SARS-COV-2 & Influenza A / B Combo Rapid Test JusChek

SARS-COV-2 & Influenza A / B Combo Rapid Test JusChek - Medical Device

Rapid test for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens and influenza A and influenza B nucleoproteins in nasal swab specimens. For in vitro self-diagnostic use.
The Combined Rapid Antigen Test for SARS-CoV-2 and Influenza A / B (Nasal Swab) is a single use test kit intended to detect the SARS-CoV-2, Influenza A and Influenza B virus which causes COVID -19 and / or influenza in self-collected nasal swab specimens. The test is intended for use in symptomatic / asymptomatic individuals 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 tract samples 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 required to determine the status of the infection. Positive results are indicative of the presence of SARS-CoV-2 and / or influenza A / B. People who test positive should self-isolate and contact their healthcare provider for additional assistance. A positive result does not rule out the presence of bacterial infection or co-infection with other viruses. A negative result does not rule out the presence of SARS-CoV-2 and / or influenza A / B infection. People who test negative and continue to exhibit symptoms of COVID-19 or the flu should contact their healthcare provider for additional assistance.

How to use

Wash your hands with soap and water for at least 20 seconds before and after the test. If soap and water are not available, use a hand sanitizer with at least 60% alcohol.
Remove the lid of the tube with the extraction buffer solution and place the tube in the rack in the box.

Nasal Swab Specimen Collection: 1. Remove the sterile swab from the pouch. Do not touch the soft end of the swab. 2. Insert the swab into the nostril until a slight resistance is felt (about 2 cm in the nose). Slowly rotate the swab, rubbing it along the inside of the nostril 5-10 times against the nasal wall. Note: This may be troublesome. If you feel severe resistance or pain, do not insert the tampon deeper. When the nasal mucosa is damaged or bleeding, nasal swab is not recommended. If you are picking up other people, wear the mask. With children, it may not be necessary to insert the tampon that deeply into the nostril. For very young children, another person may be required to hold the baby's head during the collection. 3. Gently remove the swab. 4. Using the same swab, repeat in the other nostril. 5. Remove the swab. Sample Preparation 1. Place the swab into the extraction tube, making sure it touches the bottom, and shake the swab to mix well. Press the swab tip against the tube and rotate the swab for 10-15 seconds. 2. Remove the swab by pressing the tip of the swab against the inner wall of the extraction tube. 3. Place the swab in a plastic bag. 4. Close the cap or place the cap of the tube on the tube.

Carrying out the test

1. Remove the test cassette from the sealed foil pouch and use it within one hour. The most reliable results are obtained if the test is performed immediately after opening the pouch. Place the test cassette on a flat, even surface. 2. Invert the Sample Extraction Tube and add 3 drops of the extracted sample to each well (S) of the Test Cassette, then start the timer. During the test, do not move the cassette. 3. Read the result after 10 minutes. Do not interpret the result after 20 minutes. Note: After the test is complete, place all components in a plastic bag, seal it well and dispose of it according to local regulations.

Reading the results

Communicate test results to your healthcare provider and carefully follow local guidelines / requirements to combat the spread of COVID-19.

POSITIVE to SARS-CoV-2: * two colored lines appear in the COVID-19 window. One colored line should be in the control area (C) and the other in the test area (T).

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 influence area A (A).

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 influenza B area (B). A + B three colored lines are displayed. One colored line must be in the control area (C) and the other two in the area of influence A (A) and influence B (B). * NOTE: The intensity of the color in the test area (T / B / A) will vary based on the amount of SARS-CoV-2 antigen and / or Influenza A / B present in the sample. Therefore, any shade of color in the test area (T / B / A) should be regarded as a positive result. A positive result most likely indicates the presence of a COVID-19 and / or influenza A and / or influenza B infection, but this result must be confirmed by further tests. Immediately self-isolate in accordance with local guidelines and contact your primary care physician or local health service immediately following instructions provided by local authorities. The test result will be validated with a confirmatory PCR test and the next steps to follow will be outlined.

NEGATIVE: a colored line appears in the control area (C). No obvious colored line is displayed in the test area (T / B / A). COVID-19 and / or influenza A / influenza B infection is unlikely to be present. However, this test may give an erroneous negative (false negative) result in some individuals with COVID-19 and / or influenza A / influenza B. This means that the subject may have a COVID-19 and / or influenza A / influenza B infection even if the test result is negative. Also, you can repeat the test with a new kit. If infection is suspected, repeat the test after 1-2 days, as coronavirus / influenza virus cannot be accurately detected at all stages of infection. Even if the test result is negative, regulations regarding distancing and hygiene, commuting and travel, attending events and so on must be respected, according to local guidelines / requirements relating to COVID-19 / all. 'influence.

INVALID: the control line does not appear. The most likely causes of control line failure are insufficient sample volume or incorrect procedural techniques. Read the instructions again and repeat the test, using a new product, or contact a COVID-19 swab / influenza center.

Warnings

• For in vitro self-test only. Do not use beyond the expiration date.
• Do not eat, drink or smoke in the area where specimens or kits are handled.
• Do not drink the buffer solution contained in the kit. Handle the buffer solution with care and avoid it coming into contact with the skin or eyes; in case of contact, rinse immediately with plenty of running water.
• This test kit is to be used only as a preliminary test and repeatedly abnormal results should be analyzed with your doctor or healthcare professional.
• Strictly respect the times indicated.
• Use the test only once. Do not disassemble and touch the test cassette window. - The kit must not be frozen or used after the expiration date printed on the package.
• In children, the test should be used with the help of an adult.
• Wash hands thoroughly before and after handling.
• Be sure to use an appropriate amount of sample for testing. Too much or too little of the sample could cause the results to deviate.

Limitations

1. Performance was evaluated with nasal swab specimens only, using the procedures described in this package insert.
2. The Combined Rapid Antigen Test for SARS-CoV-2 and Influenza A / B (Nasal Swab) only indicates the presence of SARS-CoV-2 and / or Influenza A / Influenza B antigens in the sample.
3. If the test result is negative or non-reactive and clinical symptoms persist, the virus may not be 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 rule out infection in these subjects.
4. Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. To rule out infection in these individuals, a confirmatory molecular test should be considered.
5. A negative result for influenza A or influenza B obtained from this kit must be confirmed by culture / RT-PCR.
6. Positive COVID-19 results 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 does not rule out underlying co-infection with another pathogen, therefore the possibility of an underlying bacterial infection should be considered.
7. Failure to follow these procedures could impair test performance.
8. If a sample is taken or handled improperly, the test could return false negative results.
9. If inadequate levels of virus are present in the sample, the test may return false negative results.

storage

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 must remain in the sealed pouch until use. Do not freeze. Do not use beyond the expiration date.

Format

Test Cassette, Package Insert, Sterile Swab, Extraction Buffer Solution, Biohazard Waste Bag (optional).