COVID-19 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab),SARS-CoV-2 Nucleocapsid protein
COVID-19 and Influenza A+B Antigen Combo Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 Nucleocapsid protein, Influenza A and Influenza B virus antigens present in human nasopharynx.
For research use only.
|COVID-19 And Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab),SARS-CoV-2 Nucleocapsid Protein
The COVID-19 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 Nucleocapsid protein, Influenza A and Influenza B virus antigens in nasopharyngeal swab specimens from individuals with suspected SARS-CoV-2/Influenza infection in conjunction with clinical presentation and the results of other laboratory tests.
Results are for the detection of SARS-CoV-2 Nucleocapsid protein and Influenza A+B Antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.
Negative results do not preclude SARS-CoV-2/ Influenza A+B infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if
necessary for patient management. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19/ Influenza A+B.
The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.
Influenza (commonly known as ‘flu’) is a highly contagious, acute viral infection of the respiratory tract. It is a communicable disease easily transmitted through the coughing and sneezing of aerosolized droplets containing live virus.1 Influenza outbreaks occur each year during the fall and winter months. Type A viruses are typically more prevalent than type B viruses and are associated with most serious influenza epidemics, while type B infections are usually milder.
The gold standard of laboratory diagnosis is 14-day cell culture with one of a variety of cell lines that can support the growth of influenza virus.2 Cell culture has limited clinical utility, as results are obtained too late in the clinical course for effective patient
intervention. Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) is a newer method that is generally more sensitive than culture with improved detection rates over culture of 2-23%.3 However, RT-PCR is expensive, complex and must be performed in specialized laboratories.
The COVID-19 Antigen Rapid Test (Nasopharyngeal Swab) is a qualitative membrane-based immunoassay for the detection of SARS-CoV-2 Nucleocapsid protein in human nasopharyngeal swab specimen. SARS-CoV-2 antibody is coated in test line region. During testing, the specimen reacts with SARS-CoV-2 antibody-coated particles in the test. The mixture then migrates upward on the membrane by capillary action and reacts with the SARS-CoV-2 antibody in test line region. If the specimen contains SARS-CoV-2 Nucleocapsid protein, a colored line will appear in test line region as a result of this. If the specimen does not contain antigens to SARS-CoV-2, no colored line will appear in the test line region, indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
The Influenza A+B Rapid Test (Nasopharyngeal Swab) is a qualitative, lateral flow immunoassay for the detection of Influenza A and Influenza B nucleoproteins in human nasopharyngeal swab specimen. In this test, antibody specific to the Influenza A and
Influenza B is separately coated on the test line regions of the test. During testing, the extracted specimen reacts with the antibody to Influenza A and/or Influenza B that are coated onto particles. The mixture migrates up the membrane to react with the antibody to Influenza A and/or Influenza B on the membrane and generate one or two colored lines in the test regions. The presence of this colored line in either or both of the test regions indicates a positive result. To serve as a procedural control, a colored line will always appear in the control region if the test has performed properly.
STORAGE AND STABILITY
Store as packaged in the sealed pouch at room temperature or refrigerated (2-30°C). The test is stable through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.
SPECIMEN COLLECTION, TRANSPORT AND STORAGE
1. Insert a sterile swab into the nostril of the patient, reaching the surface of the posterior nasopharynx.
2. Swab over the surface of the posterior nasopharynx.
3. Withdraw the sterile swab from the nasal cavity.
Caution: If the swab stick breaks during specimen collection, repeat specimen collection with a new swab.
Specimen transport and storage
Specimens should be tested as soon as possible after collection. If swabs are not been processed immediately, it is highly recommended the swab sample is placed into a dry, sterile, and tightly sealed plastic tube for storage. The swab specimen in dry and sterile condition is stable for up to 24 hours at 2-8°C.
Only the extraction buffer and tubes provided in the kit is to be used for swab specimen preparation.
Please refer to the Procedure card for detailed information of Specimen Extraction.
1. Place the swab specimen in the Extraction tube with Extraction Buffer. Rotate the swab for approximately 10 seconds while pressing the head against the inside of the tube to release the antigen in the swab.
2. Remove the swab while squeezing the swab head against the inside of the Extraction tube as you remove it to expel as much liquid as possible from the swab. Discard the swab in accordance with your biohazard waste disposal protocol.
*NOTE: The storage of the specimen after extraction is stable for 2 hours at room temperature or 24 hours at 2-8°C.
The test contains anti-SARS-COV-2, anti-Influenza A and anti-Influenza B as the capture reagent, anti-SARS-COV-2, anti-Influenza A and anti-Influenza B as the detection reagent.
DIRECTIONS FOR USE
Allow the test, extracted specimen and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
1. Remove the test cassette from the sealed foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch.
2. Invert the specimen extraction tube and add 3 drops of extracted specimen (approx.75-100μl) to each of the specimen well(S) respectively and then start the timer.
3. Wait for the colored line(s) to appear. Read the result at 15 minutes. Do not interpret the result after 20 minutes.
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
POSITIVE COVID-19:* Two distinct colored lines appear in the left window. One colored line should be in the control region (C) and another colored line should be in the Test region (T). Positive result in the Test region indicates detection of COVID-19 antigens in the sample.
POSITIVE Influenza A:* Two distinct colored lines appear in the right window.
One colored line should be in the control region (C) and another colored line should be in the Influenza A region (A). A positive result in the Influenza A region indicates that Influenza A antigen was detected in the sample.
POSITIVE Influenza B:* Two distinct colored lines appear in the right window.
One colored line should be in the control region (C) and another colored line should be in the Influenza B region (B). A positive result in the Influenza B region indicates that Influenza B antigen was detected in the sample.
POSITIVE Influenza A and Influenza B:* Three distinct colored lines appear in the right window. One colored line should be in the control region (C) and two colored line should be in the Influenza A region (A) and Influenza B region (B). A positive result in
the Influenza A region and Influenza B region indicates that Influenza A antigen and Influenza B antigen were detected in the sample.
*NOTE: The intensity of the color in the test line region (T) will vary based on the amount of COVID-19 antigen, Flu A and/or B antigen present in the sample. So any shade of color in the test region (T/B/A) should be considered positive.
NEGATIVE: One colored line appears in the control region (C). No apparent colored line appears in the test line region (T/B/A).
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test Cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
Sensitivity, Specificity and Accuracy
The COVID-19 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab) has been evaluated with specimens obtained from the patients.
RT-PCR(Nasopharyngeal Swab) is used as the reference method for the COVID-19 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab). Specimens were considered positive if RT-PCR(Nasopharyngeal Swab) indicated a positive result.
Specimens were considered negative if RT-PCR(Nasopharyngeal Swab) indicated a negative result.