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SARS-Cov-2&Influenza A&B Combo Rapid Test Cassette (swab)

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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.Influenza outbreaks occur each year during the fall andwinter 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.The Influenza A&B Rapid Test device qualitatively detects the presence of Influenza A and/or Influenza B antigen in nasalswab or throat swab or nasal aspirate specimens,providing results within 15 minutes.The test uses antibodies specific for Influenza A and Influenza B to selectively detect Influenza A and Influenza B antigen in nasal swab,throat swab or nasal aspirate specimens.

PRINCIPLE

The Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to Novel coroinavirus.The test device is composed of the following three parts, namely sample pad, reagent pad and reaction membrane. The whole strip is fixed inside a plastic device. The reagent membrane contains the colloidal-gold conjugated with the monoclonal antibodies against Novel coroinavirus;the reaction membrane contains the secondary antibodies for Novel coroinavirus, and the polyclonal antibodies against the mouse globulin, which are pre-immobilized on the membrane.When the sample is added into the sample window,conjugates dried in the reagent pad are dissolved and migrate along with the sample. If Novel coroinavirus is present in the sample, a complex formed between the anti- Novel coroinavirus conjugate and the virus will be caught by the specific antiNovel coroinavirus monoclonal coated on the T region. Whether the sample contains the virus or not, the solution continues to migrate to encounter another reagent (an anti-mouse IgG antibody) that binds the remaining conjugates, thereby producing a red line on the region C.

The Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) product can detect SARS-Cov-2 nucleo-protein(mainly) and spike protein.More than 90% antibody used in Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette(swab) is anti-nucleoprotein of SARS-Cov-2 and target protein is SARS-Cov-2 nucleoprotein.

The rest antibody used in Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) is anti-Spike protein and target protein is SARS-Cov-2 Constant fragment of Spike protein.

At present, whether the N501Y in the United Kingdom or the 501Y.V2 in South Africa, the variant fragments are mainly the RBD fragment of the S protein, and the target fragments of the antibodies used in Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) have not been mutated.So,The Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) can reliably detect the SARS-Cov-2 variants.

So,The Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) can reliably detect the nucleo-protein and spike protein of genetic SARS-Cov-2 variants.The Influenza A&B Rapid Test is a qualitative,lateral flow immunoassay for the detection of Influenza A and Influenza B nucleoproteins in nasal swab,throat swab or nasal aspirate specimens. In this test, antibody specific to the Influenza A and Influenza B nucleoproteins is

separately coated on the test line regions of the test device.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.

SPECIMEN COLLECTION AND PREPARATION

1. Specimen collection:

It is applicable to the diagnosis of the Novel coroinavirus or Influenza A&B virus from the samples of Nasopharyngeal swab.Use freshly collected samples for optimal test performance. Inadequate sample collection or improper sample handling may yield a false-negative result. Completely insert the sterilized swab supplied in this kit into the nasal basin, and swab several times to collect the epidermal cells of the mucus. It is recommended to collect sample from Nasopharyngeal for more accurate results.

2. Specimen preparation:

1) Take out 1 bottle of Sample Extraction Buffer, remove the bottle cap, add all the extraction buffer into the extraction tube.

2) Nasopharyngeal Swabbing

Insert the swab into the extraction tube which contains Sample Extraction Buffer. Rotate the swab inside the tube using a circular motion to roll the side of the extraction tube so that liquid is expressed and reabsorbed from the swab, remove the swab. The extracted solution will be used as test sample.

DIRECTIONS FOR USE

Allow the test, specimen, extraction buffer to equilibrate to room temperature (15-30°C)prior to testing.

1.Remove the test device from the sealed foil pouch and use it as soon as possible. Place the test device on a clean and level surface. Best results will be obtained if the assay is performed immediately after opening the foil pouch.

2. Take out the Extraction Tube.

3. Take out 1 bottle of Sample Extraction Buffer, remove the bottle cap, add all the extraction buffer into the extraction tube. 4.Place the sterilized swab specimen in the sample extraction buffer. Rotate the swab for approximately 10 seconds while pressing the head against the inside of the tube to release the antigen in the swab.

5.Remove the sterilized swab while squeezing the sterilized swab head against the inside of Buffer as you remove it to expel as much liquid as possible from the swab. Discard the sterilized swab in accordance with your biohazard waste disposal protocol.

6. Screw on and tighten the Nozzle with Filter onto the specimen collection tube, then shake the specimen collection tube vigorously to mix the specimen and the sample extraction buffer.See illustration .

7.Add 3 drops of the solution (approx.80ul) to each sample well and then start the timer. Read the result at 10~20 minutes. Don’t interpret the result after 20 minutes.

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INTERPRETATION OF RESULTS

POSITIVE SARS-Cov-2: Two red lines appear. One red line appears in the control region(C),and one red line in the test region(T).

POSITIVE Influenza A:Two distinct colored lines appear. 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. 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. 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 shade of color may vary,but it should be considered positive whenever there is even a faint line.

NEGATIVE: Only one red line appears in the control region(C), and no line in the test region(T/A/B).

INVALID: No red line appears in the control region(C). The test is invalid even if there is a line on test region(T/A/B). Insufficient sample volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the test procedure and repeat the test using a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.


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