IVD In Vitro Diagnostic Test Kits Nasal Swab Rapid Antigen Self Test
Brand Name:Aichek
Certification:CE
Model Number:COVID-19-G02001A
Minimum Order Quantity:5000 Test
Payment Terms:T/T
Place of Origin:China
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Location:
Hangzhou Zhejiang China
Address:
3rd Floor, Building 9, Hexiang Technology Center, Xiasha Street, Qiantang District, 310018 Hangzhou, Zhejiang, P.R. China
Supplier`s last login times:
within 41 hours
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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 |
| 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
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