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-
Additional information on CPT codes for Antigen tests: https://www.ama-assn.org/practice-management/cpt/cpt-code-approved-sars-cov-2-antigen-testing
- 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.
- Negative results, should be treated as presumptive and confirmation with a molecular assay,
if necessary for patient management, may be performed.
- Failure to follow the instructions for use may adversely affect test performance and/or
invalidate the test result.
- If the differentiation of specific SARS viruses and strains is needed, additional testing, in
consultation with state or local public health departments, is required.
- Clinical performance using VTM was established on frozen specimens and performance may
be different with fresh clinical specimens.
- 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.
- 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.
- 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.
- 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.
- Results from the device should be correlated with the clinical history, epidemiological data
and other data available to the clinician evaluating the patient.
- This device has been evaluated for use with human specimen material only.
- False-negative results may occur if the concentration of the target antigen in the clinical
specimen is below the detection limits of the device.
- This device is a qualitative test and does not provide information on the viral concentration
present in the specimen.
- This test cannot rule out diseases caused by other bacterial or viral pathogens.
- The prevalence of infection will affect the test’s predictive values.
- 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.
- False-positive test results are more likely during the periods of low SARS-CoV-2 activity
when prevalence is moderate to low.