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COVID-19 Ag Detection Kit (Immunofluorescence-Based) [CE-IVD]
(CE Marking: NL-CA002-2021-59066)
REAGENTS AND MATERIALS
- COVID-19 Ag strip (20 tests/kit): One aluminum pouch with a strip
- Sample lysis buffer (10 mL)
- Extraction Tubes (20 tubes): The tubes and nozzle cap come in a zip-locked plastic bag
- Swabs (20 nasal swabs): Individually pouched flocked swabs
- Transfer Pipets (20 transfer pipets): Individually pouched plastic transfer pipet
- Positive Control Swab: Non-infectious recombinant SARS-CoV-2 nucleocapsid antigen dried onto a swab
- Negative Control Swab: The use of a sterile swab to ensure a negative result is obtained
- Package Insert
- Procedure Card
INTENDED USE
COVID-19 Ag Detection Kit (Immunofluorescence- Based) is a lateral flow test for the detection of SARS-CoV-2 Nucleocapsid protein (NP) in direct nasal swabs from individuals suspected of COVID-19 within the first seven days of symptom onset, which is intended to be used by healthcare professionals. This test is intended for a Point-of-Care setting.
SUMMARY
The spread of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) has caused a worldwide COVID-19 pandemic. Rapid identification and isolation of COVID-19 patients and asymptomatic carriers is the main strategy to contain this pandemic.
COVID-19 Ag Detection Kit (Immunofluorescence- Based) is a rapid flow immunoassay for the qualitative detection and diagnosis of SARS-CoV-2 from nasal swab.
ASSAY PRINCIPLE
COVID-19 Ag Detection Kit (Immunofluorescence- Based) is an immunochromatographic membrane assay that uses highly-specific monoclonal antibodies to detect SARS-CoV-2 NP from nasal swab specimens. An anti-SARS-CoV-2 NP monoclonal antibody is pre-coated on the nitrocellulose membrane as the test line, while the chicken IgY is pre-coated as the control line.
During the test, the sample reacts with another fluorescent microspheres-conjugated anti-SARS-CoV-2 NP monoclonal antibody in the conjugation pad. The fluorescent microspheres-conjugated goat anti-chicken IgY in the conjugation pad serves as the control particles. The sample migrates upward on the membrane by capillary action and reacts with the test line and control line. The result can be read within 15-20 minutes using a dry immunofluorescence analyzer or a blue LED light. If the sample contains SARS-CoV-2 NP, a fluorescent signal can be detected from the test line, revealing a positive result. If the sample does not contain SARS-CoV-2 NP, no fluorescent signal can be detected from the test line, indicating a negative result. As a procedural control, a fluorescent signal can be detected from the control line.
STORAGE
- Store kit at 4-30 °C. The Kit is stable until the expiration date marked on the package label.
- Avoid freezing strips and buffer.
- The test strip is stable until the expiry date only if it has not been opened and kept in the sealed aluminum pouch.
- Do not open the sealed pouch until use. Once opened, the strip should be used within 1 hour.