• Fresh Swabs COVID-19 Antigen Rapid Test Kit CE approved Safe and Accurate
  • Fresh Swabs COVID-19 Antigen Rapid Test Kit CE approved Safe and Accurate
  • Fresh Swabs COVID-19 Antigen Rapid Test Kit CE approved Safe and Accurate
  • Fresh Swabs COVID-19 Antigen Rapid Test Kit CE approved Safe and Accurate
Fresh Swabs COVID-19 Antigen Rapid Test Kit CE approved Safe and Accurate

Fresh Swabs COVID-19 Antigen Rapid Test Kit CE approved Safe and Accurate

Product Details:

Place of Origin: Beijing
Certification: CE; ISO13485

Payment & Shipping Terms:

Minimum Order Quantity: 10-100pcs
Price: USD1.8-3.5/pc
Packaging Details: 25pcs per case
Delivery Time: 3-5working days
Supply Ability: 1million per week
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Detail Information

Clinical Specificity: 100% Overall Agreement: 96.21%
Certificate: CE Room Temperature Or Refrigerated: 2-30°C
High Light:

Fresh Swabs COVID-19 Antigen Rapid Test Kit

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CE COVID-19 Antigen Rapid Test Kit

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CE Throat Swab Test Kits

Product Description

Fresh Swabs COVID-19 Antigen Rapid Test Kit CE approved Safe and Accurate

 Quick Antigen Throat/Nasal Swab Test for fresh swabs COVID-19 Antigen Rapid Test Kit Clinical CE approved China OEM

 

 PERFORMANCE CHARACTERCS

 The assay demonstrated excellent clinical specificity 100% (95% CI: 98.12%-100%). Overall Agreement was 96.21% (93.34%-97.87%).

 

 Clinical Performance of Antigen Test for fresh swabs

 Using 127 fresh NP swabs which were collected freshly in Extraction Buffer in the kit to evaluate the Clinical performance of the COVID-19  Antigen Rapid Test Kit. 67 Patients who presented within 7 days of symptom onset and 60 normal persons were included in the initial primary  evaluation. The Result is below:

 

    Sansure Covid-19 RT-PCR Assay
    Positive Negative Total
Kewei COVID-19 Antigen Rapid Assay Positive 64 0 64
Negative 3 60 63
Total 67 60 127

 Interference

 Potential Endogenous Interference of the COVID-19 Antigen Rapid Test was evaluated using natural clinical samples. No Antigen false negative  or false positive results were observed with the following potential interference substances at the stated concentrations:

Human Blood 1% V/V
Mucosal protein 1mg/ml
Phenylephrine 1% V/V
Oxymetazoline 1% V/V
Triamcinolone 50mg/L
Ribavirin 50mg/L

 

 

The assay demonstrated acceptable clinical sensitivity for fresh swab samples is 95.52% (95% CI: 87.64%-98.47%) when compared to a  molecular device produced by Sansure Inc. The assay demonstrated excellent clinical specificity 100% (95% CI: 93.98%-100%). Overall  Agreement was 97.64% (93.28%-99.19%).

 The assay demonstrated acceptable total clinical sensitivity is 91.08% (95% CI: 85.59%-94.61%) when compared to a molecular device  produced by Sansure Inc. The assay demonstrated excellent clinical specificity 100% (95% CI: 98.54%-100%). Overall Agreement was 96.64%  (94.44%-97.99%).

 

 The novel coronaviruses belong to the β genus.COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently,  the patients infected by 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. The main manifestation include fever, fatigue and dry  cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.Coronaviruses are enveloped RNA viruses that  are distributed broadly among humans, other mammals, and birds and that cause respiratory, enteric, hepatic, and neurologic diseases. Seven  coronavirus species are known to cause human disease. Four viruses - 229E, OC43, NL63, and HKU1 - are prevalent and typically cause  common cold symptoms in immunocompetent individuals. The three other strains - severe acute respiratory syndrome coronavirus (SARS-CoV),  Middle East respiratory syndrome coronavirus (MERS-CoV) and 2019 Novel Coronavirus (COVID-19) - are zoonotic in origin and have been  linked to sometimes fatal illness. The COVID-19 Antigen Rapid Test Kit can detect pathogen antigens directly from nasopharyngeal swab, nasal  or throat swabs specimens.

 

 

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