SARS-CoV-2 Antigen Rapid Test Kits Antibody Covid-19 Reagent Kits

【Product name】 Cov-Sars2 Antibody Test.pdf

SARS-CoV-2 Antigen Rapid Test Kit(Fluorescence immunoassay)

【Intended use】

Negative results should be treated as presumptive, and do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history, and the presence of clinical signs and symptoms consistent with SARS-CoV-2, and confirmed with a molecular assay, if necessary, for patient management.

The SARS-COV-2 Antigen Rapid Test Kit is intended for use by trained clinical laboratory personnel specifically instructed and trained in vitro diagnostic procedures.

【Inspection principle】

The SARS-CoV-2 Nucleocapsid proteins Rapid Test is a one-step chromatographic sandwich immunoassay designed for the quantitative measurement of SARS-CoV-2 Nucleocapsid proteins. The SARS-CoV-2 Nucleocapsid proteins in the sample was first bound with the conjugated compound of fluorescent labeled SARS-CoV-2 Nucleocapsid proteins monoclonal antibody, then moved and combined with another SARS-CoV-2 Nucleocapsid proteins monoclonal antibody fixed on the nitrocellulose membrane, and the double antibody sandwich complex was formed at the detection line of the cellulose nitrate membrane. The quantitative detection results were obtained by NIR-1000 dry fluoroimmunoassay analyser.

【Components】

The components in different batches of kits cannot be used interchangeably.

【Note】

• For in vitro diagnostic use.
• This test has been authorized only for the detection of SARS-CoV-2 antigen, not for any other viruses or pathogens.
• Treat all specimens as potentially infectious. Follow universal precautions when handling samples, this kit and its contents.
• Proper sample collection, storage and transport are essential for correct results.
• Leave test card sealed in its foil pouch until just before use. Do not use if pouch is damaged or open.
• Do not use kit past its expiration date.
• Do not mix components from different kit lots.
• Do not reuse the used test card.
• Inadequate or inappropriate sample collection, storage, and transport may yield false test results.
• Do not store specimens in viral transport media for specimen storage.
• All components of this kit should be discarded as Biohazard waste according to Federal, State and local regulatory requirements.
• Solutions used to make the positive control swab are non-infectious. However, patient samples, controls, and test cards should be handled as though they could transmit disease. Observe established precautions against microbial hazards during use and disposal.
• Wear appropriate personal protection equipment and gloves when running each test and handling patient specimens. Change gloves between handling of specimens suspected of SARS-COV-2.
• INVALID RESULTS can occur when an insufficient volume of extraction reagent is added to the test card. To ensure delivery of adequate volume, hold vial vertically, ½ inch above the swab well, and add drops slowly.
• False Negative results can occur if the sample swab is not rotated (twirled) prior to closing the card.
• Swabs in the kit are approved for use with SARS-COV-2 Ag Card. Do not use other swabs.
• The Extraction Buffer packaged in this kit contains salts, detergents and preservatives that will inactivate cells and virus particles. Samples eluted in this solution are not suitable for culture.
• Do not store the swab after specimen collection in the original paper packaging, if storage is needed use a plastic tube with cap.