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

Hangzhou Aichek Medical Technology Co.,Ltd
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Hangzhou Aichek Medical Technology Co.,Ltd

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

Country/Region china
City & Province hangzhou zhejiang
Categories Cotton Pad
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Product Details

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

FormatsDevice(4mm)
Place of OrigenChina
SpecimenSwab
Read Time15 minutes
Shelf life2 years
Package25 device/box or 1Test/Box
Storage2℃-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.

 

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