SARS-CoV-2/Influenza A+B/RSV/Adenovirus/ M.pneumoniae Antigen Combo Rapid Test (Nasopharyngeal Swab)
| Principle |
Chromatographic Immunoassay |
| Format |
Cassette |
| Specimen |
Nasopharyngeal Swab |
| Certificate |
CE |
| Reading Time |
15 minutes |
| Pack |
20 T |
| Storage Temperature |
2-30°C |
| Shelf Life |
2 Years |
Application
The SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test (Nasopharyngeal Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 Nucleocapsid protein, Influenza A, Influenza B, Respiratory Syncytial Virus(RSV), Adenovirus and M.pneumoniae antigens present in human nasopharynx. For professional in vitro diagnostic use only.
The SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test (Nasopharyngeal Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 Nucleocapsid protein, Influenza A, Influenza B, Respiratory Syncytial Virus(RSV), Adenovirus and M.pneumoniae antigens in nasopharyngeal swab specimens from individuals with suspected SARS-CoV-2/Influenza/RSV/Adenovirus/M.pneumoniae infection in conjunction with clinical presentation and the results of other laboratory tests.
Results are for the detection of SARS-CoV-2, Influenza A+B, RSV, Adenovirus and M.pneumoniae antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of correlative antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out other bacterial/viral infection.
The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae 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 SARS-CoV-2, Influenza A+B, RSV , Adenovirus and M.pneumoniae.
PRINCIPLE
The SARS-CoV-2 Antigen Rapid Test (Nasopharyngeal Swab) is a qualitative membrane-based immunoassay for the detection of SARS-CoV-2 Nucleocapsid protein in human nasopharyngeal swab specimen. SARS-CoV-2 antibody is coated in 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 Nucleocapsid protein, 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.
The Influenza A+B Rapid Test (Nasopharyngeal Swab) is a qualitative, lateral flow immunoassay for the detection of Influenza A and Influenza B nucleoproteins in human nasopharyngeal swab specimen. In this test, antibody specific to the Influenza A and Influenza B nucleoproteins is separately coated on the test line regions of the test. 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.
The RSV Rapid Test (Nasopharyngeal Swab) is a qualitative, lateral flow immunoassay for the detection of Respiratory Syncytial Virus nucleoproteins in nasopharyngeal swab specimens. In this test, antibody specific to the Respiratory Syncytial Virus nucleoproteins is coated on the test line region of the test. During testing, the extracted specimen reacts with the antibody to Respiratory Syncytial Virus that are coated onto particles. The mixture migrates up the membrane to react with the antibody to Respiratory Syncytial Virus on the membrane and generate one colored line in the test region. The presence of this colored line in the test region 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.
The Adenovirus Antigen Rapid Test (Nasopharyngeal Swab) is a qualitative membrane-based immunoassay for the detection of adenovirus antigen in nasopharyngeal swab specimen. In this test, antibody specific to the adenovirus is separately coated on the test line region of the test. During testing, the extracted specimen reacts with the antibody to adenovirus that are coated onto particles. The mixture migrates up the membrane to react with the antibody to adenovirus on the membrane and generate a color line in the test line region. The presence of this color line in the test line region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control region if the test has performed properly.
The Mycoplasma pneumoniae Antigen Rapid Test (Nasopharyngeal Swab) a qualitative, lateral flow immunoassay for the detection of M. pneumoniae antigen in nasopharyngeal swab specimen. In this test, antibody specific to M. pneumoniae antigen is coated on the test line region of the test. During testing, the extracted throat swab specimen reacts with an antibody to M.pneumoniae that is coated onto particles. The mixture migrates up the membrane to react with the antibody to M. pneumoniae on the membrane and generate a colored line in the test line region. The presence of this colored line in the test line region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that 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 the 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 specimens and used kit contents.
6. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
7. Viral Transport Media (VTM) may affect the test result, do not store specimens in viral transport media; extracted specimens for PCR tests cannot be used for the test.
8. Wash hands thoroughly after handling.
9. Please ensure that an appropriate amount of specimens are used for testing. Too much or too little specimen size may lead to deviation of results.
10.The used test should be discarded according to local regulations.
11.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 5-10 times.
3. Withdraw the sterile swab from the nasal cavity and avoid excess volume and highly-viscous nasopharyngeal discharge.
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 specimen 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 collection tube and add 3 drops of the extracted specimen to each of the specimen well(S) respectively 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.
Internal Quality Control
Internal procedural controls are included in the test. A colored line appearing in the control region (C) is an internal procedural control. It confirms sufficient specimen volume and correct procedural technique.
External Quality Control
Controls are not included in this kit. However, in compliance with Good Laboratory Practice (GLP) positive/negative controls are recommended.
Sensitivity, Specificity and Accuracy
The SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test (Nasopharyngeal Swab) has been evaluated with specimens obtained from the patients. RT-PCR is used as the reference method for the SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test (Nasopharyngeal Swab). Specimens were considered positive if RT-PCR indicated a positive result. Specimens were considered negative if RT-PCR indicated a negative result.
