CareStart™ COVID-19 Antigen Test Kit

(20 Tests Per Kit – $25 Per Test)

The CareStart™ COVID-19 Antigen test kit allows for the rapid screening of COVID-19 infection on a large scale, with results in just 10 minutes. The CareStart™ COVID-19 Antigen Test is a lateral flow immunochromatographic assay for the detection of extracted nucleocapsid protein antigens specific to SARS-CoV-2 in swab specimens directly collected from individuals who are suspected of COVID-19 by their healthcare providers. This product is CLIA waived under FDA/EUA authorization.

This Item is NOT for resale and you must provide a valid CLIA License Number in order to purchase. A minimum of 2 kits must be ordered at the time of purchase. 

Kit Components

  • 20 Test Devices
  • 20 Assay Buffers
  • 20 Extraction Vials and Caps
  • 20 Specimen Collection Swabs
  • 1 Positive and 1 Negative
  • 1 Instruction Flyer for Use
  • Online Training
CLIA Application Instructional Video

CLIA License Number

Please provide your CLIA License Number – Valid CLIA licenses are 10 digits with letter “D” in third position (**D*******)

If you have applied but not received your CLIA Number yet you can upload a signed PDF on the practice letterhead from the practice manager stating that the CLIA Application has been applied for.

(max file size 64 MB)

It is the provider’s responsibility to comply with all state and federal regulations in regards to administering and reporting covid-19 testings, including appropriate CLIA certification. REFUND & RETURN POLICY for COVID-19 Test: Due to FDA guidelines and Supply Chain Demands, all orders and sales are final once placed. NO EXCHANGES OR REFUNDS WILL BE MADE.

Features

  • Lateral flow assay
  • Rapid results in 10 minutes
  • Minimally invasive specimen collection (nasopharyngeal)
  • Intended at POC setting (i.e., in patient care settings) by medical professionals
  • Made in the U.S.A

Clinical Features

  • Detect SARS-CoV-2 nucleocapsid protein antigen
  • Identify acute infection with high sensitivity and 100% specificity
Weight 16 oz
Dimensions 9 × 6 × 3 in

Frequently Asked Questions


This step-by-step guide will walk you through the 10 sections of the CLIA Application for Waived COVID-19 tests.  The CLIA Certificate of Waiver is required before you provide testing to your patients. This and more are also covered in the online course COVID-19 Testing for Dental Practices.

All orders can be expected to arrive within 3 to 5 business days from your order date. Once your order has shipped you will receive an email notification with tracking information.

Due to the shipping system picking up orders locally is not available. 

Yes, included in every purchase of CareStart™ COVID-19 Antigen Test is Devdents online course COVID-19 Testing For Dentistry which is regularly $199.

For general questions about the CareStart™ COVID-19 Antigen Test Kit contact support@devdent.com or call 855-534-1433.


You can also contact the manufacturer.

Access Bio, INC.
65 Clyde Road, Suite A
Somerset, NJ 08873, U.S.A.
732-873-4040
info@accessbio.net

Technical Support

For questions, or to report a problem, please call Technical Support at +1-888-898-1270 (Available Hours: Mon. to Fri.: 8 A.M.- 5 P.M EST) or TShelp@accessbio.net (24/7 available).

There are different kinds of tests for diagnosing COVID-19. Molecular tests (also known as PCR tests) detect genetic material from the virus. Antigen tests detect proteins from the virus. Antigen tests are very specific for the virus, but are not as sensitive as molecular tests. This means that a positive result is highly accurate, but a negative result does not rule out infection. 

If your test result is negative, you should discuss with your healthcare provider whether an additional molecular test would help with your care, and when you should discontinue home isolation. If you do not have an additional test to determine if you are infected and may spread the infection to others, the CDC currently recommends that you should stay home until three things have happened: 

• You have had no fever for at least 24 hours (that is one full day of no fever without the use of medicine that reduces fevers) 

AND 

• Other symptoms have improved (for example, when your cough or shortness of breath has improved) 

AND 

• At least 10 days have passed since your symptoms first appeared. 

For more information, the CDC has provided guidelines on how to prevent the spread of COVID-19 if you are sick: https://www.cdc.gov/coronavirus/2019-ncov/downloads/sick-with-2019-nCoV-fact-sheet.pdf. 

No. This test is not yet approved or cleared by the United States FDA. When there are no FDA-approved or cleared tests available, and other criteria are met, FDA can make tests available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA for this test is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics for the detection and/or diagnosis of the virus that causes COVID-19. This EUA will remain in effect (meaning this test can be used) for the duration of the COVID-19 declaration justifying emergency of IVDs, unless it is terminated or revoked by FDA (after which the test may no longer be used). 

Due to FDA guidelines and Supply Chain Demands, all orders and sales are final once placed. NO EXCHANGES OR REFUNDS WILL BE MADE.

Yes, the CareStart™ COVID-19 Antigen Test Kit fulfills the requirements of relevant European product directives. Meets all the requirements of the relevant recognized European harmonized performance and safety standards.

 

Intended Use:

The CareStart™ 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. Testing 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 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.

Disclaimer: 

In the USA, this test has not been FDA cleared or approved; this test has been authorized by FDA under an EUA for use by authorized laboratories; use by laboratories certied under the CLIA, 42 U.S.C. §263a, that meet 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 Certicate of Waiver, Certicate of Compliance, or Certicate of Accreditation. This test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. In the USA, – this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

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