Flu a/B & Covid-19 AG Combo Test (Lateral Flow Immunoassay)

• Customization: Available
• Type: Test Strips & Test Tube
• Material: Plastic
• Model NO.: LK-TC11
• Ethylene Oxide Sterilization: Ethylene Oxide Sterilization
• Quality Guarantee Period: Two Years
• Group: Adult
• Logo Printing: Without Logo Printing
• Transport Package: Carton
• Specification: 20pcs/box
• Trademark: Likang
• Origin: China
• HS Code: 3822001020
• Production Capacity: 30000000

Product Description

Product Application

    Flu A/B & COVID-19 Ag Combo Test (Lateral Flow Immunoassay) uses Immunochromatographic Assay (ICA) technology which is intended for the in vitro qualitative detection of the SARS-CoV-2 and (or) Influenza A/B virus antigen nucleocapsid (N) protein in human nasal swab, nasopharyngeal swab, oropharyngeal swab samples. SARS-CoV-2 with envelope and round or oval particles is a new type of coronavirus within the genus of betacoronaviruses. Respiratory droplet transmission and contact transmission are the main transmission routes. The population is generally susceptible, the incubation period is generally 3 to 7 days, a few cases exceed 14 days, and there is infectiousness during the incubation period. Nucleocapsid protein (N protein) is an important conserved structural protein of SARS-CoV-2. It plays a key role in the process of virus assembly, replication and protein translation. It can usually be detected in upper respiratory tract specimens in the acute phase of infection. Influenza, commonly known as "Flu", is an acute respiratory infectious disease caused by influenza virus, which is infectious and mainly transmitted by coughing and sneezing. Generally, the autumn and winter seasons are high incidence periods. It is divided into influenza A, influenza B and influenza C. Among them, influenza A viruses have extremely strong variability and cause worldwide pandemics many times. The antigen-specific variation of influenza virus is mainly the variation of surface antigens HA and NA. Nucleoprotein is an important conserved structural protein of influenza virus, which plays a key role in the process of virus assembly, replication and protein translation, and is detected in the upper respiratory tract samples at the acute stage of infection. Different viral variants are usually detected by the N protein.
    This kit can be used for the clinical diagnosis of patients with the novel coronavirus infection. A negative result needs to be supplemented by PCR testing and is not the only criterion for clinical diagnosis.

 

Clinical Studies

[Testing Principle]
This kit uses microsphere immunochromatography technology, which is composed of mouse anti SARS-CoV-2 and (or) influenza A/B N protein antibody nitrocellulose membrane and N protein antibody labeled microspheres and other reagents. During detection, if SARS-CoV-2 and (or) influenza A/B is present in the sample, after the sample is processed, the microsphere antibody will specifically bind to the SARS-CoV-2 and (or) influenza A/B N protein to form a complex. This complex moves forward along the test strip due to the chromatographic effect and is captured by the mouse anti-N protein antibody in the testing line where forms a sandwich complex and agglomerates to develop color. If it is a negative specimen, it cannot form a complex and cannot be captured by a specific antibody in the detection area, so it does not develop color. Regardless of whether there is SARS-CoV-2 and (or) influenza A/B in the sample, a colored bar will appear at the quality control line (C) as an internal control standard for whether the chromatography process is normal and whether the reagent is invalid.

[Components] 

[Storage Conditions and Validity Period]
1. The kit should be stored at 2~30°C and keep away from light. The validity period is 12 months.
2. If the test card is unused, it must be immediately put back into the packaging bag with desiccant and sealed for storage.
3. Production date and expiration date are shown on the label.

[Sample Requirements]
1. This kit is limited to the detection of human nasal swabs, nasopharyngeal swabs, oropharyngeal swabs, etc.
2. Collection requirements:
Nasal swab: When collecting a nasal swab sample, carefully insert the swab into the nostril with the most secretions. Rotate gently and push the cotton swab until the resistance is encountered. Rotate the swab against the nasal wall several times, and then remove the swab from the nostril;
Nasopharyngeal swab: The subject cleans the nasal cavity in advance. After gently insert the nasopharyngeal swab through the subject's nostrils, it goes deep perpendicular to the surface of the head or face, from the lower nasal passage to the posterior wall of the nasopharynx. The nasopharyngeal swab should be twisted on the nasopharyngeal mucosa, and kept for 10-15 seconds, and then take it out;
Oropharyngeal swab: The subject cleans the oral cavity in advance. Use a tongue depressor (spatula) to depress the tongue. The swab crosses over the subject's tongue to the posterior wall of pharyngeal and the crypts and sidewalls of tonsil etc. Repeatedly wipe 3 to 5 times to collect mucosal cells.

3. The sample can be stored at room temperature for 8 hours. If it's not available for testing immediately, it can be stored at 2~8ºC for 7 days.
 

Installation Instructions

[Assay Procedure]
1. Reagent preparation: Equilibrate kit components and the collected specimen to room temperature.
2. Sample collection: According to [Sample Requirements], use the swab to collect Nasopharyngeal or Oropharyngeal samples. 3. Measurement steps: Open the sample processing solution bottle,add the solution into it, and put the swab in the buffer. The head of the swab should be completely immersed in the SPS. Stir 3~5 times,break off the swab head, replace the cap securely and wait for 1 minute (if it is an unbreakable swab, remove it and perform disinfection treatment).
4. Measurement steps: Add 80~120μL (4~5 drops) of sample storage solution to the two sample holes and start timing. Wait for the red band to appear, the result should be interpreted within 15-30 minutes, and the result is invalid after 30 minutes.

[Interpretation of Test Results]
This product judges the result by whether there is a ribbon appears on the testing line and the quality control line. Regardless of whether there is SARS-CoV-2 and (or) Influenza A/B in the test sample, the quality control line (C) will show a good band. If there is no color band on the quality control line (C), consider whether the operation is wrong or whether the reagent is abnormal, and the test should be repeated. The SARS-CoV-2 testing line (T) is used to determine whether the sample may contain SARS-CoV-2 N protein, the Influenza A+B testing line (B) is used to determine whether the sample may contain Influenza B N protein, the Influenza A+B testing line (A) is used to determine whether the sample may contain Influenza A N protein, .
1. Negative result: if there is a ribbon on the quality control line (C), but there is no ribbon on the testing line (T or B or A), it is judged as negative.
2. Positive result: if there are color bands on the quality control line (C) and testing line (T or B or A), it is judged as positive
3. Invalid result: If there is no ribbon on the quality control line (C) and the detection line (T or B or A), or only the ribbon on the detection line (T or B or A), the result is judged to be invalid.
Note:
1. Co-infection with influenza A and B viruses is rare. If Flu A and B are detected at the same time, it is recommended to use other methods for further testing .
2. Invalid:The above " Invalid " is only part of the possible. If the SARS-CoV-2 C line appears but the Influenza A+B C line does not appear, no matter whether the Influenza A and (or) B lines appear, it is considered that the SARS-CoV-2 is effective and the Influenza A+B is invalid; if the Influenza A+B C line appears but the SARS-CoV-2 C line does not appear, no matter whether the SARS-CoV-2 has the T line or not, it is considered that the Influenza A+B is effective and the SARS-CoV-2 is invalid.

[Limitations of the Detection Method]
1. This kit is only for testing human nasal swab, nasopharyngeal swab and oropharyngeal swab samples.
2. This kit is only used for qualitative testing and cannot accurately determine the content of antigen in the sample.
3. The test results of this reagent are for clinical reference only, not as the only basis for clinical diagnosis and treatment. The clinical management of patients should be comprehensively considered in conjunction with their symptoms/signs, medical history, other laboratory tests, and treatment responses.
4. Unreasonable sample collection, transportation and processing, and low virus titers in the sample may lead to false negative results.
5. Due to the limitations of immunochromatographic methodology, for negative test results, it is recommended to use nucleic acid amplification testing or virus culture identification methods for review and confirmation.
 

Product Features

Direct indicators, early detection;
One sampling, joint inspection of three viruses;
Easy to operate, no need for professionals and equipment;
Quick detection, results in 15 minutes;
Closed treatment of medical waste, no biological safety issues;
Using microsphere chromatography technology, the sensitivity is much higher than the colloidal gold method.