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Hangzhou Aichek Medical Technology Co.,Ltd

City:hangzhou

Province/State:zhejiang

Country/Region:china

Contact Person:MrEdward YU

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ODM Rtk Nasal Swab Test Kit Antigen Detection Kit For Nasal Swab Use 1 Kit

Name: ODM Rtk Nasal Swab Test Kit Antigen Detection Kit For Nasal Swab Use 1 Kit
Brand: Aichek
Price: 1 USD

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Brand Name :Aichek

Model Number :COVID-19-G02001A

Certification :CE

Place of Origin :China

MOQ :5000 Test

Price :negotiable

Payment Terms :T/T

Supply Ability :negotiable

Packaging Details :40box/carton

Storage :2℃-30℃

User :Professional

Accuracy :99.05% (95% CI: 97.58%~99.63%)

Certificate :CE ISO 13485

Key words :Nasal Swab Covid-19 Plastic Antigen Self Test Kit OEM ODM

OEM :OEM customized packing avaliable

Formats :25T/box 1T/box

Sample :Swab

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Nasal Swab Covid-19 Plastic Antigen Self Test Kit OEM ODM

Product Name	Nasal Swab Covid-19 Plastic Antigen Self Test Kit OEM ODM
Formats	Device(4mm)
Place of Origen	China
Specimen	Swab
Read Time	15 minutes
Shelf life	2 years
Package	25 device/box or 1Test/Box
Storage	2℃-30℃

The COVID-19 Antigen Rapid Test device is a lateral flow chromatographic immunoassay for the qualitative detection of the nucleocapsid(N) protein antigen from SARS-CoV-2 in nasopharyngeal swab, oropharyngeal swab. It provides an aid in the diagnosis of infection with 2019-nCOV.

[LIMITATIONS]

1. The COVID-19 Rapid Test Device is for in vitro diagnostic use only.

2. The test should be used for nasopharyngeal swab, oropharyngeal swab. Blood, serum, plasma, urine and other samples may cause abnormal results.

3. The intensity of the test line does not necessarily correlate to SARS-CoV-2 viral titer in the specimen.

4. Test performance depends on the amount of virus (antigen) in the sample and may or may not correlate with viral culture results performed

on the same sample.

5. Test results should be correlated with other clinical data available to the physician.

6. A positive or negative test result does not rule out co-infections with other pathogens such as other viral or bacterial infections.

7. Negative results are presumptive, do not rule out COVID-19 infection and it may be necessary to obtain additional testing with a molecular assay, if needed for patient management.

8. A false negative result may occur if the level of antigen in a sample is below the detection limit of the test.

9. Incorrectly sample collected and handled, may cause a false negative result. Please make sure that a proper amount of sample is added for testing. Too much or too little sample may cause deviations in results.

[WARNINGS AND PRECAUTIONS]
l For in vitro diagnostic use only.
l For healthcare professionals and professionals at point of care sites.
l Do not use after the expiration date.
l Please read all the information in this manual before performing the test.
l The test device should remain in the sealed pouch until use.
l All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent. Wear gloves

ifneed, don’t touch the membrane.
l The used test device should be discarded according to federal, state and local regulations.
l The test is intended to be read at 15 minutes. If the test is read before 15 minutes or after 20 minutes, false negative or false positive

results may occur, and the test should be repeated with a new test cassette.
l The test device is a disposable product. Please dispose properly after use.

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