test cassette on a clean and flat surface.
3. Unscrew the top of the sample tube cap, invert it and add 3 drops of the mixture to each window of the cassette marked with the letter (S). Start the timer.
4. Read the result after 15 min. Do not take into account the test results later than 20 min.

ACCOUNTING OF THE RESULT

POSITIVE for COVID-19:** Two colored lines appear in the left test window. One colored line should appear in the control region (C) and the other in the test region (T). A positive result indicates the presence of coronavirus antigens in the specimen.

POSITIVE for Influenza A:** two colored lines appear in the right test window. One colored line should appear in the control region (C) and the other in the Influenza A result region (A). A positive result indicates the presence of Influenza A antigens in the specimen.

POSITIVE for Influenza B:** two colored lines appear in the right test window. One colored line should appear in the control region (C) and the other in the Influenza B result region (B). A positive result indicates the presence of Influenza B antigens in the specimen.

POSITIVE for Influenza A and B:** three colored lines appear in the right test window. One colored line should appear in the control region (C) and two other colored lines should appear in the result region for Influenza A and Influenza B. A positive result indicates the presence of Influenza A and Influenza B antigens in the specimen.

**NOTE:

The intensity of the lines in the test regions may vary depending on the concentration of virus antigens in the specimen. Therefore, the appearance of a colored line of any intensity in the test region should be considered a positive result.

NEGATIVE: One colored line appears in the control region (C). No lines appear in the test region (T/B/A)

INVALID: Control line does not appear. The reason for an invalid test result may be insufficient sample amount used, non-compliance with the testing procedure, non-compliance with the expiration dates and storage conditions of rapid tests. If an invalid test result is obtained, the study must be repeated using a different test cassette.

Storage conditions

The test can be stored and transported at 2-30°C. The test is stable until the expiration date indicated on the sealed pouch. The test should remain in the sealed pouch until use. Do not freeze. Do not use after the expiration date. The test has a shelf life of 24 months.

QUALITY CONTROL

The test is equipped with an internal quality control. The colored lines that appear in the control region (C) of the test strips are the internal control of the procedure. Their presence confirms the use of a sufficient amount of specimen and the correct performance of the testing procedure.

Technical specifications

The sensitivity and specificity of CITO TEST® COMBO Ag COVID-19 - FLU have been determined in clinical studies. The sensitivity for detecting coronavirus antigens (SARS-CoV-2) is 97.7%; for detecting influenza A virus antigens – 97.0%; for detecting influenza B virus antigens – 94.6%. The specificity for detecting coronavirus antigens (SARS-CoV-2) is 99.0%; for detecting influenza A virus antigens – 99.4%; for detecting influenza B virus antigens – 99.4%.

LIMITATION

1. A positive test result only indicates the presence of SARS-CoV-2/influenza A and B antigens in the sample and should not be the sole criterion for diagnosing coronavirus infection or influenza. After testing with the results obtained, a doctor should be consulted. The final diagnosis should be established by a doctor after clinical and additional laboratory tests.
2. In case the test result is negative and clinical symptoms of the disease are present, it is recommended to repeat the test after a few days or to perform PCR testing. A negative test result is possible if the sample contains coronavirus/influenza A and B antigens in a concentration below the detection limit of the test.
3. A negative test result does not rule out coronavirus infection, especially in contacts. Further testing using PCR should be considered.
4. A negative result for influenza A or B obtained with this test must be confirmed by PCR or culture.
5. Positive results for COVID-19 may be due to infection with other types of coronavirus, or the influence of other factors. A positive result for influenza A and/or B is possible in case of concomitant bacterial infection.
6. Excess blood or mucus in the sample may result in false positive results.

*s – second

Location of the legal entity: LLC "NVC "PHARMASCO": 03193, Kyiv, Dmytra Lutsenko St., building 10