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Covid-19 Antigen Rapid Test, Nasal Swab for Detecting SARS-COV-2, box/25

Covid-19 Antigen Rapid Test, Nasal Swab for Detecting SARS-COV-2, box/25

$675.00
Part Number:
RT-ANTIGEN
Lead Time:
1-2 weeks
Shipping:
Free Shipping on most orders*
Quantity:
25

Description

Novel Coronavirus SARS-COV-2 Antigen Rapid Test Cassette Kits (Box of 25) For Professional Use Only. Medical professionals, and all Chemical, Biological, Biochemical and other research facilities can order these kits for research and development purposes. All orders are evaluated due to FDA guidelines. If we deem your order as not for professional use, your order will not be processed. We are required to abide by Federally enforced rules.

Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab). A RAPID TEST FOR THE QUALITATIVE DETECTION OF NOVEL CORONAVIRUS ANTIGENS IN NASAL SWAB AND NASAL ASPIRATE SPECIMENS.

  • For professional In Vitro Diagnostic Use Only.
  • Nasal Swab
  • Testing time: 10 minutes
  • Sensitivity: 84.4%
  • Specificity: >99%
Warning: The Data for this Antigen test has not been reviewed by the FDA. Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals. Results from antigen test should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. Must be confirmed by a molecular diagnostic (PCR test). Results from antigen test should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. Must be confirmed by a molecular diagnostic (PCR test). Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E. Must be confirmed by a molecular diagnostic Test (PCR Test).

Documentation (PDF download)


INTENDED USE The Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) is an in vitro diagnostic test for the qualitative detection of novel coronavirus antigens in Nasal Swab and nasal aspirate samples, using the rapid immunochromatographic method. The identification is based on the monoclonal antibodies specific for the novel coronavirus antigen. It will provide information for clinical doctors to prescribe correct medications.

SUMMARY The Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) is used for the in vitro qualitative detection of novel coronavirus in the throat swabs, sputum samples of suspected pneumonia patients infected by novel coronavirus, suspected clustering cases and others needing diagnosis or differential diagnosis for novel coronavirus. The definitions of "suspected cases" and "patients with suspected aggregated cases" and other groups are implemented with reference to the "Diagnosis and Treatment Plan for Pneumonia Infected in novel coronavirus" and "Monitoring Plan for Pneumonia Infected in novel coronavirus"" and other documents (current version) issued by CDC. The product is only used for auxiliary diagnosis of related cases and emergency reserve for in vitro diagnosis of this epidemic during the pneumonia epidemic infected by novel coronavirus (SRAS-Cov-2) since December 2019 and it cannot be used as routine in vitro diagnostic reagents in clinical practice. The kit shall comply with the relevant requirements of the "Diagnosis and Treatment Plan for Pneumonia Infected in novel coronavirus" and "Prevention and Control Plan for Pneumonia Infected in novel coronavirus" and other documents in use. The detection results of this kit are for clinical reference only and should not be used as the sole criteria for clinical diagnosis. It is recommended to conduct a comprehensive analysis on the condition in combination with the clinical manifestations and other laboratory tests.

PRINCIPLE The Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to Novel coronavirus . The test device is composed of the following three parts, namely sample pad, reagent pad and reaction membrane. The whole strip is fixed inside a plastic device. The reagent membrane contains the colloidal-gold conjugated with the monoclonal antibodies against Novel coronavirus; the reaction membrane contains the secondary antibodies for Novel coronavirus, and the polyclonal antibodies against the mouse globulin, which are pre-immobilized on the membrane. When the sample is added into the sample window, conjugates dried in the reagent pad are dissolved and migrate along with the sample. If Novel coronavirus is present in the sample, a complex formed between the anti- Novel coronavirus conjugate and the virus will be caught by the specific anti- Novel coronavirus monoclonal coated on the T region. Results appear in 10 minutes in the form of a red line that develops on the strip. Whether the sample contains the virus or not, the solution continues to migrate to encounter another reagent (an anti-mouse IgG antibody) that binds the remaining conjugates, thereby producing a red line on the region C. REAGENTS The reagent membrane contains the colloidal-gold conjugated with the monoclonal antibodies against Novel coronavirus; the reaction membrane contains the secondary antibodies for Novel coronavirus and the polyclonal antibodies against the mouse globulin, which are pre-immobilized on the membrane.

PRECAUTIONS

  • For in vitro diagnostic use only.
  • Do not use after the expiration date.
  • Ensure foil pouch containing test device is not damaged before opening for use.
  • Perform test at room temperature 15 to 30°C.
  • •Wear gloves when hanging the samples, avoid touching the reagent membrane and sample window.
  • All samples and used accessories should be treated as infectious and discarded according to local regulations.
  • Avoid using bloody samples.

STORAGE AND STABILITY Store the Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) at room temperature or refrigerated (2-30°C). Do not freeze. All reagents are stable until the expiration dates marked on their outer packaging and buffer vial.

SPECIMEN COLLECTION AND PREPARATION 1. Specimen collection: It is applicable to the diagnosis of the Novel coronavirus from the samples of nasal swabs or nasal aspirates. Use freshly collected samples for optimal test performance. Inadequate sample collection or improper sample handling may yield a false-negative result.

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Product Reviews

MPN:
RT-ANTIGEN