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Early January 2020, a novel coronavirus (SARS-CoV-2, formerly known as 2019-nCoV) was identified as the infectious agent causing an outbreak of viral pneumonia in Wuhan, China, where the first cases had their symptom onset in December 2019.
Coronaviruses are enveloped RNA viruses that are distributed broadly among humans, other mammals, and birds and that cause respiratory, enteric, hepatic, and neurologic diseases.Six 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 two other strains severe acute respiratory syndrome coronavirus (SARS-CoV) and Middle East respiratory syndrome coronavirus (MERS-CoV) are zoonotic in origin and have been linked to sometimes fatal illness.
Coronaviruses are zoonotic, meaning they are transmitted between animals and people. Common signs of infection include respiratory symptoms,fever, cough, shortness of breath and breathing difficulties. In more severe cases, infection can cause pneumonia, severe acute respiratory syndrome, kidney failure and even death.
Standard recommendations to prevent infection spread include regular hand washing, covering mouth and nose when coughing and sneezing, thoroughly cooking meat and eggs. Avoid close contact with anyone showing symptoms of respiratory illness such as coughing and sneezing.
Easy to collect samples
Instant result at 15 minutes
No equipment required
Results are clearly visible
Suitable for large-scale rapid screening
| Packaging detail:Standard export package Delivery detail:within 7-10 workdays after receipt of payment |
Some recent studies suggested the role of saliva in the detection of SARS-CoV-2. Most of studies reported that there is no statistically significant difference between nasopharyngeal or oropharyngeal swab and saliva samples regarding viral load.
Clongene has developed the COVID-19 Antigen Rapid Test Cassette (Saliva). Lepu COVID-19 Saliva Antigen Rapid Test Cassette MSLRDT115 is a lateral flow immunoassay intended for the qualitative detection SARS-CoV-2 nucleocapsid antigens in saliva from individuals who are suspected of COVID-19 by their healthcare provider.
Lepu COVID-19 Saliva Antigen Rapid Test Cassette MSLRDT115 Product Features
Easy to collect samples
Instant result at 15 minutes
No equipment required
Results are clearly visible
Suitable for large-scale rapid screening
Lepu COVID-19 Saliva Antigen Rapid Test Cassette MSLRDT115 Principle
The COVID-19 Antigen Rapid Test (Saliva) is a lateral flow immunoassay based on the principle of the double-antibody sandwich technique. A colored test line (T) would be visible in the result window, if SARS-CoV-2 antigens are present in the specimen. Absence of the T line suggests a negative result.
Lepu COVID-19 Saliva Antigen Rapid Test Cassette MSLRDT115 Performance Characteristics
Clinical Performance
645 individual symptomatic patients and asymptomatic patients who were suspected of COVID- 19. The specimens
were detected by COVID-19 Antigen Rapid Test and RT-PCR. The test results showed as the tables below
Lepu COVID-19 Saliva Antigen Rapid Test Cassette MSLRDT115
Limit of Detection (Analytical Sensitivity)
The study used cultured SARS-CoV-2 virus (Isolate Hong Kong/M20001061/2020, NR-52282), which is heat in-activated and spiked into saliva. The Limit of Detection (LoD) is 8.6X100 TCIDso /mL.
Cross Reactivity (Analytical Specificity)
32 commensal and pathogenic microorganisms that may be present in the oralcavity were evaluated, and no cross-reactivity was observed.
Interference
17 potentially interfering substances with different concentration were evaluated and found no affect to the test performance.
High-dose Hook Effect
Lepu COVID-19 Saliva Antigen Rapid Test Cassette MSLRDT115 was tested up to 1.15X 105 TCIDso /mL of inactivated SARS-CoV-2 and no high-dose hook effect was observed.
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