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Rapid COVID-19 Antigen Nasal Test Kit

Product Discount
1 - 45 - 1112+
$500.00 per box$440.00 per box$400.00 per box
Model Configuration
DTS-COVID-AG /

FDA EMERGENCY USE AUTHORIZED/ CLIA WAIVED POC DEVICE

Approved for Shallow Nasal Collection

 

$600.00 $500.00

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.

Rapid COVID-19 Antigen Product Insert | FDA Emergency Use Authorization Letter | Fact Sheet For Healthcare Providers | Fact Sheet for Patients

CPT Codes and Billing Information

Accuracy Summary:

Positive Percent Agreement: 88.37%

Negative Percent Agreement: 100%

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 20 individual testing cassettes and includes the following:

  • (20) Rapid Testing Cassettes
    • Foil pouched test device containing one test strip which
      is encased in plastic device cassette.
  • (20) Extraction Vials/Caps
    • The extraction vial contains 400 μl extraction buffer
      solution.
  • (20) Nasopharyngeal Swabs
    • Swabs for nasopharyngeal specimen collection.
  • (1) Instruction For Use Insert
    • Click Here To Download

Clinical Accuracy Findings

A full report of clinical findings can be found on page 13 of the product insert

Antigen results table

 

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 CareStart 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 CareStart 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.

antigen naso collection pic

Testing Procedures

Procedural Notes

  • Allow test devices, reagents, specimens, and/or controls to equilibrate to room
    temperature (15~30°C) prior to testing.
  •  Remove the CareStart™ COVID-19 Antigen test device and extraction vial from its foil
    pouch immediately before testing.
  •  The CareStart™ 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 CareStart™ 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.

 

antigen test pic 1

 

antigen test pic 2

 

7. Read and interpret the test result at the 10 minute mark. The test result should not be read and interpreted after 15 minutes.

 

Interpretation of Results

Positive: Two distinct colored lines appear. One red-colored line next to “C” and one blue-colored line next to “T” indicates COVID-19 positive result.

antigen result 1

 

 

 

 

NOTE: The color intensity in the test region will vary depending on the amount
of SARS-CoV-2 nucleocapsid protein antigen present in the sample. Any faint
colored line(s) in the test region(s) should be considered as positive.

 

 

Negative: One red-colored line only next to “C” indicates a negative result.

antigen result 2

 

 

 

 

 

Invalid: If the red-colored line in the control region “C” is not visible, the result is invalid. Re-run the test one time using the remaining specimen in the extraction vial if an invalid result is obtained during initial testing.

antigen result 3

 

 

 

 

Summary of Antigen Testing

COVID-19 Antigen Rapid Tests are in vitro immunochromatography assays that detect nucleocapsid protein antigen from the SARS-CoV-2 virus from nasopharyngeal (NP) samples. Antigen tests can detect the SARS-CoV-2 virus during the active phase of the infection. It is a relatively simple collection process and the results are provided immediately when compared to a PCR test. 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

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