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.
