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RAPID Antigen Test

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$40.00$560.00

CareStart Antigen test by Access Bio– This is a 100% American made test with the FDA EUA number found at the FDA link below- https://accessbiodiagnostics.net/wp-content/uploads/2020/10/EUA202625_ABI-CareStart-COVID-19-Antigen-EUA-LOA-10082020-FINAL.pdf

 

The lab manufacturing the test is Access Bio. https://accessbiodiagnostics.net/

The FDA approved IFU is on this link- https://www.fda.gov/media/142919/download

 

This test uses a Nasopharyngeal swab and a cassette to produce a result in just 15 minutes at the point of care. Minimum order is 100 tests and shipping is an additional charge.

There is a 3-5 day lead time for shipping at this time.

This test is being sold to Urgent med centers, hospitals, companies, surgery centers, municipalities, and anywhere you need a screening tool that is quick and accurate. 

Every positive antigen test should be followed by a saliva or nasal swab lab test to confirm the positive test and report to CDC. This test may be reimbursed by insurance under specific CPT codes found at this link-

 https://www.ama-assn.org/delivering-care/public-health/new-cpt-code-covid-19-testing-what-you-should-know?gclid=Cj0KCQjwit_8BRCoARIsAIx3Rj4jEnBfAVJ-qSBWodA-t4RZy3nxza92jxZHv3j8m-wEpWgNRuPdn-4aAsYUEALw_wcB

 

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Description

CareStart Antigen test by Access Bio– This is a 100% American made test with the FDA EUA number found at the FDA link below- https://accessbiodiagnostics.net/wp-content/uploads/2020/10/EUA202625_ABI-CareStart-COVID-19-Antigen-EUA-LOA-10082020-FINAL.pdf

 

The lab manufacturing the test is Access Bio. https://accessbiodiagnostics.net/

The FDA approved IFU is on this link- https://www.fda.gov/media/142919/download

 

This test uses a Nasopharyngeal swab and a cassette to produce a result in just 15 minutes at the point of care. Minimum order is 100 tests and shipping is an additional charge.

There is a 3-5 day lead time for shipping at this time. 

 

This test is being sold to Urgent med centers, hospitals, companies, surgery centers, municipalities, and anywhere you need a screening tool that is quick and accurate. 

Every positive antigen test should be followed by a saliva or nasal swab lab test to confirm the positive test and report to CDC. This test may be reimbursed by insurance under specific CPT codes found at this link-

 https://www.ama-assn.org/delivering-care/public-health/new-cpt-code-covid-19-testing-what-you-should-know?gclid=Cj0KCQjwit_8BRCoARIsAIx3Rj4jEnBfAVJ-qSBWodA-t4RZy3nxza92jxZHv3j8m-wEpWgNRuPdn-4aAsYUEALw_wcB

Additional information on CPT codes for Antigen tests: https://www.ama-assn.org/practice-management/cpt/cpt-code-approved-sars-cov-2-antigen-testing

Limitations:

  1. False negative results may occur in patients who have indicated or whose clinical status or
    history would indicate they are currently taking high doses of biotin (> 10 mg per day). Biotin
    levels of 2.5 µg/mL have been demonstrated to result in false negative test results.
  2. Negative results, should be treated as presumptive and confirmation with a molecular assay,
    if necessary for patient management, may be performed.
  3. Failure to follow the instructions for use may adversely affect test performance and/or
    invalidate the test result.
  4. If the differentiation of specific SARS viruses and strains is needed, additional testing, in
    consultation with state or local public health departments, is required.
  5. Clinical performance using VTM was established on frozen specimens and performance may
    be different with fresh clinical specimens.
  6. Extracted specimens may be frozen at -80°C and used up to 5 days after freezing and it are
    stable for 4 hours in extraction buffer at room temperature.
  7. Results from antigen testing should not be used as the sole basis to diagnose or exclude
    SARS-CoV-2 infection or to determine infection status.
  8. This test will indicate the presence of SARS-CoV-2 nucleocapsid protein antigen in the
    specimen from both viable and non-viable SARS-CoV-2 virus. Test performance depends on
    the amount of virus (antigen) in the sample and may or may not correlate with viral culture
    results performed on the same sample.
  9. The detection of SARS-CoV-2 nucleocapsid antigen is dependent upon proper specimen
    collection, handling, storage, and preparation. Failure to observe proper procedures in any
    one of these steps can lead to incorrect results.
  10. Results from the device should be correlated with the clinical history, epidemiological data
    and other data available to the clinician evaluating the patient.
  11. This device has been evaluated for use with human specimen material only.
  12. False-negative results may occur if the concentration of the target antigen in the clinical
    specimen is below the detection limits of the device.
  13. This device is a qualitative test and does not provide information on the viral concentration
    present in the specimen.
  14. This test cannot rule out diseases caused by other bacterial or viral pathogens.
  15. The prevalence of infection will affect the test’s predictive values.
  16. Positive and negative predictive values are highly dependent on prevalence. False-negative
    test results are more likely during peak activity when the prevalence of the disease is high.
  17. False-positive test results are more likely during the periods of low SARS-CoV-2 activity
    when prevalence is moderate to low.

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