Technical considerations for labs
In order to work with schools, you will need to have a HIPAA- and FERPA-compliant integrated software system for consenting, test accession, resulting, and reporting. The more user-friendly the software is, the better, as the people running testing on the ground may or may not be tech-savvy or have experience reviewing batched laboratory results.
The main challenge that labs face when implementing pooling is that of integrating the pooled testing workflow into an existing LIS. If you have a strong in-house development team, you can consider developing your own LIS system, but it’s a huge undertaking, involving tracking, storing, and reporting pools; symptom tracing; test result integration; and an online portal for users. In most situations, you’ll be much better off partnering with a company that’s already developed a turnkey solution.
The purpose of the Pooling Playbook is to breakdown processes for pooled testing of SARS CoV-2. Such protocols aid in decreasing the transmission of COVID19 by allowing labs to increase their testing capacity.
Although pooling is beneficial in testing, there have been barriers to utilizing it which we would like to help close the gap on. For additional information please review this Understanding the Barriers to Pooled SARS-CoV-2 Testing in the United States article from American Society for Microbiology.
Frequently asked questions
- What is the scale at which your lab can work? Do you have access to an overflow/reference lab?
- What will you need to charge per sample in a pool and per follow-up test? Can you match market costs?
- Turnaround time
You need to be able to return pooled results within 24 hours of lab receipt of samples and individual results within 48 hours. This will require a significant commitment to logistics planning and workflow management.
You may choose to partner with other companies to handle various aspects of the workflow. Examples include couriers for sample transportation, software companies for accessioning and resulting, or testing services providers for all customer-facing tasks.
- Will your current lab equipment support pooling? Do you have the required amount of space? Can you provide services such as couriers, customer service, and software - or will you need to outsource them?
- School administrators and nurses have already taken on huge levels of added responsibility in response to the pandemic. The easier you make it for them to offer pooled testing, the more likely they are to use your service. Make it simple to enroll students and get consent from parents, see results, and download reports. You can certainly partner with other companies to handle this aspect of the process, but be sure that whatever option you choose is easy to onboard and use.
- Regulatory considerations
- Does your laboratory currently hold a CLIA certificate for moderate to high complexity testing? Will your testing follow manufacturer’s instructions, will you be internally validating some aspect of the test (e.g., pooling front end), or will you be developing your own “homebrew”?
Pooling: technical decisions
Frequently asked questions
- Specimen type
- For schools, your options are either saliva or anterior nasal swabs. Nasopharyngeal swabs are not well tolerated by young children.
- Site of specimen collection
- Can specimens be collected at home, or do they need to be collected at the school? Your EUA will often have requirements that answer these questions.
- Pooling model: on-site or in-lab
This choice will impact your workflow, ease of pooling, and cost.
On-site pooling may not be a viable solution for large or extra-large school districts in either urban or extremely rural areas, as families in those areas often have difficulty getting students back to the school for reflex testing.
- Sample chemistry
- Follow-up testing on positive pools
Schools will have varying levels of ability to handle re-sampling for reflex testing. Smaller and/or more affluent, homogenous districts will have an easier time getting students back to the school for reflex testing and will have more nursing resources to devote to it. Large and/or underserved districts, especially those with higher prevalence rates, may not be able to handle resampling at all – they may need a service that provides in-lab pooling and automatic reflex.
The choice you make here will also impact your infrastructure and may impact partnerships you make with other companies. Options include:
- In-lab pooling (reflex automated)
- Resampling with PCR reflex
- Resampling with antigen test
- Approach: automated or manual
COVID-19 testing in schools is continuing during the 2021-22 school year, with abundant funding from the Biden/Harris administration available.
That being said, any capital expenditures are still best considered as long-term investments. There is no way to know exactly how long ongoing screening will continue to be required.
Going manual will limit the scale at which you’ll be able to offer pooling.
- Validation study design
- If you’re creating your own “homebrew,” the FDA template will help you put together a protocol for your validation study. The number of specimens per pool will influence your validation study design.
Frequently asked questions
- Epidemiology and Laboratory Capacity (ELC) reopening schools
This money is flowing through state departments of public health. Depending on how the state is organizing testing, you may be working with someone at the state level or directly with the school.
Here’s an overview of the instructions the states have received on how to disburse the funds; it includes requirements regarding how they select vendors and how they publicize those vendors to the schools.
- Increasing Community Access to Testing (ICATT) Program
- This program is intended to provide a turnkey testing solution for districts that have underserved populations. If you'd like to offer services to that program send an email; you'd be working with the US Department of Health and Human Services directly.
- Elementary and Secondary School Emergency Relief (ESSER) Funds
- In some cases, schools will use their ESSER funds for testing. This can happen when the state gives schools a limited list of vendors and a school wants to use a vendor that’s not on the list. In these situations, you’ll invoice the school or district directly.
- Operation Expand Testing (ET)
This program, administered by the US Department of Health and Human Services in partnership with the US Department of Defense, has established four coordinating hubs to provide testing for K-12 schools and other “congregate settings” (e.g., homeless shelters and nursing homes) in their respective regions.
The hub coordinator connects schools that need testing with labs in the region that have "excess capacity" for testing. If you would like to be part of the hub program in your region, get in touch with the hub coordinator directly via the websites linked below.
(Hub Coordinator: Battelle)
Colorado, Illinois, Indiana, Iowa, Kansas, Michigan, Minnesota, Missouri, Montana, Nebraska, North Dakota, Ohio, South Dakota, Utah, Wisconsin, Wyoming
Northeast and South
(Hub Coordinator: Affinity)
Alabama, Arkansas, Connecticut, Delaware, Florida, Georgia, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Mississippi, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Vermont, Virginia, West Virginia
(Hub Coordinator: PerkinElmer)
Alaska, Arizona, California, Hawaii, Idaho, Nevada, Oregon, Pacific Islands, Washington
- Midwest (Hub Coordinator: Battelle)
Important Regulatory Information about SalivaDirect™
SalivaDirect™has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories. The test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.