Description

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, 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.

SUMMARY

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. 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%. However, RT-PCR is expensive, complex and must be performed in specialized laboratories.

 

TEST PRINCIPLE

The COVID-19 Antigen Rapid Test (Nasopharyngeal Swab) is a qualitative membrane-based immunoassay for the detection of SARS-CoV-2 Antigens 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 Antigens, 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 antigen 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.

 

REAGENTS

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.

 

STORAGE INSTRUCTIONS

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.

 

MATERIALS PROVIDED

• Test cassettes •Package insert •Sterile swabs          •Extraction Buffer
• Extraction tubes and tips (Optional) •Workstation •Procedure card

Materials required but not provided

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.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.

• Timer

 

SPECIMEN COLLECTION

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.

 

SAMPLE TRANSPORT AND STORAGE

Freshly collected specimens should be prepared as soon as possible and no later than one hour after specimen collection. Specimen already prepared may be stored at 2-8℃ for no more than 24 hours. If long-term storage is required, store at -70 ℃ and avoid repeated freeze-thaw cycles.

 

SPECIMEN COLLECTION 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 8 hours at room temperature and 24 hours at 2-8°C.
• Do not store specimens in viral transport media.

 

SPECIMEN PREPARATION

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 (Approx. 350μl). 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.

 

RESULTS

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.

 

PRECAUTIONS

1. This package insert must be read completely before performing the test. Failure to follow
2. directions in package insert may yield inaccurate test results.
3. For professional in vitro diagnostic use only. Do not use after expiration date.
4. Do not eat, drink or smoke in the area where the specimens or kits are handled.
5. Do not use test if pouch is damaged.
6. Handle all specimens as if they contain infectious agents. Observe established precautions against
7. microbiological hazards throughout in the collection, handling, storage, and disposal of patient samples and used kit contents.
8. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
9. Viral Transport Media (VTM) may affect the test result, do not store specimens in viral transport media; extracted specimens for PCR tests cannot be used for the test.
10. Wash hands thoroughly after handling.
11. Please ensure that an appropriate amount of samples are used for testing. Too much or too little
12. sample size may lead to deviation of results.
13. The used test should be discarded according to local regulations.
14. Humidity and temperature can adversely affect results.

 

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 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 indicated a positive result. Specimens were considered negative if RT-PCR indicated a negative result.

 

INTERNAL QUALITY CONTROL

Internal procedural controls are included in the test. A colored line appearing in the control region (C) is an internal positive procedural control. It confirms sufficient specimen volume and correct procedural technique. A clear background is an internal negative procedural control. If the test is working properly, the background in the result area should be white to light pink and not interfere with the ability to read the test result.

 

EXTERNAL QUALITY CONTROL

Controls are not included in this kit. However, in compliance with Good Laboratory Practice (GLP)

positive/negative controls are recommended.