InfluenzaA+B/COVID-19AntigenTestKitUserManua
3Pages

InfluenzaA+B/COVID-19 Antigen TestKit User Manual (Dry Color Latex Immunoassay) ForSelf-testing Use If C line, T line, A line and/or B line appear, the test results are positive for both COVID-19 and influenza (as in the following case). accessories in the test kit. Tear off thesealing film on theupper part of the tube. [PRODUCTNAME] InfluenzaA+B/COVID-19 Antigen Test Kit (Dry ColorLatex Immunoassay) [PACKAGE SPECIFICATION] 1 pc/bag, 5 pcs/bag, 20 pcs/Kit, 25 pcs/Kit REF Nasal Swabs Prefilled BufferKit If only the C and T linesappear, thetest resultsare positive forCOVID-19 and negativeforinfluenza (as in thefollowing case). If C line, A line and/or B line appear, the test results are positive for influenza and negative for COVID-19 (as in the following case). [INTENDEDUSE] Influenza A+B/COVID-19 Antigen Test is an immunochromatographic assay for rapid, qualitative detection of SARS- CoV- 2 nucleocapsid & Influenza A & Influenza B antigen antigen in human nasal samples.from individuals suspected of coronavirusinfection disease (COVID-19) within the first seven days of the onset of symptoms or Influenza infection disease within the first four days by lay person. The test is to be used as an aid in the diagnosis of coronavirus infection disease (COVID-19) or Influenza infection disease, which is caused by 2019-nCoV or InfluenzaA /Influenza B antigen. The test provides preliminary test results. Negative results cannot exclude 2019-nCoV or Influenza infection and they cannot be used as the sole basis fortreatment or other management decision. This test is intended for Self-Testing by persons aged 18 years or above and also for an adult testing another person under 18 years of age. Individuals over 65 years of age should consider to seek assistance in performing the test. Based on the usability verification report, the availability of Lansion Influenza A+B/COVID-19 Antigen Test Kit(Dry ColorLatex ImmunoasFeY).meets the acceptance criteria. [TEST PRINCIPLE] InfluenzaA+B/COVID-19 Antigen Test Kit usesthe principle of antigen-antibody reaction. The testing specimen will migrateforward due to capillary action, then theanalyte of thespecimen will combine with antibody which is attached to dyed microspheres(red). This marked complex is attached to thedetection areaof immobilized antibody and the otherdyed microspheres (blue)are attached to the control area. After the detection time, judgenegative or positiveaccording to the line on thetest strip. [MATERIALS REQUIRED BUTNOT PROVIDED] 1. Clock, timer or stopwatch 2.Disposable gloves [STORAGE AND VALIDITY] Store the test kit at 4°C-30°C, with a valid period of 18 months. Teststrip is individually packaged.Test strip should be used within 1hour once thefoil pouch is opened. The reagent can be transported at room temperaturefora short time. In hot summer and winter, some protective measures should be taken to avoid high temperatureor freezing and thawing. [OPERATIONSTEPS] 1. Preparation Gently hold the swab and insert the swab into one nostril of the patient. The swab tip should be inserted up to 2.5 cm (1 inch) from the edge of the nostril. Roll the swab 5 times or more If no C line appears, the test is invalid (asin the following case). • Continue to comply with all applicable rules regarding contact with others and protective measures • Negative results do not rule out infection, particularly in those who have been in contact with patients. •If it is suspected, repeat the test after 1-2 days, as the coronavirus cannot be precisely detected in all phases of an infection • If you are experiencing COVID-19 or influenza symptoms, you must follow the guidance from your local State or Territory Health Department for guidance on confirmation testing if necessary and if unwell seek medical assistance for SARS-CoV-2 positives, and with Individuals with a positive result or who are unwell are advised to consult with a medical practitioner for follow-up clinical care for Influenza A and/or Influenza B positive results. Note: For the detection of novel coronavirus and possible subtypes (mutant strains), the changes of epitopes caused by mutation sites of Nucleocapsid Protein may reduce the analytical sensitivity of the reagent and lead to false negative results. •There is a suspicion of COVID-19 ,Flu A or Flu B •For COVID-19 positives:Follow the guidance from your local State or Territory Health Department for guidance on confirmation testing if necessary and if unwell seek medical assistance • For Influenza A and/or Influenza B positive result: Individuals with a positive result or who are unwell are advised to consult with a medical practitioner for follow-up clinical care •Continue to comply with all applicable rules regarding contact with others and protective measures •Some causes of invalid results are because of not following the directions correctly or the test may have deteriorated beyond the expiration date. •It is recommended to repeat test with a new test kit. •If the test results are still invalid, contact a doctor or a testing center for a laboratory PCR test •If symptoms persist, you should self-isolate at home and avoid contact with others prior to the re-test along the mucosa inside the nostril. Using the same swab, repeat this process for the other nostril. 3. Sample Treatment Insert the swab into the tube as soon as possible, slowly squeeze near the bottom of the Sample Extraction Tube 5 times, each lasting 2 seconds. Remove the Swab while squeezing the bottle of the tube to remove the liquid from the swab. Press the cap firmly onto the tube containing the processed sample. 4. Test Hold the extraction tubevertically and add 4 drops of treated sample in each sample port. Reaction Time: 15 minutes. Do not handle or move the strip until the 15 minutes is complete. Read the results. Note: The test is intended to be read at 15 minutes. If the test is read before this or is read more than 5 minutes after the indicated read time, results may be inaccurate (false negative, false positive, invalid) and the testshould be repeated. [INTERPRETATION OFRESULT] Negative If only C line appears, the test result is negative(as in the following case). Please read the instruction carefully before operation. Then wash hands and remove