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CLIA-waived testing: Point‑of‑care testing, by the book

Our CLIA program ran point-of-care testing for hundreds of California school districts and community sites. It’s no longer offered, but it’s quick to bring back. If your state would like to set one up, contact us.

Talk to our team Explore the Health platform

About

What is CLIA-waived testing?

CLIA (Clinical Laboratory Improvement Amendments of 1988)

Generally, facilities that test and result samples in the United States for health assessments, diagnosis, prevention, or treatment are regulated under CLIA.

Waived tests are those cleared by the FDA for home use or approved for waiver under CLIA criteria.

Key Features

How can Primary.Health support your CLIA-waived testing?

Automated reporting

Eliminate paperwork and reduce errors by automating state reporting and participant notifications.

On-site workflow management

We help you test participants quickly and efficiently to minimize organizational disruptions.

Data analytics & dashboards

Monitor program metrics to identify outbreaks quickly and track cases over time at a district level.

Digital consent for participants and parents

Easily capture digital signatures and consent of all participants.

Automated result notifications & communication

We provide digital proof of test result/vaccination. Communication via the Primary.Health platform is easy, fast, and able to send automated result notifications to participants.

Fully HIPAA-compliant system

Millions of users have registered. Available in 24+ languages. HIPAA-compliant.

Device-agnostic app

The easiest way to record at-home tests! Works on any browser.

Access digital records wherever you are

We provide digital proof of test result/vaccination.

Additional services

  • Registration, consent, resulting, and reporting software

  • Real-time data and dashboards customized for your organization

  • Account management

  • Access to a call center to support participants

Primary.Health’s Mission

Create and scale access to simple and streamlined healthcare experiences.

We built the platform to bring testing to places people already are, including schools, shelters, and long-term care, with registration and results in 23 languages.

Testimonials

What our partners say

Public Programs

While our students are back to focusing on learning, credit is due to the district’s ongoing commitment to testing and responding proactively to the data with the measures and care our educators and health experts have at their disposal. Testing contributed to where we are today: a reduction of in-school transmission to almost zero.

Don Geddis
Governing Member of the Board of Trustees
Hillsborough City School District

Public Programs

With Primary.Health’s software, we were able to integrate our testing technology and deploy school-based surveillance programs in a matter of days. Working with their team really was a great experience and we could not have accomplished what we did without them!

Nicholas Meyerson
CEO
Darwin Biosciences

Public Programs

Primary.Health’s platform helped us create a safer in-person learning environment for all of our staff, especially our teachers and students.

Roy Mendiola, Ed.D
Superintendent
McSwain Union Elementary School District

Public Programs

We began using antigen testing following extended breaks. After Winter Break, we were able to significantly decrease exposure due to a staggered school day start and antigen testing. This program has kept our school in-person through the Omicron surge and we are very grateful for it.

Tanya Spishak
Director of Communications
Woodland School
offer more testing

CLIA waivers make point-of-care testing possible

A CLIA Certificate of Waiver lets a site such as a school, clinic, or community program run FDA-waived tests. The site becomes a CLIA-certified testing site, so it follows the manufacturer’s instructions and the program’s quality requirements.

You can offer professional point-of-care testing with the proper training and a CLIA waiver. Primary can help.

With a CLIA waiver you can offer:

  • Flu, RSV, COVID and Strep tests

  • Hemoglobin A1C tests

  • Rapid HIV tests

  • Cholesterol monitoring

  • Urine pregnancy tests

…and more!

LEARN MORE

On-Demand Webinar: From Illness to Action: Test to Treat in Real Time

Discover the power of point-of-care testing to transform care in residential settings by enabling faster diagnostics and immediate treatment decisions during our recorded webinar:

From Illness to Action: Test to Treat in Real Time

Don’t miss this exclusive discussion designed for residential care facility administrators, clinicians, and administrative staff!

Watch the on-demand webinar

DO MORE FOR YOUR COMMUNITY

Point-of-care tests help keep all communities safe

Schools

Point-of-care flu and RSV tests at the nurse’s office help students get a diagnosis and care sooner.

Residential care facilities

Stay compliant and keep your residents safe with on-site point-of-care testing made possible by Primary’s CLIA waiver.

Community organizations

Meet compliance requirements and keep your residents safe with on-site point-of-care testing made possible by Primary’s CLIA certification.

Employers

Support workplace health programs with professional testing protocols.

State & government

From fire departments to Veterans Affairs, support your community with point-of-care tests to keep them safe and healthy.

We’ve supported hundreds of CLIA-waived testing programs in California

8M+

Tests Administered

4K+

Testing Sites

700+

School Districts Supported

Already have CLIA coverage? Learn how Primary’s clinic management solution can power your community health efforts.

  • Automated reporting

  • Simplified workflows

  • Data & dashboards

  • Digital registration

  • Treatment

About Primary.Health

Our mission is to reduce the spread and severity of disease by making diagnostics, immunization, and preventive care simple and affordable to deliver at scale.

Address

Primary.Health
595 Pacific Ave, Floor 4
San Francisco, CA 94133

Phone Number

1-855-970-3223

Email Addresses

sales@primary.health

support@primary.health

Contact us

Let’s start talking

Tell us about your organization and how we can help.

Testing anywhere, done by the book.

Want a CLIA-waived testing program in your state? It’s quick to bring back. Let’s talk.

Talk to our team Explore the Health platform