Sale!

Celltrion Rapid COVID-19 Antigen Nasal Test Kit (25 Tests Per Box)

$300.00


(25 Tests Per Box)

FDA EMERGENCY USE AUTHORIZED/ CLIA WAIVED POC DEVICE

 

SKU: DTS-COVID-AG-CTR Categories: ,
Product Discount
1 - 9 boxes 10 - 19 boxes 20 - 39 boxes 25+ boxes
$300.00 per box $275.00 per box $250.00 per box $225.00 per box

 

What is this rapid COVID test kit?

This rapid COVID test for sale is available to qualified healthcare professionals, as well as business owners looking to secure a supply of rapid COVID tests for onsite testing. This rapid test kit will give an easy to read result in about 10 minutes for an active COVID infection. This rapid test kit was also recently approved for a shallow nasal collection, making sample collection much more efficient and comfortable.

Disclosure:

This test has not been FDA cleared or approved; the test has been authorized by FDA under an Emergency Use Authorization (EUA) for use by laboratories certified under the CLIA that meet the requirements to perform moderate, high or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

Product Insert Information | FDA Emergency Use Authorization Letter | Fact Sheet For Healthcare Providers |Fact Sheet For Patients

CPT Codes and Billing Information

Accuracy Summary:

Positive Percent Agreement: 98.20%

Negative Percent Agreement: 99.80%

CPT CODE: 87426

Who Can Use This Test?

This COVID-19 Rapid Test Kit is currently only available to qualified healthcare providers. Looking for COVID testing options for your business? Please call (321) 206-0302.

What is included with this kit?

This COVID-19 rapid antigen nasal test kit is sold in boxes of 25 individual testing cassettes and includes the following:

  • (25) Rapid Testing Cassettes
    • Foil pouched test device containing one test strip which
      is encased in plastic device cassette.
  • (25) Extraction Vials/Caps
    • The extraction vial contains 400 μl extraction buffer
      solution.
  • (25) Nasopharyngeal Swabs
    • Swabs for nasopharyngeal specimen collection
    • Can be used for shallow nasal collection as well
  • (1) Instruction For Use Insert

Clinical Accuracy Findings

 

 

Intended Use of Rapid COVID-19 Antigen Nasal Test Kit

  • This COVID-19 Antigen test is a lateral flow immunochromatographic assay
    intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in
    nasopharyngeal swab specimens directly collected, or collected in BD universal transport media,
    from individuals suspected of COVID-19 by their healthcare provider within five days of symptom
    onset.
  • This test is authorized for use at the Point of Care (POC), i.e.,
    in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance,
    or Certificate of Accreditation
  • Results are for the identification of the SARS-CoV-2 nucleocapsid protein antigen. The antigen
    is generally detectable in nasopharyngeal swab specimens during the acute phase of infection.
  • Positive results indicate the presence of viral antigens, but the clinical correlation with patient
    history and other diagnostic information is necessary to determine infection status. Positive
    results do not rule out a bacterial infection or co-infection with other viruses. The agent detected
    may not be the definite cause of disease. Laboratories within the United States and its territories
    are required to report all results to the appropriate public health authorities.
  • Negative results are presumptive and confirmation with a molecular assay, if necessary, for
    patient management may be performed. Negative results 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 COVID-19.
  • The Celltrion COVID-19 Antigen is intended for use by medical professionals or trained
    operators who are proficient in performing tests and trained clinical laboratory personnel or
    individuals trained in point of care settings. The Celltrion COVID-19 Antigen is only for use
    under the Food and Drug Administration’s Emergency Use Authorization.

Instructions for Collection and Use

Nasopharyngeal Swab Sample Collection Procedure

Procedural Notes
• Process the test sample immediately after collection.
• Use only provided or recommended nasopharyngeal swab for specimen collection.
• Collect the specimen wearing safety gloves to avoid contamination.
• Do not touch the tip (specimen collection area) of the swab.
• Collect samples as soon as possible after the onset of symptoms.

Additional Notes

  • Allow test devices, reagents, specimens, and/or controls to equilibrate to room
    temperature (15~30°C) prior to testing.
  •  Remove the Celltrion™ COVID-19 Antigen test device and extraction vial from its foil
    pouch immediately before testing.
  •  The Celltrion™ COVID-19 Antigen kit IS INTENDED to be used only with a direct
    nasopharyngeal swab specimen or a swab in BD universal transport media.
  •  The Celltrion™ COVID-19 Antigen kit IS NOT INTENDED for testing other liquid
    samples such as nasal wash or aspirate samples as results can be compromised by over
    dilution.

 

 

Summary of Antigen Testing

COVID-19 Antigen Tests are designed to detect protein antigen from the SARS-CoV-2 virus from nasal specimen samples. Antigen tests can detect the SARS-CoV-2 virus during the active phase of the infection. The collection process is only a couple of steps, and the results are directly onsite in about 10 minutes with no machinery required. Providers can quickly and effectively test large numbers of patients and receive immediate results to help facilitate timely treatment decisions when using a rapid antigen test kit.
Similar to a PCR test, rapid antigen tests can detect the presence of the SARS-CoV-2 virus during the acute stage infection. Although much more efficient in providing timely results, rapid antigen tests can have a lower sensitivity rating when compared to PCR testing, Any negative result on a rapid antigen test should be verified with a PCR test confirmation to appropriately diagnose and treat the case.

Additional information

Weight 1.25 oz
Configuration

Antigen, SARS-CoV-2

Drug Testing Supplies