SCREEN Description The SARS-CoV-2/Influenza A+B/RSV Antigen Rapid Combined Test is a rapid immunochromatographic assay for the qualitative detection of nucleocapsid protein antigens of SARS-CoV-2, Influenza A, Influenza B, and respiratory syncytial virus (RSV) present in the human nasopharyngeal tract. For professional in vitro diagnostic use only. The SARS-CoV-2/Influenza A+B/RSV Rapid Combined Antigen Test (Nasopharyngeal Swab) is a rapid immunochromatographic assay for the qualitative detection of nucleocapsid protein antigens of SARS-CoV-2, Influenza A, Influenza B, and Respiratory Syncytial Virus (RSV) present in the nasopharyngeal tract of individuals with suspected SARS-CoV-2/Influenza/RSV infection, in association with clinical evaluation and other laboratory tests. Results detect SARS-CoV-2, influenza A+B, and RSV nucleocapsid proteins. An antigen is generally detectable in upper respiratory tract specimens during the acute phase of an infection. Positive results indicate the presence of viral antigens, but clinical comparison with the patient’s history and other diagnostic information is required to determine the infectious status. Positive results do not exclude bacterial or viral infection. The agent detected may not be the definitive cause of the disease. Negative results do not exclude SARS-CoV-2 and/or influenza A+B/RSV infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should always be considered presumptive and confirmed by molecular testing, if necessary for patient management. Negative results should be evaluated in conjunction with the patient’s recent exposure, medical history, and the presence of clinical symptoms and signs consistent with SARS-CoV-2, influenza A+B, and RSV. The SARS-CoV-2 Antigen Rapid Test (Nasopharyngeal Swab) is a qualitative, membrane-based immunoassay for the detection of SARS-CoV-2 nucleocapsid protein in nasopharyngeal swab specimens. SARS-CoV-2 antibodies coat the test line region. During testing, the specimen reacts with the SARS-CoV-2 antibody particles coating the membrane. The compound then migrates up the membrane by capillary action and reacts with SARS-CoV-2 antibodies in the test line region. If the specimen contains SARS-CoV-2 nucleocapsid protein, a colored line appears in the test line region. If the specimen does not contain SARS-CoV-2 antigen, no colored line appears in the test line region, indicating a negative result. As a procedural control, a colored line will always appear in the control line region, indicating that an adequate volume of specimen has been used and that the membrane has been adequately saturated. The Influenza A+B Rapid Test Cassette (Nasopharyngeal Swab) is a qualitative lateral flow immunoassay for the detection of influenza A and B nucleoproteins in nasopharyngeal swab specimens. In this assay, nucleoproteins specific for influenza A and B antibodies separately coat the test line regions. During testing, the extracted specimen reacts with the influenza A and/or B antibodies coating the particles. The compound then migrates up the membrane to react with the influenza A and/or B antibodies on the membrane and produce one or two colored lines in the test region. The presence of these colored lines in one or both test regions indicates a positive result. As a procedural control, a line will always appear in the control region if the test has been performed correctly. The RSV Rapid Test Cassette (Nasopharyngeal Swab) is a qualitative lateral flow immunoassay for the detection of respiratory syncytial virus (RSV) nucleoproteins in nasopharyngeal swab specimens. In this assay, antibodies specific to RSV nucleoproteins coat the test line region. During testing, the extracted specimen reacts with the RSV antibodies coating the particles. The compound then migrates up the membrane to react with the RSV antibodies therein, producing a colored line in the test region. The presence of this colored line in the test region indicates a positive result. As a procedural control, a line will always appear in the control region if the test has been performed correctly. How to use Sample collection, transport and storage Sample collection 1. Insert a sterile swab into the patients nostril, reaching the posterior nasopharyngeal surface. 2. Massage onto the posterior nasopharyngeal surface. 3. Remove the sterile swab from the nasal cavity. Caution: If the swab breaks during sample collection, repeat the operation with a new swab. Transport and storage of samples Samples should be tested as soon as possible after collection. If samples are not being analyzed immediately, it is recommended to store them in a dry, sterile, tightly closed tube. Samples, if stored in a dry, sterile environment, are stable for up to 24 hours at 2-8°C. Sample preparation Only the extraction buffer and tubes provided in this kit may be used for sample preparation. Please refer to the Procedural Sheet for detailed information on sample collection. 1. Place the swab sample in the extraction tube with the extraction buffer. Swirl the swab for approximately 10 seconds, pressing the tip against the walls of the tube to release the antigen. 2. Remove the swab, continuing to press the tip against the wall of the extraction tube to remove as much liquid as possible. Dispose of the swab according to biohazardous materials disposal protocol. *NOTE: After extraction, the sample is stable for 2 hours at room temperature or 24 hours at 2-8°C. Instructions for use Bring the test and the extracted sample to a stable room temperature (15-30°C) before testing. 1. Remove the test from the sealed pouch and use within one hour. Best results are obtained if the test is performed immediately after opening the sealed pouch. 2. Invert the sample collection tube and apply 3 drops of extracted sample to each sample well, then start the timer. 3. Wait for the colored line(s) to appear. Read results after 15 minutes. Do not interpret results after 20 minutes. Interpretation of results SARS-CoV-2/RSV POSITIVE:* Two colored lines appear in the SARS-CoV-2/RSV window. One should be in the control region (C) and the other in the test region (T). A positive result in the test region indicates the presence of SARS-CoV-2/RSV antigens in the sample. Influenza A POSITIVE:* Two colored lines appear in the FLU window. One should be in the control region (C) and another colored line should appear in the Influenza A test region (A). A positive result in the test region indicates the presence of Influenza A antigens in the specimen. Influenza B POSITIVE:* Two colored lines appear in the FLU window. One should be in the control region (C) and the other in the test region (B). A positive result in the test region indicates the presence of influenza B antigens in the specimen. Influenza A and Influenza B POSITIVE:* three colored lines appear in the FLU window. One should be in the control region (C), and two colored lines should appear in the Influenza A test region (A) and the Influenza B test region (B). A positive result in the test region indicates the presence of Influenza A and B antigens in the specimen. *NOTE: The color intensity in the test region (T) varies depending on the amount of SARS-CoV-2, influenza A and/or B, or RSV antigen present in the sample. Therefore, any color intensity in this region (T/B/A) should be classified as positive. NEGATIVE: A single colored line appears in the control region (C). No colored line is visible in the test region (T/B/A). NULL: Control line does not appear. Insufficient volume or incorrect procedural techniques are the most likely reasons for the control line not appearing. Review the procedure and repeat the test with a new device. If the problem persists, discontinue use of the kit and contact your local distributor immediately. warnings 1. Read this entire package insert before performing the test. Failure to follow the instructions in this package insert may result in inaccurate test results. 2. In vitro diagnostic test for professional use only. Do not use after the expiration date. 3. Do not eat, drink, or smoke in the sample or kit handling area. 4. Do not use the test if the packaging is damaged. 5. Handle all specimens as if they were potentially infectious. Follow established precautions to limit microbiological risk during all phases of collection, handling, storage, and disposal of patient specimens and used kit components. 6. Wear protective clothing, such as lab coats, disposable gloves, and eye protection during specimen analysis. 7. Viral transport medium (VTM) may affect the test result; do not store specimens in VTM; specimens extracted for PCR testing cannot be used for testing. 8. Wash your hands thoroughly after handling. 9. Please ensure that an adequate amount of sample is used for testing. Too much or too little can lead to deviant results. 10. Used tests should be disposed of in accordance with local regulations. 11. Humidity and temperature can negatively affect results. limitation 1. The test procedure and instructions for interpreting results must be carefully followed when analyzing SARS-CoV-2/Influenza A/Influenza B/RSV antigens in nasopharyngeal swab specimens from suspect individuals. Proper specimen collection is essential for optimal test performance. Failure to follow the correct procedure may result in inaccurate results. 2. The performance of the SARS-CoV-2/Influenza A/Influenza B/RSV Rapid Antigen Combination Test (Nasopharyngeal Swab) has been evaluated only using the procedures described in this package insert. Modification of these procedures may alter the performance of the test. 3. The SARS-CoV-2/Influenza A/Influenza B/RSV Antigen Rapid Test (Nasopharyngeal Swab) is for in vitro diagnostic use only. This test should be used to detect SARS-CoV-2/Influenza A/Influenza B/RSV antigens in nasopharyngeal swab specimens and to aid in the diagnosis of patients suspected of having SARS-CoV-2, Influenza A, Influenza B, or RSV infection, in conjunction with clinical evaluation and other laboratory tests. This qualitative test cannot provide either a quantitative value or a rate of increase in the concentration of SARS-CoV-2, Influenza A, Influenza B/RSV antigens. 4. The SARS-CoV-2/Influenza A/Influenza B/RSV Antigen Rapid Test (Nasopharyngeal Swab) only indicates the presence of SARS-CoV-2, Influenza A, Influenza B, or RSV antigens in the specimen and should not be used as the sole criterion for diagnosing SARS-CoV-2, Influenza A/B/RSV infections. 5. The results obtained with this test should be evaluated in conjunction with other clinical results from other laboratory tests and analyses. 6. If the test result is negative or non-reactive and clinical symptoms persist, it is recommended to repeat the test after a few days with a new kit or molecular diagnostic equipment to rule out infection in these individuals. 7. The test will give negative results under the following conditions: a) the concentration of the antigens of the new Coronavirus, influenza A virus, influenza B virus or RSV virus in the sample is below the minimum detection limit of the test; b) The optimal time for assessment (maximum virus concentration) after infection has not been verified, so taking samples at different times from the same patient may help avoid false negative results; c) inadequate collection and storage of samples. 8. Negative results do not rule out SARS-CoV-2 infection, especially in individuals who have been in contact with the virus. Additional testing with molecular diagnostic tools is recommended to rule out infection in these individuals. 9. A negative result for influenza A, B or RSV obtained with this kit must be confirmed by RT-PCR culture. 10. Positive results for SARS-CoV-2 may be due to infection with non-SARS-CoV-2 coronavirus strains or other interfering factors. A positive result for influenza A and/or B and RSV does not exclude co-infection with other pathogens and therefore the possibility of a pre-existing bacterial infection should be assessed. Conservation Store in the sealed pouch at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch. The test should remain in the sealed pouch until use. Do not freeze. Do not use after the expiration date. Format Test cassettes, extraction buffer, procedure sheet, leaflet, extraction tubes and tips, sterile swabs, work base.