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:

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.

WUXI OWGELS MEDICAL INSTRUMENTS CO., LTD.

was established in 2001, is a hi-tech manufacturer of oxygen concentrator with 20 years manufacturing experience in China.

Main products are medical oxygen concentrators, respiratory therapy equipements and Covid-19 Antigen Rapid test kits with the CE, SGS, FDA and ISO certificates. Our products already received unanimous praise from hundreds of our clients at home and abroad.

With outbreak of the COVID-19 virus, to provide epidemic prevention and control supplies to our old clients, in 2020, we established two more factories to produce disposable medical masks and KN95 masks. Besides these products, we also provide detection reagents.

1. Oxygen concentrators
2. Covid 19 Antigen Rapid Test Kits

3. Oxygen atomizer
4. Disposable medical face mask

5. KN95 medical face mask