COVID-19 Antigen Rapid Test (Swab), Detection of SARS-CoV-2 Nucleocapsid Protein antigens
Application
COVID-19 Antigen Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 Nucleocapsid Protein antigens in swab specimen. For professional in vitro diagnostic use only.
Sensitivity, Specificity and Accuracy
The SARS-CoV-2 Antigen Rapid Test (Swab) has been evaluated with swab specimens obtained from the patients. RT-PCR (Nasopharyngeal Swab) is used as the reference method for the SARS-CoV-2 Antigen Rapid Test (Swab). Specimens were considered positive if RT-PCR (Nasopharyngeal Swab) indicated a positive result. Specimens were considered negative if RT-PCR (Nasopharyngeal Swab) indicated a negative result.
HOW TO USE ?
The COVID-19 Antigen Rapid Test (Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 Nucleocapsid Protein antigens in swab specimens from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 Antigens. An antigen is 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 results do not preclude SARS-CoV-2 infection and should not be used as the
sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. 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.
Product features |
Parameters |
Principle |
Chromatographic Immunoassay |
Format |
Cassette |
Specimen |
Oral fluid/Nasopharyngeal Swab/Nasal Swab |
Certificate |
CE |
Reading Time |
15 minutes |
Pack |
20 T |
Storage Temperature |
2-30°C |
Shelf Life |
2 Years |
PRINCIPLE
The COVID-19 Antigen Rapid Test (Swab) is a qualitative membrane-based immunoassay for the detection of SARS-CoV-2 Antigens in human swab specimen. SARS-CoV-2 antibody is coated in the test line region. During testing, the specimen reacts with SARS-CoV-2 antibody-coated particles in the test. The mixture then migrates upward on the membrane by capillary action and reacts with the SARS-CoV-2 antibody in test line region. If the specimen contains SARS-CoV-2 Antigens, a colored line will appear in test line region as a result of this. If the specimen does not contain antigens to SARS-CoV-2, no colored line will appear 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 proper volume of specimen has been added and membrane wicking has occurred.
PRECAUTIONS
1. This package insert must be read completely before performing the test. Failure to follow directions in package insert may yield inaccurate test results.
2. For professional in vitro diagnostic use only. Do not use after expiration date.
3. Do not eat, drink or smoke in the area where the specimens or kits are handled.
4. Do not use test if pouch is damaged.
5. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout in the collection, handling, storage, and disposal of patient samples and used kit contents.
6. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
7. Wash hands thoroughly after handling.
8. Please ensure that an appropriate amount of samples are used for testing. Too much or too little sample size may lead to deviation of results.
9. Sterile Swabs for the collection of Nasopharyngeal specimen and Nasal specimen are different, Do not mix the using of the two types of sampling swabs.
10.Viral Transport Media (VTM) may affect the test result; extracted specimens for PCR tests cannot be used for the test.
11.The used test should be discarded according to local regulations.
12.Humidity and temperature can adversely affect results.
SPECIMEN COLLECTION, TRANSPORT AND STORAGE
Nasopharyngeal Swab Specimen Collection
1. Insert a sterile swab into the nostril of the patient, reaching the surface of the posterior nasopharynx.
2. Swab over the surface of the posterior nasopharynx.
3. Withdraw the sterile swab from the nasal cavity.
Nasal Swab Specimen Collection
1. Insert a sterile swab less than one inch (about 2 cm) into a nostril (until resistance is met at the turbinates).
2. Rotate the swab 5-10 times against the nasal wall. Using the same swab repeat the collection procedure with the second nostril.
3. Withdraw the sterile swab, avoid excess volume and high-viscous nasal discharge.
Caution:
If the swab stick breaks during specimen collection, repeat specimen collection with a new swab.
Specimen transport and storage
Specimens should be tested as soon as possible after collection. If swabs are not been processed immediately, it is highly recommended the swab sample is placed into a dry, sterile, and tightly sealed plastic tube for storage. The swab specimen in dry and sterile condition is stable for up to 24 hours at 2-8°C.
DIRECTIONS FOR USE
Allow the test, extracted specimen and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
1. Remove the test cassette from the sealed foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch.
2. Invert the specimen extraction tube and add 3 drops of extracted specimen (approx.75-100μl) to the specimen well(S) and then start the timer.
3. Wait for the colored line(s) to appear. Read the result at 15 minutes. Do not interpret the result after 20 minutes.
POSITIVE:* Two distinct colored lines appear. One colored line should be in the control region (C) and another colored line should be in the Test region (T). Positive result in the Test region indicates detection of SARS-CoV-2 antigens in the sample.
*NOTE: The intensity of the color in the test line region (T) will vary based on the amount of SARS-CoV-2 antigen present in the sample. So any shade of color in the test region (T) should be considered positive.
NEGATIVE: One colored line appears in the control region (C). No apparent colored line appears 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. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
SUMMARY
The SARS-CoV-2 Antigen Rapid Test (Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 Nucleocapsid protein antigens in swab specimen from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests.
Results are for the detection of SARS-CoV-2 Nucleocapsid protein Antigens. An antigen is 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 results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. 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.