2019-nCoV test kit is intended for rapid, qualitative detection of coronavirus (2019-nCoV) antibodies in human serum, plasma and venous whole blood samples in vitro. This antibody detection kit is for in vitro diagnostic use only and for professional use only.
Intended Use of 2019-nCoV Test Kit
2019-nCoV antibody detection kit is only used as a supplementary detection indicator for suspected cases of negative coronavirus nucleic acid detection or in conjunction with nucleic acid detection in the diagnosis of suspected cases. The test provides preliminary test results.
A positive test result requires further confirmation. A negative test result does not rule out the possibility of infection, and it cannot be used as the sole basis for treatment or other management decision.
The test results of this kit are for clinical reference only. It is recommended to conduct a comprehensive analysis of the condition based on the patient’s clinical manifestations and other laboratory tests.
Specification: 10pcs/box, 20pcs/box, 25pcs/box, 30pcs/box, 40pcs/box, 50pcs/box, etc.
1. Individual sealed pouches, each pouch contains:
- 1 x Test cassette
- 1 x Desiccant pouch
2. Disposable droppers
3. Detection buffer (1*6 mL)
4. Instructions for use
Material Required but Not Provided
1. Specimen Collection Containers
2. Centrifuge (for serum/plasma sample)
4. Personal protective equipment, such a protective gloves, medical mask, goggles and lab coat.
5. Appropriate biohazard waste container and disinfectants.
Please read the instruction manual carefully before testing. The samples to be tested, detection reagents and other materials used for testing need to be equilibrated to room temperature. The test should be performed at room temperature.
- Remove a test cassette from the foil pouch by tearing at the notch and place it on a level surface.
- Add 10 μL of whole blood or serum or plasma specimen to the sample well (small hole) and then add 80 μL (about 2 to 3 drops) of sample dilution to the dilution card sample well (large hole).
- Wait for 15 minutes and read the results.Results shown after 20 minutes have no clinical significance
Colored bands appear at both test line (T) and control line (C).
Colored band appear at control line (C) only.
No visible colored band appear at control line after performing the test. The directions may not have been followed correctly or the test may have deteriorated. It is recommended that the specimen be re-tested.
- This kit is for in vitro diagnostic use only.
- All specimens should be treated as capable of transmitting diseases. Appropriate precautions should be taken when collecting, processing, storing and disposing of patient samples and used kit contents. And follow biosafety level 2 or higher guidelines.
- When handling items in this kit, wear appropriate personal protective equipment such asgowns, gloves, eye protection.
- Proper collection and transportation of specimens is critical to the performance of this test.
- Please discard after first use. This test cannot be used multiple times.
- Do not touch the reaction area of the test strip.
- Do not use the test kitif it has expired.
- Do not use the kit if the pouch is punctured or not properly sealed.
- Testing should be performed by trained personnel working in a qualified laboratory or clinic, and sampling should be performed by qualified medical personnel in that laboratory.
- Test results should be interpreted by the doctor along with clinical results and other laboratory test results.
- Diagnostic Disposal: All specimens and used kits carry the risk of infection. The process of disposing of the diagnostic procedure must follow local infectious disposal laws or laboratory regulations.
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