Testsealabs COVID-19 Antigen & Flu A&B rapid test kit

Short Description:

The Testsealabs COVID-19 Antigen + Flu A&B rapid test is intended for use in the simultaneous rapid in vitro detection and differentiation of influenza A virus, influenza B virus, and COVID-19 virus nucleocapsid protein antigen , but does not differentiate, between SARS-CoV and COVID-19 viruses and is not intended to detect influenza C antigens. Performance characteristics may vary against other emerging influenza viruses.


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You can use Testsealabs COVID-19 Antigen + Flu A&B rapid test kit by yourself

Cassette Intended Use

Influenza A, influenza B, and COVID-19 viral antigens are 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 COVID-19 results, from patients with symptom onset beyond five days, should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed. Negative results do not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. 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.Negative results do not preclude influenza virus infections and should not be used as the sole basis for treatment or other patient management decisions.

Principle

The Flu A/B + COVID-19 Antigen Combo Test Cassette is a qualitative membrane strip based immunoassay for the detection of influenza A virus, and influenza B virus, COVID-19 virus in nasopharyngeal swab specimen.

For Flu A/B Test Cassette: In this test procedure, anti-influenza A antibody, and anti-influenza B antibody is immobilized in the differrnt test line regions of the device. After a nasopharyngeal swab specimen specimen is placed in the specimen well, it reacts with anti-influenza A antibody, or anti-influenza B antibody coated particles that have been applied to the specimen pad. This mixture migrates chromatographically along the length of the test strip and interacts with the immobilized anti-influenza A antibody or anti-influenza B antibody. If the specimen contains influenza A virus, or influenza B virus, a colored line will appear in the corresponding test line region indicating a positive result. If the specimen does not contain influenza A virus and influenza B virus, a colored line will not appear in these regions indicating a negative result. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

For COVID-19 Antigen Test Cassette: In this test procedure, anti-COVID-19-N antibody is immobilized in the differrnt test line regions of the device. After a nasopharyngeal swab specimen specimen is placed in the specimen well, it reacts with anti-COVID-19-N antibody coated particles that have been applied to the specimen pad. This mixture migrates chromatographically along the length of the test strip and interacts with the immobilized antiCOVID-19-N antibody. If the specimen contains COVID-19 virus, a colored line will appear in the corresponding test line region indicating a positive result. If the specimen does not contain COVID-19 virus, a colored line will not appear in the region indicating a negative result. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

Specimen Collection And Preparation

Swab Specimen collection

1. Only the swab provided in the kit is to be used for nasopharyngeal swab collection. To collect a nasopharyngeal wab sample, carefully insert the swab into the nostril exhibiting the most visible drainage, or the nostril that is most congested if drainage is not visible. Using gentle rotation, push the swab until resistance is met at the level of the turbinates (less than one inch into the nostril). Rotate the swab 5 times or more against the nasal wall then slowly remove from the nostril. Using the same swab, repeat sample collection in the other nostril.
2. Flu A/B + COVID-19 Antigen Combo Test Cassette can be applied to nasopharyngeal swab.
3. Do not return the nasopharyngeal swab to the original paper packaging.
4. For best performance, direct nasopharyngeal swabs should be tested as soon as possible after collection. If immediate testing is not possible, and to maintain best performance and avoid possible contamination, it is highly recommended the nasopharyngeal swab is placed in a clean, unused plastic tube labeled with patient information, preserving sample integrity, and capped tightly at oomtemperature (15-30°C) for up to 1 hour prior to testing. Ensure the swab fits securely within the tube and the cap is tightly closed. If greater than 1 hour delay occurs, dispose of sample. A new sample must be collected for testing.
5. If specimens are to be transported, they should be packed in compliance with local regulations covering the transportation of etiological agents.

Materials

Materials provided
● Test devices
● Extraction buffer
● Extraction Tubes
● Package insert
● Swab
● Work station

Material srequired but not provided
● Timer

Directions For Use

Allow the test, specimen, buffer and/or controls to reach room temperature 15-30℃ (59-86℉) prior to testing.

1. Place the Extraction Tube in the workstation. Hold the extraction reagent bottle upside down vertically. Squeeze the bottle and let the solution drop into the extraction tube freely without touching the edge of the tube. Add 10 drops of solution to the Extraction Tube.
2.Place the swab specimen in the Extraction Tube. Rotate the swab for approximately 10 seconds while pressing the head against the inside of the tube to release the antigen in the swab.
3.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.
4.Cover the tube with cap,then add 3 drops of the sample into the left sample hole vertically and add another 3 drops of the sample into the right sample hole vertically.
5.Read the result after 15 minutes. If left unread for 20 minutes or more the results are invalid and a repeat test is recommended.

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Interpretation Of Results

Interpretation of Flu A/B results(On the left)

Influenza A Virus POSITIVE:* Two colored lines appear. One colored line should always appear in the control line region (C) and another line should be in the Flu A line region (2).
Influenza B Virus POSITIVE:* Two colored lines appear. One colored line should always appear in the control line region (C) and another line should be in the Flu B line region(1).
Influenza A Virus andInfluenza B Virus POSITIVE:* Three colored lines appear. One colored line should always appear in the control line region (C) and two test lines should be in the Flu A line region (2) and Flu B line region(1)
*NOTE: The intensity of the color in the test line regions may vary depending on the concentration of influenza A virus and influenza B virus present in the specimen. Therefore, any shade of color in the test line region should be considered positive.
Negative: One colored line appears in the control region(C).No apparent colored line appear in the test line regions.
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 device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

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Interpretation of COVID-19 antigen results(On the right)

Positive: Two lines appear. One line should always appear in the control line region(C), and another one apparent colored line should appear in the test line region(T).
*NOTE: The intensity of the color in the test line regions may vary depending on the concentration of COVID-19 antigen present in the specimen. Therefore, any shade of color in the test line region should be considered positive.
Negative: One colored line appears in the control region(C).No apparent colored line appear in the test line region(T).
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 device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

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COVID-19 antigen results


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