Hangzhou Aichek Medical Technology Co.,Ltd

Hangzhou Aichek Medical Technology Co.,Ltd

Manufacturer from China
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4 Years
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IVD In Vitro Diagnostic Test Kits Nasal Swab Rapid Antigen Self Test

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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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IVD In Vitro Diagnostic Test Kits Nasal Swab Rapid Antigen Self Test

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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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SARS-CoV-2 IVD Reagent Rapid Antigen Self Test Kit Individual Test

Product Name

SARS-CoV-2 IVD Reagent Rapid Antigen Self Test Kit Individual Test

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.

Limited of Detection (Analytical Sensitivity)
The detection limit of the product to SARS-CoV-2 is 50TCID50/mL. Analytical Specificity: Cross-reactivity and Interference
1. Cross-reactivity of the device was evaluated by testing, related pathogens and microorganisms that are likely to be present in the
respiratory tract. No cross-reactivity was observed with the following organisms presented in the table below.
Microorganisms Concentration of Cross-reactivity substance
Human coronavirus HKU1 1× 106TCID50 /mL
Human coronavirus OC43 1× 106TCID50 /mL
Human coronavirus NL63 1× 106TCID50 /mL
Human coronavirus 229E 1× 106TCID50 /mL
MERS-coronavirus 1× 106TCID50 /mL
Influenza A virus 1× 106TCID50 /mL
Influenza B virus 1× 106TCID50 /mL
Rhinovirus 1× 106TCID50 /mL
Adenovirus 1× 106TCID50 /mL
Enterovirus 1× 106TCID50 /mL
Human Metapneumovirus 1× 106TCID50 /mL
Parainfluenza 1× 106TCID50 /mL
Respiratory syncytial virus 1× 106TCID50 /mL
Mycoplasma pneumonia 1× 107 CFU/mL
Chlamydia pneumonia 1× 107 CFU/mL
Streptococcus pneumonia 1× 107 CFU/mL
Staphylococcus aureus 1× 107 CFU/mL
Mycobacterium tuberculosis 1× 107 CFU/mL
Haemophilus influenzae 1× 107 CFU/mL
Streptococcus pyogenes 1× 107 CFU/mL

[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.

IVD In Vitro Diagnostic Test Kits Nasal Swab Rapid Antigen Self Test

IVD In Vitro Diagnostic Test Kits Nasal Swab Rapid Antigen Self Test

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