Lepu COVID-19 Antigen Rapid Test Cassette MSLRDT115

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 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 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 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 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.