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COVID-19 Antigen Neo P211136 20Tests

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COVID-19 Antigen Neo P211136 20Tests

COVID-19 Antigen Neo P211136 20Tests
COVID-19 Antigen Neo P211136 20TestsCOVID-19 Antigen Neo P211136 20TestsCOVID-19 Antigen Neo P211136 20TestsCOVID-19 Antigen Neo P211136 20Tests
Categorieskit swab samples
ModelP211136
CE certificate NoNLCA002202049626
SpecimenWhole blood/Plasma/Serum
MaterialPlastic
FOB portTianjin xingang
Terms of PaymentL/C, D/A, D/P, Western Union, MoneyGram, T/T, Paypal
Update Time2021-09-19
Detail Information
COVID-19 IgG/IgM Rapid Test Device(Colloidal Gold)
BACKGROUND

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 symptoms including manifestations include fever, fatigue and dry cough, nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.
CONTENTS
COVID-19 antigen test devices
20 tests
Sterilized swabs
20 pcs.
Extraction buffer, 7mL
2 pcs.
Nozzles with filter
20 pcs.
Plastic tubes
20 pcs.
Tube Stand
1 pcs.
Package Insert 
1 pcs.
STORAGE CONDITIONS

Test devices must be stored at 2~30°C. DO NOT
FREEZE. Devices must be at ambient room temperature at time of testing.
Warnings and Precautions

1. For in vitro Diagnostic Use
2. Pathogenic microorganisms may be present in clinical specimens. All specimen and the related contaminated items need to be handled, stored and disposed following “Standard Precautions” and institutional guidelines.
3. Use the Flocked swab supplied in the kit for collection nasal or nasopharyngeal sample.
4. Proper specimen collection, storage and transport are critical to the performance of this test.
5. Wear protective clothing such as laboratory coats,disposable gloves, and eye protection when specimens are collected and evaluated.
6. Do not use kit components beyond the expiration date.
7. Apply universal precaution when performing the test.
8. The test plate should be used immediately after opening the packaging. When it absorbs moisture, the quality deteriorates and an accurate result cannot be obtained.
9. Please do not touch the sample drop and the judgment part of the test board directly by hand.
10. Do not reuse the device.
11. If the test is invalid, one should consider the possible improper handling, inaccurate operation procedure, or device quality. Repeat the test with a new device ensuring that the test procedure has been followed accurately.
12. Assessment must be conducted exactly 15 minutes after starting the reaction. Given the nature of the KaiBiLi TM COVID-19 Antigen Neo P211136 This kit is designed for testing freshly collected swab samples . Nov. 2020, Ver. 03 2 / 4 measurement, the reaction and color development may slightly continue and progress even after 15 minutes.
13. The color tone of the line may vary depending on the color tone and specimen properties. However, the test result is valid as long as a red line is present.
14. If the line is not red at all (e.g. black), the test result is invalid and another test should be performed.
15. A highly viscous specimen may affect sample migration and/or the reaction, resulting in weak coloration, delayed or no formation of the line, or a nonspecific reaction because of specimen retention.
LIMITATIONS OF THE PROCEDURE

1. This kit is a qualitative test and cannot determine the amount of antigen in the sample.
2. The COVID-19 Antigen Rapid Test Neo detects both viable and non-viable SARS-CoV-2 antigens.Therefore, the results must be compared with all other available clinical and laboratory information to makean accurate diagnosis.
3. Users should test specimens as quickly as possible after specimen collection.
4. Positive test results do not rule out co-infections with other pathogens.
5. A false-negative test result may occur if the specimen contains antigen amount below the reagent’s sensitivity threshold or if the sample was collected or transported improperly; therefore, a negative test result does not eliminate the possibility of SARS-CoV-2 virus infection.
6. Specimen obtained early with sudden onset of symptoms will contain the highest viral titers and are recommended for the test, the amount of antigen in a sample may decrease as the duration of illness increases.
7. Failure to follow the test procedure may adversely affect test performance and/or invalidate the testresult.
8. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary, for clinical management.
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