JusChek
Combined Rapid Antigenic Test
For SARS-CoV-2 and influenza A/B (nasal swab)
Description
Rapid test for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens and influenza A and influenza B nucleoproteins in nasal buffer samples.
The test is intended for use in symptomatic/asymptomatic subjects with suspected COVID-19 infection and/or influenza A/B.
The results indicate the detection of SARS-CoV-2 nucleocapsid protein antigens and influenza A and B nucleoproteins. An antigen is generally detectable in upper respiratory pathway samples during the acute phase of infection.
Positive results indicate the presence of viral antigens, but a clinical correlation with the patient's medical history and other diagnostic information is necessary to determine the state of the infection. Positive results are indicative of the presence of SARS-CoV-2 and/or influenza A/B. Those who test positive must self-isolate and turn to their health care provider for additional assistance. A positive result does not exclude the presence of bacterial infection or co-infection with other viruses. A negative result does not exclude the presence of infection with SARS-CoV-2 and/or influenza A/B.
Those who test negative and continue to experience symptoms of COVID-19 or influenza should contact their healthcare provider for additional assistance.
For self-diagnostic use in vitro.
How to use
Sample levy
Wash hands with soap and water for at least 20 seconds before and after the test. If no soap and water is available, use a hand sanitizer with at least 60% alcohol.
Remove the sterile swab from the case. Do not touch the soft end of the tampon. Insert the tampon into the nostril until you feel a slight resistance (about 2 cm deep in the nasal cavity). Slowly rotate the tampon, rubbing it along the inside of the nostril for 5-10 times. This may be annoying. If you feel strong resistance or pain, do not insert the tampon deeper.
When the nasal mucosa is damaged or bleeding, nasal swab sampling is not recommended.
If you pick up other people, wear a mask.
With children, you may not need to insert the tampon so thoroughly into the nostril. For very young children, you may need another person to keep the child's head during the pick.
Gently remove the tampon. Using the same tampon, repeat the procedure in the other nostril.
Pull out the tampon.
Sample preparation
Remove the tube lid with the extraction buffer solution and place the test tube in the tube holder in the box.
Place the tampon in the extraction tube, making sure it touches the bottom, and shake the tampon to mix well. Press the tip of the tampon against the test tube and rotate the tampon for 10-15 seconds. Remove the tampon by pressing the tip of the tampon against the inner wall of the extraction tube.
Place the tampon in a plastic bag. Close the extraction tube.
Execution of the test
Remove the test box from the sealed aluminum bag and use it within an hour. The most reliable results are obtained if the test is carried out immediately after the envelope is opened.
Place the test box on a flat and even surface. Flip the sample extraction tube and add 3 drops of extracted sample to each well (S) of the test box, then start the timer. During the test, do not move the cassette.
Read the result after 10 minutes. Do not interpret the result after 20 minutes.
Interpretation of results
Communicate the test results to your health care provider and carefully follow local COVID-19 spread contrast guidelines/requirements.
POSITIVE to SARS-CoV-2: One colored line must be in the control area (C) and the other in the test area (T). The color intensity in the test area (T) will vary based on the amount of SARS-CoV-2 antigen present in the sample. Therefore, any color shade in the test area (T) should be considered as a positive result.
A positive result most likely indicates the presence of a COVID-19 infection, but this result should be confirmed by further tests. Immediately put yourself into self-isolation in accordance with local guidelines and contact your GP or local health service immediately following instructions given by local authorities. The test result will be validated with a confirmatory PCR test and the next steps to follow will be explained.
POSITIVE to Influenza A: Two colored lines are displayed in the FLU A B window. One colored line must be in the control area (C) and the other in the area of influenza A (A). The intensity of the color in the test area (A) will vary according to the amount of influenza A antigen present in the sample. Therefore, any color shade in the test area (A) should be considered as a positive result.
A positive result most likely indicates the presence of influenza A infection, but this outcome must be confirmed by further tests. Immediately put yourself into self-isolation in accordance with local guidelines and contact your GP or local health service immediately following instructions given by local authorities. The test result will be validated with a confirmatory PCR test and the next steps to follow will be explained.
POSITIVE to Influenza B: Two colored lines are displayed in the FLU A B window. One colored line must be in the control area (C) and the other in the area of influenza B (B). The intensity of the color in the test area (B) will vary according to the amount of influenza B antigen present in the sample. Therefore, any color shade in the test area (B) should be considered as a positive result.
A positive result most likely indicates the presence of a influenza B infection, but this outcome must be confirmed by further tests. Immediately put yourself into self-isolation in accordance with local guidelines and contact your GP or local health service immediately following instructions given by local authorities. The test result will be validated with a confirmatory PCR test and the next steps to follow will be explained.
POSITIVE to Influenza A and Influenza B: Three colored lines are displayed in the FLU A B window. One colored line must be in the control area (C) and the other two in the area of influenza A (A) and influenza B (B). The intensity of the color in the test area (A/B) will vary according to the amount of influenza A/B antigen present in the sample. Therefore, any color shade in the test area (A/B) should be considered as a positive result.
A positive result most likely indicates the presence of influenza A and influenza B infection, but this outcome must be confirmed by further tests. Immediately put yourself into self-isolation in accordance with local guidelines and contact your GP or local health service immediately following instructions given by local authorities. The test result will be validated with a confirmatory PCR test and the next steps to follow will be explained.
NEGATIVE: A colored line appears in the control area (C). No obvious colored line is displayed in the test area (T/B/A).
An infection with COVID-19 and/or influenza A/influenza B is unlikely to be present. However, it is possible that this test provides an incorrect negative result (false negative) in some subjects with COVID-19 and/or influenza A/influenza B. This means that the subject may have an infection with COVID-19 and/or influenza A/influenza B even if the test is negative. In addition, you can repeat the test with a new kit.
In case of suspected infection, repeat the test after 1-2 days, since it is not possible to accurately detect the coronavirus/influenza virus at all stages of infection.
Even if the test result is negative, it is necessary to comply with the standards of distancing and hygiene, travel and travel, event participation, and so on, according to the local guidelines/requirements for COVID-19/influenza.
NOT VALID: The control line does not appear. The most likely causes of the non-appearance of the control line are insufficient sample volume or incorrect procedural techniques.
Read the instructions again and retest, using a new kit, or contact a COVID-19/flu swab center.
Warnings
In vitro self-test only. Do not use beyond the expiration date.
Before performing the test, read all the information in the package leaflet.
Do not eat, drink or smoke in the area where samples or kits are handled.
Do not drink the extraction solution contained in the kit. Handle the extraction solution with care and prevent it from coming into contact with skin or eyes; in case of contact, rinse immediately with plenty of running water.
If the aluminum packaging is damaged or has been opened, do not use the product.
This test kit should only be used as a preliminary test, and repeatedly abnormal results should be analyzed with the doctor or a healthcare provider.
Strictly abide by the times indicated.
Use the test only once. Do not disassemble and touch the test box window.
The kit should not be frozen or used after the expiration date printed on the packaging.
In children, the test should be performed with the help of an adult.
Wash hands thoroughly before and after manipulation.
Be sure to use an appropriate amount of sample for testing. An excessive or insufficient amount of sample could cause a deviation of the results.
Performance was evaluated only with nasal swab samples, employing the procedures described in the package leaflet.
The test only indicates the presence of SARS-CoV-2 and/or influenza A/influenza B antigens in the sample.
If the test result is negative or non-reactive and clinical symptoms persist, it is possible that the virus is not detected in the very early stages of infection. It is recommended to repeat the test with a new device or with a molecular diagnostic tool to exclude infection in these subjects. Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. To exclude infection in these subjects, a confirmatory molecular test should be considered.
A negative result for influenza A or influenza B obtained from this kit should be confirmed by culture/RT-PCR.
COVID-19 positive results may be due to infection with non-SARS-CoV-2 coronavirus strains or other interference factors. A positive result for influenza A and/or B does not exclude co-infection with another pathogen, therefore the possibility of a underlying bacterial infection should be considered.
Failure to follow test procedures could alter test performance.
If a sample is taken or manipulated improperly, the test could give false negative results.
If there are virus levels below the test detection limit in the sample, the test may return false negative results.
storage
Store in sealed packaging at room temperature or in a refrigerator (2-30 °C). Do not freeze.
The test is stable until the expiration date printed on the sealed envelope. The test must remain in the sealed envelope until use.
Validity with intact packaging: 24 months.
Format
The kit contains:
-Test cassette;
-Sterile buffer;
-Package leaflet;
-Extraction solution.
Bibliography
1. Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 7). National Health Commission & National Administration of Traditional Chinese Medicine.2020.
2. Williams, KM, Jackson MA, Hamilton M. (2002) Rapid Diagnostic Testing for URIs in Children; Impact on Physician Decision Making and Cost. Infec. Come on. 19(3): 109-111.
Cod. ISIN-525H