SARS-CoV-2 Antigen Rapid Test Cassette / Kit FIA POCT Assay Fluorescence Immunoassay

SARS-CoV-2 Antigen Rapid Test Cassette / Kit FIA POCT Assay Fluorescence Immunoassay

【Product name】
SARS-CoV-2 Antigen Rapid Test Kit(Fluorescence immunoassay)Cov-Sars2 Antigen Test.pdf

【Package specification】
25 Tests/kit

【Intended use】
SARS-CoV-2 Antigen Rapid Test Kit is a lateral flow immunoassay intended for the quantitative detection of the Nucleocapsid antigen from SARS-CoV-2 in nasopharyngeal swabs from individuals who are suspected of SARS-COV-2 by their healthcare provider within the first 7 days of symptom onset, or for screening of individuals without symptoms, or other reasons to suspect SARS-COV-2 infection, if applicable.
Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.
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.

【Storage conditions and validity】
The kit should be stored at 4℃~30℃, out of direct sunlight. It is valid for 18 months. The test card should be used within 15 minutes after unsealing under the environment of 15℃~30℃ and 20% ~ 90% relative humidity.
The production date, batch number and expiration date are shown in the outer package of the product.

【Applicable instruments】
Nir-1000 dry fluorescent immunoassay analyzer produced by WWHS Biotech. Inc.

【Sample requirements】
1.Nasal Mid-Turbinate (NMT) swabs can be used for testing.Venous blood was collected according to routine laboratory methods to avoid hemolysis.
2.Nasal Mid-Turbinate (NMT) swab specimens need to be tested immediately and within 30 minutes of collection.
3.Specimens can be stored at room temperature (15-30 °C) for up to 60 minutes until testing.

【Interpretation of results】
1.This reagent is only used for auxiliary detection. If the test results are abnormal, it should be reviewed in time and judged in combination with clinical symptoms.
2.For samples with SARS-CoV-2 Nucleocapsid proteins concentration lower than 0.025ng/ml and higher than 500ng/ml, the detection results are reported as "< 0.025ng/ml" and "> 500ng /ml", respectively.

【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.

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