ADEXUSDx

COVID-19 Test

The ADEXUSDx® COVID-19 Test is an in vitro lateral-flow immunoassay intended for qualitative detection of total antibodies to SARS-CoV-2 in human venous whole blood (dipotassium EDTA), plasma (dipotassium EDTA), serum, and fingerstick whole blood. The ADEXUSDx® COVID-19 Test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

  • Fingerstick with lab accurate results
  • Easy to use
  • Low cost per test
Regular price $250.00
Regular price Sale price $250.00
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Industry Disruptive Rapid Fingerstick COVID-19 Antibody Test

Lab Accurate
Detects antibodies to the RBD
Touch-to-test
No in demand ancillary items
Undiluted sample Accurate results in only 15 minutes Self-contained: no reagents or buffers needed Only one drop of blood to test Made in USA Lightweight and portable No equipment, electricity, or internet required No refrigeration required
  • Specifications
  • Test Method
  • Product Insert
  • FAQs
  • Resources

The ADEXUSDx® COVID-19 Test is an in vitro lateral-flow immunoassay intended for qualitative detection of total antibodies to SARS-CoV-2 in human venous whole blood (dipotassium EDTA), plasma (dipotassium EDTA), serum, and fingerstick whole blood. The ADEXUSDx® COVID-19 Test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The ADEXUSDx® COVID-19 Test should not be used to diagnose or exclude acute SARS-CoV-2 infection. Testing of venous whole blood (dipotassium EDTA), plasma (dipotassium EDTA), and serum specimens is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, that meet requirements to perform moderate or high complexity tests. Testing of fingerstick whole blood specimens is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform high, moderate, or waived complexity tests. Testing of fingerstick whole blood specimens 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 detection of SARS-CoV-2 antibodies. Total antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion.


Time to Result: 15 minutes
Result Window: 15-30 minutes
Storage Conditions: Room temperature storage or 15°C – 30°C (59°F -86°F)
Operating Temperature: Room temperature storage or 15°C – 30°C (59°F -86°F)
Test Shelf Life: 15 months
Sample Type(s:): Human venous whole blood (dipotassium EDTA), plasma (dipotassium EDTA), serum, and fingerstick whole blood

What are the benefits of the ADEXUSDx® COVID-19 Test?

  • ‘Touch to test’: No sample collection tool or pipette; transfer device not required
  • Rapid and self-contained: 15 minutes to result; no buffer, diluents, reagents
  • Easy to use: Simple instructions, fewer steps than competitor tests, no equipment
  • Secure: Protected by large patent portfolio and trade secrets
  • Volume controlled separation of plasma from cells: Membrane will absorb 17.5 uL of plasma from drop of blood
  • ‘Our lab at the tip of your finger’: Yields laboratory quality results
  • Samples are not diluted: Driving improved sensitivity
  • Made in the USA: Tests manufactured in Northwest Arkansas

What antibodies does the test detect?

  • The ADEXUSDx® COVID-19 Test is designed to detect total antibodies (IgA, IgM, IgG) to SARS-CoV-2, specifically antibodies to the RBD section of the spike protein. These antibodies are produced upon natural infection and upon vaccination.

How accurate is the test?

  • We have exceeded the minimum sensitivity and specificity required by the FDA for Emergency Use Authorization. Please reference our Product Insert for details. The accuracy of the test has been externally validated.

What is the reimbursement code for the ADEXUSDx® COVID-19 Test?

  • CPT Code 86328 Immunoassay for infectious agent antibody(ies), qualitative or semiquantitative, single step method (eg, reagent strip); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19])

What size lancet is recommended?

  • 21 Gauge

What sample anticoagulants are FDA cleared for use?

  • EDTA

What are the sample storage specifications?

  • Venous blood samples may be stored for up to 4 hours at room temperature. Plasma or serum may be stored up to 72 hours refrigerated 2 to 8.

Is it possible to underfill the device?

  • Underfilling can occur, although if inadequate volume is obtained, a control line will not appear.

Is it possible to overfill the device?

  • No, the test has automatic volume controls that prevent overfilling.

Is a lab analyzer or reader required to perform the test?

  • No

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