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Clungene Swab Rapid Test Covid-19

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What is Clungene Swab Rapid Test Covid-19 

The COVID-19 Antigen Rapid Test Cassette is a lateral flow immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen in the nasal swab of individuals with symptoms or other epidemiological reasons suspecting COVID-19 infection. 19. The test is intended for use by laypersons age 15 and older and, as appropriate, by adults to test another person under the age of 15. Individuals over the age of 65 should request assistance in carrying out the test. The antigen is usually detectable in the nasopharyngeal swab and oropharyngeal swab during the acute phase of the infection. The test provides only a preliminary screening result for the SARS-CoV-2 virus. Positive results must be confirmed by a PCR test performed in the laboratory. People with a negative test result who continue to experience symptoms similar to those of COVID-19 should seek medical attention. The kit contains: - 1 test cassette; - 1 test tube containing extraction reagent; - 1 tampon; - 1 disposal bag; - 1 instructions for use. The COVID-19 Antigen Rapid Test Cassette is designed to detect nucleocapsid antigen from SARS-CoV-2 in nasopharyngeal swab and oropharyngeal swab of patients with suspected COVID-19. During testing, a sample migrates upward by capillary action. SARS-CoV-2 antigens, if present in the sample, will bind to the antibody. The immune complex is then captured on the membrane by the SARS-CoV-2 nucleocapsid protein pre-coated monoclonal antibody and a visible colored line will appear in the test line region indicating a positive result. In the absence of SARS-CoV-2 antigen, a colored line will not form in the test line region indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that the appropriate volume of specimen has been added and membrane passage has occurred.

How to use Clungene Rapid Test Covid-19

 1. Collection of samples: Samples obtained early in the onset of symptoms will contain the highest viral titers; samples obtained after five days of symptoms are more likely to produce negative results than an RT-PCR test. Inadequate specimen collection, improper specimen handling and/or transportation may produce false negative results; therefore, skill in sample collection is highly recommended for generating accurate results. Nasopharyngeal swab specimen: Insert a mini-swab with a flexible shaft (wire or plastic) through the nostril parallel to the palate (not straight up) until resistance is met or the distance is equivalent to ear to nostril of the patient, indicating contact with the nasopharynx. The swab should reach a depth equal to the distance from the nostrils to the outer opening of the ear. Gently rub and roll the swab. Leave the swab in place for several seconds to absorb secretions. Slowly remove the swab by twisting it. Samples can be collected from both sides using the same swab, but it is not necessary to collect samples from both sides if the mini-swab is saturated with fluid from the first collection. If a deviated septum or obstruction makes it difficult to obtain the sample from one nostril, use the same swab to obtain the sample from the other nostril. Oropharyngeal Swab Specimen: Insert the swab into the posterior areas of the pharynx and tonsils. Rub the swab over both tonsillar pillars and posterior oropharynx and avoid touching the tongue, teeth, and gums. Freshly collected samples should be processed as soon as possible, but no later than one hour. The collected sample can be kept at 2-8°C for no more than 24 hours; Store at -70°C for a long time, but avoid repeated freeze-thaw cycles.

2. Sample Preparation: Unscrew the lid of an extraction reagent. Add all of the sample extraction reagent to an extraction tube and place it on the workstation. Insert the swab sample into the extraction tube containing the reagent. Roll the swab at least 5 times by pressing the head against the bottom and side of the extraction tube. Leave the swab in the extraction tube for one minute. Remove the swab by squeezing the sides of the tube to extract the liquid from the swab. The extracted solution will be used as a test sample. Insert a dropper tip firmly into the tube. 

3. Test procedure: Allow the test device and samples to reach temperature (15-30°C or 59-86°F) before testing. Remove the test cassette from the sealed pouch. Invert the sample extraction tube, holding the sample tube upright, transfer 3 drops (approximately 100 mcL) to the sample well (S) of the test cassette, then start the timer. Wait for the colored lines to appear. Interpret test results in 15 minutes. Do not read results after 20 minutes.

4. Interpretation of results: POSITIVE: Two lines appear. One colored line should be in the control region (C) and another adjacent apparent colored line should be in the test region (T). Positive for the presence of SARS-CoV-2 nucleocapsid antigen. Positive results indicate the presence of viral antigens, but a clinical correlation with patient history and other diagnostic information is required to determine infected status. Positive results do not rule out bacterial infection or co-infection with other viruses. The detected agent may not be the definitive cause of the disease. NEGATIVE: A colored line appears in the control region (C). No line appears in the test region (T). Negative results are presumptive. Negative test results do not preclude infection and should not be used as the sole basis for treatment or other patient management decisions, including infection control decisions, particularly in the presence of clinical signs and symptoms consistent with COVID-19. 19, or in those who have been in contact with the virus. It is recommended that these results be confirmed by a molecular testing method if needed for patient management. INVALID: The control line is not displayed. Insufficient sample quantity or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test using a new test cassette. If the problem persists, stop using the lot immediately and contact your local distributor.

Warnings 

Do not use this product as the sole basis for diagnosing or excluding SARS-CoV-2 infection or informing about COVID-19 infection status. Read all the information contained in the package insert before performing the test. The test cassette should remain in the sealed pouch until use. All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent. The COVID-19 Antigen Rapid Test Cassette is limited to providing qualitative detection. The intensity of the test line does not necessarily correlate with the antigen concentration of the samples. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. A physician must interpret the results in conjunction with the patient's history, physical findings, and other diagnostic procedures. A negative result may occur if the amount of SARS-CoV-2 virus antigens present in the sample is below the assay's detection threshold or if the virus has undergone one or more minor amino acid mutations in the region of the target epitope recognized by the antibodies monoclonals used in the test. Proper specimen collection is critical and failure to follow the procedure may lead to inaccurate results. Improper specimen collection, improper storage, or repeated freezing and thawing of specimens may lead to inaccurate results. The used test cassette must be disposed of according to state and local regulations. 

Storage 

Store as packaged in the sealed pouch at 4-30°C (or 40-86°F). The kit is effective within the expiration date printed on the label. Once the pouch is opened, the test should be used within one hour. Prolonged exposure to a hot, humid environment will cause product deterioration. Validity with intact packaging: 24 months. 

Format

Pack with: - 1 test cassette; - 1 test tube containing extraction reagent; - 1 tampon; - 1 disposal bag; - 1 instructions for use.


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