CLIA-Antigen-Overview Own-CLIA Antigen Testing Program Overview

Own-CLIA Antigen Testing Program Overview

Introduction

To improve the equitable distribution of testing resources to communities facing disproportionate effects of COVID-19, the State of California supplies professional antigen test to qualifying sites with their own CLIA Certificate of Waiver.* 

*Note: Organizations that have their own CLIA may not use the State's CLIA.

Steps to Onboarding

  1. Identify testing need and submit application form
  2. Choose a method of reporting to CalREDIE
  3. Sign MOU and receive antigen tests
  4. Begin testing and reporting antigen test results

Primary Contact

Each testing location must have a designated primary contact.

Primary Contact Responsibilities:

  • Submit the organization's application to the Antigen Testing Program.
  • Serve as the primary Point of Contact (POC) for communications with the Testing Task Force (ie. submitting reorder requests; informing TTF of changes to POC, testing status, etc).
  • Sign the Memorandum of Understanding (MOU).
  • Work with your CLIA director for organization-specific guidance on training and quality control (QC) measures.
  • Maintain all associated training, quality control and testing documents and records per your CLIA Director
  • Ensure mandated electronic reporting to public health (CalREDIE).

Choosing a Method of Reporting

Organizations using their own CLIA Certificate of Waiver and Ordering Physician must electronically report results to public health (CalREDIE). Some IT platforms perform this function and also support patient registration. Reporting methods include:

  1. CalREDIE Manual Lab Reporting
  2. Navica App
  3. Primary Health
  4. Simple Report

Compare methods of reporting here

​Method

CalREDIE

​Navica
​Primary Health
Simple Report
Website

CalREDIE Manual Reporting (PDF)

Navica App for BinaxNOW 

Primary Health

Simple Report

​Cost
​Free
​Free

​Free to organization, state pays fees

​Free
​Functionality

​Direct system upload, limited to public health reporting only
Note: does NOT include participant registration, consent, or results reporting to participant. 

Participant registration and result upload capability.
Automated reporting to participant, site, and public health. Collection site dashboard.

​Participant registration and result upload capability.
Automated reporting to participant, site, and public health. Custom messaging options, collection site dashboard. Integrated consent.

​Participant registration and result upload capability. Automated reporting to participant and public health.

Timeline for adoption

​Login access required, easy registration.

​Immediately available 

​Requires registration and configuration for each entity

​Login access required, easy registration

​User


​Organization
​Org/Individual

​​Org/Individual

​​Org/Individual


Consent for Participants

Organizations using their own CLIA waiver and Ordering Physician will need to manage consent for their participants. A sample consent is provided below.
NOTE: Because SARS-CoV2 is recognized as a communicable disease, which is required to be reported, California state law provides that minors 12 years and older can consent to diagnosis and treatment of COVID-19 and receive results through their own contact information or through their parent's contact information.
However, only minors 13-17 years of age may provide consent electronically or via paper informed consent forms.  Minors who are 12 years old are limited to providing consent via paper informed consent forms.

For minors under the age of 12, the parent or legal guardian must provide consent provide consent (electronically or via paper informed consent forms) and use parent or guardian email/phone to obtain results. 

Sample Consent 

Organization is pleased to offer site-based screening for COVID-19 using Abbott laboratories BinaxNOW COVID-19 Ag Card tests. These are rapid, point-of-care tests that deliver results in 15-30 minutes. This test is voluntary and will only be completed if this form is signed.

To collect the specimen, the participant will place a swab, similar to a cotton swab/Q-Tip, inside of the tip of the nose. A trained staff member will observe the specimen collection.

  • I authorize Organization to conduct specimen collection and testing for COVID-19 via nasal swab.
  • I acknowledge that a positive test result is an indication that I may have the COVID-19 virus. If I receive a positive test result, I acknowledge that I must self-isolate and continue to wear a face-covering to avoid infecting others.
  • I understand that Organization is not acting as my medical provider; that this testing does not replace treatment by my medical provider; and I assume complete and full responsibility to take appropriate action concerning my test result. I agree to seek medical advice, care, and treatment from my medical provider if I have questions or concerns, or if my condition worsens.
  • I understand that, as with any medical test, there is the potential for incorrect test results. I understand that a confirmatory test may be required depending on the result.
  • I have been informed about the test purpose, procedures, possible benefits and risks and I have received a copy of this informed consent. I have been given the opportunity to ask questions before I sign, and I may ask additional questions at any time.
  • I understand that my test results will be shared with clinical and other staff at the collection site and the local Public Health Department.
  • I have read, understand and agree to the above.
  • Signature of Participant

Disclaimer: Your decision to consent to the screening test is completely voluntary. Organization will take reasonable precautions for the safety of the population. Neither the test administrator nor Organization nor any of its trustees, officers, employees, or organization sponsors are liable for any accident, injuries, or other damage that may occur to you arising out of or in any way connected to this consent or the administration, evaluation, or results of the BinaxNOW COVID-19 Ag Card rapid antigen test for the COVID-19 virus.

EUA Patient Fact Sheet for Participants

Each participant should be given the BinaxNow EUA Patient Fact Sheet, either electronically or as a paper copy. ​​​